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

Official title

TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE-65)

Overview

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.

Detailed description

The research study procedures include screening for eligibility. After participants are determined to be eligible and have signed consent, they will participate in a baseline visit to collect measurements (e.g., weight/height/waist measurements) and questionnaires, a memory test, functional movement and strength testing, and a physical activity assessment. After baseline measures are collected, participants will be randomized to either the THRIVE Exercise and Diet Intervention or the Heath Education and Support Program during chemotherapy. There is a follow up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires.

The duration of the study will be 10-26 weeks, depending on the type of chemotherapy participants are receiving.

The THRIVE Intervention will involve:

* Exercise: Participants in the THRIVE Intervention arm work with an exercise coach to participate in both muscle strengthening exercises and aerobic exercises. There is one in-person exercise session at the beginning of the study. The remainder of the exercise sessions are done twice weekly via telehealth throughout chemotherapy treatment. * Protein intake support: Participants in the THRIVE Intervention will meet with a dietitian to make sure they are eating enough protein throughout their chemotherapy treatments. Participants will be asked to keep a daily protein checklist and share this with the exercise coach each week.

The Health Education Support Program will involve:

\- Health education tablet: Participants in the Health Education Support program will receive a tablet with information regarding mediation, stretching and gentle movement, relaxation and creative arts throughout chemotherapy.

Interventions

• Behavioral THRIVE
  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
• Behavioral Health Education Support Program
  Participants will receive a tablet with information and resources regarding mediation, stretching and gentle movement, relaxation and creative arts during chemotherapy

Primary outcome measures

• Received Dose Intensity (RDI) [Time frame: Baseline to 26 weeks]

Secondary outcome measures (12)

• Patient-reported chemotoxicities [Time frame: Baseline to 26 weeks]
• Measure of hematologic chemotoxicity - Hematocrit [Time frame: Baseline to 26 weeks]
• Measure of hematologic chemotoxicity- White blood cell count [Time frame: Baseline to 26 weeks]
• Measure of hematologic chemotoxicity - Platelet count [Time frame: Baseline to 26 weeks]
• Measure of hematologic chemotoxicity - Neutrophil count [Time frame: Baseline to 26 weeks]
• Accelerometry [Time frame: Baseline to 26 weeks]
• Morgenstern Physical Activity Questionnaire (PAQ-M) [Time frame: Baseline to 26 weeks]
• Diet [Time frame: Baseline to 26 weeks]
• Strength [Time frame: Baseline to 26 weeks]
• MOS SF-36 Questionnaire [Time frame: Baseline to 26 weeks]
• Pittsburgh Sleep Quality Index (PSQI) [Time frame: Baseline to 26 weeks]
• Anthropometric measure - height [Time frame: Baseline to 26 weeks]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Open label

Primary purpose

Supportive care

Study locations

United States · 4 centers

• Dana Farber Cancer Institute — Boston
• Case Western Reserve University/University Hospitals Cleveland — Cleveland
• University of Pittsburgh — Pittsburgh
• Mount Nittany Medical Center — State College

Identifiers

NCT: NCT05535192 · 22-250 · 1U01CA271277-01

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗