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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

154 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-11-05

Study Completion Date

2023-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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).

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

The Impact of Physical Exercise on Sleep in Colorectal Cancer Patients During Prehabilitation Period

NCT04270500

Colo-rectal Cancer Surgery

UNKNOWN NA

Health Education Materials With/Out a Physical Activity Program for Patients Who Have Undergone Treatment for High-Risk Stage II or Stage III Colon Cancer

NCT00819208

Anxiety Disorder Cognitive/Functional Effects Colorectal Cancer +5 more

ACTIVE_NOT_RECRUITING NA

The Effects of Exercise Training on the Health-related Fitness of Colon Cancer Survivors

NCT00813540

Colonic Neoplasms

COMPLETED PHASE2/PHASE3

Exercise Program During Chemotherapy in Metastatic Colorectal Cancer

NCT03111823

Stage IV Colorectal Cancer

TERMINATED NA

Aerobic Fitness or Muscle Mass Training to Improve Colorectal Cancer Outcome

NCT04754672

Colorectal Cancer Chemotherapeutic Toxicity Survivorship +1 more

RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Colorectal Cancer

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Exercise Program

Arm I (exercise program): Oncologist advice; Resistance bands \& pedometer with written/DVD instructions for resistance exercise twice a week for 16 weeks. Brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day. Monthly newsletters; Telephone counseling weekly for 4 weeks then monthly for 12 weeks; and tailored message telephone prompts once every 2 weeks during last 12 weeks of the study intervention.

Group Type EXPERIMENTAL

Exercise Program

Intervention Type BEHAVIORAL

Resistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day

Telephone-based intervention

Intervention Type BEHAVIORAL

Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.

Counseling intervention

Intervention Type OTHER

Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter.

Questionnaire administration

Intervention Type OTHER

Relaxation Intervention

Arm II (relaxation program): Oncologist advice; Written/CD audio instructions on diaphragmatic breathing and guided imagery. Practice relaxation techniques for 15 minutes/day, 5-7 days/week, for 16 weeks. Monthly newsletters, telephone counseling, and tailored-message telephone prompts as in arm I.

Group Type EXPERIMENTAL

Telephone-based intervention

Intervention Type BEHAVIORAL

Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.

Counseling intervention

Intervention Type OTHER

Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter.

Questionnaire administration

Intervention Type OTHER

Relaxation Program

Intervention Type BEHAVIORAL

Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Exercise Program

Resistance exercising using resistance bands 2 days per week, and brief moderate-intensity walks multiple times a day for a total of 30 minutes increasing steps weekly by 10% to reach a minimum of 10,000 steps a day

Intervention Type BEHAVIORAL

Telephone-based intervention

Patients will receive encouragement and social support from a telephone counselor once a week for the first 4 weeks and then once a month for the remaining 12 weeks.

Intervention Type BEHAVIORAL

Counseling intervention

Patients will receive advice from their doctor (in person), physician assistant, or other midlevel provider about exercising. They will also be given this advice in a letter.

Intervention Type OTHER

Questionnaire administration

Intervention Type OTHER

Relaxation Program

Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.

Intervention Type BEHAVIORAL

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Survey

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No