Contemporary clinical trials · 2026
Technology-enabled collaborative care management of depression in urban and rural cancer centers: Protocol and baseline results from the SCOPE pragmatic hybrid effectiveness-implementation trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Fann Jesse R, Lostutter Ty W, Andris Lydia, Bates Nicole, Rhew Isaac C, Bauer Amy M, Bennett Ian M, Martin Daniel, Irwin Blair, Powers Diane M, Cruz Jourdan, Hsieh Gary, Fogarty James
Аннотация
BACKGROUND: Up to 25% of people with cancer will become clinically depressed. Unfortunately, most cancer patients with depression do not receive adequate treatment. The Collaborative Care Model (CoCM) is an evidence-based system of care that can lead to sustained improvement in depression symptoms and quality of life in patients with cancer, but high fidelity implementation has been slow. We previously used a human-centered design approach to design and develop a patient- and provider-facing web platform to enhance the implementation and fidelity of CoCM for depression in patients undergoing cancer treatment. We describe the methods and baseline characteristics for a trial that compares technology-enhanced CoCM to the current CoCM approach.
METHODS: The technology-enhanced CoCM system (t-CoCM) will be compared to usual CoCM (u-CoCM) in a 9-month pragmatic hybrid effectiveness-implementation randomized controlled trial among patients receiving treatment for cancer at an NCI-designated comprehensive cancer center and a community cancer center. Outcomes include clinical outcomes and CoCM fidelity as well as implementation obstacles and opportunities.
RESULTS: The 297 patients randomized to the study (149 t-CoCM, 148 u-CoCM) represent a diverse sample with high medical and psychiatric comorbidity. 35% had breast cancer and 43% had metastatic disease. Mean (SD) baseline Hopkins Symptom Checklist-20 (1.9 [0.7]) and Patient Health Questionnaire-9 (15.3 [4.0]) depression scores indicate significant depression symptomatology.
CONCLUSIONS: The study will provide valuable practice-based information on processes and outcomes of CoCM for depression in patients receiving acute cancer treatment and on implementation of a web platform to enhance delivery of CoCM in this setting.
TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05012124 (submitted 8/11/21).
METHODS: The technology-enhanced CoCM system (t-CoCM) will be compared to usual CoCM (u-CoCM) in a 9-month pragmatic hybrid effectiveness-implementation randomized controlled trial among patients receiving treatment for cancer at an NCI-designated comprehensive cancer center and a community cancer center. Outcomes include clinical outcomes and CoCM fidelity as well as implementation obstacles and opportunities.
RESULTS: The 297 patients randomized to the study (149 t-CoCM, 148 u-CoCM) represent a diverse sample with high medical and psychiatric comorbidity. 35% had breast cancer and 43% had metastatic disease. Mean (SD) baseline Hopkins Symptom Checklist-20 (1.9 [0.7]) and Patient Health Questionnaire-9 (15.3 [4.0]) depression scores indicate significant depression symptomatology.
CONCLUSIONS: The study will provide valuable practice-based information on processes and outcomes of CoCM for depression in patients receiving acute cancer treatment and on implementation of a web platform to enhance delivery of CoCM in this setting.
TRIAL REGISTRATION: Clinicaltrials.gov identifier: NCT05012124 (submitted 8/11/21).