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

• ClinicalTrials.gov Identifier: NCT05535192
• Recruitment Status: Recruiting
• First Posted: September 10, 2022
• Last Update Posted: April 5, 2024
• Sponsor: Dana-Farber Cancer Institute
• Collaborators: National Cancer Institute (NCI); Case Western Reserve University; University of Pittsburgh
• Information provided by (Responsible Party): Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute

Tracking Information

• First Submitted Date: August 29, 2022
• First Posted Date: September 10, 2022
• Last Update Posted Date: April 5, 2024
• Actual Study Start Date: March 20, 2023
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 8, 2022)

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

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

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: September 8, 2022)

• Patient-reported chemotoxicities [ Time Frame: Baseline to 26 weeks ]
  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 [ Time Frame: Baseline to 26 weeks ]
  Review of medical record to abstract hematocrit values (% of red blood cells in blood).
• Measure of hematologic chemotoxicity- White blood cell count [ Time Frame: Baseline to 26 weeks ]
  Review of medical record to abstract white blood cell count.
• Measure of hematologic chemotoxicity - Platelet count [ Time Frame: Baseline to 26 weeks ]
  Review of medical record to abstract platelet count.
• Measure of hematologic chemotoxicity - Neutrophil count [ Time Frame: Baseline to 26 weeks ]
  Review of medical record to abstract neutrophil count.
• Accelerometry [ Time Frame: Baseline to 26 weeks ]
  Physical activity will be measured objectively using Actigraph accelerometry. Accelerometer data will include estimated average metabolic equivalents expended daily and in hours/week as well as time in sedentary, low, moderate and vigorous activity.
• Morgenstern Physical Activity Questionnaire (PAQ-M) [ Time Frame: Baseline to 26 weeks ]
  Self-reported physical activity will be measured at baseline and end-of-study using the Morgenstern Physical Activity Questionnaire (PAQ-M), which has been used to reliably capture recreational, occupational and household activity in sedentary adults.
• Diet [ Time Frame: Baseline to 26 weeks ]
  Dietary intake will be estimated using repeat administrations of the self-reported, validated Arizona Food Frequency Questionnaire. This questionnaire has been used extensively in large dietary intervention trials among cancer survivors. The instrument will be completed by patients during baseline and end of chemotherapy, reflecting on previous 4 weeks of usual dietary intake.
• Strength [ Time Frame: Baseline to 26 weeks ]
  Participants will undergo 10 Repetition Submaximal Strength Testing at baseline and follow-up, collected by the site-based exercise trainer, using a standardized protocol.
• MOS SF-36 Questionnaire [ Time Frame: Baseline to 26 weeks ]
  General health-related quality of life (including vitality) will be assessed at baseline and end-of-study using the well-validated MOS SF-36 survey.
• Pittsburgh Sleep Quality Index (PSQI) [ Time Frame: Baseline to 26 weeks ]
  Sleep will be assessed at baseline and end-of-study using the PSQI, which is a widely used measure of subjective sleep disturbance; its validity and reliability have been established in various clinical populations, including patients with cancer.
• Anthropometric measure - height [ Time Frame: Baseline to 26 weeks ]
  Measure of participant height in centimeters.
• Anthropometric measure - weight [ Time Frame: Baseline to 26 weeks ]
  Measure of participant weight in centimeters.
• Anthropometric measure - waist circumference [ Time Frame: Baseline to 26 weeks ]
  Measure of participant waist circumference in centimeters.

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: 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)
• 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.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: None (Open Label); Primary Purpose: Supportive Care

Condition

• Breast Cancer
• Stage III Breast Cancer
• Breast Cancer Female
• Stage I Breast Cancer
• Stage II Breast Cancer

Intervention

• 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

Study Arms

• Active Comparator: HEALTH EDUCATION AND SUPPORT CONTROL GROUP
  The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the Heath Education Support Program will receive a tablet from the study that is pre-loaded with material to help support them during chemotherapy. The tablet materials will include supportive care and resources that focus on movement (light stretching and gentle yoga), soothing music, meditation/mindfulness, and recipes/cooking demos. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy and the amount of time they spend engaging with the tablet. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
  Intervention: Behavioral: Health Education Support Program
• Experimental: THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
  The research study procedures include screening for eligibility and a baseline visit to collect measurements and questionnaires. After the baseline appointment, participants randomized into the THRIVE Exercise and Diet Intervention will work with a coach to gradually build exercise and stay active during chemotherapy treatment. Participants will work with an exercise coach to reach the muscle strengthening and aerobic exercise goals of the study. Participants will also consult with a dietician to ensure adequate protein intake during the study. Participants in this arm will be asked to fill out questionnaires at the start of each chemotherapy cycle to indicate any side effects from chemotherapy. At the end of participants' chemotherapy, they will be asked to complete end-of-study measures.
  Intervention: Behavioral: THRIVE

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: September 8, 2022): 270
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: February 1, 2027
• Estimated Primary Completion Date: September 30, 2026 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 65 Years and older (Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Kathryn Schmitz, PhD, MPH; 412-623-6216; schmitzk@upmc.edu

Contact: Jennifer Ligibel, MD; 617-632-3800; jennifer_ligibel@dfci.harvard.edu

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT05535192
• Other Study ID Numbers: 22-250; 1U01CA271277-01 ( U.S. NIH Grant/Contract )
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: Yes
• Plan Description: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to Sponsor Investigator or designee. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.
• Supporting Materials: Study Protocol
• Supporting Materials: Statistical Analysis Plan (SAP)
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

• Current Responsible Party: Jennifer A. Ligibel, MD, Dana-Farber Cancer Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Dana-Farber Cancer Institute
• Original Study Sponsor: Same as current

Collaborators

• National Cancer Institute (NCI)
• Case Western Reserve University
• University of Pittsburgh

Investigators

• Principal Investigator: Kathryn Schmitz (contact), PhD, MPH; University of Pittsburgh
• Principal Investigator: Jennifer Ligibel, MD; Dana-Farber Cancer Institute
• Principal Investigator: Nathan Berger, MD; Case Western Reserve University/University Hospitals Cleveland

• PRS Account: Dana-Farber Cancer Institute
• Verification Date: April 2024