Trial record 1 of 1 for:
2009-0288
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
This study is currently recruiting participants.
Verified May 2013 by M.D. Anderson Cancer Center
Sponsor:
M.D. Anderson Cancer Center
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00985400
First received: September 25, 2009
Last updated: May 20, 2013
Last verified: May 2013
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Purpose
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).
| Condition | Intervention |
|---|---|
|
Colorectal Cancer |
Behavioral: Exercise Program Behavioral: Telephone-based intervention Other: Counseling intervention Other: Questionnaire administration Behavioral: Relaxation Program |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care |
| Official Title: | Comparative Study of Oncologist Recommended, Home-Based Exercise Program and Relaxation Training for Physical Functioning and Symptom Control in Colon Cancer Patients |
Resource links provided by NLM:
Further study details as provided by M.D. Anderson Cancer Center:
Primary Outcome Measures:
- Recruitment rate [ Time Frame: 3 year study period ] [ Designated as safety issue: No ]
- Patient retention [ Time Frame: 3 year study period ] [ Designated as safety issue: No ]
- Program and assessment implementation [ Time Frame: 3 year study period ] [ Designated as safety issue: No ]
- Patient adherence to behavioral recommendations [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
- Effect size of the exercise intervention on physical function [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Effect size of the exercise intervention on symptoms and quality of life [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 150 |
| Study Start Date: | November 2010 |
| Estimated Primary Completion Date: | December 2014 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: 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.
|
Behavioral: 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
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.
Other: 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.
Other: Questionnaire administration
Other Name: Survey
|
|
Experimental: 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.
|
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.
Other: 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.
Other: Questionnaire administration
Other Name: Survey
Behavioral: Relaxation Program
Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
|
Show Detailed Description Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00985400
Locations
| United States, Texas | |
| M. D. Anderson Cancer Center at University of Texas | Recruiting |
| Houston, Texas, United States, 77030-4009 | |
| Contact: Clinical Trials Office - M. D. Anderson Cancer Center 713-792-3245 | |
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
| Study Chair: | Karen Basen-Engquist, PhD | M.D. Anderson Cancer Center |
| Study Chair: | Michael J. Fisch, MD, MPH, FACP | M.D. Anderson Cancer Center |
More Information
Additional Information:
No publications provided
| Responsible Party: | M.D. Anderson Cancer Center |
| ClinicalTrials.gov Identifier: | NCT00985400 History of Changes |
| Other Study ID Numbers: | 2009-0288, MDA-2009-0288, CDR0000654446 |
| Study First Received: | September 25, 2009 |
| Last Updated: | May 20, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by M.D. Anderson Cancer Center:
|
recurrent colon cancer stage IV colon cancer Gastrointestinal |
Exercise Relaxation Meditation |
Additional relevant MeSH terms:
|
Colonic Neoplasms Colorectal Neoplasms Intestinal Neoplasms Gastrointestinal Neoplasms Digestive System Neoplasms Neoplasms by Site |
Neoplasms Digestive System Diseases Gastrointestinal Diseases Colonic Diseases Intestinal Diseases Rectal Diseases |
ClinicalTrials.gov processed this record on May 21, 2013