The aim of this trial will be to determine whether participating in a physical activity program, along with health education, is more effective at decreasing colorectal cancer recurrence than health education alone. The primary outcome measured in this trial will be disease-free survival (how long following treatment a patient remains disease free). This trial is recruiting in the U.S., Australia and Canada.
The details
Physical activity is known to increase both physical fitness and psychological well-being in the general population as well as in patients recovering from colon cancer surgery and treatment. Participation in a physical fitness program can be especially helpful. However, it is not known whether participation in such a program can help to decrease the risk of cancer recurrence, or whether it does so more than health education alone.
The current trials aims to determine whether a physical activity program combined with health education is more effective than health education alone at reducing recurrence rates in colon cancer patients. The main outcome of this study will be disease-free survival time, but overall survival (time from treatment until death from any cause), patient quality of life, and overall physical fitness will also be measured.
Who are they looking for?
This trial will recruit 962 patients with completely resected (surgically removed) stage 2 (not yet spread beyond the colon) or stage 3 (spread to nearby lymph nodes) adenocarcinoma of the colon. Patients must have received a 5-fluorouracil-based chemotherapy regimen, completed 60–180 days prior to the start of the study. Patients must not show any evidence of metastatic (spread to other areas) or locally-recurrent (recurring in the same area as the original tumor) colon cancer or rectal cancer.
Patients must have normal blood values, must not be pregnant or planning to become pregnant, must not be taking part in a physical activity program prior to the start of study, but must be able and likely to complete one. Patients currently undergoing chemotherapy, radiation, or any other form of anti-cancer therapy will be excluded.
How will it work
In this trial, patients will be randomly assigned to one of two treatment groups. One group will be given general health education materials only. The second group will be given both general health education and will take part in a directed physical activity program. Patients will meet with a personal counselor who will help to provide a directed program (a walking program is a popular choice), as well as offer support and advice.
Patients will undergo quality of life assessments, fatigue assessments, and demographic assessments every 6 months, and will be followed for up to 10 years to measure disease-free survival, overall survival, and fitness levels.
