[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"trial:NCT05984589":3,"trial-entities:NCT05984589":110,"trial-summary:NCT05984589":115},{"id":4,"nct_id":4,"org_study_id":5,"brief_title":6,"official_title":7,"overall_status":8,"completion_date":9,"status_verified_date":10,"last_update_date":11,"start_date":12,"sponsor_name":13,"lead_sponsor_class":14,"has_dmc":15,"brief_summary":16,"detailed_description":17,"conditions":18,"keywords":24,"study_type":26,"primary_purpose":27,"phases":28,"enrollment_info":30,"interventions":33,"primary_outcomes":45,"secondary_outcomes":50,"sex":61,"minimum_age":62,"maximum_age":17,"healthy_volunteers":63,"eligibility_criteria":64,"std_ages":76,"locations":79,"central_contacts":102,"overall_officials":106,"references":108,"see_also_links":109},"NCT05984589","3C-24-9","Personalized Health Self-Management Training for Colorectal Cancer Survivors","A Prospective, Randomized, Controlled, Double-Arm Study of RISE (Re-Invent, Integrate, Strengthen, Expand) Personalized Self-Management Training (PSMT) Compared to Standardized Self-Management Training (SSMT) in Gastrointestinal Cancer (GI) Patients","RECRUITING","2028-11-30","2026-03","2026-06-10","2024-03-01","University of Southern California","OTHER",true,"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.\n\nThis study aims to examine whether PSMT is more effective in increasing adherence to healthy behavior recommendations compared to SSMT in GI cancer patients.",null,[19,20,21,22,23],"Colorectal Cancer","Healthy Lifestyle","Behavior, Health","Health Behavior","Gastrointestinal Cancers",[25],"self-management training","INTERVENTIONAL","SUPPORTIVE_CARE",[29],"NA",{"count":31,"type":32},120,"ESTIMATED",[34,40],{"type":35,"name":36,"description":37,"armGroupLabels":38},"BEHAVIORAL","RISE Personalized Self-Management Training (PSMT)","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.",[39],"RISE-PSMT",{"type":35,"name":41,"description":42,"armGroupLabels":43},"Standardized Self-Management Training (SSMT)","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\u002FAmerican Institute for Cancer Research (WCRF\u002FAICR) 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\u002FAICR 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.",[44],"SSMT",[46],{"measure":47,"description":48,"timeFrame":49},"To compare the difference in WCRF\u002FAICR score between the intervention (RISE-PSMT) and control (SSMT) groups.","Outcome measures contributing to each component of WCRF\u002FAICR Healthy Behavior Adherence scale will be collected from baseline and end-of-study visits (Session 6 and Follow-up). The WCRF\u002FAICR scale comprises of 7 categories with each category given a score for non-\u002Flow adherence, moderate\u002Fsome 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.",[51,54,57],{"measure":52,"description":53,"timeFrame":49},"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.",{"measure":55,"description":56,"timeFrame":49},"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.",{"measure":58,"description":59,"timeFrame":60},"To assess percent change across the various component scores on the WCRF\u002FAICR (e.g. grams of fiber) to better understand what might be driving any changes in the overall WCRF\u002FAICR composite score.","To assess percent change across the various component scores on the WCRF\u002FAICR, the WCRF\u002FAICR will be collected at Screening, Baseline (Session 1) unless screening visit was \\\u003C30 days ago, End of Study Week 6 (Session 6), and Follow-up Visit (6 weeks Post Session 6).","12 weeks","ALL","18 Years",false,{"inclusion":65,"exclusion":73,"raw_text":75},[66,67,68,69,70,71,72],"Age ≥18 years at the time of consent.","History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment.","Ability to speak, write, and read English sufficiently to allow for program participation.","Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use.","Scoring ≤3.5 on the World Cancer Research Fund\u002FAmerican Institute for Cancer Research (WCRF\u002FAICR) Health Behavior Adherence Scale or in the low-to-moderate range in any subcategory consistent with moderate to low adherence to healthy behavior recommendations (HBRs).","Ambulatory and independent in activities of daily living (ADL).","Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.",[74],"Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.","Inclusion Criteria:\n\n* Age ≥18 years at the time of consent.\n* History of Stage I-IV colorectal cancer (CRC) or other gastrointestinal cancer within the past 10 years prior to enrollment.\n* Ability to speak, write, and read English sufficiently to allow for program participation.\n* Identified by self-report as having willingness and interest to work on at least one lifestyle-related risk factor. Lifestyle-related risk factors include diet, physical activity, body composition, alcohol use.\n* Scoring ≤3.5 on the World Cancer Research Fund\u002FAmerican Institute for Cancer Research (WCRF\u002FAICR) Health Behavior Adherence Scale or in the low-to-moderate range in any subcategory consistent with moderate to low adherence to healthy behavior recommendations (HBRs).\n* Ambulatory and independent in activities of daily living (ADL).\n* Written informed consent obtained from subject and ability for subject to comply with the requirements of the study.\n\nExclusion Criteria:\n\n* Cognitive or mental impairments that in the opinion of the Principal Investigator or study physician would hinder the program participation.",[77,78],"ADULT","OLDER_ADULT",[80,90],{"facility":81,"status":82,"city":83,"state":84,"zip":85,"country":86,"geoPoint":87},"Cedars-Sinai Medical Center","ACTIVE_NOT_RECRUITING","Los Angeles","California","90048","United States",{"lat":88,"lon":89},34.05223,-118.24368,{"facility":13,"status":8,"city":83,"state":84,"zip":91,"country":86,"contacts":92,"geoPoint":101},"90089",[93,98],{"name":94,"role":95,"phone":96,"email":97},"Johanna Carrera","CONTACT","323-442-0146","Johanna.CarreraCajabon@med.usc.edu",{"name":99,"role":100},"Alix G Sleight@chan.usc.edu, PhD, OTD, MPH, OTR\u002FL","PRINCIPAL_INVESTIGATOR",{"lat":88,"lon":89},[103],{"name":104,"role":95,"phone":96,"email":105},"Alix G Sleight, PhD, OTD, MPH, OTR\u002FL","alix.sleight@chan.usc.edu",[107],{"name":104,"affiliation":13,"role":100},[],[],{"nct_id":4,"conditions":111,"biomarkers":114},[112,113],"Colorectal Carcinoma","Malignant Digestive System Neoplasm",[],{"nct_id":4,"found":15,"summary":116,"prompt_version":124},{"design":117,"status":118,"heading":6,"summary":119,"follow_up":117,"word_count":120,"commitments":121,"compensation":122,"drugs_mentioned":123},"Not specified.","completed","{\n   \"Personalized Health Self-Management Training for Colorectal Cancer Survivors\",\n   \"This study is testing two types of self-management training programs for people who have had colorectal or other gastrointestinal (GI) cancer. One program, called RISE Personalized Self-Management Training (PSMT), helps you replace unhealthy habits with healthy ones by setting specific, measurable goals. The other, Standardized Self-Management Training (SSMT), provides general health information. The study wants to see if PSMT is better at helping people follow healthy lifestyle recommendations. You can join if you are at least 18 years old, have a history of GI cancer, can read and write English, and are interested in improving your lifestyle. The study is currently unclear about its recruitment status and plans to enroll 120 participants.\",\n  \"design\": \"This is a Phase 2 study that will randomly assign 120 participants to receive either personalized or standardized self-management training. It is a controlled study, meaning one group receives the new approach while the other receives a standard approach.\",\n  \"commitments\": \"You would participate in a 6-week self-management training program led by occupational therapists. The primary outcome will be measured at 12 weeks.\",\n  \"compensation\": \"Not stated in the trial record.\",\n  \"follow_up\": \"The main outcome of the study will be measured at 12 weeks after the training begins.\",\n}",209,"Not specified in the trial record.","Not stated in the trial record.",[36,41],"v2"]