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Anxiety DisorderCHALLENGENCT00819208

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

A study testing exercise intervention, counseling intervention and educational intervention in people with Anxiety Disorder and Cognitive/Functional Effects, run by Canadian Cancer Trials Group at 47 sites in 6 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
exercise intervention, counseling intervention and educational intervention
Could I receive a placebo?
No, everyone receives an active treatment
How many people
889 participants
Where
47 sitesin 6 countries
Study dates
2 Jun 2009to 17 Mar 2026
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Trial locations and contacts

47 sites in 6 countries.

47 sites in 6 countries

Canada21 sites

  • Tom Baker Cancer Centre

    Calgary, Alberta, T2N 4N2

  • Cross Cancer Institute

    Edmonton, Alberta, T6G 1Z2

  • Horizon Health Network

    Fredericton, New Brunswick, E3B 5N5

  • Juravinski Cancer Centre at Hamilton Health Sciences

    Hamilton, Ontario, L8V 5C2

  • Kingston Health Sciences Centre

    Kingston, Ontario, K7L 2V7

  • Grand River Regional Cancer Centre

    Kitchener, Ontario, N2G 1G3

  • Study site

    Lévis, Quebec, G6V 3Z1

  • London Regional Cancer Program

    London, Ontario, N6A 5W9

  • Trillium Health Partners - Credit Valley Hospital

    Mississauga, Ontario, L5M 2N1

  • The Moncton Hospital

    Moncton, New Brunswick, E1C 6Z8

  • Stronach Regional Health Centre at Southlake

    Newmarket, Ontario, L3Y 2P9

  • Ottawa Hospital Research Institute

    Ottawa, Ontario, K1H 8L6

  • Allan Blair Cancer Centre

    Regina, Saskatchewan, S4T 7T1

  • Regional Health Authority B, Zone 2

    Saint John, New Brunswick, E2L 4L2

  • Saskatoon Cancer Centre

    Saskatoon, Saskatchewan, S7N 4H4

  • Niagara Health System

    St. Catharines, Ontario, L2S 0A9

  • Toronto Rehab

    Toronto, Ontario, M4G 1R7

  • Odette Cancer Centre

    Toronto, Ontario, M4N 3M5

  • Sinai Health System

    Toronto, Ontario, M5G 1X5

  • BCCA - Vancouver Cancer Centre

    Vancouver, British Columbia, V5Z 4E6

  • CancerCare Manitoba

    Winnipeg, Manitoba, R3E 0V9

Other trials in Canada

Australia20 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Armidale Hospital

    Armidale, New South Wales, 2350

  • Bankstown-Lidcombe Hospital

    Bankstown, New South Wales, 2200

  • Flinders Medical Centre

    Bedford Park, South Australia, 5042

  • Macarthur Cancer Therapy Centre - Campbelltown Hospital

    Campbelltown, 2560

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • North Coast Cancer Institute Coffs Harbour

    Coffs Harbour, New South Wales, 2450

  • Concord Repatriation General Hospital

    Concord, New South Wales, 2139

  • St Vincent's Hospital Melbourne

    Fitzroy, Victoria, 3065

  • Royal Brisbane and Women's Hospital

    Herston, Queensland, 4029

  • Liverpool Hospital

    Liverpool, New South Wales, 2170

  • Newcastle Private Hospital

    Newcastle, New South Wales, 2305

  • Royal Perth Hospital

    Perth, Western Australia, 6000

  • North Coast Cancer Institute - Port Macquarie

    Port Macquarie, New South Wales, 2444

  • Royal North Shore Hospital

    St Leonards, New South Wales, 2065

  • Tamworth Hospital

    Tamworth, New South Wales, 2340

  • Riverina Cancer Care Centre

    Wagga Wagga, New South Wales, 2650

  • Sydney Adventist Hospital

    Wahroonga, New South Wales, 2076

  • The Queen Elizabeth Hospital

    Woodville, South Australia, 5011

  • Princess Alexandra

    Woolloongabba, Queensland, 4102

Other trials in Australia

United States3 sites

  • University of North Carolina at Chapel Hill

    Chapel Hill, North Carolina, 27599-1651

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • Dartmouth-Hitchcock

    Lebanon, New Hampshire, 03756

Other trials in United States

France1 site

  • Study site

    Montpellier, CEDEX 5

Other trials in France

South Korea1 site

  • Exercise Medicine Center for Diabetes and Cancer

    Seoul

Other trials in South Korea

United Kingdom1 site

  • Belfast City Hospital

    Belfast, Co. Antrim, BT9 7AB

Other trials in United Kingdom

About this study

Official title: A Phase III Study of the Impact of a Physical Activity Program on Disease-Free Survival in Patients With High-Risk Stage II or Stage III Colon Cancer: A Randomized Controlled 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.

Read the detailed description

OBJECTIVES:

Primary

  • To compare the disease-free survival (DFS) of medically fit patients who have completed surgical resection and adjuvant chemotherapy for high-risk stage II or stage III colon cancer when administered a physical activity program with general health education materials vs general health education materials alone.

Secondary

  • To compare the two intervention arms with respect to overall survival (OS); patient-reported outcomes using the SF-36, FACIT-F, PSQI, and HADS questionnaires; objective markers of physical fitness using body mass index, hip and waist circumference, submaximal exercise testing, and the Seniors' Fitness Test; physical activity behavior using the Total Physical Activity Questionnaire (TPAQ); safety profile as assessed by NCI CTCAE version 3.0; serum levels of insulin (i.e., IGF-1, IGF-2, and IGFBP3); cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF) and C-reactive protein levels; economic evaluations including cost-effective and cost-utility analyses; and predictors of physical activity adherence using the Social-Cognitive Determinants of Exercise Measure questionnaire.
  • To evaluate the potential prognostic associations of the serum levels of insulin, IGF-1, IGF-2, IGFBP3, blood glucose, cytokines (i.e., IL- 1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein with DFS, OS, level of physical activity, and level of fatigue in these patients.
  • To evaluate the potential prognostic associations of age, gender, country, incremental increase in physical activity, and change in cardiovascular fitness with DFS, OS, level of fatigue, and quality of life in these patients.

OUTLINE: This is a multicenter study. Patients are stratified according to disease stage (II vs III), participating center, body mass index (≤ 27.5 vs > 27.5), and ECOG performance status (0 vs 1). Patients are randomized to 1 of 2 treatment interventions.

  • Arm I: Patients receive general health education materials regarding nutrition and physical activity and undergo the Colon Health And Life Long Exercise Change (CHALLENGE) physical activity program consisting of behavior-support sessions and supervised physical activity sessions with a physical activity consultant.
  • Part I (intensive intervention for 6 months): Patients undergo 12 mandatory biweekly face-to-face behavior support sessions combined with 12 mandatory supervised physical activity sessions to increase their physical activity goal by 10 metabolic equivalent task (MET) hours/week. Twelve supervised physical activity sessions are also recommended on alternate weeks.
  • Part II (reduced intervention for months 6-12): Patients undergo 12 mandatory biweekly face-to-face or telephone behavior support sessions combined with 12 recommended supervised physical activity sessions to increase their physical activity goal by 20 MET hours/week.
  • Part III (minimal intervention for months 12-36): Patients undergo mandatory monthly face-to-face or telephone behavior support sessions combined with recommended supervised physical activity sessions to increase their physical activity goal to a maximum total of 27 MET hours/week.
  • Arm II: Patients receive general health education materials regarding nutrition and physical activity.

Patients complete the Total Physical Activity Questionnaire (TPAQ) to assess exercise participation and undergo fitness testing periodically by the submaximal exercise test and Seniors' Fitness Test (SFT).

Patients complete the SF-36, FACT-F, Pittsburgh Sleep Quality Index (PSQI), Hospital Anxiety and Depression Scale (HADS), and Social Cognitive Determinants of Exercise Measure questionnaires periodically. Patients also complete a 30-day resource use diary and undergo a health economics analysis by the Work Productivity and Activity Impairment (WPAI) questionnaire.

Blood samples are collected periodically for correlative studies and fasting glucose. Samples are analyzed for markers of insulin level, IGF-1, IGF-2, and IGFBP3, cytokine levels (i.e., IL-1β, IL-6, IL-2, IL-4, IL-8, IL-10, IL-12, TNF-α, IFN-γ, and GM-CSF), and C-reactive protein levels.

During the 3 year intervention period, patients are followed every 6 months for 3 years and then annually for 4-10 years.

Being tested
exercise intervention, counseling intervention, educational intervention, laboratory biomarker analysis, questionnaire administration
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
Medical subject headings
Anxiety Disorders, Colorectal Neoplasms, Depression, Fatigue, Sleep Wake Disorders, Colonic Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • exercise interventionBehavioural

    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

  • counseling interventionOther

    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.

  • educational interventionOther

    Once at the beginning of the program

  • laboratory biomarker analysisOther

    Every 12 months

  • questionnaire administrationOther

    Every 6 months

  • study of socioeconomic and demographic variablesOther

    Every 6 months

  • fatigue assessment and managementProcedure or surgery

    Every 6 months

  • quality-of-life assessmentProcedure or surgery

    Every 6 months

  • Educational InterventionOther

    For Arm 2 just once at beginning of program.

  • Fitness testingOther

    Objective fitness testing for both arms

Study groups in NCT00819208
Study groupRoleWhat they receive
Physical Activity Program + General Health Education MaterialsActive comparatorIntervention Arm
Receives: 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 MaterialsActive comparatorControl Arm
Receives: 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

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 5 Years after randomization

Secondary outcomes (1)

  1. Overall Survival

    Time from randomization to death of any cause. Patients last known to be alive are censored at their last contact date. The outcome for overall survival will be presented as 8 year overall survival rate.

    Measured: 8 years after randomization.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Jan 2009 (estimated)
  2. Study start2 Jun 2009
  3. Primary completion7 Feb 2025
  4. Study completion17 Mar 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Other
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
889 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00819208
Sponsor's protocol ID
CO21
Other IDs
CAN-NCIC-CO21, CDR0000629834
Acronym
CHALLENGE
Status last verified
Apr 2026
First submitted
7 Jan 2009
Last updated
24 Apr 2026
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • 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.

    PubMed 19079628

  • 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.

    PubMed 21088311

  • 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.

    PubMed 27197271

  • 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 Jun 1;118(6):1054-1062. doi: 10.1093/jnci/djag023.

    PubMed 41609410

  • 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.

    PubMed 40450658

Questions about this trial

What is this clinical trial studying?

A study testing exercise intervention, counseling intervention and educational intervention in people with Anxiety Disorder and Cognitive/Functional Effects, run by Canadian Cancer Trials Group at 47 sites in 6 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in Canada, Australia, United States, France, South Korea and 1 more country. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Apr 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Disease-free Survival (time frame: 5 Years after randomization). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00819208, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2026.

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