Clinical trial · Interventional
Part II: Exercise in Hispanic Breast Cancer Survivors
NCT01504789CI-TRIAL-00114826active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (4)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Baseline Fitness Test | Behavioral | — | UNRESOLVED |
| Individualized Exercise Program | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Written Materials | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Cultural Related Material Group
- description
- 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.
- interventionNames
- Behavioral: Baseline Fitness Test
- Behavioral: Questionnaires
- Behavioral: Individualized Exercise Program
- Behavioral: Written Materials
- type
- EXPERIMENTAL
- label
- Non-Cultural Related Material Group
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 21 Years
Show eligibility criteria text
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)
References
Publications (1)
- DERIVEDPalacios 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