Preliminary Effectiveness of the Comprehensive Oncology Rehabilitation and Exercise (CORE) Clinical Workflow...

The Comprehensive Oncology Rehabilitation and Exercise (CORE) pilot trial aimed to test the feasibility and acceptability of a clinical workflow algorithm that integrated exercise and rehabilitation services from breast cancer diagnosis throughout the first 24 weeks of care. Here, we investigated the preliminary effectiveness of the CORE algorithm compared with standard of care (SOC) on changes in physical function, health-related quality of life (HRQoL), and exercise engagement in women newly diagnosed with Stage I-III breast cancer with plans for surgery as first-line treatment.

Seventy-two women were randomly assigned in a 2:1 ratio to CORE or SOC. All participants completed study assessments at three time points that aligned with routine breast surgical oncology clinic visits: surgical consultation (i.e., baseline), postoperative, and 24 weeks postoperative. The following outcomes and associated assessments were carried out in the clinic: physical function: PROMIS physical function survey (primary function assessment), five-time chair stand, 10-m walk, back scratch, and QuickDASH survey; HRQoL: FACT-B survey; and exercise engagement: modified Godin physical activity survey (primary engagement assessment) and accelerometer wear for 1 week following each clinic visit.

Fifty-nine participants had evaluable data, with the majority having Stage I disease (83%), being primarily White (75%) and non-Hispanic (90%), and having a median age and BMI of 58 years and 26.0 kg/m², respectively. Mean difference in change in PROMIS physical function score from baseline to 24 weeks postoperative between CORE and SOC was not statistically significant (-1.86, 95% CI -6.02 to 2.3). A modest advantage in exercise engagement was observed in the CORE arm (Godin: 5.46, 95% CI -1.06 to 11.98; effect size: 0.36, 95% CI -0.07 to 0.78; accelerometry: median difference 12 min, bootstrapped 95% CI -37 to 40).

The CORE clinical workflow algorithm demonstrates promise in improving exercise engagement. More work is needed in an adequately powered trial to confirm these findings and evaluate effectiveness on other outcomes.

ClinicalTrials.gov identifier: NCT04594473.