Physical and Functional Improvement via Cancer Rehabilitation Triaging (PIVOT) Trial

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. Project Number: 1R01CA312306-01 | Fiscal Year: 2026 | NIH Institute/Center: National Cancer Institute (NCI) | Principal Investigator: Ann Flores (+1 co-PI) | Institution: NORTHWESTERN UNIVERSITY, CHICAGO, IL | Award Amount: $544,080 | Activity Code: R01 | Study Section: Special Emphasis Panel[ZRG1 HSS-Z (90)] View on NIH RePORTER: https://reporter.nih.gov/project-details/11343341