Physical Activity and Education for Colorectal Cancer

(CHALLENGE Trial)

Recruiting at48 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Canadian Cancer Trials Group

No Placebo Group

Trial Summary

What is the purpose of this trial?

RATIONALE: Participating in a physical activity program designed to increase free time physical activity and receiving written health education materials may influence the chance of cancer recurring as well as impact on physical fitness, psychological well-being and the quality of life of patients who have undergone surgery and chemotherapy for colon cancer. It is not yet known whether giving a physical activity program together with health education materials is more effective than giving health education materials alone for patients who have undergone colon cancer treatment. PURPOSE: This randomized phase III 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.

Research Team

Janette Vardy, PhD, FRACP

Principal Investigator

Sydney Cancer Centre at Concord Repatriation General Hospital

Kerry Courneya, PhD

Principal Investigator

University of Alberta

Christopher Booth, MD

Principal Investigator

Cancer Centre of Southeastern Ontario at Kingston General Hospital

Eligibility Criteria

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.

Inclusion Criteria

Your platelet count is at least 100,000 per cubic millimeter.

My cancer is at stage T4.

My cancer is at stage III, confirmed by a positive lymph node or tumor deposit.

Exclusion Criteria

I am not currently receiving any other chemotherapy or radiation treatments.

I am not currently on any cancer treatments like chemotherapy.

I have had radiotherapy for my initial cancer.

Treatment Details

Interventions

• Health Education Materials (Behavioral Intervention)
• Physical Activity Program (Behavioral Intervention)

Trial Overview 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.

Participant Groups

Group I: Physical Activity Program + General Health Education Materials Active Control 9 Interventions

Intervention Arm

Group II: General Health Education Materials Active Control 7 Interventions

Control Arm

Who Is Running the Clinical Trial?

Canadian Cancer Trials Group

Lead Sponsor

Trials

135

Recruited

70,300+

Dr. Janet Dancey

Canadian Cancer Trials Group

Chief Medical Officer since 2014

MD, FRCPC

Susan Marlin

Canadian Cancer Trials Group

Chief Executive Officer since 2012

BSc (Hons) from Dalhousie University, MSc in Community Health and Epidemiology from Queen’s University

Queen's University, Belfast

Collaborator

Trials

179

Recruited

142,000+

Professor Sir Ian Greer

Queen's University, Belfast

Chief Executive Officer since 2018

MD from the University of Glasgow

Dr. Joann

Queen's University, Belfast

Chief Medical Officer since 2023

PhD in Molecular Pharmacology

Survivorship Research Group

Collaborator

Trials

1

Recruited

890+