search
Back to results

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

Primary Purpose

Colorectal Cancer

Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Telephone-based intervention
Counseling intervention
Questionnaire administration
Relaxation Program
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Colorectal Cancer focused on measuring recurrent colon cancer, stage IV colon cancer, Gastrointestinal, Exercise, Relaxation, Meditation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Exercise Program

Relaxation Intervention

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Recruitment rate
Patient retention
Program and assessment implementation
Patient adherence to behavioral recommendations
Effect size of the exercise intervention on physical function

Secondary Outcome Measures

Effect size of the exercise intervention on symptoms and quality of life

Full Information

First Posted
September 25, 2009
Last Updated
March 29, 2022
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
search

1. Study Identification

Unique Protocol Identification Number
NCT00985400
Brief Title
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

2. Study Status

Record Verification Date
March 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 5, 2010 (Actual)
Primary Completion Date
March 31, 2023 (Anticipated)
Study Completion Date
March 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Colorectal Cancer
Keywords
recurrent colon cancer, stage IV colon cancer, Gastrointestinal, Exercise, Relaxation, Meditation

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
154 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Program
Arm Type
Experimental
Arm Description
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.
Arm Title
Relaxation Intervention
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
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
Intervention Name(s)
Telephone-based intervention
Intervention Description
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
Other
Intervention Name(s)
Counseling intervention
Intervention Description
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
Intervention Name(s)
Questionnaire administration
Other Intervention Name(s)
Survey
Intervention Type
Behavioral
Intervention Name(s)
Relaxation Program
Intervention Description
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
Primary Outcome Measure Information:
Title
Recruitment rate
Time Frame
3 year study period
Title
Patient retention
Time Frame
3 year study period
Title
Program and assessment implementation
Time Frame
3 year study period
Title
Patient adherence to behavioral recommendations
Time Frame
Up to 20 weeks
Title
Effect size of the exercise intervention on physical function
Time Frame
Up to 20 weeks
Secondary Outcome Measure Information:
Title
Effect size of the exercise intervention on symptoms and quality of life
Time Frame
Up to 20 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Diagnosis of stage IV or recurrent colorectal cancer Age >/= 18 years ECOG performance status of 0 -1 Able to communicate in English or Spanish Able to give informed consent 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 Adequate bone marrow function: - Absolute neutrophil count > 1,000/microLiters; Platelets > 50,000/microLiters Able to ambulate without assistance Has access to a telephone in order to receive pre-recorded telephone messages and for multiple counseling sessions. Exclusion Criteria: Major surgery in the past 8 weeks Medical contraindications to home-based exercise as defined by the treating physician Symptomatic Bone Metastases Unstable Angina (current symptomatic angina at time of enrollment) Class III/IV heart failure according to NYHA classification system Pulmonary conditions that require oxygen Unable to ambulate without assistance (cane, walker, etc) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Karen Basen-Engquist, PhD
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Michael J. Fisch, MD, MPH, FACP
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Study Chair
Facility Information:
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030-4009
Country
United States

12. IPD Sharing Statement

Links:
URL
https://clinicaltrials.gov/ct2/show/NCT00985400?term=2009-0288&draw=2&rank=1
Description
Clinical trial summary from the National Cancer Institute's PDQ® database
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Official Website

Learn more about this trial

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

We'll reach out to this number within 24 hrs