Grant Details
| Grant Number: |
1R01CA312306-01 Interpret this number |
| Primary Investigator: |
Flores, Ann |
| Organization: |
Northwestern University |
| Project Title: |
Physical and Functional Improvement Via Cancer Rehabilitation Triaging (PIVOT) Trial |
| Fiscal Year: |
2026 |
Abstract
Project Summary
Among the 18.1 million U.S. cancer survivors, approximately 40% experience physical and functional
impairments (PFIs) due to cancer and its treatment. PFIs are frequently undertreated, contributing to functional
disability in 10–25% of survivors. They negatively affect health-related quality of life (HRQoL), interfere with
treatment completion, drive costly acute care utilization, and may impact survival. Despite the proven benefits of
physical, occupational, and speech therapy, cancer rehabilitation services remain underutilized (e.g., often
initiated only after impairments become chronic). Cancer survivors are ill-equipped to self-manage PFIs or
navigate the healthcare system to access appropriate services, and oncology teams lack tools for timely
detection and referral. Health systems also lack decision support tools to match patients to the appropriate
rehabilitation specialty and nearby clinic locations. Timely identification and treatment of PFIs is essential to
improving outcomes and reducing avoidable disability, and both symptom and financial burden. To address these
gaps, we developed the 4Rs Cancer Rehabilitation Triaging System: a novel, EHR-integrated platform that
identifies the Right patient at the Right time and matches them to the Right rehabilitation specialty in the Right
location. By embedding systematic PFI monitoring and triaging into routine oncology care, 4Rs reduces clinician
burden while supporting early intervention and patient self-management. This R01 will conduct a two-arm
randomized controlled trial to evaluate the clinical and implementation outcomes of 4Rs across oncology clinics
in a large healthcare system (Northwestern Medicine). Aim 1 will assess the efficacy of 4Rs among 1,000 cancer
survivors with PFIs identified within three months of diagnosis, compared to usual care. Participants will be
followed for two years. The primary outcome is PFI measured by PROMIS-PF. Secondary outcomes include
urgent/emergency care utilization, HRQoL, and survival. Aim 2 will evaluate (a) the pre-implementation process
and cost effectiveness of 4Rs using the PRISM/RE-AIM framework to assess reach, adoption, implementation,
and maintenance via surveys and focus groups with patients, clinicians, and administrators (n=60); (b) cost
effectiveness of 4Rs that includes potential implementation and maintenance costs as well as cost savings. Aim
3 will evaluate mechanisms of action, examining intervention targets, mediators (e.g., patient self-efficacy), and
moderators (e.g., cancer type, treatments received) that influence 4Rs outcomes. By improving access to timely,
tailored cancer rehabilitation, this project has the potential to transform survivorship care, reduce disparities in
rehabilitation access, and inform scalable models for value-based cancer care delivery.
Publications
None