TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE-65)

Protocol # :
Breast Cancer
Stage III Breast Cancer
Breast Cancer Female
Stage I Breast Cancer
Stage II Breast Cancer
Disease Sites
Principal Investigator
Ligibel, Jennifer, A

Trial Description

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 Requirements

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 anthracycline or
taxane-based 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

- 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 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 within past 3 years

- Engaging in 90 minutes or more of weekly aerobic activity of moderate intensity (e.g.
brisk walking, aerobics/dance or bicycling) for at least 3 consecutive months within
the past 3 years

- Presence of medical conditions or medications that would prohibit participation in an
exercise program

- Current use of weight-loss medication

- Self-report alcohol or substance abuse within the past 12 months, including at-risk
drinking (defined as current consumption of >14 alcoholic drinks per week)

- History of dementia