Trial record 1 of 1 for:    2009-0288
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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 ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT00985400
First received: September 25, 2009
Last updated: June 13, 2014
Last verified: June 2014
  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: 154
Study Start Date: November 2010
Estimated Primary Completion Date: December 2015 (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:

  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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00985400

Locations
United States, Texas
M. D. Anderson Cancer Center at University of Texas
Houston, Texas, United States, 77030-4009
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, NCI-2011-02280
Study First Received: September 25, 2009
Last Updated: June 13, 2014
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 August 27, 2014