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

September 25, 2009
June 13, 2014
November 2010
December 2015   (final data collection date for primary outcome measure)
  • 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 ]
  • Recruitment rate [ Designated as safety issue: No ]
  • Patient retention [ Designated as safety issue: No ]
  • Program and assessment implementation [ Designated as safety issue: No ]
  • Patient adherence to behavioral recommendations [ Designated as safety issue: No ]
  • Effect size of the exercise intervention on physical function [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00985400 on ClinicalTrials.gov Archive Site
Effect size of the exercise intervention on symptoms and quality of life [ Time Frame: Up to 20 weeks ] [ Designated as safety issue: No ]
  • Effect size of the exercise intervention on symptoms and quality of life [ Designated as safety issue: No ]
  • Associations between the hypothesized mediators and exercise adherence [ Designated as safety issue: No ]
Not Provided
Not Provided
 
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

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).

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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Colorectal Cancer
  • 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
  • Behavioral: Relaxation Program
    Relaxation techniques (breathing and meditation) provided at least 15 minutes per day for 5-7 days per week.
  • 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.
    Interventions:
    • Behavioral: Exercise Program
    • Behavioral: Telephone-based intervention
    • Other: Counseling intervention
    • Other: Questionnaire administration
  • 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.
    Interventions:
    • Behavioral: Telephone-based intervention
    • Other: Counseling intervention
    • Other: Questionnaire administration
    • Behavioral: Relaxation Program
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Active, not recruiting
154
Not Provided
December 2015   (final data collection date for primary outcome measure)

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.
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00985400
2009-0288, MDA-2009-0288, CDR0000654446, NCI-2011-02280
Yes
M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
National Cancer Institute (NCI)
Study Chair: Karen Basen-Engquist, PhD M.D. Anderson Cancer Center
Study Chair: Michael J. Fisch, MD, MPH, FACP M.D. Anderson Cancer Center
M.D. Anderson Cancer Center
June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP