Clinical trial NCT00985400: Doctor-Recommended Home-Based Exercise Program or Relaxation Training in Improving Physical Function and Controlling Symptoms in Patients With Stage IV or Recurrent Colon Cancer That Cannot Be Removed By Surgery
Official title: Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Cancer
Keywords: recurrent colon cancer
stage IV colon cancer
Gastrointestinal
Exercise
Relaxation
Meditation
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2009-09-28
Enrollment: 154
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: The goal of this study is to compare the effects of exercise with the effects of relaxation training on physical function (how well participants perform normal daily activities) and symptoms related to your cancer diagnosis (such as tiredness, pain, and nausea).

Detailed description: 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 154 patients will take part in this multicenter study. Up to 154 may be enrolled at MD Anderson.

Eligibility criteria: Inclusion Criteria:

1. Diagnosis of stage IV or recurrent colorectal cancer
2. Age \>/= 18 years
3. ECOG performance status of 0 -1
4. Able to communicate in English or Spanish
5. Able to give informed consent
6. Adequate organ function -Total bilirubin \< 1.5 x the institutional upper-normal limits (IUNL); AST (SGOT) and/or ALT (SGPT) \< 2.5 x IUNL; Patients with liver metastasis AST/ (SGOT) and/or ALT (SGPT) \< 5 x IUNL
7. Adequate bone marrow function: - Absolute neutrophil count \> 1,000/microLiters; Platelets \> 50,000/microLiters
8. Able to ambulate without assistance
9. Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions.

Exclusion Criteria:

1. Major surgery in the past 8 weeks
2. Medical contraindications to home-based exercise as defined by the treating physician
3. Symptomatic Bone Metastases
4. Unstable Angina (current symptomatic angina at time of enrollment)
5. Class III/IV heart failure according to NYHA classification system
6. Pulmonary conditions that require oxygen
7. Unable to ambulate without assistance (cane, walker, etc)
8. Exercising at a moderate-vigorous intensity for 150 minutes or more per week, exercising at a vigorous intensity for more than 20 minutes on 3 or more days per week, or performing resistance exercises for more than 20 minutes per day on two or more days per week for 3 months or more.

Primary outcomes:
measure: Recruitment rate
timeFrame: 3 year study period
measure: Patient retention
timeFrame: 3 year study period
measure: Program and assessment implementation
timeFrame: 3 year study period
measure: Patient adherence to behavioral recommendations
timeFrame: Up to 20 weeks
measure: Effect size of the exercise intervention on physical function
timeFrame: Up to 20 weeks
Secondary outcomes:
measure: Effect size of the exercise intervention on symptoms and quality of life
timeFrame: Up to 20 weeks
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, PhD
role: STUDY_CHAIR
affiliation: M.D. Anderson Cancer Center
name: Michael J. Fisch, MD, MPH, FACP
role: STUDY_CHAIR
References: