The rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions.

Cheville AL, Moynihan T, Basford JR, Nyman JA, Tuma ML, Macken DA, Therneau T, Satelel D, Kroenke K. The rationale, design, and methods of a randomized, controlled trial to evaluate the effectiveness of collaborative telecare in preserving function among patients with late stage cancer and hematologic conditions. Contemporary clinical trials. 2018 Jan 1; 64:254-264.

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Abstract:

Disablement affects over 40% of patients with advanced stage cancer, devastates their quality of life (QoL), and increases their healthcare costs. Proactively treating the causes of disablement; physical impairments, pain, and immobility, can prolong functional independence, improve QoL and, potentially, reduce utilization. However rehabilitation service delivery models are reactive in nature and focus on catastrophic rather than incipient disability. A validated collaborative approach, the Three Component Model (TCM), optimizes important clinical outcomes and may provide an ideal framework to overcome barriers to proactively integrating rehabilitation into cancer care. A novel expansion of the TCM that targets disablement by engaging local physical therapists to address physical impairments and immobility, the TCM-Rehabilitation Services (TCM-RS), benefits and is well received by patients. However, its effectiveness has not been rigorously assessed. The 3-arm randomized COllaborative Care to Preserve PErformance in Cancer (COPE) Trial compared: 1) enhanced usual care, 2) rehabilitation services targeting physical impairments and immobility via the TCM-RS, and 3) TCM-RS plus conventional TCM pain management TCM-RS+Pain. Of the 516 participants, those randomized to arms 2 and 3 underwent an initial 4-week intervention period and were then followed for 6months with remote monitoring and monthly telephone calls. The trial's primary outcome, functional status, and secondary outcomes were assessed at baseline, 3, and 6months. Utilization was abstracted from clinical records. By estimating the effectiveness and cost-utility implications of the TCM-RS and TCM-RS+Pain, COPE will inform future delivery research, practice and policy in the means to reduce disablement in chronically diseased populations.