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Physical Activity and Education for Colorectal Cancer (CHALLENGE Trial)

N/A
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Completely resected histologically confirmed adenocarcinoma of the colon
T4 lesions
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 10 years
Awards & highlights
No Placebo-Only Group

CHALLENGE Trial Summary

This trial is studying a physical activity program given together with health education materials to see how well it works compared with giving health education materials alone for patients who have undergone treatment for high-risk stage II or stage III colon cancer.

Who is the study for?
This trial is for patients who've completed certain chemotherapy for high-risk stage II or III colon cancer within the last 60-180 days. They should be able to communicate, complete questionnaires and exercise tests, not meet current physical activity guidelines, and have no evidence of recurring cancer. Pregnant individuals or those planning pregnancy in the next 3 years are excluded.Check my eligibility
What is being tested?
The study compares two approaches: one group receives health education materials plus a physical activity program designed to increase free time physical activity; another group gets only the health education materials. The goal is to see which method better prevents cancer recurrence and improves fitness and well-being.See study design
What are the potential side effects?
Since this trial involves exercise and educational interventions rather than drugs, side effects may include typical exercise-related issues such as muscle soreness or strain. Psychological discomfort could also occur due to changes in lifestyle or from discussing health-related topics.

CHALLENGE Trial Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My colon cancer was surgically removed and confirmed by a lab test.
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My cancer is at stage T4.
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My cancer is of a type that grows and spreads quickly.
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My cancer is at stage III, confirmed by a positive lymph node or tumor deposit.
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I finished my chemotherapy between 2 to 6 months ago.
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My cancer is high-risk stage II with specific features.
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I do not have rectal cancer.
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My colon cancer was surgically removed and confirmed by a lab test.
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My cancer is high-risk stage II with specific features.
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My cancer is stage III with at least one confirmed positive lymph node.
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I have another primary cancer in my colon.
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I completed a 5-fluorouracil-based chemotherapy for colon cancer.
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I finished chemotherapy between 2 to 6 months ago.
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My recent scans show no signs of my colon cancer spreading or returning.
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I do not have rectal cancer.
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I am fully active or can carry out light work.
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I have no cancer history, except for certain types treated over 5 years ago.

CHALLENGE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~10 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and 10 years for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Disease-free survival
Secondary outcome measures
Correlative biological markers including biochemical and molecular markers associated with insulin-related growth factor and cytokines associated with the mechanisms of fatigue
Economic evaluations including cost-effective analysis and cost utility analysis
Objective markers of physical fitness (i.e., body mass index, hip and waist circumference, cardiovascular fitness, and physical function)
+5 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

CHALLENGE Trial Design

2Treatment groups
Active Control
Group I: Physical Activity Program + General Health Education MaterialsActive Control9 Interventions
Intervention Arm
Group II: General Health Education MaterialsActive Control7 Interventions
Control Arm

Find a Location

Who is running the clinical trial?

Canadian Cancer Trials GroupLead Sponsor
122 Previous Clinical Trials
66,663 Total Patients Enrolled
Queen's University, BelfastOTHER
163 Previous Clinical Trials
134,144 Total Patients Enrolled
Survivorship Research GroupUNKNOWN

Media Library

Health Education Materials Clinical Trial Eligibility Overview. Trial Name: NCT00819208 — N/A
Colorectal Cancer Research Study Groups: Physical Activity Program + General Health Education Materials, General Health Education Materials
Colorectal Cancer Clinical Trial 2023: Health Education Materials Highlights & Side Effects. Trial Name: NCT00819208 — N/A
Health Education Materials 2023 Treatment Timeline for Medical Study. Trial Name: NCT00819208 — N/A
Colorectal Cancer Patient Testimony for trial: Trial Name: NCT00819208 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are currently being recruited for this trial?

"Correct. According to the information on clinicaltrials.gov, this medical trial is actively recruiting patients since first being posted in December 2008 and recently updated in October 2022. There are 23 sites that need to enroll a total of 962 participants."

Answered by AI

How many locations are administering this experimental trial?

"Presently, this medical research project is running in 23 centres across the nation; Toronto, Saskatoon, Edmonton and an additional 20 cities are all participating. To reduce strain associated with travel for patients involved in the trial, it may be wise to join a centre close by."

Answered by AI

Is enrollment in this experiment still available for participants?

"According to the information listed on clinicaltrials.gov, this medical experiment is currently recruiting participants and has been since December 3rd 2008. The trial was last amended on October 7th 2022."

Answered by AI

Who else is applying?

What state do they live in?
New Hampshire
Ohio
What portion of applicants met pre-screening criteria?
Did not meet criteria
What site did they apply to?
Dartmouth-Hitchcock
How many prior treatments have patients received?
0

Why did patients apply to this trial?

Seeing if this might help me deal with my cancer. I have cml and am suffering a lot of stress and anxiety and pain and nausea.
PatientReceived 1 prior treatment
Recent research and studies
~249 spots leftby Dec 2029