Trial Title:
TeleHealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients
NCT ID:
NCT05535192
Condition:
Breast Cancer
Stage III Breast Cancer
Breast Cancer Female
Stage I Breast Cancer
Stage II Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Breast Cancer
Stage III Breast Cancer
Stage II Breast Cancer
Stage I Breast Cancer
Exercise Intervention
Nutrition Intervention
Supportive Care
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
None (Open Label)
Intervention:
Intervention type:
Behavioral
Intervention name:
THRIVE
Description:
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
Arm group label:
THRIVE: EXERCISE INTERVENTION WITH PROTEIN INTAKE SUPPORT
Intervention type:
Behavioral
Intervention name:
Health Education Support Program
Description:
Participants will receive a tablet with information and resources regarding mediation,
stretching and gentle movement, relaxation and creative arts during chemotherapy
Arm group label:
HEALTH EDUCATION AND SUPPORT CONTROL GROUP
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.
Criteria for 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
Gender:
Female
Minimum age:
65 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Dana Farber Cancer Institute
Address:
City:
Boston
Zip:
02215
Country:
United States
Status:
Recruiting
Contact:
Last name:
Jennifer Ligibel, MD
Phone:
617-632-3800
Email:
Jennifer_Ligibel@dfci.harvard.edu
Investigator:
Last name:
Jennifer Ligibel, MD
Email:
Principal Investigator
Facility:
Name:
Case Western Reserve University/University Hospitals Cleveland
Address:
City:
Cleveland
Zip:
44106
Country:
United States
Status:
Recruiting
Contact:
Last name:
Nathan Berger, MD
Email:
nab@case.edu
Contact backup:
Last name:
Cynthia Owusu, MD
Email:
cxo34@case.edu
Facility:
Name:
University of Pittsburgh
Address:
City:
Pittsburgh
Zip:
15232
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kathryn Schmitz, PhD, MPH
Phone:
412-623-6216
Email:
schmitzk@upmc.edu
Start date:
March 20, 2023
Completion date:
February 1, 2027
Lead sponsor:
Agency:
Dana-Farber Cancer Institute
Agency class:
Other
Collaborator:
Agency:
National Cancer Institute (NCI)
Agency class:
NIH
Collaborator:
Agency:
Case Western Reserve University
Agency class:
Other
Collaborator:
Agency:
University of Pittsburgh
Agency class:
Other
Source:
Dana-Farber Cancer Institute
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05535192
