NCT00819208: CHALLENGE

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

Active, enrolled NA Last updated 16 September 2025

What this trial tests

NA trial testing exercise intervention in Anxiety Disorder in 889 participants. Participants enrolled and being followed up; not accepting new ones.

Timeline

2 June 2009

Primary endpoint
7 February 2025

15 December 2030

Quick facts

Lead sponsor	Canadian Cancer Trials Group
Phase	NA
Status	Active, enrolled
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	other
Enrollment	889
Start date	2 June 2009
Primary completion	7 February 2025
Estimated completion	15 December 2030
Sites	47 locations across France, United Kingdom, South Korea, Canada, Australia, United States

Drugs / interventions tested

• exercise intervention
• counseling intervention
• educational intervention
• laboratory biomarker analysis — full drug profile →
• questionnaire administration
• study of socioeconomic and demographic variables
• fatigue assessment and management
• quality-of-life assessment
• Educational Intervention
• Fitness testing

Conditions studied

• Anxiety Disorder — all drugs for Anxiety Disorder →
• Cognitive/Functional Effects — all drugs for Cognitive/Functional Effects →
• Colorectal Cancer — all drugs for Colorectal Cancer →
• Depression — all drugs for Depression →

Sponsor

Canadian Cancer Trials Group — full company profile →

Who can join

18 and older, any sex, with Anxiety Disorder or Cognitive/Functional Effects. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

1. Obesity and Cancer: A Current Overview of Epidemiology, Pathogenesis, Outcomes, and Management.
   Pati S, Irfan W, Jameel A, Ahmed S, et al · · 2023 · cited 393× · PMID 36672434 · DOI 10.3390/cancers15020485
2. Structured Exercise after Adjuvant Chemotherapy for Colon Cancer.
   Courneya KS, Vardy JL, O'Callaghan CJ, Gill S, et al · · 2025 · cited 152× · PMID 40450658 · DOI 10.1056/nejmoa2502760
3. Energy balance and gastrointestinal cancer: risk, interventions, outcomes and mechanisms.
   Ulrich CM, Himbert C, Holowatyj AN, Hursting SD. · · 2018 · cited 88× · PMID 30158569 · DOI 10.1038/s41575-018-0053-2
4. Effect of exercise on colorectal cancer prevention and treatment.
   Oruç Z, Kaplan MA. · · 2019 · cited 72× · PMID 31139306 · DOI 10.4251/wjgo.v11.i5.348
5. Exercise and immunometabolic regulation in cancer.
   Koelwyn GJ, Zhuang X, Tammela T, Schietinger A, et al · · 2020 · cited 50× · PMID 32929232 · DOI 10.1038/s42255-020-00277-4
6. Physical Activity Reduces the Risk of Recurrence and Mortality in Cancer Patients.
   Brown JC, Gilmore LA. · · 2020 · cited 48× · PMID 31913187 · DOI 10.1249/jes.0000000000000214
7. Exercise and colorectal cancer: prevention and molecular mechanisms.
   Amirsasan R, Akbarzadeh M, Akbarzadeh S. · · 2022 · cited 38× · PMID 35945569 · DOI 10.1186/s12935-022-02670-3
8. Vitamin D and Physical Activity in Patients With Colorectal Cancer: Epidemiological Evidence and Therapeutic Implications.
   Morales-Oyarvide V, Meyerhardt JA, Ng K. · · 2016 · cited 27× · PMID 27341603 · DOI 10.1097/ppo.0000000000000197