Trial Information

Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients

Study Groups:

If you are found to be eligible to take part in this study, you will be randomly assigned
(as in the flip of a coin) to 1 of 2 groups.

If you are in the exercise group, you will receive a doctor's recommendation to exercise
(in-person advice and letters), newsletters on behavior change methods, resistance bands, a
pedometer, and telephone counseling. A pedometer is a small device used to measure the
number of steps you take.

If you are in the relaxation group, you will receive a doctor's recommendation to practice
relaxation training (in-person advice and letters), newsletters on behavior change methods,
written and video instructions for doing the relaxation techniques, and telephone
counseling.

If you are in the Exercise Group:

- You will receive advice from your doctor (in person), physician's assistant, or other
mid-level provider about exercising. You will be given advice on the use of your
pedometer and resistance bands provided to you in this study, about the exercises
provided and about keeping track of your progress on the exercise logs provided to you.
You will also be given this advice in a letter.

- You will receive encouragement and support from a telephone counselor. The telephone
counselor will contact you once a week for the first 4 weeks and then once a month for
12 weeks. The call will take about 5 minutes to complete.

- You will receive newsletters with stories about other cancer survivor experiences.

- You will be do resistance exercises using the resistance bands 2 days a week.

If you are in the Relaxation Group:

- You will receive advice from your doctor (in person), physician's assistant or other
mid-level provider about relaxation techniques. You will be given advice on practicing
the breathing and meditation techniques provided to you in this study, on how long and
how often you are performing your relaxation techniques, and on keeping track of your
relaxation practice on the relaxation logs provided to you. You will also be given this
advice in a letter.

- You will receive encouragement and support from a telephone counselor. The telephone
counselor will contact you once a week for the first 4 weeks and then once a month for
12 weeks. The call will take about 5 minutes to complete.

- You will receive newsletters with stories about other cancer survivor experiences.

- You will be perform the relaxation techniques at least 15 minutes a day for 5-7 days a
week.

All participants will continue the group exercises or relaxation techniques for 16 weeks.

Follow-Up Visit:

You will have a follow-up visit during Weeks 16-20. At this visit, you will complete the
following tests and procedures:

- Your medical history will be recorded.

- Your performance status will be recorded.

- You will complete the 11 questionnaires.

- You will complete the exercise tests to measure how your body uses oxygen, to test your
lower body strength, to test your upper body strength, and to test your flexibility and
balance.

Length of Study:

You will remain on study for 16-20 weeks.

This is an investigational study.

Up to 150 patients will take part in this multicenter study. Up to 150 may be enrolled at
MD Anderson.