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Behavioural Intervention
Exercise Intervention for Colorectal Cancer Survivors
N/A
Waitlist Available
Led By Heather Greenlee
Research Sponsored by Fred Hutchinson Cancer Center
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 at 8 weeks
Awards & highlights
Study Summary
This trial studies if exercise can improve outcomes of colorectal cancer by influencing the bacteria in the gut. The results may show that exercise can help people with colorectal cancer.
Who is the study for?
This trial is for stage II-III colorectal cancer survivors aged 18-70, with a BMI of 18.5-30, not currently smoking or pregnant, and within 60 days to 3 years post-cancer treatment. Participants must be able to exercise, have smartphone access, and commit to attending the study sessions.Check my eligibility
What is being tested?
The trial studies how an exercise program affects gut bacteria in colorectal cancer survivors. It involves moderate-to-vigorous workouts at a research center, along with health education and monitoring through interviews and questionnaires.See study design
What are the potential side effects?
Since this intervention focuses on exercise rather than medication, side effects are minimal but may include typical exercise-related discomforts such as muscle soreness or fatigue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ at 8 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 8 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Acceptability
Adherence
Recruitment
+1 moreSecondary outcome measures
Effects of an 8 week supervised exercise intervention on fecal concentrations of butyrate
Effects of an 8 week supervised exercise intervention on fecal concentrations of other short chain fatty acids
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Arm A (exercise intervention)Experimental Treatment4 Interventions
Patients receive the supervised exercise intervention over 8 weeks on study. Patients also undergo collection of blood samples at baseline and week 8.
Group II: Arm B (waitlist control)Active Control5 Interventions
Patients receive health-related information for 8 weeks on study. Patients are then offered a session of supervised exercise followed by 7 weeks of tele-coaching sessions. Patients also undergo collection of blood samples at baseline and week 8.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Biospecimen Collection
2004
Completed Phase 2
~1730
Find a Location
Who is running the clinical trial?
Fred Hutchinson Cancer CenterLead Sponsor
556 Previous Clinical Trials
1,343,238 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,123 Total Patients Enrolled
Heather GreenleePrincipal InvestigatorFred Hutch/University of Washington Cancer Consortium
3 Previous Clinical Trials
760 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My BMI is either below 18.5 or above 30.I have not taken antibiotics, antifungals, or antiparasitics in the last 6 months.I am not pregnant, breastfeeding, nor planning to become pregnant.I have an ileostomy or colostomy.I had stage II-III colon cancer but currently have no signs of it spreading.It's been 2 months to 3 years since my last cancer treatment.I have a phone for study communications.My doctor has approved me for an 8-week exercise program.I am fully active or can carry out light work.I have an inflammatory bowel disease like Crohn's or ulcerative colitis.I am between 18 and 70 years old.
Research Study Groups:
This trial has the following groups:- Group 1: Arm A (exercise intervention)
- Group 2: Arm B (waitlist control)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
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.
Am I eligible to become part of this experiment?
"This medical trial is seeking a total of 30 participants with colorectal cancer aged between 18 and 70 years old."
Answered by AI
Does this clinical experiment accept participants older than two decades?
"This clinical trial is recruiting patients aged between 18 to 70. Separately, there are 29 studies for minors and 895 trials targeting senior citizens."
Answered by AI
Is the enrollment period for this trial still open?
"The clinical trial in question is not presently accepting any new patients, having been first posted on November 1st 2023 and last updated on June 26th 2023. However, there are 907 other medical studies actively seeking volunteers at this time."
Answered by AI
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