About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Parallel
Treatments tested in this trial
THRIVE
BehavioralThe THRIVE Intervention will involve: 1\) one in-person exercise sessions, followed by twice-weekly, home-based exercise sessions, supervised remotely through telehealth, and 2) a remotely delivered dietary assessment and recommendations to support protein intake throughout the study
Health Education Support Program
BehavioralParticipants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy
Treatment groups
Trial outcomes
Primary outcomes
Received Dose Intensity (RDI)
Review of electronic medical records to discern chemotherapy dose received versus prescribed.
Secondary outcomes
Patient-reported chemotoxicities
Participants will be asked to complete the PRO-CTCAE survey at each chemotherapy cycle. This well-validated survey includes symptoms and adverse events related to chemotherapy. The constructs we will measure include mouth/throat sores, nausea, constipation, diarrhea, neuropathy, concentration, memory, pain, insomnia, and fatigue. A level of 3 or higher will be the threshold for defining a chemotoxicity (yes/no).
Measure of hematologic chemotoxicity - Hematocrit
Review of medical record to abstract hematocrit values (% of red blood cells in blood).
Measure of hematologic chemotoxicity- White blood cell count
Review of medical record to abstract white blood cell count.
Measure of hematologic chemotoxicity - Platelet count
Review of medical record to abstract platelet count.
Sponsors and contacts
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Dana-Farber Cancer Institute
Lead sponsor
National Cancer Institute (NCI)
Collaborator
Case Western Reserve University
Collaborator
University of Pittsburgh
Collaborator