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| ID | Type | Description | Link |
|---|---|---|---|
| WFBCCC 99420 | Other Identifier | Wake Forest Baptist Comprehensive Cancer Center | |
| 1P50CA244693-01 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The primary purpose of this study is conduct a pilot study testing the study protocols, implementation program, and mixed-methods data collection.
Primary Objectives:
• To evaluate how successfully SHARE-S can be implemented into clinical care as characterized by rates of enrollment. Investigators hypothesize >30% of patients e-referred to SHARE-S will enroll.
Secondary Objectives:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| SHARE-S | Experimental | Three components consisting of electronic referral, health coaching and tailored text/email messages for patients that have been referred to the cancer survivorship clinic. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SHARE-S Implementation Program | Behavioral | The program consists of three components: An electronic referral among clinical teams for potential participants, patient engagement with survivorship care planning guidelines through self-management/health coaching. One coaching call before a clinic visit (60 minutes) and two coaching calls after the clinic visit (30 minutes each). Participants will also receive automated, tailored text messages (daily for three weeks before and after a clinic visit for a total of six weeks). |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Patients Enrolled Out of Those Electronically Referred | Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S. | 1 year, 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review] | Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S | 1 year, 8 months |
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Inclusion Criteria:
Children under the age of 18 with cancer will be excluded due to the potentially different self-management support intervention needs of this population that will likely include parental involvement. Results from this research may inform future studies in children with cancer under 18 who should be researched separately.
Exclusion Criteria
- Declined participation in the study
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| Name | Affiliation | Role |
|---|---|---|
| Stephanie Sohl, Ph.D | Wake Forest University Health Sciences | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Wake Forest Baptist Comprehensive Cancer Center | Winston-Salem | North Carolina | 27157 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | SHARE-S Intervention | SHARE-S Intervention |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Single Arm | Intervention |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Patients Enrolled Out of Those Electronically Referred | Using a 95% confidence interval (CI) to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to be referred to SHARE-S. | Total number reflects the total number of participants who were electronically referred in SHARE-S intervention. | Posted | Number | 95% Confidence Interval | number of participants | 1 year, 8 months |
|
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Up to 30 days after the final intervention session.
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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 | Overall | Single Arm - Intervention | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Carol Kittel | Wake Forest Baptist Comprehensive Cancer Center | 336-399-3832 | c.kittel@wakehealth.edu |
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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 | Sep 15, 2021 | Feb 9, 2023 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Nov 17, 2021 | Jun 30, 2022 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
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|
| Acceptability of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability. | Up to 30 days after the final intervention session. |
| Appropriateness of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness. | Up to 30 days after the final intervention session. |
| Number of Participants Enrolled Per Month | This will be defined as the average number of participants that enroll per month that the study is open to enrollment. | 1 year, 8 months |
| Feasibility of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility. | Up to 30 days after the final intervention session. |
| Retention Rates | Retention is defined as participants that complete the follow up assessment. | Up to 30 days after the final intervention session. |
| Number of Participants Adhering to Text Responses | Defined as participants that adhere to responding to text messages received during intervention. | 1 year, 8 months |
| Participant Adherence to Coaching Sessions | Defined as adherence to completing coaching sessions during the intervention. | 1 year, 8 months |
| Length of Coaching Sessions | Defined as how long each completed coaching sessions lasted during the intervention. | Up to 30 days after the final intervention session. |
| Number of Coaching Sessions Completed | Defined as an observational checklist completed for a subset of coaching sessions. | 1 year, 8 months |
| Total Number of Patients Enrolled | Number of patients enrolled will be defined as overall participants for the entirety of the study. | 1 year, 8 months |
| Frequency of Adverse Events | Adverse events related to the intervention will be assessed in adverse event log. | Up to 30 days after the final intervention session. |
| HEAL Patient-Provider Connection | Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication. | Up to 30 days after the final intervention session. |
| Patient-Reported Health Outcomes PROMIS Profile 29 | Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct. | At baseline and up to 30 days after the final intervention session. |
| 36-Item Short Form Survey (SF-36) | Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health. | At baseline and up to 30 days after the final intervention session. |
| Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings. | At baseline and up to 30 days after the final intervention session. |
| Index of Autonomous Functioning - Self Congruence Subscale Only | The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning. | At baseline and up to 30 days after the final intervention session. |
| Self-Efficacy to Manage Chronic Disease Questionnaire | A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy. | At baseline and up to 30 days after the final intervention session. |
| Engagement With the Survivorship Care Plan | Self-reported use of the care plan since enrolled on the study. | 1 year, 8 months |
| Satisfaction of Care | Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good. | Up to 30 days after the final intervention session. |
| Health Behaviors Questionnaire - Tobacco Use | Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users. | At baseline and up to 30 days after the final intervention session. |
| Health Behaviors Questionnaire - Alcohol Use Disorder | Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous. | At baseline and up to 30 days after the final intervention session. |
| Health Behaviors Questionnaire - Physical Activity | Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with <90 minutes considered insufficient. | At baseline and up to 30 days after the final intervention session. |
| Health Behaviors Questionnaire - Fruit and Vegetable Intake | Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient. | At baseline and up to 30 days after the final intervention session. |
| Health Behaviors Questionnaire - Mindfulness Practice | Participants will be asked individual questions how many days/week they practice mindfulness. | At baseline and up to 30 days after the final intervention session. |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| BMI, Continuous | Mean | Standard Deviation | Kg/m^2 |
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| Marital Status, Categorical | Count of Participants | Participants |
|
| Highest Grade, Categorical | Count of Participants | Participants |
|
| Primary Tumor Site, Categorical | Count of Participants | Participants |
|
| History of Cancer-Related Surgical Procedure, Categorical | Count of Participants | Participants |
|
| History of Radiation Therapy, Categorical | Count of Participants | Participants |
|
| History of Chemotherapy, Categorical | Count of Participants | Participants |
|
| Time since last treatment/surgery (months) | Median | Inter-Quartile Range | months |
|
| Difficult to pay monthly bills, Categorical | Count of Participants | Participants |
|
| Travel to clinic bills (minutes) | Mean | Standard Deviation | minutes |
|
| Use internet or email at least occasionally, Categorical | Count of Participants | Participants |
|
| Confident filling out medical forms, Categorical | Count of Participants | Participants |
|
| Number of times received income assistance, Categorical | Count of Participants | Participants |
|
| Rural residence, Categorical | Count of Participants | Participants |
|
| Participants |
|
|
|
| Secondary | Adoption - Number of Electronically Referred Patients - Those Possible [Based on Chart Review] | Using a 95% confidence interval to determine the range of estimates that are consistent with our data. Investigators will track the number of new patients seen in the Survivorship Clinic, and the percent who agree to enroll in SHARE-S | Total number given a care plan | Posted | Count of Participants | Participants | 1 year, 8 months |
|
|
|
| Secondary | Acceptability of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess acceptability of intervention with different cancer types. Acceptability ranges from 1-5 with higher scores indicating more acceptability. | Initial cohort less 6 lost to follow-up at time of subsequent survey administration | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Appropriateness of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess appropriateness of intervention with different cancer types. Appropriateness ranges from 1-5 with higher scores meaning more appropriateness. | Initial cohort less 6 lost to follow-up at time of subsequent survey administration | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Number of Participants Enrolled Per Month | This will be defined as the average number of participants that enroll per month that the study is open to enrollment. | Number enrolled per month. | Posted | Mean | Full Range | participants/month | 1 year, 8 months |
|
|
|
| Secondary | Feasibility of Intervention Measure | This measure will be used along with qualitative feedback among participants using a mixed-methods to assess feasibility of intervention with different cancer types. Feasibility ranges from 1-5 with higher scores indicating more feasibility. | Initial cohort less 6 lost to follow-up at time of subsequent survey administration | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Retention Rates | Retention is defined as participants that complete the follow up assessment. | SHARE-S Intervention enrolled participants less 5 lost in follow-up. | Posted | Count of Participants | Participants | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Number of Participants Adhering to Text Responses | Defined as participants that adhere to responding to text messages received during intervention. | 40 enrolled | Posted | Count of Participants | Participants | 1 year, 8 months |
|
|
|
| Secondary | Participant Adherence to Coaching Sessions | Defined as adherence to completing coaching sessions during the intervention. | 40 enrolled | Posted | Count of Participants | Participants | 1 year, 8 months |
|
|
|
| Secondary | Length of Coaching Sessions | Defined as how long each completed coaching sessions lasted during the intervention. | 40 enrolled (mean minutes over coach calls at 3 timepoints). | Posted | Mean | Full Range | minutes | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Number of Coaching Sessions Completed | Defined as an observational checklist completed for a subset of coaching sessions. | 40 enrolled | Posted | Number | sessions | 1 year, 8 months |
|
|
|
| Secondary | Total Number of Patients Enrolled | Number of patients enrolled will be defined as overall participants for the entirety of the study. | 40 participants enrolled | Posted | Count of Participants | Participants | 1 year, 8 months |
|
|
|
| Secondary | Frequency of Adverse Events | Adverse events related to the intervention will be assessed in adverse event log. | 40 participants enrolled | Posted | Number | events | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | HEAL Patient-Provider Connection | Patient reported measure of patient-centered communication/relatedness completed only at follow-up. Range 0-35 with higher scores indicating better communication. | Initial cohort with 6 lost to follow-up at time of subsequent survey administration | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Patient-Reported Health Outcomes PROMIS Profile 29 | Questionnaire to assess the social role (0-100), physical functioning (0-100), anxiety (0-100), depression (0-100), fatigue (0-100), sleep disturbance (0-100), pain interference (0-100), pain intensity (0-10). Lower scores indicate less of construct. | 40 enrolled at baseline; 35 available at follow-up | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | 36-Item Short Form Survey (SF-36) | Participants will only answer the single item question that provides an indication of perceived change in health. Score range: 1 - excellent health, 2 - very good health, 3 - good health, 4 - fair health and 5 - poor health. | 40 enrolled at baseline; 35 answered follow-up questionnaire | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Cancer-specific Quality of Life in Adult Cancer Survivors (QLACS) Questionnaire | Investigators will only assess the quality of life of adult cancer survivors measuring domains of cancer survivorship that are cancer-specific. Cancer-Specific Quality of Life (range 15-105) - higher score indicates more quality of life; Benefits of Having Cancer (range 4-28) - higher score indicates more benefits; Positive Feelings (range 4-28) - lower score indicates more positive feelings. | 40 participants at baseline; 35 participants answered follow-up questionnaire | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Index of Autonomous Functioning - Self Congruence Subscale Only | The Index of Autonomous Functioning - self congruence subscale only. 5 Items were paired with a Likert-type scale with 1 = "not at all true", 2 = "a bit true", 3 = "somewhat true", 4 = "mostly true", and 5 = "completely true." Mean score is average of 5 items. Higher mean score indicate a higher level of self congruence functioning. | 40 participants at baseline; 35 participants answered follow-up questionnaire | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Self-Efficacy to Manage Chronic Disease Questionnaire | A questionnaire made up of 6-items on a visual analog scale, ranging from 1 (not at all confident) to 10 (totally confident). Higher the mean score indicates higher self-efficacy. | 40 participants at baseline; 35 participants answered follow-up questionnaire | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Engagement With the Survivorship Care Plan | Self-reported use of the care plan since enrolled on the study. | 34 participants available at follow-up | Posted | Count of Participants | Participants | 1 year, 8 months |
|
|
|
| Secondary | Satisfaction of Care | Participants will evaluate their overall satisfaction with their care after the study intervention. Mean of Likert scale. 1=very poor, 5=very good. | Follow-up only | Posted | Mean | Standard Deviation | score on a scale | Up to 30 days after the final intervention session. |
|
|
|
| Secondary | Health Behaviors Questionnaire - Tobacco Use | Participants will be asked about their tobacco use within the last seven days. Tobacco use is scored 1=yes, 0=no. Higher values represent more participants were tobacco users. | 40 participants at baseline; 34 participants answered follow-up questionnaire | Posted | Count of Participants | Participants | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Health Behaviors Questionnaire - Alcohol Use Disorder | Participants will be asked individual questions about their alcohol use. Alcohol use disorder is on a scale of 0-12 with higher scores indicating more hazardous; men ≥ 4, women ≥ 3 is considered hazardous. | Entire cohort at baseline; 34 participants at follow-up. | Posted | Mean | Standard Deviation | score on a scale | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Health Behaviors Questionnaire - Physical Activity | Participants will be asked individual questions about their physical activity. Physical activity is minutes/week with <90 minutes considered insufficient. | Entire cohort at baseline; 34 participants at follow-up. | Posted | Mean | Standard Deviation | minutes/week | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Health Behaviors Questionnaire - Fruit and Vegetable Intake | Participants will be asked individual questions about their fruit and vegetable intake. Mean for the responses were calculated in cups so ½ to 1 cup = 0.75 cups, at least 2-3 cups for both considered sufficient. | Entire cohort at baseline; 34 participants at follow-up. | Posted | Mean | Standard Deviation | cups/day | At baseline and up to 30 days after the final intervention session. |
|
|
|
| Secondary | Health Behaviors Questionnaire - Mindfulness Practice | Participants will be asked individual questions how many days/week they practice mindfulness. | Entire cohort at baseline; 34 participants at follow-up. | Posted | Mean | Standard Deviation | days/week | At baseline and up to 30 days after the final intervention session. |
|
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|
| 40 |
| 0 |
| 40 |
| 0 |
| 40 |
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| depression (0-100) |
|
| fatigue (0-100) |
|
| sleep disturbance (0-100) |
|
| social roles (0-100) |
|
| pain interference (0-100) |
|
| pain intensity (0-10) |
|
| Positive Feelings |
|