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Behavioural Intervention
Personalized vs Standardized Self-Management Training for Colorectal Cancer
Phase 2
Recruiting
Led By Alix G Sleight, PhD, OTD, MPH, OTR/L
Research Sponsored by Alix G. Sleight, PhD
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 12 weeks
Awards & highlights
Study Summary
This trial will compare two self-management programs to see which is more effective for colorectal cancer patients. It's led by occupational therapists with doctoral training.
Who is the study for?
This trial is for adults over 18 who've had Stage I-III colorectal cancer in the last year, are willing to improve at least one lifestyle risk factor like diet or exercise, and can speak English. They should have moderate to low adherence to healthy behaviors but can't be planning major cancer treatments within 6 months or have stage IV cancers.Check my eligibility
What is being tested?
The study compares two types of self-management training programs for colorectal cancer patients: a personalized program (PSMT) and a standardized one (SSMT). Each patient will undergo a 6-week course led by specialized occupational therapists to see if PSMT leads to better health behavior adherence.See study design
What are the potential side effects?
Since this trial involves self-management training rather than medication, traditional side effects aren't expected. However, participants may experience stress or discomfort from lifestyle changes such as new diets or exercise routines.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 12 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~12 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
To compare the difference in WCRF/AICR score between the intervention (RISE-PSMT) and control (SSMT) groups.
Secondary outcome measures
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.
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 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 .
Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RISE-PSMTExperimental Treatment1 Intervention
Personalized self-management training using RISE (Re-Invent, Integrate, Strengthen, Expand) program.
Group II: SSMTPlacebo Group1 Intervention
Standardized self-management training.
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Who is running the clinical trial?
Alix G. Sleight, PhDLead Sponsor
National Institutes of Health (NIH)NIH
2,701 Previous Clinical Trials
7,506,730 Total Patients Enrolled
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)NIH
1,965 Previous Clinical Trials
2,672,677 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My cancer has spread to other parts of my body.I am willing to work on improving my diet, exercise, body weight, or alcohol use.I plan to undergo cancer treatment, excluding long-term hormonal or biologic therapy, within the next 6 months.I was diagnosed with Stage I-III colorectal cancer in the last year.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: RISE-PSMT
- Group 2: SSMT
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is RISE-PSMT a viable option for individuals in terms of safety?
"Our team at Power rated RISE-PSMT with a safety score of 2 since it is only in Phase 2, so there are some studies that prove its safety but none confirming efficacy."
Answered by AI
Are there any open registration slots for this clinical experiment?
"According to the data found on clinicaltrials.gov, this medical study is not presently looking for new participants and has been inactive since August 2nd 2023. Nevertheless, there are still 1254 other trials searching actively seeking patients at this time."
Answered by AI
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