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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01NR015458-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| St. Jude Children's Research Hospital | OTHER |
| Akron Children's Hospital | OTHER |
| National Institute of Nursing Research (NINR) | NIH |
| Masonic Cancer Center, University of Minnesota |
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To test the efficacy of FACE-TC on key outcomes, the investigators propose using an intent-to-treat, longitudinal, prospective, multi-site, randomized controlled trial (RCT) design. Adolescents with cancer, aged 14 up to 20 years, and their families (N=130 dyads; N=260 participants) will be recruited and randomized to FACE-TC or Treatment as Usual (TAU) control. Participants will complete standardized questionnaires at baseline and 3, 6, 12, and 18 months post-intervention. Our goal is to assess the extent to which FACE-TC helps adolescents and young adults with cancer and their families: (1) reach and maintain better congruence in treatment preferences over time; (2) improve their quality of life; and (3) document goals of care and advance directives earlier in the course of their potentially life limiting illness.
The investigators propose a prospective, longitudinal, 2-arm RCT to test the efficacy of FACE-TC on key measurable outcomes through 18 months post-intervention. Dyads composed of adolescents with cancer and their families (N=130 dyads; 260 subjects) will be enrolled and randomized to either the FACE-TC intervention or Treatment as Usual (TAU) Control group at a ratio of 2:1 [N=87 FACE-TC dyads and N=43 TAU Control dyads]. The investigators estimate 30% attrition by the 18 month post-intervention assessment (20%-25% due to death/complications and 10% due to dropout). Of the original sample of 130 randomized dyads (N=260 subjects), the investigators estimate the investigators will have full longitudinal data at 18 months post-intervention for 91 dyads (N=182 subjects). Participants will be recruited from Akron Children's Hospital, St. Jude Children's Research Hospital and University of Minnesota Masonic Children's Hospital pediatric oncology programs. Participants will undergo written informed consent/assent. Eligible participants will be enrolled and complete the baseline assessment followed by randomization. Randomization will be at the level of the dyad. Allocation will be concealed from the RA-Assessor to prevent bias. Block randomization by study site will control for site differences. Intervention and Control Conditions: The curriculum based FACE-TC consists of: The Session 1 ACP Survey; Session 2 Respecting Choices Interview; and the Session 3 Five Wishes advance directive. To minimize the burden to ill adolescents, the investigators have chosen a Treatment as Usual comparison condition. This group will be provided with an advance care planning booklet/information only. Assessments occur at baseline, and 3, 6, 12, and 18 months post-intervention. At each site the assessments and intervention will be administered by a research team comprised of the site Co-Investigator and two Research Assistants (RA) (RA-Assessor & RA-Interventionist).Visit protocol: Screening Visit: The RA-Assessor presents the adolescent with cancer and family with an Information Sheet describing the study and conduct an initial assessment about whether they are eligible for enrollment. After consent/assent, further screening for inclusion/exclusion criteria is conducted. Baseline Visit: At enrollment and prior to randomization, baseline measures will be obtained. Entry of baseline data by the RA-Assessor will trigger computerized randomization of patient/family dyads to either FACE-TC intervention or TAU Control using a randomly permuted block design and a 2:1 ratio by study site. The Children's National clinical coordinator will then notify the RA-Interventionist who will schedule the next study visit. The adolescent and family will learn their assignment when the RA-Interventionist calls to schedule study sessions. Attendance will be recorded to assess effects of full vs. partial participation in FACE-TC. Follow-up Visits: RA-Assessor will obtain follow-up measures from the adolescent and family at 3, 6, 12 and 18 month post intervention.
Site Co-Is will oversee site activities and provide weekly, face-to-face supervision of the RAs. They are responsible for recruitment, retention, safety, fidelity to protocol, and supervision and support of RAs. The RAs will assist with recruitment, screening, enrollment and baseline screening measure collection, as well as the day-to-day functioning. RAs will be blind to random assignment. RA-Interventionists will be trained to implement the protocol. Only the RA-Assessor will be permitted to administer post-randomization assessments. Children's National will serve as the data coordinating center and will be responsible for database design and maintenance and the statistical analyses. Sites will be overseen by a Safety Monitoring Committee (SMC). A 2-day Investigator Meeting will be held in Washington, District of Columbia (DC) and will include all site Co-Is, RA-Assessors and consultants. The protocol, its scientific rationale, underlying ethics issues, implementation including recruitment and retention, will be reviewed with the entire team. In month 9 of Year 1 there will be a 3-day training meeting of the RA-Interventionists and RA-Assessors on the intervention, which site-Co-Is will also attend. RA-Assessors will attend only one day of this training in order to maintain blindness. Site Initiation. To begin screening/enrollment (1) the protocol must be approved at each site's Institutional Review Board (IRB) and all personnel must be certified in Human Subjects Research training, (2) personnel are recruited and trained for RA roles, and (3) each RA-Interventionist must complete certification as a Next Steps-ACP Facilitator. Dr. Lyon and the Research Coordinator will verify that the site has all components in place for the logistics of screening, enrolling, scheduling, performing assessments, administering interventions, and collecting the data. To assure continuous quality for the intervention and its evaluation, monitoring will be ongoing. Dr. Lyon and Ms. Briggs will review the first 5 DVD/audio recordings of intervention sessions from each site to ensure fidelity with the protocol. Thereafter, they will randomly review 1 DVD per week, rotating sites. Dr. Lyon and Ms. Briggs will use a competency checklist. Dr. Lyon and Research Coordinator will monitor ongoing site IRB approval documentation and assist sites in annual continuing reviews. The Research Coordinator will keep copies of all regulatory forms, including consent-stamped templates from each site and staff members' Human Subjects Research Training approval certificates. Dr. Lyon and the Research Coordinator will perform twice yearly site monitoring visits while the intervention is being implemented to assure standardization of procedures and resolve any problems that are identified. They will review and confirm that all consents have occurred properly at the sites and that the sites are maintaining all participant and regulatory data. The REDCap database from the FACE-TC pilot will be updated and expanded for this study, and the systems for data entry will be revised to address multi-site implementation. A data dictionary will be created. An external Safety Monitoring Committee (SMC) will be assembled by Dr. Lyon with the responsibility of reviewing safety information, study progress, and other relevant data. The SMC will meet a minimum of once a year. Prior to parametric testing, scale reliabilities for multi-item measures (e.g., pain/fatigue, child and parent psychological, spiritual/religious measures) will be assessed using Cronbach's alpha and their composite scores will be used for data analyses. Analytical Plan for AIM 1. To evaluate the efficacy of FACE-TC on adolescent-family congruence in treatment preferences. Congruence in decision-making for medical treatment will be tested based on agreement (i.e., both patient and his/her family choose the same option) on the Statement of Treatment Preferences in four different cancer-related situations. Kappa coefficients will be applied to assess chance-adjusted agreement between patient and family responses. Change in Kappa coefficient (congruence improvement) from baseline to each follow-up time point during the study period will be tested using bootstrapping technique. The latent growth model (LGM) with categorical outcome will be used to test Hypotheses H1a, i.e., FACE-TC participants will have a higher congruence rate over time. In the LGM, the investigators will set time scores, except those for identification purpose, as free parameters to let the shape of growth trajectory be determined by data. As such, the congruence development trajectory would have an empirically based nonlinear shape, instead of assuming a linear or nonlinear polynomial function. The investigators will apply the growth mixture model (GMM) to test heterogeneity of congruence development trajectories and identify possible patterns of congruence in development trajectories in the full sample. The latent class variable estimated from the GMM captures the pattern of congruence development trajectories. Time-invariant covariates will be used to predict the memberships of the latent trajectory groups; and time-varying covariates will be included to predict the level of congruence at different time points. To test Hypotheses H1b, the investigators will regress the latent growth slope factor and the latent class variable on FACE-TC intervention, controlling for covariates in the GMM to assess 1) how FACE-TC would affect the membership of the latent classes of congruence development; and 2) how the effect of FACE-TC on congruence change over time varies across the latent trajectory classes. Analytical Plan for AIM 2. To evaluate efficacy of FACE-TC on AYA quality of life and family QOL. The LGM and GMM models proposed for evaluating Aim 1 can be readily applied to evaluate Aim 2 and test Hypotheses H2 where the outcome measures are continuous variables. When examining the effects of FACE-TC on QOL for AYAs with cancer and their families, socio-demographics will be controlled as time-invariant covariates, while time-varying covariates will be included in the model to predict measures of QOL at different time points. In addition, family caregiver appraisal/depression measured at the end of the study period will be included as a distal outcome in the GMM models, and how this distal outcome is associated with the patterns of the developmental trajectories of AYA QOL will be assessed. As the same model will be used to evaluate multiple outcomes, Bonferroni correction will be applied to exert a stringent control over false discovery. As attrition is inevitable in longitudinal studies, robust model estimator (e.g., MLR) using the full information maximum likelihood will be used for model estimation. Importantly, missing at random (MAR), instead of missing completely at random, can be assumed in MLR. MAR is a plausible assumption that allows missingness to be dependent on observed measures like intervention assignment. Analytical Plan for AIM 3. To evaluate the efficacy of FACE-TC on early completion of pACP goals of care and advance directives. First, the investigators will use the two-proportion z-test to test the differences in proportions of completion of pACP goals of care and advance directives between FACE-TC and control groups. Then logistic regressions will be used to test the Hypothesis H3, controlling for socio-demographics. Interaction between intervention and ethnicity will be included in the models to test ethnic disparity in regard to intervention efficacy. The investigators will also explore if FACE-TC improves the match between patients' goals of care and the medical care received at the EOL among the adolescents who may die. Descriptive statistics will be used to estimate the frequencies of the study variables. Chi-square statistics with Fisher Exact tests will be used to assess the difference in the match between FACE-TC and controls; and exact logistic regression will be applied to examine the effect of FACE-TC on such a match, controlling for covariates. For continuous outcomes with a modest observation autocorrelation (p=0.20) and moderate effect size (delta=0.35), the estimated sample size to achieve a power of 0.80 at =0.05 level and detect a moderate effect size (delta=0.35) is about N=76 individuals at each of the 5 observation time points. For binary outcomes, a sample size of N=70 can achieve a power of 0.80 to detect a moderate response probability difference of d=0.17 given p=0.20. Our proposed sample of N=130 dyads will ensure a large enough statistical power for our proposed longitudinal analyses on patient data and parent data, respectively. For the cross-sectional logistic regression model proposed to evaluate Aim 3, a sample size of N=100 would achieve a power of 0.83 at alpha=0.05 level to detect an odds ratio of 4.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| FACE-TC Intervention | Experimental | Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. |
|
| Treatment As Usual (TAU) | No Intervention | Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| FAmily CEntered Advance Care Planning for Teens with Cancer | Behavioral | 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive. |
| Measure | Description | Time Frame |
|---|---|---|
| Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. | Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome. | Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months. |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. | Assessed adolescent Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference using these PROMIS subscales. Each subscale has 8 items each. Minimum value is 8. Maximum value is 40. Higher scores mean worse outcomes for anxiety, depressive symptoms, fatigue, and pain interference. |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of End of Life Communication (QOC) | Curtis's Quality of Participant-Interviewer Communication Questionnaire (Curtis et al 1999) evaluated quality of communication that occurred between participants and facilitator. The first 4 items are: 1. Do you think that your attitudes are known by the interviewer? 2. Did you feel that the interviewer cared about you as a person? 3. Did you feel that the interviewer listened to what you said? 4. Did you feel that the interviewer gave you enough attention? 5-point Likert scale ranging from Probably no to probably yes. The 5th item is: How would you rate the overall quality of the discussions you just had with the interviewer? Range of scores is from 5 to 25. Higher scores indicate higher quality of communication. |
AYA Inclusion Criteria:
Inclusion Criteria for Legal Guardians of Adolescents Age 14-17:
Inclusion Criteria for Surrogates of AYAs Age 18-20:
Exclusion Criteria - for AYA or surrogate decision-maker:
Developmental delay; foster care; active homicidality or suicidality, depression in the severe range
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| Name | Affiliation | Role |
|---|---|---|
| Maureen E Lyon, PhD | Children's National Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Children's National Medical Center | Washington D.C. | District of Columbia | 22314 | United States | ||
| University of Minnesota Masonic Children's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24411819 | Background | Lyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. A longitudinal, randomized, controlled trial of advance care planning for teens with cancer: anxiety, depression, quality of life, advance directives, spirituality. J Adolesc Health. 2014 Jun;54(6):710-7. doi: 10.1016/j.jadohealth.2013.10.206. Epub 2014 Jan 7. | |
| 23479062 | Background | Lyon ME, Jacobs S, Briggs L, Cheng YI, Wang J. Family-centered advance care planning for teens with cancer. JAMA Pediatr. 2013 May;167(5):460-7. doi: 10.1001/jamapediatrics.2013.943. |
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No, only de-identified data.
Estimated April 30, 2022
Graduate students in accredited programs, residents, fellows and faculty from accredited programs.
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There were 260 participants enrolled in the study. Randomization was at the level of the dyad (adolescent with cancer and family surrogate decision maker). After enrollment a secondary screening occurred. 4 participants who were part of an adolescent/family dyad (n=8 participants) failed this secondary screening. Thus, 252 participants (126 adolescent/family dyads) completed the baseline assessment and were then randomized. The flow chart is reported as adolescent/family dyads.
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| ID | Title | Description |
|---|---|---|
| FG000 | FACE-TC Intervention | Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive. |
| FG001 | Treatment As Usual (TAU) | Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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260 participants were consented/assented and enrolled. Upon secondary screening 8 participants were excluded, leaving 252 participants. Participants were randomized as adolescent/family surrogate dyads at 2:1 ratio of intervention (n=83 dyads) to control (n=43 dyads). Baseline analysis was at level of participant with separate analysis for adolescents and family surrogates. Outcome measure for Statement of Treatment Preferences (SOTP) was at level of the dyad and not administered at baseline.
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| ID | Title | Description |
|---|---|---|
| BG000 | FACE-TC Intervention | Adolescent/family dyads randomized to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Row population represents analysis by adolescents separately from family surrogate decision makers. Secondary analysis was conducted with each group separately. Primary outcome was congruence in treatment preferences and analysis was at the level of the adolescent/family dyad. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Statement of Treatment Preferences (SOTP) a Tool to Measure Goals of Care. | Statement of Treatment Preferences documented adolescents' goals of care and families' understanding. Situations were: (1) prolonged hospital stay with ongoing medical intervention and low chance of survival; (2) treatments extend life by no more than 2-3 months with side-effects; (3) physical impairment; and (4) mental impairment. Choices for the four situations were "to continue all treatments …", "to stop all efforts to keep me alive…", or "do not know." Responses for data analysis were recoded into two categories: congruent (family accurately reported what the patient reported as their treatment preference) versus "stop all treatments." Dyadic responses, "do not know" were treated as not congruent and removed from analysis. Percentage dyadic agreement or disagreement was calculated for each situation. Minimum agreement is 0%. Maximum agreement is 100%. Higher percentage dyadic agreement is better outcome. | Total number for overall congruence of Statement of Treatment Preferences 2-weeks post baseline or post-Session 2 (n=115 dyads). Data were analyzed and are presented at the level of dyadic congruence, i.e. 73 dyads (146 adolescent and family participants) in the intervention arm and 42 dyads (84 participants) in the control arm. 1 dyad (2 participants) had missing data. | Posted | Count of Units | Dyads | Agreement on SOTP was assessed 2 weeks post-baseline for controls or immediately following Session 2 for FACE-TC intervention dyads, and at 3, 6, 12 and 18 months. |
From enrollment through study completion up to 18 months post-intervention (+/- 1 month study window).
Potential adverse event data were collected over the 6 year trial period and reported in bi- annual to annual meetings with the Safety Monitoring Committee. Monthly investigator meetings consistently reviewed adverse events during the prior month and potential adverse events. Site monitoring visits also monitored adverse events and their documentation. All patients died from their cancer related illness or side effect of treatment. One parent died from disease progression of chronic illness.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | FACE-TC Intervention Adolescent | Adolescent randomized with family member as dyad to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Maureen E. Lyon, PhD, Professor of Pediatrics, Principal Investigator | Children's National Medical Center | 703-346-2873 | mlyon@childrensnational.org |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 19, 2016 | Aug 28, 2024 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Apr 5, 2016 | Aug 28, 2024 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D003643 | Death |
| D003142 | Communication |
| D019066 | Facies |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001519 | Behavior |
| D020969 | Disease Attributes |
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| OTHER |
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| Change from baseline in quality of life (defined as symptoms of anxiety, depression, fatigue and pain interference) at 3, 6, and 12 months post baseline compared to controls |
| Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) | Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace. Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace. Total score range is from 0 minimum value to maximum value of 92. Higher scores indicate better spiritual well-being. | Controlling for baseline, change in of meaning and peace subscale and faith subscale at 3, 6, 12 months post intervention for intervention adolescents compared to control adolescents. Total scores provided for interested investigators were not outcome. |
| Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) | The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5. | Baseline and 3 months post baseline administered to family surrogates only. |
| Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out. | The effect of the intervention on documentation in the Electronic Health Record of any advance directive for the adolescent was conducted at study close, using a standardized chart abstraction form. | This adolescent outcome was measured at one time point only, between 18 months post-intervention or study close-out. At study close out we had 117 adolescents in the study. Attrition was due to deaths, lost to follow-up, and withdrawals. |
| 234 participants completed this assessment at two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This process assessment is not in the flow diagram because it is not an intervention outcome. |
| Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "How often do you go to religious services? Responses ranged from "more than once a week" to "once or twice a year." Higher scores indicated greater attendance at religious services. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. | Assessed at baseline and at 3, 6, and 12 months post-intervention. |
| Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "To what extent do you consider yourself a religious person? Responses ranged from "not religious at all" to "very religious." Higher scores indicated greater religiousness. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research indicated that this item was associated with quality of life outcomes. | Change from baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls |
| Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "To What Extent do You Consider Yourself a spiritual person?" Responses ranged from "not spiritual at all" to "very spiritual." Higher score meant more spiritual. Reported are frequency distributions and percentages. | Baseline in religiousness/spirituality at 3, 6, and 12 months post-intervention. Used as a covariate in generalized linear mixed effect models. |
| Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "How often do you pray privately?" Frequency of behavior was surveyed. Responses ranged from never to a few times a week. Higher scores indicated more praying privately. 5 items were used in this study based on previous research with adolescent populations, which showed that these 5 items moderated study outcomes. Responses were used as covariates in the initial modeling. | Baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls for adolescents only. |
| Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to item "I feel God's presence". Responses range from never to many times a day. Higher scores indicated greater experience of feeling God's presence. Prior research had demonstrated this item moderated study outcomes with respect to quality of life outcomes. | Baseline in religiousness/spirituality and at 3, 6, and 12 months post baseline compared to controls. Responses were used as a covariate in the initial generalized linear mixed effect models. |
| Satisfaction Questionnaire | Items for this 13-item assessment of adolescent and family satisfaction with the FACE-TC intervention were developed using input from the community about the emotional of participation. Items are on a 5-point Likert scale from strongly disagree to strongly agree. 6 items were negative (felt afraid, too much to handle, harmful, angry, sad hurtful) and 7 items were positive (useful, helpful, load off my mind, satisfied, something I needed to do, courageous, worthwhile). Each subscale was scored separately. The minimum positive score was 17 and the maximum positive score was 35 for adolescents. The minimum negative score was 6 and the maximum negative score was 22 for adolescents. The minimum positive score was 11 and maximum score was 35 for family surrogate. The minimum negative score was 6 and the maximum negative score was 23 for surrogates. Higher score for positive scale was better outcome. Higher score for negative scale was worse outcome. | Two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This was a process measure and as such is not reflected in the flow diagram, as it was not a primary or secondary outcome. |
| Minneapolis |
| Minnesota |
| 55455-2070 |
| United States |
| Akron Children's Hospital | Akron | Ohio | 44308 | United States |
| St. Jude Children's Research Hospital | Memphis | Tennessee | 38105-3678 | United States |
| 19327074 | Background | Lyon ME, Garvie PA, Briggs L, He J, McCarter R, D'Angelo LJ. Development, feasibility, and acceptability of the Family/Adolescent-Centered (FACE) Advance Care Planning intervention for adolescents with HIV. J Palliat Med. 2009 Apr;12(4):363-72. doi: 10.1089/jpm.2008.0261. |
| 22096382 | Background | Lyon ME, Garvie PA, Briggs L, He J, Malow R, D'Angelo LJ, McCarter R. Is it safe? Talking to teens with HIV/AIDS about death and dying: a 3-month evaluation of Family Centered Advance Care (FACE) planning - anxiety, depression, quality of life. HIV AIDS (Auckl). 2010;2:27-37. doi: 10.2147/hiv.s7507. Epub 2010 Feb 18. |
| 19171571 | Background | Lyon ME, Garvie PA, McCarter R, Briggs L, He J, D'Angelo LJ. Who will speak for me? Improving end-of-life decision-making for adolescents with HIV and their families. Pediatrics. 2009 Feb;123(2):e199-206. doi: 10.1542/peds.2008-2379. |
| 25545105 | Background | Jacobs S, Perez J, Cheng YI, Sill A, Wang J, Lyon ME. Adolescent end of life preferences and congruence with their parents' preferences: results of a survey of adolescents with cancer. Pediatr Blood Cancer. 2015 Apr;62(4):710-4. doi: 10.1002/pbc.25358. Epub 2014 Dec 24. |
| 23930080 | Background | Wilkins ML, Dallas RH, Fanone KE, Lyon ME. Pediatric palliative care for youth with HIV/AIDS: systematic review of the literature. HIV AIDS (Auckl). 2013 Jul 29;5:165-79. doi: 10.2147/HIV.S44275. Print 2013. |
| 22771129 | Background | Garvie PA, He J, Wang J, D'Angelo LJ, Lyon ME. An exploratory survey of end-of-life attitudes, beliefs, and experiences of adolescents with HIV/AIDS and their families. J Pain Symptom Manage. 2012 Sep;44(3):373-85.e29. doi: 10.1016/j.jpainsymman.2011.09.022. Epub 2012 Jul 7. |
| 15581537 | Background | Lyon ME, McCabe MA, Patel KM, D'Angelo LJ. What do adolescents want? An exploratory study regarding end-of-life decision-making. J Adolesc Health. 2004 Dec;35(6):529.e1-6. doi: 10.1016/j.jadohealth.2004.02.009. |
| 27749945 | Background | Rosenberg AR, Wolfe J, Wiener L, Lyon M, Feudtner C. Ethics, Emotions, and the Skills of Talking About Progressing Disease With Terminally Ill Adolescents: A Review. JAMA Pediatr. 2016 Dec 1;170(12):1216-1223. doi: 10.1001/jamapediatrics.2016.2142. |
| 28359212 | Background | Lyon ME, D'Angelo LJ, Dallas RH, Hinds PS, Garvie PA, Wilkins ML, Garcia A, Briggs L, Flynn PM, Rana SR, Cheng YI, Wang J. A randomized clinical trial of adolescents with HIV/AIDS: pediatric advance care planning. AIDS Care. 2017 Oct;29(10):1287-1296. doi: 10.1080/09540121.2017.1308463. Epub 2017 Mar 30. |
| 31280659 | Background | Weaver MS, Anderson B, Cole A, Lyon ME. Documentation of Advance Directives and Code Status in Electronic Medical Records to Honor Goals of Care. J Palliat Care. 2020 Oct;35(4):217-220. doi: 10.1177/0825859719860129. Epub 2019 Jul 7. |
| 31445136 | Background | Feudtner C, Rosenberg AR, Boss RD, Wiener L, Lyon ME, Hinds PS, Bluebond-Langner M, Wolfe J. Challenges and Priorities for Pediatric Palliative Care Research in the U.S. and Similar Practice Settings: Report From a Pediatric Palliative Care Research Network Workshop. J Pain Symptom Manage. 2019 Nov;58(5):909-917.e3. doi: 10.1016/j.jpainsymman.2019.08.011. Epub 2019 Aug 21. |
| 30829829 | Background | Watson A, Weaver M, Jacobs S, Lyon ME. Interdisciplinary Communication: Documentation of Advance Care Planning and End-of-Life Care in Adolescents and Young Adults With Cancer. J Hosp Palliat Nurs. 2019 Jun;21(3):215-222. doi: 10.1097/NJH.0000000000000512. |
| Background | Needle J, Brunnquel D, Lyon M. Mature minors, mature decisions: Advance care planning for adolescent patients with life-limiting illness. Journal of Pediatric Ethics! Advanced Care Planning and End of Life. 2018;1(3). |
| 29206683 | Background | Weaver MS, Bell CJ, Diver JL, Jacobs S, Lyon ME, Mooney-Doyle K, Newman AR, Slutsman J, Hinds PS. Surprised by Benefit in Pediatric Palliative Care Research. Cancer Nurs. 2018 Jan/Feb;41(1):86-87. doi: 10.1097/NCC.0000000000000576. No abstract available. |
| 31659933 | Background | Needle JS, Peden-McAlpine C, Liaschenko J, Koschmann K, Sanders N, Smith A, Schellinger SE, Lyon ME. "Can you tell me why you made that choice?": A qualitative study of the influences on treatment decisions in advance care planning among adolescents and young adults undergoing bone marrow transplant. Palliat Med. 2020 Mar;34(3):281-290. doi: 10.1177/0269216319883977. Epub 2019 Oct 29. |
| Background | Wiener L, Zadeh BS, Battles H, Sender L, Fasciano K, Heath C, Lyon ME, Donavan KA, Naronoha Ferrazde Arruda Colli M, Pao M. Courageous Conversations: Advance Care Planning and Family Communication. Pediatric Blood & Cancer, S596, October, 2018 |
| 28844985 | Result | Curtin KB, Watson AE, Wang J, Okonkwo OC, Lyon ME. Pediatric advance care planning (pACP) for teens with cancer and their families: Design of a dyadic, longitudinal RCCT. Contemp Clin Trials. 2017 Nov;62:121-129. doi: 10.1016/j.cct.2017.08.016. Epub 2017 Aug 24. |
| Result | Gaines ThompkinsJ, Friebert S, Baker J, Needle J, Cheng Y, Lyon M. Effect of FAmily CEntered (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teens with cancer. J Pain Symptom Manage 2019;57(2):446-447. PMID: 30267845 |
| Result | Friebert S, Gaines (Thompkins) J, Needle J, Baker J, Cheng Y, Lyon M. What do adolescents want? Values, goals and beliefs of teens with cancer. J Pain Symptom Manage 2019;57(2):378. |
| 32543698 | Result | Grossoehme DH, Friebert S, Baker JN, Tweddle M, Needle J, Chrastek J, Thompkins J, Wang J, Cheng YI, Lyon ME. Association of Religious and Spiritual Factors With Patient-Reported Outcomes of Anxiety, Depressive Symptoms, Fatigue, and Pain Interference Among Adolescents and Young Adults With Cancer. JAMA Netw Open. 2020 Jun 1;3(6):e206696. doi: 10.1001/jamanetworkopen.2020.6696. |
| 32427325 | Result | Friebert S, Grossoehme DH, Baker JN, Needle J, Thompkins JD, Cheng YI, Wang J, Lyon ME. Congruence Gaps Between Adolescents With Cancer and Their Families Regarding Values, Goals, and Beliefs About End-of-Life Care. JAMA Netw Open. 2020 May 1;3(5):e205424. doi: 10.1001/jamanetworkopen.2020.5424. |
| Result | Thompkins J, Baker JN, Friebert S, Needle J, Wang J, Cheng YI, Lyon ME. Effect of FAmily CEnterd (FACE) advance care planning (ACP) on families' appraisals of caregiving for their teen with cancer. 2020 American Society of Clinical Oncology (ASCO) Annual Meeting. (ASCO Virtual Scientific Program). J Clin Oncol 38: 2020 (suppl; abstr e22533) DOI:10.1200/JCO.2020.38.15_suppl.e2253 |
| Result | Schreiner KL, Grossoehme DH, Baker JN, Needle J, Friebert S, Lyon ME. Being healthy and living life as if I never had cancer": The meaning of "living well" from adolescents with cancer. J Clin Oncol 38: 2020 (suppl; abstr e22532) DOI: 10.1200/JCO.2020.38.15_suppl.e22532 |
| Result | Livingston J, Cheng Y, Wang J, Tweddle T, Friebert S, Baker J, Thompkins J, Greenberg I, Lyon M. FP029 SIOP19-1654 Shared Spiritual Beliefs Between Adolescents with Cancer and Their Families: An Exploration of Social Determinants of Spiritual Well-Being. Supplement: Abstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019 Pediatric Blood & Cancer. December 2019;66: IssueS4 e27989 https://doi.org/10.1002/pbc.27989 |
| 31568621 | Result | Abstracts from the 51st Congress of the International Society of Paediatric Oncology (SIOP) Lyon, France, October 23-26, 2019. Pediatr Blood Cancer. 2019 Dec;66 Suppl 4:e27989. doi: 10.1002/pbc.27989. No abstract available. |
| Result | Lyon ME, Grossoehme DH, Baker JN, Friebert S, Cheng Y, Chrastek J, Thompkins J, Tweddle M, Wang J, Needle J. Relationship of spiritual constructs to mental health PROs in adolescents with cancer.DOI: 10.1200/JCO.2019.37.31_suppl.136 Journal of Clinical Oncology 37, no. 31_suppl (November 01, 2019) 136-136. Published online November 25, 2019 |
| 35819787 | Result | Needle JS, Friebert S, Thompkins JD, Grossoehme DH, Baker JN, Jiang J, Wang J, Lyon ME. Effect of the Family-Centered Advance Care Planning for Teens with Cancer Intervention on Sustainability of Congruence About End-of-Life Treatment Preferences: A Randomized Clinical Trial. JAMA Netw Open. 2022 Jul 1;5(7):e2220696. doi: 10.1001/jamanetworkopen.2022.20696. |
| 35425986 | Result | Baker JN, Friebert S, Needle J, Jiang J, Wang J, Lyon ME. An Intervention in Congruence for End-of-Life Treatment Preference: A Randomized Trial. Pediatrics. 2022 May 1;149(5):e2021054796. doi: 10.1542/peds.2021-054796. |
| 33958436 | Result | Thompkins JD, Needle J, Baker JN, Briggs L, Cheng YI, Wang J, Friebert S, Lyon ME. Pediatric Advance Care Planning and Families' Positive Caregiving Appraisals: An RCT. Pediatrics. 2021 Jun;147(6):e2020029330. doi: 10.1542/peds.2020-029330. Epub 2021 May 6. |
| Result | - Baker JN (presenter), Friebert S, Needle JS, Thompkins JD, Grossoehme D, Jiang J, Wang J, Lyon ME. Oral Presentation. The effect of Family-Centered pediatric Advance Care Planning for Teens with Cancer (FACE®-TC) on adolescents' decisional support, preparedness, and symptoms at 3- and 12- months post-intervention. 54th Congress of the International Society of Paediatric Oncologists (SIOP). September 29, 2022. Barcelona, Spain |
| 34061435 | Result | Lyon ME, Cheng YI, Needle J, Friebert S, Baker JN, Jiang J, Wang J. The intersectionality of gender and poverty on symptom suffering among adolescents with cancer. Pediatr Blood Cancer. 2021 Aug;68(8):e29144. doi: 10.1002/pbc.29144. Epub 2021 Jun 1. |
| 32918519 | Result | Livingston J, Cheng YI, Wang J, Tweddle M, Friebert S, Baker JN, Thompkins J, Lyon ME. Shared spiritual beliefs between adolescents with cancer and their families. Pediatr Blood Cancer. 2020 Dec;67(12):e28696. doi: 10.1002/pbc.28696. Epub 2020 Sep 12. |
| 39821687 | Result | Friebert S, Trujillo Rivera EA, Baker JN, Thompkins JD, Grossoehme D, Needle J, Lyon ME. Pediatric Advance Care Planning and Adolescent Preparedness and Quality of Life: An RCT. Pediatrics. 2025 Feb 1;155(2):e2024068699. doi: 10.1542/peds.2024-068699. |
| Protocol Violation |
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| Withdrawal by Subject |
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| patient wanted to leave it behind |
|
| anxiety |
|
| family issues |
|
| no reason given |
|
| BG001 | Treatment As Usual (TAU) | Adolescent/family dyads randomized to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention. |
| BG002 | Total | Total of all reporting groups |
| Count of Participants |
| Participants |
|
| Age, Continuous | Mean | Full Range | years |
|
| Sex: Female, Male | Sex is by self-report. | Age of adolescents and family surrogate decision makers were used as separate variables in the analysis. | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Ethnicity was analyzed as a separate variable for adolescents and family surrogates. | Count of Participants | Participants |
|
| Race (NIH/OMB) | Race was measured by self-report. | Race of adolescents did not always match race of family surrogate. Therefore, the variables were analyzed separately. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Patient-Reported Outcomes Measures Short Forms pediatric | pediatric PROMIS Short Forms 8a - Pediatrics v. 2.0) is a set of person-centered measures that evaluates and monitors physical, mental, and social health in children and adolescents. Assessed adolescent Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference using these PROMIS subscales. Each subscale has 8 items each. Minimum value is 8. Maximum value is 40. Higher scores mean worse outcomes for anxiety, depressive symptoms, fatigue, and pain interference. Measures were administered to adolescents only. | Adolescents living with cancer only. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits or attrition. | Median | Inter-Quartile Range | units on a scale |
|
| Family Appraisal of Caregiving Questionnaire for Palliative Care | FACQ-PC is a 25-item measure consisting of four subscales:(i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. Minimum value for each subscale is 1 and the maximum value for each subscale is 5. | Row population differs from overall, because only family member completed this questionnaire and because of attrition from time of enrollment. | Mean | Standard Deviation | units on a scale |
|
| Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded | Assessed spiritual well-being. Subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace. Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate greater faith. Total score range is from 0 minimum value to maximum value of 92. Higher scores indicate better spiritual well-being. | Scores are reported separately for adolescents and the family member. Total participants completing FACIT-SP is 252. The other discrepancy is caused by attrition between enrollment and baseline visit. | Median | Inter-Quartile Range | units on a scale |
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| Dyads |
| Dyads |
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|
|
| Secondary | Patient-Reported Outcomes Measurement Information System (PROMIS Short Forms 8a - Pediatrics v. 2.0) is a Set of Person-centered Measures That Evaluates and Monitors Physical, Mental, and Social Health in Children and Adolescents. | Assessed adolescent Emotional distress-Anxiety; Emotional Distress-Depressive Symptoms; Fatigue; and Pain Interference using these PROMIS subscales. Each subscale has 8 items each. Minimum value is 8. Maximum value is 40. Higher scores mean worse outcomes for anxiety, depressive symptoms, fatigue, and pain interference. | Adolescents living with cancer. Higher scores indicate worse symptoms of anxiety, depressive symptoms, fatigue and pain interference. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months. Changes in number of participants reflects missing visits, deaths, or attrition. | Posted | Median | Inter-Quartile Range | raw score units on a scale | Change from baseline in quality of life (defined as symptoms of anxiety, depression, fatigue and pain interference) at 3, 6, and 12 months post baseline compared to controls |
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| Secondary | Functional Assessment of Chronic Illness Therapy (FACIT)-Spirituality-12 Version 4 Expanded (FACIT-Sp-EX) | Assessed construct of spiritual well-being. Two subscales Meaning/Peace (7 items) and Faith (5 items) and Total score (12 items) were calculated. on a 5-point Likert scale from 0=not at all to 5=very much. Some items are reverse scored. See www.facit.org Meaning/Peace subscale score range from minimum value of 0 to maximum value of 32. Higher scores indicate better meaning/peace. Faith subscale score range from 0 minimum value to maximum value of 16. Higher scores indicate better meaning/peace. Total score range is from 0 minimum value to maximum value of 92. Higher scores indicate better spiritual well-being. | Adolescents living with cancer. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months. There are no missing data. | Posted | Median | Inter-Quartile Range | units on a scale | Controlling for baseline, change in of meaning and peace subscale and faith subscale at 3, 6, 12 months post intervention for intervention adolescents compared to control adolescents. Total scores provided for interested investigators were not outcome. |
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| Secondary | Family Appraisal of Caregiving Questionnaire for Palliative Care (FACQ-PC) | The FACQ-PC is a 25-item measure consists of four theoretically derived subscales: (i) caregiver strain, (ii) positive caregiving appraisals, (iii) caregiver distress, and (iv) family well-being. Scores are from 5 = strongly agree to 1 = strongly disagree. We did not calculate a Total score. We only used the 4 subscale scores. On the subscale scores for positive caregiving appraisals and family well-being, higher scores mean better outcomes, i.e. greater positive caregiving appraisals or family well-being. On the subscale scores for caregiver strain and caregiver distress, higher scores mean worse outcomes, i.e. greater caregiver strain or caregiver distress. The FACQ-PC subscale scores were computed by taking the mean of the items (score range 1-5). Some items were reverse scored, depending on how the item is phrased, so that higher scores = higher amount of the subscale being measured. So the minimum value for each subscale is 1 and the maximum value for each subscale is 5. | Data were analyzed for family surrogate only. 83 surrogates randomized to FACE TC and 43 surrogates randomized to TAU at baseline. At 3 months post-intervention analyzed population was 65 FACE-TC and 37 TAU. One TAU surrogate missed this study visit at 3 months post intervention. Changes in number of participants reflect missed study visits, deaths, or loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | Baseline and 3 months post baseline administered to family surrogates only. |
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| Secondary | Advance Directive for Adolescent Only Located in the Electronic Health Record at Study Close Out. | The effect of the intervention on documentation in the Electronic Health Record of any advance directive for the adolescent was conducted at study close, using a standardized chart abstraction form. | Adolescent data only on documentation of an advance directive in the electronic health. | Posted | Count of Participants | Participants | This adolescent outcome was measured at one time point only, between 18 months post-intervention or study close-out. At study close out we had 117 adolescents in the study. Attrition was due to deaths, lost to follow-up, and withdrawals. |
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| Other Pre-specified | Quality of End of Life Communication (QOC) | Curtis's Quality of Participant-Interviewer Communication Questionnaire (Curtis et al 1999) evaluated quality of communication that occurred between participants and facilitator. The first 4 items are: 1. Do you think that your attitudes are known by the interviewer? 2. Did you feel that the interviewer cared about you as a person? 3. Did you feel that the interviewer listened to what you said? 4. Did you feel that the interviewer gave you enough attention? 5-point Likert scale ranging from Probably no to probably yes. The 5th item is: How would you rate the overall quality of the discussions you just had with the interviewer? Range of scores is from 5 to 25. Higher scores indicate higher quality of communication. | Participants (adolescents with cancer and their family surrogate decision-maker) ratings of quality of communication with facilitator. Separate analysis were conducted for adolescents and their family surrogate, i.e. analysis was not at the level of the dyad. Changes in participants over time reflect missed study visits, deaths, or loss to follow-up. | Posted | Mean | Standard Deviation | units on a scale | 234 participants completed this assessment at two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This process assessment is not in the flow diagram because it is not an intervention outcome. |
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| Other Pre-specified | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "How often do you go to religious services? Responses ranged from "more than once a week" to "once or twice a year." Higher scores indicated greater attendance at religious services. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research had indicated that this variable moderated quality of life outcomes. | Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention. | Posted | Count of Participants | Participants | Assessed at baseline and at 3, 6, and 12 months post-intervention. |
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| Other Pre-specified | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "To what extent do you consider yourself a religious person? Responses ranged from "not religious at all" to "very religious." Higher scores indicated greater religiousness. Responses were used as a covariate in the initial Generalized linear mixed effect models. Prior research indicated that this item was associated with quality of life outcomes. | Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention. | Posted | Count of Participants | Participants | Change from baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls |
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| Other Pre-specified | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "To What Extent do You Consider Yourself a spiritual person?" Responses ranged from "not spiritual at all" to "very spiritual." Higher score meant more spiritual. Reported are frequency distributions and percentages. | Adolescents with cancer responses at baseline, 3, 6 and 12 months post-intervention. | Posted | Count of Participants | Participants | Baseline in religiousness/spirituality at 3, 6, and 12 months post-intervention. Used as a covariate in generalized linear mixed effect models. |
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| Other Pre-specified | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to "How often do you pray privately?" Frequency of behavior was surveyed. Responses ranged from never to a few times a week. Higher scores indicated more praying privately. 5 items were used in this study based on previous research with adolescent populations, which showed that these 5 items moderated study outcomes. Responses were used as covariates in the initial modeling. | Adolescents living with cancer Higher scores indicate increased frequency of experience or behavior. There are no missing data. The numbers analyzed in some rows differ from the Overall Number of Participants Analyzed for this Outcome Measure due either to missed study visits, attrition, or deaths at 3-months, 6-months, and 12-months. | Posted | Count of Participants | Participants | Baseline in religiousness/spirituality at 3, 6, and 12 months post baseline compared to controls for adolescents only. |
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| Other Pre-specified | Brief Multidimensional Measurement of Religiousness/Spirituality (BMMRS-adapted) | Responses to item "I feel God's presence". Responses range from never to many times a day. Higher scores indicated greater experience of feeling God's presence. Prior research had demonstrated this item moderated study outcomes with respect to quality of life outcomes. | Adolescents living with cancer. | Posted | Count of Participants | Participants | Baseline in religiousness/spirituality and at 3, 6, and 12 months post baseline compared to controls. Responses were used as a covariate in the initial generalized linear mixed effect models. |
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| Other Pre-specified | Satisfaction Questionnaire | Items for this 13-item assessment of adolescent and family satisfaction with the FACE-TC intervention were developed using input from the community about the emotional of participation. Items are on a 5-point Likert scale from strongly disagree to strongly agree. 6 items were negative (felt afraid, too much to handle, harmful, angry, sad hurtful) and 7 items were positive (useful, helpful, load off my mind, satisfied, something I needed to do, courageous, worthwhile). Each subscale was scored separately. The minimum positive score was 17 and the maximum positive score was 35 for adolescents. The minimum negative score was 6 and the maximum negative score was 22 for adolescents. The minimum positive score was 11 and maximum score was 35 for family surrogate. The minimum negative score was 6 and the maximum negative score was 23 for surrogates. Higher score for positive scale was better outcome. Higher score for negative scale was worse outcome. | Adolescents with cancer and their family surrogate decision makers responding agree or strongly agree to each item. | Posted | Mean | Standard Deviation | score on a scale | Two weeks post-baseline for control; two weeks post-baseline for intervention--immediately following Session 2. This was a process measure and as such is not reflected in the flow diagram, as it was not a primary or secondary outcome. |
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| 3 |
| 83 |
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | Treatment As Usual (TAU) Adolescent | Adolescent randomized with family member as dyad to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention. | 4 | 43 | 0 | 43 | 0 | 43 |
| EG002 | FACE-TC Intervention Family Member | Family member randomized with adolescent as dyad to the experimental condition receive Family Centered Advance Care Planning for Teens with Cancer (FACE-TC) intervention - 3 sessions scheduled one week apart of approximately 60 minutes duration each. Session 1 - Lyon Advance Care Planning Survey-Adolescent & Surrogate versions. Session 2 - Respecting Choices Interview facilitated by trained/certified facilitator with adolescent and family. Focuses on patient's understanding of their illness, possible complications, goals of care and treatment preferences in 3 bad outcome situations; and the Session 3 - Five Wishes an advance directive. FAmily CEntered Advance Care Planning for Teens with Cancer: 3 session weekly intervention: 1) survey completed by adolescent and family (surrogate decision maker) separately with facilitator; 2) Respecting Choices structured interview about patient's representation of illness, goals of care, hopes, treatment preferences; 3) completion of an advance directive. | 1 | 83 | 0 | 83 | 0 | 83 |
| EG003 | TAU Family Member | Family member randomized with adolescent as dyad to the treatment as usual (TAU) condition receive written information on advance care planning, but no active intervention. | 0 | 43 | 0 | 43 | 0 | 43 |
Not provided
Not provided
| Between 18 and 65 years |
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| >=65 years |
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| Male |
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| Unknown or Not Reported |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Perfect agreement: agree all 4 situations |
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| Emotional Distress -Depressive Symptoms symptoms baseline |
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| Fatigue baseline |
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| Pain Interference baseline |
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| Emotional Distress Anxiety 3 months |
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| Emotional Distress Depressive Symptoms 3 Months |
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| Fatigue 3 months |
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| Pain Interference 3 months |
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| Emotional distress - anxiety 6 months |
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| Emotional distress - depressive symptoms 6 months |
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| Fatigue 6 months |
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| Pain Interference 6 months |
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| Emotional distress - anxiety 12 months |
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| Emotional distress - depression |
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| Fatigue - 12 months |
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| Pain Interference - 12 months |
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| Emotional distress-anxiety analysis at 3 months post baseline comparing intervention and control. We hypothesized that anxiety would be lower in the intervention group compared to controls. | Mixed Models Analysis | Model forced age, gender, race, family education, family income under the Federal Poverty level, on/off treatment. | <0.05 | The generalized mixed effect models are taking into account missingness by attrition. There were not missing values for the outcomes or predictors that we used. | Risk Ratio (RR) | 1.05037501 | 2-Sided | 95 | 0.96438584 | 1.14403138 | Superiority |
| This is analysis for 6 month outcomes of Emotional-distress - anxiety. See details in 3 month outcomes. | t-test, 2 sided | See earlier comments. | <0.05 | See earlier comments. | Risk Ratio (RR) | 1.01136067 | 2-Sided | 95 | 0.92887892 | 1.10116656 | Superiority | See earlier comments. |
| These are the 12 month outcomes for Emotional distress - anxiety. See earlier comments. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.14070431 | 2-Sided | 95 | 1.04444724 | 1.24583250 | See earlier comments. | Superiority |
| This analysis is for the outcome Emotional distress - depressive symptoms. We hypothesized that adolescent in the intervention would have lower depressive symptoms compared to controls at 3, 6, and 12 month outcomes. The following are the baseline comparisons between control and intervention which were controlled for in the 3, 6, and 12 month analysis of outcomes. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 0.98078271 | 2-Sided | 95 | 0.89845609 | 1.07065301 | Superiority |
| The results here are for the outcome variable Emotional Distress - Depressive symptoms at 3 month outcomes. We hypothesized that adolescents randomized to the intervention would have lower depressive symptoms than controls. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.04007715 | 2-Sided | 95 | 0.94970156 | 1.13905306 | Superiority |
| We hypothesize that Emotional Distress - Depressive symptoms would be lower in intervention adolescents compared to controls at 6 months post intervention. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.07347088 | 2-Sided | 95 | 0.98062710 | 1.17510491 | Superiority |
| We hypothesized that adolescents randomized to the intervention would have lower scores on Emotional Distress - Depressive symptoms compared to controls at 12 months post baseline. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.11582434 | 2-Sided | 95 | 1.01653156 | 1.22481585 | Superiority |
| We hypothesized that adolescents randomized to the intervention would have no differences in fatigue at baseline if randomization was successful. In this analysis we examine the baseline results. | t-test, 2 sided | <0.05 | Risk Ratio, log | 0.98803061 | 2-Sided | 95 | 0.89065531 | 1.09605195 | Superiority |
| We hypothesized that adolescents randomized to the intervention arm would report less Fatigue at 3 months outcome compared to controls. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.13509797 | 2-Sided | 95 | 1.01959639 | 1.26368376 | Superiority |
| We hypothesized that adolescents randomized to the intervention would report less Fatigue at 6 months post baseline compared to control adolescents. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.04944737 | 2-Sided | 95 | 0.94281417 | 1.16814089 | Superiority |
| We hypothesized that intervention adolescents would report less Fatigue than controls at 12 months post baseline. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.11042568 | 2-Sided | 95 | 0.99383841 | 1.24068981 | Superiority |
| We hypothesized that there would be no differences at baseline between intervention and control adolescents with respect to Pain Interference. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 0.96833470 | 2-Sided | 95 | 0.88658183 | 1.05762611 | Superiority |
| We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 3 months post baseline. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.04450374 | 2-Sided | 95 | 0.95307464 | 1.14470370 | Superiority |
| We hypothesized that adolescents randomized to the intervention compared to controls would report less Pain Interference at 6 months post baseline. | t-test, 2 sided | <0.05 | Risk Ratio (RR) | 1.07182133 | 2-Sided | 95 | 0.97835451 | 1.17421748 | Superiority |
| We hypothesized that at 12 month outcome adolescents randomized to the intervention would report less Pain Interference compared to control adolescents. | t-test, 2 sided | <0.05 | Risk Ratio, log | 1.09964781 | 2-Sided | 95 | 1.00051223 | 1.20860622 | Superiority |
| Faith subscale baseline |
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| Total FACIT-SP vs. 4 score baseline |
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| Meaning and Peace subscale 3 months |
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| Faith subscale 3 months |
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| FACIT-SP vs4 Total Score 3 months |
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| Meaning and Peace subscale 6 months |
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| Faith subscale 6 months |
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| FACIT-Sp v4 Total score 6 months |
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| Meaning and Peace subscale 12 month |
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| Faith subscale 12 months |
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| FACIT-SP v4 Total 12 months |
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| Mixed Models Analysis |
| <0.05 |
| Mean ratio |
| 0.97 |
| 2-Sided |
| 95 |
| 0.88 |
| 1.08 |
| Superiority |
| Meaning and Peace subscale at 12 months post intervention | Mixed Models Analysis | <0.05 | Mean ratio | 0.92 | 2-Sided | 95 | 0.82 | 1.02 | Superiority |
| Faith subscale score at 3 months post intervention | Mixed Models Analysis | <0.05 | Mean ratio | 0.92 | 2-Sided | 95 | 0.73 | 1.16 | Superiority |
| Faith subscale at 6 months post intervention | Mixed Models Analysis | <0.05 | Mean ratio | 0.96 | 2-Sided | 95 | 0.76 | 1.21 | Superiority |
| Faith subscale scores at 12 months post intervention | Mixed Models Analysis | <0.05 | Mean ratio | 0.92 | 2-Sided | 95 | 0.72 | 1.17 | Superiority |
| Caregiver distress Baseline |
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| Family Wellbeing (Higher score=better wellbeing) |
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| Caregiver strain 3 months |
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| Positive caregiving appraisal 3 months |
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| Caregiver distress 3 months |
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| Family well-being 3 months |
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| GEE model |
| <0.05 |
| Mean Difference (Final Values) |
| 0.19 |
| 2-Sided |
| 95 |
| 0.02 |
| 0.36 |
| Superiority |
| Caregiver Distress subscale at 3 months post-intervention comparing intervention to TAU, controlling for baseline levels. | GEE model | <0.05 | Mean Difference (Final Values) | -0.01 | 2-Sided | 95 | -0.35 | 0.32 | Superiority |
| Family Well-Being subscale at 3 months post-intervention, comparing intervention to TAU, controlling for baseline levels. | GEE model | <0.05 | Mean Difference (Final Values) | 0.16 | 2-Sided | 95 | -0.07 | 0.38 | Superiority |
| Family member ratings |
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| Quality of communication analysis for family member. | Regression, Linear | Testing intervention effect for family member quality of communication score controlling for age, gender, race, income nd on active treatment. | <0.01 | Slope | 1.15 | Standard Error of the Mean | 0.41 | 2-Sided | This is standard error of the slope. | Superiority |
| Every month or so |
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| Every week or more often |
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| More than once a week |
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| Never |
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| Once or twice a month |
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| Once or twice a year |
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| Missing |
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| 3 months |
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| 6 months |
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| 12 months |
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| Not religious at all |
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| Slightly religious |
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| Very religious |
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| Declined |
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| missing |
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| 3 months |
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| 6 months |
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| 12 months |
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| Not spiritual at all |
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| Slightly spiritual |
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| Very spiritual |
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| Declined |
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| Missing |
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| 3 months |
|
|
| 6 months |
|
|
| 12 months |
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| A few times a week |
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| Declined |
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| Less than once a month |
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| More than once a day |
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| Never |
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| Once a day |
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| Once a month |
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| Once a week |
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| Missing |
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| 3 months. |
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| How often do you pray privately. 6 months. |
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| How often do you pray privately. 12 months. |
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| Every day |
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| Many times a day |
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| Most days |
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| Never or almost never |
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| Once in a while |
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| Some days |
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| Missing |
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| 3 months |
|
|
| 6 months |
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| 12 months |
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| Adolescent negative score |
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| Family surrogate positive score |
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| Family surrogate negative score |
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| t-test, 2 sided |
| <0.05 |
| Mean Difference (Final Values) |
| 0.93 |
| Standard Error of the Mean |
| 0.73 |
| 2-Sided |
| Superiority |
| Family member positively worded score comparing intervention with treatment as usual. | t-test, 2 sided | <0.05 | Mean Difference (Final Values) | 2.98 | Standard Error of the Mean | 0.74 | 2-Sided | Superiority |
| Family member negative worded score comparing intervention to TAU. | t-test, 2 sided | <0.05 | Mean Difference (Final Values) | -1.15 | Standard Error of the Mean | 0.81 | 2-Sided | Superiority |