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TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
RECRUITINGN/ASponsored by Dana-Farber Cancer Institute
Actively Recruiting
PhaseN/A
SponsorDana-Farber Cancer Institute
Started2023-03-20
Est. completion2026-09-30
Eligibility
Age65 Years+
SexFEMALE
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05535192
Summary
This research is being done to assess whether an exercise intervention with protein intake support vs a health education and support program will make it easier for women age 65 or older who are receiving chemotherapy for breast cancer to receive all of their planned chemotherapy according to schedule and at the planned dose.
Eligibility
Age: 65 Years+Sex: FEMALEHealthy volunteers accepted
Inclusion Criteria: * Women age \>=65 * Diagnosed with stage I-III invasive breast cancer * BMI between 18-50 kg/m2 * Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy for curative intent * If enrolled in clinical chemotherapy drug trial, considered eligible if regimen includes an anthracycline or a taxane, unless the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials) * Self-reported ability to walk for 6 minutes and/or 2 blocks (with or without assistive device) * Ability to provide written informed consent. * Ability to understand, speak, and read English. This is because many of the study instruments used are not readily available in multiple languages. Additionally, site-based study staff, such as exercise physiologists, are not bilingual and not all sites have access to interpreters. Exclusion Criteria: * Following a therapeutic diet for co-morbid disease where the THRIVE-65 diet would be contraindicated as assessed by the RD * Engaging in 2 or more sessions of strength training exercise per week over a period of at least 3 consecutive months over the past year * Engaging in aerobic activity at a level that includes competitive events (e.g., marathon, triathlon, running races) over the past year * Presence of medical conditions or medications that would prohibit participation in an exercise program * Current use of weight-loss medication * Documented history of alcohol or substance abuse within the past 12 months * History of dementia
Conditions6
Breast CancerBreast Cancer FemaleCancerStage I Breast CancerStage II Breast CancerStage III Breast Cancer
Locations3 sites
Massachusetts
1 siteDana Farber Cancer Institute
Boston, Massachusetts, 02215
Ohio
1 siteCase Western Reserve University/University Hospitals Cleveland
Cleveland, Ohio, 44106
Nathan Berger, MDnab@case.edu
Pennsylvania
1 siteUniversity of Pittsburgh
Pittsburgh, Pennsylvania, 15232
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Actively Recruiting
PhaseN/A
SponsorDana-Farber Cancer Institute
Started2023-03-20
Est. completion2026-09-30
Eligibility
Age65 Years+
SexFEMALE
Healthy vol.Accepted
Locations3 sites
View on ClinicalTrials.gov →
NCT05535192