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TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients, THRIVE-65 Study
Trial Status: active
This clinical trial evaluates a telehealth resistance exercise intervention to preserve dose intensity and vitality in elder patients who are receiving chemotherapy for breast cancer. Support programs that include exercise and dietary counseling may provide benefits for patients receiving chemotherapy, such as fewer side effects or better quality of life. Providing support, in the form of either diet and exercise counseling or more general supportive care may make it easier for elder breast cancer patients to receive all of their planned chemotherapy according to schedule and at the planned dose.
Inclusion Criteria
Women age >= 65
Diagnosed with stage I-III invasive breast cancer
Body mass index (BMI) between 18-50 kg/m^2
Scheduled to begin at least 10 weeks of neoadjuvant or adjuvant cytotoxic chemotherapy (+/- human epidermal growth factor receptor 2 [HER-2] directed therapy or immunotherapy) for curative intent. Must be randomized before start of second cycle
Patients receiving neo/adjuvant cytotoxic chemotherapy as part of a clinical trial are generally eligible. If the trial alters the chemotherapy agents/doses according to patient response (e.g.; I-SPY trials), patients are only considered eligible if there is a standard treatment regimen of at least 10 weeks that is delivered to all patients, regardless of response. In such a trial, only the standard part of the treatment regimen will be considered in RDI calculations
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 registered dietician (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
Additional locations may be listed on ClinicalTrials.gov for NCT05535192.
I. To assess impact of an exercise intervention with protein intake support (versus health education and support control group) on received dose intensity (RDI) in women age >= 65 with breast cancer undergoing neo/adjuvant chemotherapy.
SECONDARY OBJECTIVES:
I. To assess the impact of an exercise intervention with protein intake support (versus health education and support control group) on the following in women age >= 65 with breast cancer undergoing neo/adjuvant chemotherapy:
Ia. Incidence and severity of grade 3+ hematologic and non-hematologic chemotoxicities;
Ib. Elements of the comprehensive geriatric assessment (CGA) (physical function, psychological and psychosocial status);
Ic. Quality of life, fatigue, and sleep;
Id. Health care utilization;
Ie. Physical activity behaviors and dietary intake;
If. Strength;
Ig. Body composition;
Ih. Dose delays;
Ii. Dose reductions;
Ij. Early termination.
OUTLINE: Participants are randomized to 1 of 2 groups.
GROUP I: Participants use THRIVE-65 to complete exercise sessions over 30-60 minutes 2-3 times a week for up to 16 weeks. Participants also undergo dietary assessments and receive dietary recommendations from a registered dietitian. Participants wear a Fitbit throughout the study and also undergo dual x-ray absorptiometry (DXA) scans on study.
GROUP II: Participants receive health education and support containing content that includes movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, recipes/cooking demos, and monthly newsletters with health education content. Participants wear a Fitbit throughout the study and also undergo DXA scans on study.
Trial PhaseNo phase specified
Trial Typesupportive care
Lead OrganizationDana-Farber Harvard Cancer Center