RECRUITING

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

Conditions

Breast Cancer Stage III Breast Cancer Breast Cancer Female Stage I Breast Cancer Stage II Breast Cancer Exercise Intervention Nutrition Intervention Supportive Care

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2023-03-20

Study Completion:2027-02-01

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05535192

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:65 Years

Sexes Eligible for Study:FEMALE

Accepts Healthy Volunteers:No

Standard Ages:OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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

Inclusion Criteria

Exclusion 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.

* 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

Contacts and Locations

Study Contact

Kathryn Schmitz, PhD, MPH

CONTACT

412-623-6216

schmitzk@upmc.edu

Jennifer Ligibel, MD

CONTACT

617-632-3800

jennifer_ligibel@dfci.harvard.edu

Principal Investigator

Kathryn Schmitz (contact), PhD, MPH

PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Jennifer Ligibel, MD

PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Nathan Berger, MD

PRINCIPAL_INVESTIGATOR

Case Western Reserve University/University Hospitals Cleveland

Study Locations (Sites)

Dana Farber Cancer Institute

Boston, Massachusetts, 02215

United States

Case Western Reserve University/University Hospitals Cleveland

Cleveland, Ohio, 44106

United States

University of Pittsburgh

Pittsburgh, Pennsylvania, 15232

United States

Collaborators and Investigators

Sponsor: Dana-Farber Cancer Institute

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-03-20

Study Completion Date2027-02-01

Study Record Updates

Study Start Date2023-03-20

Study Completion Date2027-02-01

Terms related to this study

Keywords Provided by Researchers

Breast Cancer
Stage III Breast Cancer
Stage II Breast Cancer
Stage I Breast Cancer
Exercise Intervention
Nutrition Intervention
Supportive Care

Additional Relevant MeSH Terms

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