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| ID | Type | Description | Link |
|---|---|---|---|
| 1K01HD110719 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
| Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) | NIH |
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This is a Phase 2 prospective, randomized, controlled, double-arm study to assess personalized self-management training (PSMT) intervention efficacy and patient experiences compared to standardized self-management training (SSMT). A total of 120 gastrointestinal (GI) cancer patients will be enrolled and randomized 1:1 to complete a 6-week self-management training program (either PSMT or SSMT) to be carried out by licensed occupational therapists with doctoral training.
This study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in GI cancer patients.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RISE-PSMT | Experimental | Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program. |
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| SSMT | Placebo Comparator | Standardized self-management training. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RISE Personalized Self-Management Training (PSMT) | Behavioral | Along with patient education and internalization of self-determination, the RISE intervention focuses on replacing unhealthy habits with health-promoting habits. Ongoing practice and guidance in generating and enacting SMART (specific, measurable, achievable, realistic, and time-bound) health goals is the centerpiece of the RISE intervention. Working one-on-one with the PI, participants will set goals and develop practical strategies to establish sustainable healthy behavior (HB) change. Motivational interviewing, cognitive behavioral therapy, and patient education will accompany intensive collaborative problem-solving and creation of accountability structures to create lasting change. The 6-week intervention includes 2 in-person visits and 4 videoconference sessions. |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups. | Outcome measures contributing to each component of WCRF/AICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF/AICR scale comprises of 7 categories with each category given a score for non-/low adherence, moderate/some adherence, or full adherence to each HBR. Total value ranges from 0 to 7 points, with a higher score indicating better adherence. HBR items include body composition, physical activity, diet, and alcohol use. | 12 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| The difference in general self-efficacy between the two groups after the 6-week self-management program will be measured by Patient-Reported Outcomes Measurement Systems (PROMIS) Item Bank v1.0 - General Self-Efficacy Short Form 4a. | Responses to this questionnaire will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up 6 Weeks Post-Session 6. The questionnaire asks the subject to rate their confidence levels in managing various situations, problems, and events. There are a total of 4 questions, and each question is answered on a scale of 1-4 where higher scores indicate the highest level of confidence. Total value ranges from 4 to 20, with a higher score indicating higher self-efficacy or highest level of confidence. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Alix G Sleight, PhD, OTD, MPH, OTR/L | Contact | 323-442-0146 | alix.sleight@chan.usc.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alix G Sleight, PhD, OTD, MPH, OTR/L | University of Southern California | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cedars-Sinai Medical Center | Active, not recruiting | Los Angeles | California | 90048 | United States | |
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| Standardized Self-Management Training (SSMT) | Behavioral | Participants randomized to the control condition will receive 6 standardized sessions from one of the occupational therapy (OT) interveners, matched to the PSMT for setting. At these visits, participants will be presented with slides containing pre-specified, standardized didactic content about the World Cancer Research Fund/American Institute for Cancer Research (WCRF/AICR) healthy behavior recommendations (HBRs). We hypothesize that these visits will control for the effect of research participation and increased knowledge about HBRs, and that simply providing standardized didactic content as an intervention modality without any personalization will have negligible effects on participants' healthy behaviors (HBs), self-efficacy, or quality of life. Content will follow the WCRF/AICR HBRs. Weeks 1-2 will focus on physical activity; weeks 3-4 will focus on diet and alcohol, and weeks 5-6 will focus on weight management and generalized strategies for HB change. |
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| 12 weeks. |
| To evaluate the difference in health-related quality of life between the two groups after completion of the self-management program, we will use the PROMIS Scale v1.2 - Global Health questionnaire . | Responses will be collected at Baseline (Session 1), End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks post Session 6).The questionnaire includes the following components to assess subject's rating on their global physical and mental health: 6 questions are each answered on a scale of 1-5 where higher scores indicate excellent health, 1 question is answered on a scale of 1-5 where higher scores indicate being able to completely carry out everyday physical activities, and the last 3 questions are answered on a scale of 1-5 where higher scores indicate less frequency or no occurrences of fatigue, pain, or emotional problems. | 12 weeks. |
| To assess percent change across the various component scores on the WCRF/AICR (e.g. grams of fiber) to better understand what might be driving any changes in the overall WCRF/AICR composite score. | To assess percent change across the various component scores on the WCRF/AICR, the WCRF/AICR will be collected at Screening, Baseline (Session 1) unless screening visit was <30 days ago, End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks Post Session 6). | 12 weeks |
| University of Southern California |
| Recruiting |
| Los Angeles |
| California |
| 90089 |
| United States |
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| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D015438 | Health Behavior |
| D005770 | Gastrointestinal Neoplasms |
| ID | Term |
|---|---|
| D007414 | Intestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D001519 | Behavior |
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