Grant Number:	5U01CA271277-03 Interpret this number
Primary Investigator:	Schmitz, Kathryn
Organization:	University Of Pittsburgh At Pittsburgh
Project Title:	Telehealth Resistance Exercise Intervention to Preserve Dose Intensity and Vitality in Elder Breast Cancer Patients (THRIVE)
Fiscal Year:	2023

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 <85% of received dose intensity (RDI), a metric that combines the total dose administered with adherence to the planned treatment schedule, have a 57% increase in the risk of disease recurrence at 10 years as compared to women who receive at least 85% RDI. Only 50-76% of breast cancer patients >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.





None