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.
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
- Conditions the study is for
- Anxiety Disorder, Cognitive/Functional Effects, Colorectal Cancer
- What is being tested?
- exercise intervention, counseling intervention and educational intervention
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- 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
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
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
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
United Kingdom1 site
Belfast City Hospital
Belfast, Co. Antrim, BT9 7AB
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.
- Conditions
- Anxiety Disorder, Cognitive/Functional Effects, Colorectal Cancer, Depression, Fatigue, Psychosocial Effects of Cancer and Its Treatment
- 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 group | Role | What they receive |
|---|---|---|
| Physical Activity Program + General Health Education Materials | Active comparator | Intervention 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 Materials | Active comparator | Control 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.
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)
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.
- First posted8 Jan 2009 (estimated)
- Study start2 Jun 2009
- Primary completion7 Feb 2025
- Study completion17 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Anxiety DisorderStudies of the same condition, open and under way.
- More trials run by Canadian Cancer Trials GroupThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Canadian Cancer Trials Group
- Sponsor type
- Research network
- Collaborators
- Survivorship Research Group, Queen's University, Belfast
- Responsible party
- Sponsor
- Investigators
- Kerry Courneya, PhD, Study chair, University of AlbertaChristopher Booth, MD, Study chair, Cancer Centre of Southeastern Ontario at Kingston General HospitalJanette Vardy, PhD, FRACP, Study chair, Sydney Cancer Centre at Concord Repatriation General Hospital
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
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19079628Vallance 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 21088311Courneya 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 27197271Courneya 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 41609410Courneya 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