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

Breast Cancer Clinical Trial

— THRIVE-65  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05535192
• Other study ID #: 22-250
• Secondary ID: 1U01CA271277-01
• Status: Recruiting
• Phase: N/A
• Start date: March 20, 2023
• Est. completion date: February 1, 2027

Study information

• Verified date: April 2024
• Source: Dana-Farber Cancer Institute
• Contact: Kathryn Schmitz, PhD, MPH
• Phone: 412-623-6216
• Email: schmitzk[@]upmc.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 270
• Est. completion date: February 1, 2027
• Est. primary completion date: September 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Locations

Country	Name	City	State
United States	Dana Farber Cancer Institute	Boston	Massachusetts
United States	Case Western Reserve University/University Hospitals Cleveland	Cleveland	Ohio
United States	University of Pittsburgh	Pittsburgh	Pennsylvania

Sponsors (4)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Case Western Reserve University, National Cancer Institute (NCI), University of Pittsburgh

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Received Dose Intensity (RDI)	Review of electronic medical records to discern chemotherapy dose received versus prescribed.	Baseline to 26 weeks
Secondary	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).	Baseline to 26 weeks
Secondary	Measure of hematologic chemotoxicity - Hematocrit	Review of medical record to abstract hematocrit values (% of red blood cells in blood).	Baseline to 26 weeks
Secondary	Measure of hematologic chemotoxicity- White blood cell count	Review of medical record to abstract white blood cell count.	Baseline to 26 weeks
Secondary	Measure of hematologic chemotoxicity - Platelet count	Review of medical record to abstract platelet count.	Baseline to 26 weeks
Secondary	Measure of hematologic chemotoxicity - Neutrophil count	Review of medical record to abstract neutrophil count.	Baseline to 26 weeks
Secondary	Accelerometry	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.	Baseline to 26 weeks
Secondary	Morgenstern Physical Activity Questionnaire (PAQ-M)	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.	Baseline to 26 weeks
Secondary	Diet	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.	Baseline to 26 weeks
Secondary	Strength	Participants will undergo 10 Repetition Submaximal Strength Testing at baseline and follow-up, collected by the site-based exercise trainer, using a standardized protocol.	Baseline to 26 weeks
Secondary	MOS SF-36 Questionnaire	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.	Baseline to 26 weeks
Secondary	Pittsburgh Sleep Quality Index (PSQI)	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.	Baseline to 26 weeks
Secondary	Anthropometric measure - height	Measure of participant height in centimeters.	Baseline to 26 weeks
Secondary	Anthropometric measure - weight	Measure of participant weight in centimeters.	Baseline to 26 weeks
Secondary	Anthropometric measure - waist circumference	Measure of participant waist circumference in centimeters.	Baseline to 26 weeks