Supportive oncology care at home interventions: protocols for clinical trials to shift the paradigm of care for patients with cancer

Ryan D Nipp, Eliza Shulman, Melissa Smith, Patricia M C Brown, P Connor Johnson, Eva Gaufberg, Charu Vyas, Carolyn L Qian, Isabel Neckermann, Shira B Hornstein, Mathew J Reynolds, Joseph Greer, Jennifer S Temel, Areej El-Jawahri, Ryan D Nipp, Eliza Shulman, Melissa Smith, Patricia M C Brown, P Connor Johnson, Eva Gaufberg, Charu Vyas, Carolyn L Qian, Isabel Neckermann, Shira B Hornstein, Mathew J Reynolds, Joseph Greer, Jennifer S Temel, Areej El-Jawahri

Abstract

Background: Patients with cancer often endure substantial symptoms and treatment toxicities leading to high healthcare utilization, including hospitalizations and emergency department visits, throughout the continuum of their illness. Innovative oncology care models are needed to improve patient outcomes and reduce their healthcare utilization. Using a novel hospital at home care platform, we developed a Supportive Oncology Care at Home intervention to address the needs of patients with cancer.

Methods: We are conducting three trials to delineate the role of Supportive Oncology Care at Home for patients with cancer. The Supportive Oncology Care at Home intervention includes: (1) a hospital at home care model for symptom assessment and management; (2) remote monitoring of daily patient-reported symptoms, vital signs, and body weight; and (3) structured communication with the oncology team. Our first study is a randomized controlled trial to test the efficacy of Supportive Oncology Care at Home versus standard oncology care for improving healthcare utilization, cancer treatment interruptions, and patient-reported outcomes in patients with cancer receiving definitive treatment of their cancer. Participants include adult patients with gastrointestinal and head and neck cancer, as well as lymphoma, receiving definitive treatment (e.g., treatment with curative intent). The second study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention for hospitalized patients with advanced cancer. Eligible participants include adult patients with incurable cancer who are admitted with an unplanned hospitalization. The third study is a single-arm trial assessing the feasibility and acceptability of the Supportive Oncology Care at Home intervention to enhance the end-of-life care for patients with advanced hematologic malignancies. Eligible participants include adult patients with relapsed or refractory hematologic malignancy receiving palliative therapy or supportive care alone.

Discussion: These studies are approved by the Dana-Farber/Harvard Cancer Center Institutional Review Board and are being conducted in accordance with the Consolidated Standards of Reporting Trials statement for non-pharmacological trials. This work has the potential to transform the paradigm of care for patients with cancer by providing them with the necessary support at home to improve their health outcomes and care delivery.

Trial registrations: NCT04544046, NCT04637035, NCT04690205.

Keywords: Hospital at home care; Oncology care at home; Supportive oncology care at home.

Conflict of interest statement

E.S., M.S., and P.M.C.B. are employed by Medically Home. RDN has received research support from Medically Home. J.G. has received research support from Gaido Health/BCG Digital Ventures, consultant fees from Concerto HealthAI, royalties for edited book from Springer (Humana Press), and consultant fees from Blue Note Therapeutics. Other authors declare that they have no competing interests.

© 2022. The Author(s).

Figures

Fig. 1
Fig. 1
Supportive Oncology Care at Home Intervention
Fig. 2
Fig. 2
Supportive Oncology Care at Home for Patients with Cancer Receiving Definitive Treatment Consort Diagram
Fig. 3
Fig. 3
Supportive Oncology Care at Home for Hospitalized Patients with Cancer Consort Diagram
Fig. 4
Fig. 4
Optimize EOL Care for Patients with Hematologic Malignancies Consort Diagram

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