Part II: Exercise in Hispanic Breast Cancer Survivors

NCT01504789 | Active Not Recruiting

• 3 other identifiers: 2011-0201U54NCI-2015-01759
• Study Type: interventional
• Target: 53
• Locations: 2 countries
• Sites: 2

Brief Summary

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.

Conditions

Breast Cancer

Keywords

Breast Cancer; Breast Cancer Survivors; Exercise; Hispanic; Mexican-American; Puerto Rican; Culturally tailored exercise; Fitness tests; Questionnaires; Surveys; Culturally tailored written material

Outcome Measures

Primary Outcomes (1)

• Changes in Exercise Behavior and Energy Expenditure

  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.

  6 months

Secondary Outcomes (1)

• Effects of Behavioral Exercise Intervention on Biological Markers

  16 weeks

Study Arms (3)

Cultural Related Material Group

EXPERIMENTAL

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; Behavioral: Questionnaires; Behavioral: Individualized Exercise Program; Behavioral: Written Materials

Non-Cultural Related Material Group

EXPERIMENTAL

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; Behavioral: Questionnaires; Behavioral: Individualized Exercise Program; Behavioral: Written Materials

Waitlist Group

ACTIVE COMPARATOR

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; Behavioral: Questionnaires

Interventions

Baseline Fitness Test BEHAVIORAL

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.

Cultural Related Material Group; Non-Cultural Related Material Group; Waitlist Group

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

Cultural Related Material Group; Non-Cultural Related Material Group; Waitlist Group

Individualized Exercise Program BEHAVIORAL

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.

Cultural Related Material Group; Non-Cultural Related Material Group

Written Materials BEHAVIORAL

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.

Cultural Related Material Group; Non-Cultural Related Material Group

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Currently receiving Herceptin or non-hormonal treatment for cancer (hormonal treatment is allowed). (Pilot Test and PreTest Criteria)
• 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)

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (2)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

University of Puerto Rico

San Juan, 00936, Puerto Rico

Location

Related Publications (1)

• Palacios C, Daniel CR, Tirado-Gomez M, Gonzalez-Mercado V, Vallejo L, Lozada J, Ortiz A, Hughes DC, Basen-Engquist K. Dietary Patterns in Puerto Rican and Mexican-American Breast Cancer Survivors: A Pilot Study. J Immigr Minor Health. 2017 Apr;19(2):341-348. doi: 10.1007/s10903-016-0398-y.

  PMID: 26984227 DERIVED

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity

Interventions

Surveys and Questionnaires

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Behavior

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Study Officials

• Karen Basen-Engquist, PHD, BA, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 5, 2012
• Study Start: February 7, 2012
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: October 27, 2025

Record last verified: 2025-10

Locations

US (1); PR (1)