TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age65+
SponsorDana-Farber Cancer Institute

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 volunteers

Qualifiers

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

Design model

Parallel

Treatments tested in this trial

  • THRIVE

    Behavioral

    The 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

    Behavioral

    Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Treatment groups

270 Participants
are divided into 2 treatment groups
Group A: HEALTH EDUCATION AND SUPPORT CONTROL GROUPActive comparator 1 intervention
Group B: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORTExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Received Dose Intensity (RDI)

Review of electronic medical records to discern chemotherapy dose received versus prescribed.

Time frame
Baseline to 26 weeks

Secondary outcomes

1

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).

Time frame
Baseline to 26 weeks
2

Measure of hematologic chemotoxicity - Hematocrit

Review of medical record to abstract hematocrit values (% of red blood cells in blood).

Time frame
Baseline to 26 weeks
3

Measure of hematologic chemotoxicity- White blood cell count

Review of medical record to abstract white blood cell count.

Time frame
Baseline to 26 weeks
4

Measure of hematologic chemotoxicity - Platelet count

Review of medical record to abstract platelet count.

Time frame
Baseline to 26 weeks

Other outcomes

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