Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

NCT00819208 | Completed Results DMC

• 3 other identifiers: CO21CAN-NCIC-CO21CDR0000629834
• Study Type: interventional
• Target: 889
• Locations: 6 countries
• Sites: 47

Brief Summary

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.

Conditions

Anxiety Disorder; Cognitive/Functional Effects; Colorectal Cancer; Depression; Fatigue; Psychosocial Effects of Cancer and Its Treatment; Sleep Disorders; Excercise

Keywords

fatigue; sleep disorders; depression; anxiety disorder; psychosocial effects of cancer and its treatment; cognitive/functional effects; stage II colon cancer; stage III colon cancer; adenocarcinoma of the colon

Outcome Measures

Primary Outcomes (1)

• Disease-free Survival

  Time from randomization to the first event that was either recurrent (local or distant) colon cancer, a new primary colorectal cancer, a second primary cancer, or death from any cause. The outcome for the disease-free survival will be presented as 5 year disease-free survival rate.

  5 Years after randomization

Secondary Outcomes (1)

• Overall Survival

  8 years after randomization.

Study Arms (2)

Physical Activity Program + General Health Education Materials

ACTIVE COMPARATOR

Intervention Arm

Behavioral: exercise intervention; Other: counseling intervention; Other: educational intervention; Other: laboratory biomarker analysis; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment; Other: Fitness testing

General Health Education Materials

ACTIVE COMPARATOR

Control Arm

Other: laboratory biomarker analysis; Other: questionnaire administration; Other: study of socioeconomic and demographic variables; Procedure: fatigue assessment and management; Procedure: quality-of-life assessment; Other: Educational Intervention; Other: Fitness testing

Interventions

exercise intervention BEHAVIORAL

3 phases Phase 1: Intensive intervention for 6 months Phase 2: Reduced intervention for months 6-12 Phase 3: Minimal intervention for months 12-36

Physical Activity Program + General Health Education Materials

counseling intervention OTHER

Achieving an increase in PA from baseline of ≥ 10 MET hours/week will require a significant amount of behavioural support. The intervention will comprise a 36-month individualized PA and behavioural support program with a PAC. This will include a personalized PA prescription which takes into account the baseline fitness test results, PA history, performance status and patient's personal PA preferences and any barriers to activity. Most patients are likely to choose a walking program however any PA of at least moderate intensity level is acceptable.

Physical Activity Program + General Health Education Materials

laboratory biomarker analysis OTHER

Every 12 months

General Health Education Materials; Physical Activity Program + General Health Education Materials

questionnaire administration OTHER

Every 6 months

General Health Education Materials; Physical Activity Program + General Health Education Materials

study of socioeconomic and demographic variables OTHER

Every 6 months

General Health Education Materials; Physical Activity Program + General Health Education Materials

fatigue assessment and management PROCEDURE

Every 6 months

General Health Education Materials; Physical Activity Program + General Health Education Materials

quality-of-life assessment PROCEDURE

Every 6 months

General Health Education Materials; Physical Activity Program + General Health Education Materials

Educational Intervention OTHER

Once at the beginning of the program

Physical Activity Program + General Health Education Materials

Fitness testing OTHER

Objective fitness testing for both arms

General Health Education Materials; Physical Activity Program + General Health Education Materials

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: * Completely resected histologically confirmed adenocarcinoma of the colon * High-risk stage II disease, including one of the following: * T4 lesions * Less than 12 sampled lymph nodes * Poorly differentiated histology * Stage III disease, defined as having at least one pathologically confirmed positive lymph node or one pathologically confirmed positive tumour deposit. * Synchronous primary colon cancer allowed * Adjuvant chemotherapy treatment for colon cancer with a 5-fluorouracil- based regimen received with an intent to provide a complete course of treatment. While one current standard is 24 weeks of treatment, patients who are pre-planned to receive a shorter duration of chemotherapy, including as part of a research study will also be permitted. The actual treatment received may be less than 24 weeks; participants must have received a minimum of one treatment cycle. * Chemotherapy must have been completed (i.e. last dose received) a minimum of 60 days and a maximum of 180 days prior to registration. * Carcinoembryonic antigen (CEA) ≤ 5 μg/L * Current physical activity levels do not meet the recommended guidelines (≥ 150 minutes of moderate-to-vigorous or ≥ 75 minutes of vigorous physical activity/week) as calculated using the Leisure Time Exercise Questionnaire (LTEQ) * Completion of chest x-ray or CT, and CT, MRI or ultrasound of abdomen within 60 days of registration; these imaging tests must not show evidence of metastatic or locally-recurrent colon cancer. * Complete one of the following: (a) at least 2 stages of the submaximal exercise test with an acceptable heart rate and blood pressure response as defined in Appendix XII or (b) the 6 minute walk test with an acceptable heart rate and blood pressure response * No rectal cancer PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Absolute granulocyte count ≥ 1,000/mm³ * Platelet count ≥ 100,000/mm³ * Hemoglobin ≥ 100 g/L * Serum creatinine ≤ 1.5 times upper limit of normal (ULN) * Total bilirubin ≤ 1.5 times upper limit of normal (ULN) * Alkaline phosphatase \< 2.5 times ULN * ALT \< 2 times ULN * Not pregnant or planning to become pregnant within the next 3 years * Able (i.e., sufficiently fluent) and willing to effectively communicate with the physical activity consultant affiliated with the originating cancer center * Able (i.e., sufficiently fluent in English or French) and willing to complete the patient-reported outcome questionnaires, social determinants of exercise measurement, health economics, and physical activity questionnaires and logs * Able to complete the baseline exercise test * No significant comorbid conditions precluding participation in a physical activity program as determined by the investigator * Likely to participate in a physical activity program, as assessed by the investigator * No history of other malignancies, except adequately treated nonmelanoma skin cancer, curatively treated in situ cancer of the cervix, other solid tumors, Hodgkin lymphoma, or non-Hodgkin lymphoma curatively treated with no evidence of disease for \> 5 years PRIOR CONCURRENT THERAPY: * See Disease Characteristics * No prior radiotherapy as a component of treatment for primary tumor * No concurrent treatment with additional chemotherapy or radiation * No concurrent treatment with any medications deemed by the investigator as likely to preclude participation in a physical activity program * No concurrent anticancer treatment including chemotherapy, biological, or targeted agents

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Canadian Cancer Trials Group: lead
• Survivorship Research Group: collaborator
• Queen's University, Belfast: collaborator

Study Sites (47)

Henry Ford Hospital

Detroit, Michigan, 48202, United States

Location

Dartmouth-Hitchcock

Lebanon, New Hampshire, 03756, United States

Location

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599-1651, United States

Location

Armidale Hospital

Armidale, New South Wales, 2350, Australia

Location

Bankstown-Lidcombe Hospital

Bankstown, New South Wales, 2200, Australia

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

North Coast Cancer Institute Coffs Harbour

Coffs Harbour, New South Wales, 2450, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Liverpool Hospital

Liverpool, New South Wales, 2170, Australia

Location

Newcastle Private Hospital

Newcastle, New South Wales, 2305, Australia

Location

North Coast Cancer Institute - Port Macquarie

Port Macquarie, New South Wales, 2444, Australia

Location

Royal North Shore Hospital

St Leonards, New South Wales, 2065, Australia

Location

Tamworth Hospital

Tamworth, New South Wales, 2340, Australia

Location

Riverina Cancer Care Centre

Wagga Wagga, New South Wales, 2650, Australia

Location

Sydney Adventist Hospital

Wahroonga, New South Wales, 2076, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Princess Alexandra

Woolloongabba, Queensland, 4102, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Flinders Medical Centre

Bedford Park, South Australia, 5042, Australia

Location

The Queen Elizabeth Hospital

Woodville, South Australia, 5011, Australia

Location

St Vincent's Hospital Melbourne

Fitzroy, Victoria, 3065, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

Macarthur Cancer Therapy Centre - Campbelltown Hospital

Campbelltown, 2560, Australia

Location

Tom Baker Cancer Centre

Calgary, Alberta, T2N 4N2, Canada

Location

Cross Cancer Institute

Edmonton, Alberta, T6G 1Z2, Canada

Location

BCCA - Vancouver Cancer Centre

Vancouver, British Columbia, V5Z 4E6, Canada

Location

CancerCare Manitoba

Winnipeg, Manitoba, R3E 0V9, Canada

Location

Horizon Health Network

Fredericton, New Brunswick, E3B 5N5, Canada

Location

The Moncton Hospital

Moncton, New Brunswick, E1C 6Z8, Canada

Location

Regional Health Authority B, Zone 2

Saint John, New Brunswick, E2L 4L2, Canada

Location

Juravinski Cancer Centre at Hamilton Health Sciences

Hamilton, Ontario, L8V 5C2, Canada

Location

Kingston Health Sciences Centre

Kingston, Ontario, K7L 2V7, Canada

Location

Grand River Regional Cancer Centre

Kitchener, Ontario, N2G 1G3, Canada

Location

London Regional Cancer Program

London, Ontario, N6A 5W9, Canada

Location

Trillium Health Partners - Credit Valley Hospital

Mississauga, Ontario, L5M 2N1, Canada

Location

Stronach Regional Health Centre at Southlake

Newmarket, Ontario, L3Y 2P9, Canada

Location

Ottawa Hospital Research Institute

Ottawa, Ontario, K1H 8L6, Canada

Location

Niagara Health System

St. Catharines, Ontario, L2S 0A9, Canada

Location

Toronto Rehab

Toronto, Ontario, M4G 1R7, Canada

Location

Odette Cancer Centre

Toronto, Ontario, M4N 3M5, Canada

Location

Sinai Health System

Toronto, Ontario, M5G 1X5, Canada

Location

Unknown Facility

Lévis, Quebec, G6V 3Z1, Canada

Location

Allan Blair Cancer Centre

Regina, Saskatchewan, S4T 7T1, Canada

Location

Saskatoon Cancer Centre

Saskatoon, Saskatchewan, S7N 4H4, Canada

Location

Unknown Facility

Montpellier, CEDEX 5, France

Location

Exercise Medicine Center for Diabetes and Cancer

Seoul, South Korea

Location

Belfast City Hospital

Belfast, Co. Antrim, BT9 7AB, United Kingdom

Location

Related Publications (5)

• Courneya KS, Booth CM, Gill S, O'Brien P, Vardy J, Friedenreich CM, Au HJ, Brundage MD, Tu D, Dhillon H, Meyer RM. The Colon Health and Life-Long Exercise Change trial: a randomized trial of the National Cancer Institute of Canada Clinical Trials Group. Curr Oncol. 2008 Dec;15(6):279-85. doi: 10.3747/co.v15i6.378.

  PMID: 19079628 BACKGROUND

• Vallance J, Lesniak SL, Belanger LJ, Courneya KS. Development and assessment of a physical activity guidebook for the Colon Health and Life-Long Exercise Change (CHALLENGE) trial (NCIC CO.21). J Phys Act Health. 2010 Nov;7(6):794-801. doi: 10.1123/jpah.7.6.794.

  PMID: 21088311 BACKGROUND

• Courneya KS, Vardy JL, O'Callaghan CJ, Friedenreich CM, Campbell KL, Prapavessis H, Crawford JJ, O'Brien P, Dhillon HM, Jonker DJ, Chua NS, Lupichuk S, Sanatani MS, Gill S, Meyer RM, Begbie S, Bonaventura T, Burge ME, Turner J, Tu D, Booth CM. Effects of a Structured Exercise Program on Physical Activity and Fitness in Colon Cancer Survivors: One Year Feasibility Results from the CHALLENGE Trial. Cancer Epidemiol Biomarkers Prev. 2016 Jun;25(6):969-77. doi: 10.1158/1055-9965.EPI-15-1267. Epub 2016 Apr 8.

  PMID: 27197271 RESULT

• Courneya KS, Booth CM, Vardy JL, Friedenreich CM, Dhillon HM, Coyle V, Campbell KL, Arthuso FZ, Turner J, Kent DE, Russell C, Gordon JJ, Henson J, Chua NS, Jonker DJ, Kay S, Gill S, O'Brien P, Tu D, O'Callaghan CJ. Effects of a structured exercise program on motivational outcomes in patients with Colon cancer. J Natl Cancer Inst. 2026 Jan 29:djag023. doi: 10.1093/jnci/djag023. Online ahead of print.

  PMID: 41609410 DERIVED

• Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, Friedenreich CM, Wong RKS, Dhillon HM, Coyle V, Chua NS, Jonker DJ, Beale PJ, Haider K, Tang PA, Bonaventura T, Wong R, Lim HJ, Burge ME, Hubay S, Sanatani M, Campbell KL, Arthuso FZ, Turner J, Meyer RM, Brundage M, O'Brien P, Tu D, Booth CM; CHALLENGE Investigators. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer. N Engl J Med. 2025 Jul 3;393(1):13-25. doi: 10.1056/NEJMoa2502760. Epub 2025 Jun 1.

  PMID: 40450658 DERIVED

MeSH Terms

Conditions

Anxiety Disorders; Colorectal Neoplasms; Depression; Fatigue; Sleep Wake Disorders; Colonic Neoplasms

Interventions

Counseling; Early Intervention, Educational; Therapeutics; Exercise Test

Condition Hierarchy (Ancestors)

Mental Disorders; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Behavioral Symptoms; Behavior; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Nervous System Diseases; Neurologic Manifestations

Intervention Hierarchy (Ancestors)

Mental Health Services; Behavioral Disciplines and Activities; Community Health Services; Health Services; Health Care Facilities Workforce and Services; Child Health Services; Preventive Health Services; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Investigative Techniques

Results Point of Contact

• Title: Dr. Chris O'Callaghan
• Organization: Canadian Cancer Trials Group

COCallaghan@ctg.queensu.ca

6135336430

Study Officials

• Kerry Courneya, PhD

  University of Alberta

  STUDY CHAIR

• Christopher Booth, MD

  Cancer Centre of Southeastern Ontario at Kingston General Hospital

  STUDY CHAIR

• Janette Vardy, PhD, FRACP

  Sydney Cancer Centre at Concord Repatriation General Hospital

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 7, 2009
• First Posted: January 8, 2009
• Study Start: June 2, 2009
• Primary Completion: February 7, 2025
• Study Completion: March 17, 2026
• Last Updated: April 24, 2026
• Results First Posted: April 24, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

AU (20); KR (1); US (3); CA (21); FR (1); GB (1)