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Part II: Exercise in Hispanic Breast Cancer Survivors

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01504789
First received: December 28, 2011
Last updated: February 12, 2014
Last verified: February 2014
  Purpose

The goal of this research study is to test an exercise program that is designed for Hispanic breast cancer survivors. Researchers want to learn the most effective strategies for promoting exercise.


Condition Intervention
Breast Cancer
Behavioral: Baseline Fitness Test
Behavioral: Questionnaires
Behavioral: Individualized Exercise Program
Behavioral: Written Materials

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Subject)
Primary Purpose: Supportive Care
Official Title: Part II: Exercise in Hispanic Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Changes in Exercise Behavior and Energy Expenditure [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Exercise behavior measured as frequency of exercise as assessed by the IPAQ score. Multiple linear regression used to test for differences in the changes between groups adjusting for relevant covariates, such as baseline activity level (IPAQ score) and BMI. Linear mixed model analysis also performed for weekly change in exercise behavior. The continuous score (MET minutes/week) used as primary physical activity outcome, measured at baseline and follow-up. Compliance measured using exercise logs, which will record resistance exercise and pedometer steps.


Secondary Outcome Measures:
  • Effects of Behavioral Exercise Intervention on Biological Markers [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
    Blood (about 1½ tablespoons) collected at baseline and 4 months visits following a 12-hour fast. Blood will be processed and stored for later biomarker analysis - body adiposity, sex hormone binding globulin, estradiol, adipokines (adiponectin, leptin, resistin), cytokines (TNF, CRP, IL-6).


Estimated Enrollment: 180
Study Start Date: February 2012
Estimated Primary Completion Date: February 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cultural Related Material Group
Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.
Behavioral: Baseline Fitness Test
Complete fitness tests to measure strength, flexibility, balance, and aerobic capacity. All of the baseline fitness tests will be repeated at the end of the program (at about the 16th week) during a follow-up visit.
Behavioral: Questionnaires
At the baseline visit, complete questionnaires about demographic information taking about 35 minutes to complete. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. It should take about 10 minutes to complete these questionnaires. Patients also be asked to fill out a questionnaire every week that asks about level of physical activity. The questionnaire should take about 5 minutes to complete.
Other Name: Surveys
Behavioral: Individualized Exercise Program
The exercise programs will be individualized based on results from baseline fitness assessments and individual medical history using ACSM guidelines. For resistance and flexibility exercises each patient will receive an exercise prescription and instructional session prior to beginning the program. Invitation extended to attend monthly Group Exercise sessions with a family member. Resistance tubes, pedometer, exercise book, and video issued for use at home.
Behavioral: Written Materials
Either culturally adapted AI materials or non-culturally intervention materials will be mailed to patients every 2 weeks. The 7 themed sessions are: Getting Started;Goal Setting;Effective Energy Balance;Getting Confident;Uncovering Barriers;Lapsing, Relapsing, Collapsing;and Continuing to be Active.
Experimental: Non-Cultural Related Material Group
Patients will be randomized to receive either culturally adapted AI materials or non-culturally adapted SI materials. Intervention materials will be mailed to patients every 2 weeks. Based on the results of the fitness tests, a specific exercise program will be presented. The research staff will call about every 2 weeks to check that materials were received and have been sent back whatever materials are due. The phone call should take no more than 15 minutes. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. The questionnaire packet will be mailed with a postage-paid return envelope. It should take about 10 minutes to complete the questionnaires.
Behavioral: Baseline Fitness Test
Complete fitness tests to measure strength, flexibility, balance, and aerobic capacity. All of the baseline fitness tests will be repeated at the end of the program (at about the 16th week) during a follow-up visit.
Behavioral: Questionnaires
At the baseline visit, complete questionnaires about demographic information taking about 35 minutes to complete. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. It should take about 10 minutes to complete these questionnaires. Patients also be asked to fill out a questionnaire every week that asks about level of physical activity. The questionnaire should take about 5 minutes to complete.
Other Name: Surveys
Behavioral: Individualized Exercise Program
The exercise programs will be individualized based on results from baseline fitness assessments and individual medical history using ACSM guidelines. For resistance and flexibility exercises each patient will receive an exercise prescription and instructional session prior to beginning the program. Invitation extended to attend monthly Group Exercise sessions with a family member. Resistance tubes, pedometer, exercise book, and video issued for use at home.
Behavioral: Written Materials
Either culturally adapted AI materials or non-culturally intervention materials will be mailed to patients every 2 weeks. The 7 themed sessions are: Getting Started;Goal Setting;Effective Energy Balance;Getting Confident;Uncovering Barriers;Lapsing, Relapsing, Collapsing;and Continuing to be Active.
Active Comparator: Waitlist Group
Patients may choose to participate in the exercise program after 16-week assessment. After 4 months of exercise, all the follow-up tests repeated. Exercise recommendation then given, and all of the intervention materials.
Behavioral: Baseline Fitness Test
Complete fitness tests to measure strength, flexibility, balance, and aerobic capacity. All of the baseline fitness tests will be repeated at the end of the program (at about the 16th week) during a follow-up visit.
Behavioral: Questionnaires
At the baseline visit, complete questionnaires about demographic information taking about 35 minutes to complete. At 6 months after the follow-up visit, a packet of follow-up questionnaires about physical activity and quality of life will be mailed or given over the phone. It should take about 10 minutes to complete these questionnaires. Patients also be asked to fill out a questionnaire every week that asks about level of physical activity. The questionnaire should take about 5 minutes to complete.
Other Name: Surveys

  Show Detailed Description

  Eligibility

Ages Eligible for Study:   21 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Be Female and be 21 years of age or older. (Pilot Test and PreTest Criteria)
  2. Self-reported Mexican-American ( for Mexican-American participants) or Puerto Rican ethnicity. (Pilot Test and PreTest Criteria)
  3. History of breast cancer (invasive or ductal carcinoma in situ). (Pilot Test Criteria only)
  4. At least 3 months post treatment (surgery, chemotherapy, radiation). (Pilot Test Criteria only)
  5. Not meeting current recommended physical activity guidelines. (Pilot Test and PreTest Criteria)
  6. Able to read/write in either English or Spanish. (Pilot Test and PreTest Criteria)
  7. Reside in Harris County, Texas or one of the contiguous counties or metropolitan area of San Juan, Puerto Rico. (Pilot Test and PreTest Criteria)
  8. Be able to provide informed consent. (Pilot Test and PreTest Criteria)
  9. Be oriented to person, place, and time. (Pilot Test and PreTest Criteria)

Exclusion Criteria:

  1. Currently receiving Herceptin or non-hormonal treatment for cancer (hormonal treatment is allowed). (Pilot Test and PreTest Criteria)
  2. Present with any of American College of Sports Medicine's absolute contraindications to exercise testing: (A recent significant change in the resting ECG suggesting significant ischemia, recent myocardial infarction (within 2 days), or other acute cardiac event; unstable angina; uncontrolled cardiac dysrhythmias causing symptoms or hemodynamic compromise; symptomatic severe aortic stenosis; uncontrolled symptomatic heart failure; acute pulmonary embolus or pulmonary infarction; acute myocarditis or pericarditis; suspected or known dissecting aneurysm acute systemic infection, accompanied by fever, body aches, or swollen lymph glands). ( Pilot Test and PreTest Criteria)
  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: NCT01504789

Locations
United States, Texas
UT MD Anderson Cancer Center
Houston, Texas, United States, 77030
Puerto Rico
University of Puerto Rico
San Juan, Puerto Rico, 00936
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Karen Basen-Engquist, PHD, BA, MPH UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01504789     History of Changes
Other Study ID Numbers: 2011-0201
Study First Received: December 28, 2011
Last Updated: February 12, 2014
Health Authority: United States: Institutional Review Board
United States: Federal Government

Keywords provided by M.D. Anderson Cancer Center:
Breast Cancer
Breast Cancer Survivors
Exercise
Hispanic
Mexican-American
Puerto Rican
Culturally tailored exercise
Fitness tests
Questionnaires
Surveys
Culturally tailored written material

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases

ClinicalTrials.gov processed this record on November 25, 2014