Home
Search
Study Topics
Glossary
|
|
|
|
|
|
Sponsored by: |
National Cancer Institute of Canada |
---|---|
Information provided by: | National Cancer Institute (NCI) |
ClinicalTrials.gov Identifier: | NCT00819208 |
RATIONALE: Participating in a physical activity program and receiving written health education materials may improve 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.
Condition | Intervention | Phase |
---|---|---|
Cancer-Related Problem/Condition Colorectal Cancer Fatigue |
Procedure: counseling Procedure: educational intervention Procedure: exercise intervention Procedure: fatigue assessment and management Procedure: laboratory biomarker analysis Procedure: quality-of-life assessment Procedure: questionnaire administration Procedure: study of socioeconomic and demographic variables |
Phase III |
Study Type: | Interventional |
Study Design: | Randomized, Open Label, Active Control |
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 (CHALLENGE) |
Estimated Enrollment: | 962 |
Study Start Date: | December 2008 |
Estimated Primary Completion Date: | January 2017 (Final data collection date for primary outcome measure) |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
DISEASE CHARACTERISTICS:
Histologically confirmed adenocarcinoma of the colon
High-risk stage II disease, including one of the following:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
Study Chair: | Kerry Courneya, PhD | University of Alberta Hospital |
Investigator: | Sharlene Gill, MD | British Columbia Cancer Agency |
Investigator: | Janette Vardy, PhD, FRACP | Sydney Cancer Centre at Concord Repatriation General Hospital |
Study ID Numbers: | CDR0000629834, CAN-NCIC-CO21 |
Study First Received: | January 7, 2009 |
Last Updated: | January 15, 2009 |
ClinicalTrials.gov Identifier: | NCT00819208 |
Health Authority: | Unspecified |
fatigue sleep disorders depression anxiety disorder psychosocial effects/treatment |
cognitive/functional effects stage II colon cancer stage III colon cancer adenocarcinoma of the colon |
Fatigue Depression Digestive System Neoplasms Gastrointestinal Diseases Colonic Diseases Sleep Disorders Intestinal Diseases Depressive Disorder Rectal Diseases |
Intestinal Neoplasms Signs and Symptoms Digestive System Diseases Anxiety Disorders Gastrointestinal Neoplasms Adenocarcinoma Colonic Neoplasms Colorectal Neoplasms |
Neoplasms Neoplasms by Site |