Clinical Trial

Health Education Materials Patients with Colon Cancer

Study Description

Health Education Materials With or Without a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

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.

Location

Locations Selected Location

Methods

No pharmaceutical medication involved No pharmaceutical medication involved
Recruiting patients only Recruiting patients only

Behavioral - exercise intervention

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 intervention

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 an ...read more on ClinicalTrials.org

educational intervention

Once at the beginning of the program

laboratory biomarker analysis

Every 12 months

questionnaire administration

Every 6 months

study of socioeconomic and demographic variables

Every 6 months

Procedure - fatigue assessment and management

Every 6 months

Procedure - quality-of-life assessment

Every 6 months

Educational Intervention

For Arm 2 just once at beginning of program.

Fitness testing

Objective fitness testing for both arms

Additional Information

Official Study 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)

Clinical Trial ID

NCT00819208

ParticipAid ID

penZRe