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
Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients
4 other identifiers
interventional
154
1 country
1
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable colorectal-cancer
Started Nov 2010
Longer than P75 for not_applicable colorectal-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 25, 2009
CompletedFirst Posted
Study publicly available on registry
September 28, 2009
CompletedStudy Start
First participant enrolled
November 5, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 31, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
March 31, 2023
CompletedMarch 31, 2022
March 1, 2022
12.4 years
September 25, 2009
March 29, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (5)
Recruitment rate
3 year study period
Patient retention
3 year study period
Program and assessment implementation
3 year study period
Patient adherence to behavioral recommendations
Up to 20 weeks
Effect size of the exercise intervention on physical function
Up to 20 weeks
Secondary Outcomes (1)
Effect size of the exercise intervention on symptoms and quality of life
Up to 20 weeks
Study Arms (2)
Exercise Program
EXPERIMENTALArm 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.
Relaxation Intervention
EXPERIMENTALArm 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.
Interventions
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
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.
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.
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- M.D. Anderson Cancer Centerlead
- National Cancer Institute (NCI)collaborator
Study Sites (1)
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030-4009, United States
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Karen Basen-Engquist, PhD
M.D. Anderson Cancer Center
- STUDY CHAIR
Michael J. Fisch, MD, MPH, FACP
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 25, 2009
First Posted
September 28, 2009
Study Start
November 5, 2010
Primary Completion
March 31, 2023
Study Completion
March 31, 2023
Last Updated
March 31, 2022
Record last verified: 2022-03