Clinical trial NCT05535192: 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)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Breast Cancer
Stage III Breast Cancer
Breast Cancer Female
Stage I Breast Cancer
Stage II Breast Cancer
Keywords: Breast Cancer
Stage III Breast Cancer
Stage II Breast Cancer
Stage I Breast Cancer
Exercise Intervention
Nutrition Intervention
Supportive Care
Lead sponsor: Dana-Farber Cancer Institute
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: Case Western Reserve University
name: University of Pittsburgh
First posted: 2022-09-10
Enrollment: 270
Sex: FEMALE
Minimum age (years): 65
Standard ages: OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

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

Primary outcomes:
measure: Received Dose Intensity (RDI)
timeFrame: Baseline to 26 weeks
Secondary outcomes:
measure: Patient-reported chemotoxicities
timeFrame: Baseline to 26 weeks
measure: Measure of hematologic chemotoxicity - Hematocrit
timeFrame: Baseline to 26 weeks
measure: Measure of hematologic chemotoxicity- White blood cell count
timeFrame: Baseline to 26 weeks
measure: Measure of hematologic chemotoxicity - Platelet count
timeFrame: Baseline to 26 weeks
measure: Measure of hematologic chemotoxicity - Neutrophil count
timeFrame: Baseline to 26 weeks
measure: Accelerometry
timeFrame: Baseline to 26 weeks
measure: Morgenstern Physical Activity Questionnaire (PAQ-M)
timeFrame: Baseline to 26 weeks
measure: Diet
timeFrame: Baseline to 26 weeks
measure: Strength
timeFrame: Baseline to 26 weeks
measure: MOS SF-36 Questionnaire
timeFrame: Baseline to 26 weeks
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Baseline to 26 weeks
measure: Anthropometric measure - height
timeFrame: Baseline to 26 weeks
measure: Anthropometric measure - weight
timeFrame: Baseline to 26 weeks
measure: Anthropometric measure - waist circumference
timeFrame: Baseline to 26 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Dana Farber Cancer Institute
state: Massachusetts
city: Cleveland
country: United States
facility: Case Western Reserve University/University Hospitals Cleveland
state: Ohio
city: Pittsburgh
country: United States
facility: University of Pittsburgh
state: Pennsylvania
Study officials:
affiliation: University of Pittsburgh
name: Kathryn Schmitz (contact), PhD, MPH
role: PRINCIPAL_INVESTIGATOR
affiliation: Dana-Farber Cancer Institute
name: Jennifer Ligibel, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Case Western Reserve University/University Hospitals Cleveland
name: Nathan Berger, MD
role: PRINCIPAL_INVESTIGATOR
References: