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

NCT ID: NCT05535192

Last Updated: 2025-04-01

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 270 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-20
• Study Completion Date: 2027-02-01

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.

Conditions

Breast Cancer; Stage III Breast Cancer; Breast Cancer Female; Stage I Breast Cancer; Stage II Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

Health Education Support Program

Intervention Type: BEHAVIORAL

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

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.

Group Type: EXPERIMENTAL

THRIVE

Intervention Type: 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

Interventions

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

Intervention Type: 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

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

National Cancer Institute (NCI)

NIH

Sponsor Role: collaborator

Case Western Reserve University

OTHER

Sponsor Role: collaborator

University of Pittsburgh

OTHER

Sponsor Role: collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role: lead

Responsible Party

Jennifer A. Ligibel, MD

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Kathryn Schmitz (contact), PhD, MPH

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Jennifer Ligibel, MD

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Nathan Berger, MD

Role: PRINCIPAL_INVESTIGATOR

Case Western Reserve University/University Hospitals Cleveland

Locations

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status: RECRUITING

Case Western Reserve University/University Hospitals Cleveland

Cleveland, Ohio, United States

Site Status: RECRUITING

University of Pittsburgh

Pittsburgh, Pennsylvania, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Kathryn Schmitz, PhD, MPH

Role: CONTACT

schmitzk@upmc.edu

412-623-6216

Jennifer Ligibel, MD

Role: CONTACT

jennifer_ligibel@dfci.harvard.edu

617-632-3800

Facility Contacts

Jennifer Ligibel, MD

Role: primary

Jennifer_Ligibel@dfci.harvard.edu

617-632-3800

Nathan Berger, MD

Role: primary

nab@case.edu

Cynthia Owusu, MD

Role: backup

cxo34@case.edu

Kathryn Schmitz, PhD, MPH

Role: primary

schmitzk@upmc.edu

412-623-6216

Other Identifiers

1U01CA271277-01

Identifier Type: NIH

Identifier Source: secondary_id

View Link

22-250

Identifier Type: -

Identifier Source: org_study_id