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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
65 Years and older
Sex
Female only
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 4 weeks
  • Procedures mentioned: Questionnaires, Pills

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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."
  • "There is a follow up visit up to 4 weeks after the completion of chemotherapy to repeat measurements and questionnaires."
  • "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."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study is for women age 65 or older who are getting chemotherapy for breast cancer. It compares an exercise program with protein intake support to a health education and support program. Researchers want to see if exercise and protein support help women get all planned chemotherapy on time and at the planned dose.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Women age 65 or older.
  • Have stage I–III invasive breast cancer, meaning cancer that has grown into nearby breast tissue.
  • Have a body mass index (BMI), a measure of weight compared to height, between 18 and 50.
  • Plan to start at least 10 weeks of cancer-killing chemotherapy before or after surgery, with the goal of curing the cancer.
  • If in a chemotherapy drug trial, treatment must include an anthracycline or taxane drug. The trial must not change chemotherapy drugs or doses based on how the cancer responds.
  • Report being able to walk for 6 minutes or 2 blocks, with or without a walking aid.
  • Can give written consent to join the study.
  • Can understand, speak, and read English.

Who can't join

  • Follow a special diet for another illness that a dietitian says would conflict with the study diet.
  • Did strength training at least twice a week for 3 months in a row or longer during the past year.
  • Did aerobic exercise that included competitive events, such as running races or triathlons, during the past year.
  • Have a health condition or take medicine that prevents joining an exercise program.
  • Currently take weight-loss medicine.
  • Have a documented history of alcohol or drug abuse in the past 12 months.
  • Have a history of dementia, a condition that affects memory and thinking.

Simplified for readability. The official criteria below are what the study team uses.

Official 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

Study sites (4)

MA

OH

PA