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| ID | Type | Description | Link |
|---|---|---|---|
| R21CA235788 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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This trial tests telephone-based Acceptance and Commitment Therapy (ACT), a type of psychotherapy, to reduce fatigue interference with activities, mood, and cognition in advanced gastrointestinal (GI) cancer patients and family caregiver burden. ACT includes mindfulness exercises (e.g., meditations, performing activities with greater awareness), identifying personal values (e.g., family, spirituality), and engaging in activities consistent with these values. A total of 40 patient-caregiver dyads were randomly assigned in equal numbers to either the ACT intervention or an education/support condition. Dyads in both conditions participated in six weekly 50-minute telephone sessions. Outcomes were assessed at baseline, 2 weeks post-intervention, and 3 months post-intervention. The investigators hypothesize that ACT will lead to improved primary and secondary outcomes as compared to education/support. Study findings will inform a large-scale trial of intervention efficacy.
This trial evaluates the feasibility, acceptability, and preliminary efficacy of telephone-based Acceptance and Commitment Therapy (ACT) on fatigue interference in advanced gastrointestinal (GI) cancer patients and family caregiver burden as well as secondary outcomes. The study team recruited advanced GI cancer patients receiving care at the Indiana University Simon Cancer Center or Eskenazi Health hospital. Potentially eligible patients were mailed an introductory letter signed by their oncologist and the PI along with a consent form. The letter had a number to call if they did not wish to be contacted further. A research assistant (RA) called all prospective participants who did not opt out approximately 1 to 2 weeks after the letter was mailed. The RA described the study as outlined in the consent form and answered any questions. Then the RA administered an eligibility screening to those who consented to participate. Eligible and consenting patients identified a potentially eligible family caregiver. If the family caregiver was eligible and consented to participate, then the patient and caregiver each completed a baseline phone assessment. Following baseline assessments, patient-caregiver dyads (N = 40 dyads) were randomly assigned in equal numbers to ACT or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2). Dyads in both study conditions completed six weekly 50-minute telephone sessions with the first session occurring one week after baseline. For ACT participants, adherence to home practice during the past week was assessed and recorded during each session. Feasibility will be examined via accrual, attrition, and adherence rates, and acceptability will be evaluated using a mixed methods approach (qualitative and quantitative). Blind interviewers assessed outcomes during follow-up phone assessments at 2 weeks and 3 months post-intervention.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Acceptance and Commitment Therapy | Experimental | Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). |
|
| Education/Support | Active Comparator | Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Acceptance and Commitment Therapy | Behavioral | Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Interference Subscale of Fatigue Symptom Inventory | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients. | 2 weeks and 3 months post-intervention |
| Short-form of Zarit Burden Interview | Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers. | 2 weeks and 3 months post-intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients. |
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Patient Inclusion Criteria:
Patient Exclusion Criteria:
Caregiver Inclusion Criteria:
Caregiver Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Catherine E Mosher, Ph.D. | Indiana University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eskenazi Health | Indianapolis | Indiana | 46202 | United States | ||
| Indiana University Simon Comprehensive Cancer Center |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 33879253 | Background | Mosher CE, Secinti E, Kroenke K, Helft PR, Turk AA, Loehrer PJ Sr, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for fatigue interference in advanced gastrointestinal cancer and caregiver burden: protocol of a pilot randomized controlled trial. Pilot Feasibility Stud. 2021 Apr 20;7(1):99. doi: 10.1186/s40814-021-00837-9. | |
| 35637615 | Result | Mosher CE, Secinti E, Wu W, Kashy DA, Kroenke K, Bricker JB, Helft PR, Turk AA, Loehrer PJ, Sehdev A, Al-Hader AA, Champion VL, Johns SA. Acceptance and commitment therapy for patient fatigue interference and caregiver burden in advanced gastrointestinal cancer: Results of a pilot randomized trial. Palliat Med. 2022 Jul;36(7):1104-1117. doi: 10.1177/02692163221099610. Epub 2022 May 30. |
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Results of this trial will be presented at professional meetings and published in peer-reviewed journals. The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. The data set will contain necessary identifiers, excluding those prohibited by HIPAA. The investigators will be required to sign a data use agreement and obtain Institutional Review Board (IRB) approval before receiving the data set.
The data set will be made available to qualified investigators within 6 months of the publication of the primary outcome paper. Data will be available for at least 6 years.
The data set and supporting information will be made available to qualified investigators to allow replication of analyses or secondary data analyses. The PI will review requests for data access. The investigators will be required to sign a data use agreement and obtain IRB approval before receiving the data set. The mechanism for data sharing will be reviewed by the IRB.
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2 patients and 2 caregivers were excluded from the study before assignment to groups. Here is a list of the reasons:
Patient death (1) Caregiver withdrew because patient died (1) Patient lost to follow-up (1) Caregiver withdrew because patient was lost to follow-up (1)
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| ID | Title | Description |
|---|---|---|
| FG000 | Acceptance and Commitment Therapy | Patients and caregivers in the Acceptance and Commitment Therapy arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a compact disc (CD) that we developed to guide mindfulness practices. |
| FG001 | Education/Support | Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Acceptance and Commitment Therapy | Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Patient and caregiver age | Age data are presented separately for patients and caregivers. |
| 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 | Fatigue Interference Subscale of Fatigue Symptom Inventory | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 3 months post-intervention |
|
Adverse event data were collected on each participant from the point of baseline until 21 weeks post-baseline.
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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 | Acceptance and Commitment Therapy | Patients and caregivers in the ACT arm learn new and more adaptive ways to respond to difficult internal experiences (e.g., fatigue, thoughts, and feelings). Acceptance and Commitment Therapy: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers practice various mindfulness exercises, clarify their values, and set specific goals in alignment with their values. Through in-session and home practice of skills, participants learn new and more adaptive ways to respond to unwanted internal experiences (e.g., fatigue, distress). Participants receive handouts on session topics and a CD that we developed to guide mindfulness practices. |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Deaths | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Non-systematic Assessment | All patients had advanced cancer at the time of enrollment and the serious adverse events (deaths) were expected and unrelated to the study intervention. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Catherine Mosher | Indiana University | 3172746769 | cemosher@iupui.edu |
Not provided
| 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 | Jun 9, 2020 | Aug 6, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form for Patients | Jun 9, 2020 | Aug 6, 2022 | ICF_001.pdf |
| ICF | No | No | Yes | Informed Consent Form: Consent Form for Family Caregivers | Jun 9, 2020 | Aug 6, 2022 | ICF_002.pdf |
Not provided
| ID | Term |
|---|---|
| D005770 | Gastrointestinal Neoplasms |
| D005221 | Fatigue |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D064869 | Acceptance and Commitment Therapy |
| D004522 | Educational Status |
| D010166 | Palliative Care |
| ID | Term |
|---|---|
| D015928 | Cognitive Behavioral Therapy |
| D001521 | Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
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Advanced gastrointestinal cancer patient-family caregiver dyads (N = 40) were randomly assigned in equal numbers to Acceptance and Commitment Therapy (ACT) or education/support using a stratified block randomization scheme to balance the groups by patient performance status (patient-reported Eastern Cooperative Oncology Group [ECOG] scores 0 or 1 vs. 2).
Not provided
Not provided
Not provided
|
| Education/Support | Behavioral | Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. |
|
| 2 weeks and 3 months post-intervention |
| PROMIS Ability to Participate in Social Roles and Activities | This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers. | 2 weeks and 3 months post-intervention |
| Acceptance and Action Questionnaire-II | This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers. | 2 weeks and 3 months post-intervention |
| McGill Quality of Life Questionnaire-Revised | This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients. | 2 weeks and 3 months post-intervention |
| PROMIS Global Health | This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers. | 2 weeks and 3 months post-intervention |
| Value Progress Subscale of the Valuing Questionnaire. | This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers. | 2 weeks and 3 months post-intervention |
| Indianapolis |
| Indiana |
| 46202 |
| United States |
| Withdrawal by Subject |
|
| Caregiver withdrawn because patient was withdrawn for any reason |
|
| BG001 | Education/Support | Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. |
| BG002 | Total | Total of all reporting groups |
| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Sex data are presented separately for patients and caregivers. | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Racial data are presented separately for patients and caregivers. | Count of Participants | Participants |
|
| Fatigue Interference Subscale of Fatigue Symptom Inventory | Seven items are rated on 11-point scales (0=no interference to 10=extreme interference) that assess the extent to which fatigue in the past week interfered with general level of activity, ability to bathe and dress, normal work activity (including housework), ability to concentrate, relations with others, enjoyment of life, and mood. The seven items are summed with higher total scores indicating greater fatigue interference. The total score range is 0 to 70. This is the primary outcome for patients. | This outcome was only collected on patients. | Mean | Standard Deviation | units on a scale |
|
| Short-Form of Zarit Burden Interview | Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers. | This primary outcome measure was only collected on caregivers. | Mean | Standard Deviation | units on a scale |
|
| Education | Years of education | Education data are presented separately for patients and caregivers. | Mean | Standard Deviation | years |
|
| Household income | Income data were collected in categories. | Income data are presented separately for patients and caregivers. | Count of Participants | Participants |
|
| Caregiver's relationship to the patient | Data are specific to caregivers. | Count of Participants | Participants |
|
| Caregiver lives with the patient | Data are specific to caregivers. | Count of Participants | Participants |
|
| Type of gastrointestinal cancer | Collected from patient medical records | Data are specific to patients. | Count of Participants | Participants |
|
| Time since gastrointestinal cancer diagnosis | Collected from patient medical records at baseline | Data are specific to patients. | Mean | Standard Deviation | years |
|
| Chemotherapy | Collected from patient medical records at baseline | Data are specific to patients. | Count of Participants | Participants |
|
| Radiation | Data collected from patient medical records at baseline. | Data are specific to patients. | Count of Participants | Participants |
|
| Chemoradiation | Data collected from patient medical records at baseline. | Data are specific to patients. | Count of Participants | Participants |
|
| Surgery to remove primary tumor | Data were collected from patient medical records at baseline. | Data are specific to patients. | Count of Participants | Participants |
|
| Surgery to remove metastases | Data were collected from patient medical records at baseline. | Data are specific to patients. | Count of Participants | Participants |
|
| Targeted Therapy | Data were collected from patient medical records at baseline. | Data are specific to patients. | Count of Participants | Participants |
|
| OG001 | Education/Support | Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. |
|
|
|
| Primary | Short-form of Zarit Burden Interview | Twelve items are rated on 5-point scales (0=never to 4=nearly always) that assess personal strain and role strain due to caregiving. The 12 items are summed with higher total scores indicating greater caregiving burden. The total score range is 0 to 48. This is the primary outcome for caregivers. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | Patient-Reported Outcome Measurement Information System (PROMIS) Sleep-Related Impairment | This 8-item measure assesses the perceived interference of sleep problems with activities, mood, and cognition (e.g., difficulty concentrating or completing tasks). Each item is rated on a scale from 1 (not at all) to 5 (very much). Item #2 is reverse-scored and then the 8 items are summed with higher total scores indicating greater sleep-related impairment. The total scores are converted to T-scores with a range from 30.0 to 80.1. Higher T-scores indicate a worse outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for patients. | Posted | Mean | Standard Deviation | T-score | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | PROMIS Ability to Participate in Social Roles and Activities | This 6-item measure assesses participants' ability to participate in social roles and activities. The items measure difficulty engaging in social and recreational activities as well as usual work (including housework). Each item is rated on a scale from 1 (never) to 5 (always) and is reverse coded. Then the six items are summed with higher total scores indicating greater ability to participate in social roles and activities. The total scores are converted to T-scores with a range from 26.7 to 65.0 with higher scores indicating a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome for both patients and caregivers. | Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm | Posted | Mean | Standard Deviation | T-score | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | Acceptance and Action Questionnaire-II | This 7-item measure assesses psychological flexibility, or the ability to fully experience the present moment while persisting in actions aligned with personal values. Each item is rated on a scale from 1 (never true) to 7 (always true). The seven items are summed with higher total scores indicating greater levels of psychological inflexibility. The total score range is 7 to 49. This is a secondary outcome for both patients and caregivers. | Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | McGill Quality of Life Questionnaire-Revised | This 15-item measure evaluates physical, psychological, existential, and social quality of life in patients with serious illnesses. Each of the 4 subscale scores (i.e., physical, psychological, existential, and social quality of life) is the sum of the items with higher scores indicating better quality of life. Items are rated on 0 to 10 scales. The physical quality of life subscale is the sum of 3 items (2 items reverse-coded) with a range of 0 to 30. The psychological quality of life subscale is the sum of 4 items (all items reverse-coded) with a range of 0 to 40. The existential quality of life subscale is the sum of 4 items (1 item reverse-coded) with a range of 0 to 40. The social quality of life subscale is the sum of 3 items (none reverse-coded) with a range of 0 to 30. This is a secondary outcome measure for patients. | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | PROMIS Global Health | This 10-item measure assesses global health, including physical, mental, and social well-being. With the exception of pain, which is rated on a 0 to 10 scale, all items are rated on 5-point scales from 1 to 5. The item on pain is recoded from a 0-10 to a 1-5 scale and reverse-scored. Two additional items are reverse-scored. Then four of the items are summed, with higher physical quality of life subscale scores indicating better physical quality of life. Four other items are also summed with higher psychological quality of life subscale scores indicating better psychological quality of life. The subscale scores are converted to T-scores with a range from 16.2 to 67.7 for physical quality of life and a range from 21.2 to 67.6 for psychological quality of life. Higher T-scores for the physical and psychological quality of life subscales indicate a better outcome. The population mean for T-scores is 50 with a standard deviation of 10. This is a secondary outcome measure for caregivers. | Posted | Mean | Standard Deviation | T-score | 2 weeks and 3 months post-intervention |
|
|
|
|
| Secondary | Value Progress Subscale of the Valuing Questionnaire. | This 5-item subscale assesses progress in living according to one's personal values, a construct related to activity engagement. Items are rated on 0 to 6 scales. The 5 items are summed with higher total subscale scores indicating greater progress in living according to one's personal values. The total subscale score range is 0 to 30. This is a secondary outcome measure for patients and caregivers. | Number analyzed = 20 patients and 20 caregivers in the Acceptance and Commitment Therapy arm and 20 patients and 20 caregivers in the Education/Support arm | Posted | Mean | Standard Deviation | units on a scale | 2 weeks and 3 months post-intervention |
|
|
|
|
| 1 |
| 20 |
| 1 |
| 20 |
| 0 |
| 20 |
| EG001 | Education/Support | Patients and caregivers in the education/support arm discuss their cancer-related concerns and receive education on services available in their medical center and community. Education/Support: Across six weekly 50-minute sessions, advanced GI cancer patients and caregivers are directed to resources for practical and health information and contact information for psychosocial services. Sessions include an orientation to the patient's medical center and treatment team, education regarding common quality-of-life concerns experienced by cancer patients and caregivers, and an overview of medical center and community resources for addressing these concerns. The therapist also describes resources for addressing financial concerns and methods of evaluating health information available via the Internet and other modalities. Participants receive handouts summarizing session topics and are asked to review them as homework. | 2 | 20 | 2 | 20 | 0 | 20 |
| EG002 | Before Randomization | All-cause mortality and adverse events prior to randomization to a study arm | 1 | 22 | 1 | 22 | 0 | 22 |
|
Not provided
Not provided
Not provided
| D005767 |
| Gastrointestinal Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012959 | Socioeconomic Factors |
| D011154 | Population Characteristics |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D006296 | Health Services |
| D005159 | Health Care Facilities Workforce and Services |
| Male |
|
| Unknown or Not Reported |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| Asian |
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|
| $100,000 or more |
|
| Missing data |
|
| $51,000-$99,999 |
|
| $100,000 or more |
|
| Missing data |
|
| Other gastrointestinal cancer |
|
| Patient ability to participate in social roles and activities at 3 months post-intervention |
|
|
| Caregiver ability to participate in social roles and activities at 2 weeks post-intervention |
|
|
| Caregiver ability to participate in social roles and activities at 3 months post-intervention |
|
|
| Patient psychological inflexibility at 3 months post-intervention |
|
|
| Caregiver psychological inflexibility at 2 weeks post-intervention |
|
|
| Caregiver psychological inflexibility at 3 months post-intervention |
|
|
| Patient psychological quality of life at 2 weeks post-intervention |
|
| Patient psychological quality of life at 3 months post-intervention |
|
| Patient existential quality of life at 2 weeks post-intervention |
|
| Patient existential quality of life at 3 months post-intervention |
|
| Patient social quality of life at 2 weeks post-intervention |
|
| Patient social quality of life at 3 months post-intervention |
|
| Mixed Models Analysis |
degrees of freedom = 76. Multiply imputed data were used. |
| 0.24 |
P-value for study group x time interaction for patient psychological quality of life. Two-tailed p-values <.05 were considered statistically significant. |
| partial correlation |
| 0.14 |
| 2-Sided |
| 95 |
| -0.18 |
| 0.45 |
| Superiority |
| Mixed Models Analysis | degrees of freedom = 76. Multiply imputed data were used. | 0.78 | P-value for study group x time interaction for patient existential quality of life. Two-tailed p-values <.05 were considered statistically significant. | partial correlation | 0.06 | 2-Sided | 95 | -0.26 | 0.37 | Superiority |
| Mixed Models Analysis | degrees of freedom = 76. Multiply imputed data were used. | 0.29 | P-value for study group x time interaction for patient social quality of life. Two-tailed p-values <.05 were considered statistically significant. | partial correlation | 0.13 | 2-Sided | 95 | -0.19 | 0.44 | Superiority |
| Caregiver psychological quality of life at 2 weeks post-intervention |
|
| Caregiver psychological quality of life at 3 months post-intervention |
|
| Mixed Models Analysis |
degrees of freedom = 76. Multiply imputed data were used. |
| 0.79 |
P-value for study group x time interaction for caregiver psychological quality of life. Two-tailed p-values <.05 were considered statistically significant. |
| partial correlation |
| 0.06 |
| 2-Sided |
| 95 |
| -0.26 |
| 0.37 |
| Superiority |
| Patient values progress at 3 months post-intervention |
|
|
| Caregiver values progress at 2 weeks post-intervention |
|
|
| Caregiver values progress at 3 months post-intervention |
|
|