What is the CHALLENGE trial?

Colorectal cancer is the second leading cause of death from cancer (men and women combined). One in 14 men is expected to develop colorectal cancer during their lifetime and one in 27 will die of it. One in 16 women is expected to develop colorectal cancer during their lifetime and one in 31 will die of it.

Physical activity is strongly associated with reduced risk of colon cancer but not rectal cancer. For this reason only participants with colon cancer are considered eligible for this study.

Specifically, the CHALLENGE research study is for those patients with high risk stage II or stage III colon cancer. These two groups of patients are both felt to be at moderate risk of disease recurrence and receive similar types of treatment. Following surgery and chemotherapy, there is usually no further treatment provided for patients other than being monitored by their doctor.

The purpose of this study is to find out whether it is better to take part in a structured physical activity program designed to increase the amount of physical activity you do in addition to receiving general health education materials or better to receive general health education materials only after surgery and chemotherapy for colon cancer.

Why is this study being done?

The CHALLENGE research study is a phase III colon cancer clinical trial. It is designed to compare the effects on colon cancer of two different approaches of intervention to see which one is better. This research is being done because we do not know if a structured physical activity program designed to increase the physical activity done in participants' free time will reduce the chance of cancer recurring (coming back).

The goal is to learn more about how taking part in a physical activity program influences physical activity participation, physical fitness, quality of life and psychological well-being. We also hope to learn how increasing physical activity influences colon cancer and the processes in the body which may play a role in the development of cancer.

Other studies have shown that being more physically active after a colon cancer diagnosis has been associated with a lower risk of colon cancer recurring. Several studies have also shown that physical activity may improve other aspects, such as qualify of life, physical fitness and fatigue for cancer survivors. However, few studies have focused on colon cancer survivors and large, better controlled studies are needed to see if this is true.

The CHALLENGE research study is coordinated by the NCIC Clinical Trials Group. About 960 people from Canada and Australia will take part in this study.

What is the design of the CHALLENGE trial?

Women and men eligible for the study will be randomly assigned to 1 of 2 intervention groups.

• If you are in Group 1 you will participate in a three-year Physical Activity Program and receive General Health Education Materials.
• If you are in Group 2 you will receive General Health Education Materials.

What are the two interventions used in this trial?

Group 1: Physical Activity Program + General Health Education Materials

Patients randomized to Group 1 will receive the following:

Group 2: General Health Education Materials

Patients randomized to Group 2 will receive the following:

How long will the study last?

The study should take 6 years to complete and the results should be known in 8 years.