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Completed NON-SBIR/STTR RPGS NIH (US)

TeleHealth Resistance exercise Intervention to preserve dose intensity and Vitality in Elder breast cancer patients (THRIVE)

$3.69M USD

Funder NATIONAL CANCER INSTITUTE
Recipient Organization Pennsylvania State University Hershey Med Ctr
Country United States
Start Date Apr 11, 2022
End Date Sep 30, 2022
Duration 172 days
Number of Grantees 3
Roles Co-Investigator; Principal Investigator
Data Source NIH (US)
Grant ID 10450916
Grant Description
Project Summary/Abstract

More than 276,480 women were diagnosed with breast cancer in 2020, with 120,000 cases occurring in

women 65 years or older. Given the increasing median age of the US population, the number of breast cancers

diagnosed in older women is expected to rise by 50% in the coming decades. Older women with breast cancer

experience worse breast cancer-specific outcomes as compared to younger women, under-treatment is likely

to play a central role. Studies have demonstrated that breast cancer patients who receive 65 receive an RDI >85, largely due to

increased toxicity of therapy in these patients. Reducing treatment-related toxicity to enhance RDI is

critical to improving disease outcomes among the growing population of older breast cancer patients.

To this end, models predicting for severe chemotoxicity demonstrate that a number of potentially modifiable

factors (commonly assessed as part of the geriatric assessment), are important determinants of chemotoxicity,

including function, depression, and falls (or use of assistive devices). Exercise has a significant positive impact

on each of these modifiable factors, in the general population and in cancer patients. However, data on the

ability of exercise interventions to improve treatment tolerance and preserve dose intensity among older breast

cancer patients are lacking. We propose a randomized controlled trial to assess the effects of a

multicomponent, hybrid telehealth (TH) exercise and protein intake support (the THRIVE Intervention)

on RDI, incidence and severity of chemotoxicities, functional status, muscle mass, and patient

reported outcomes in 270 breast cancer patients age ≥ 65 receiving neo/adjuvant chemotherapy.

Participants will be randomized to the THRIVE Intervention or to a Health Education and Support control

group. The intervention will be delivered through a hybrid model, leveraging the existing Breast Cancer Weight

Loss (BWEL) Trial call center. After 2 in-person, onsite exercise sessions, we will transition to TH sessions

delivered on study provided tablets, by certified exercise coaches who will tailor behavior change to support

adherence relative to symptom burden. To optimize intervention effectiveness, participants will undergo a TH

evaluation of diet adequacy with a registered dietitian, focused on optimal daily protein intake. Protein

supplementation will be provided if needed to achieve 1.2 gm/kg daily intake. The TH focus consolidates

expertise at a well-established call center (BWEL), elevating the potential for broad implementation across the

U.S., including cancer treatment centers with too few patients to justify necessary personnel. The project also

seeks to evaluate intervention cost, as well as the facilitators and barriers to implementation of this TH

intervention, toward the goal of translation to clinical practice upon successful completion of the THRIVE trial.
All Grantees

Pennsylvania State University Hershey Med Ctr

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