MC1193: Collaborative Care to Preserve Performance in Cancer (COPE)
I. Establish the comparative effectiveness of the Collaborative Care to Preserve Performance
in Cancer (COPE) trial arms in preserving functional status.
II. To assess the comparative cost-effectiveness and cost-utility of the COPE interventions.
OUTLINE: Patients are randomized to 1 of 3 arms.
ARM I: Patients undergo enhanced usual care comprising telephonic monitoring, monthly status
reports, and an oncology care team for 6 months.
ARM II: Patients undergo enhanced usual care as in Arm I and participate in an
individualized conditioning program delivered by a local physical therapist and coordinated
by the Rehabilitation Care Manager (RCM) for 6 months.
ARM III: Patients undergo enhanced usual care as in Arm I, participate in an individualized
conditioning program coordinated by the RCM as in Arm II, and receive optimized pain
management through a Pain Care Manager (PCM) for 6 months.
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
Change in Acute Care CAT (APC) score in cancer patients out to 6 months.
An overall test using a linear contrast across the three arms will be used. If this is significant then tests between individual pairs of arms will follow. A mixed-effects regression model will allow use of multiple APC measurements per subject while allowing for an appropriate within-subject covariance structure. Time will be incorporated as a continuous variable, a polynomial function, or using assessment-specific indicator variables to determine the most parsimonious model that adequately describes the observed patterns.
Baseline to 6 months
Andrea Cheville, M.D.
United States: Food and Drug Administration
|Mayo Clinic||Rochester, Minnesota 55905|