Abstract
Background: Rates of clinically elevated depressive symptoms among ambulatory oncology patients are higher than in the general population and are associated with poorer health-related quality of life. Furthermore, a reduction in depressive symptoms may be associated with improved cancer survival. Several interventions have demonstrated efficacy in reducing oncologic depressive symptoms, including cognitive-behavioral stress management (CBSM). However, more work is needed to understand how to best implement CBSM into practice, such as through stepped-care approaches and digital health interventions linked to electronic health records (EHR). This manuscript presents the protocol of the My Well-Being Guide study, a pragmatic type 1 effectiveness-implementation hybrid study. This trial will test the effectiveness of My Well-Being Guide, a seven-week structured, CBSM-based digital health intervention designed to reduce depressive symptoms. This trial will also evaluate My Well-Being Guide's implementation across two health systems. Methods: The final sample (N = 4561) will be oncology patients at Northwestern Medicine or University of Miami Health System who are ≥18 years of age; have a cancer diagnosis; elevated depressive symptoms on the Patient-Reported Outcomes Measurement Information System Depression; and primary language is English or Spanish. Data collection will occur at baseline, and 2-, 6-, and 12-months post baseline. Outcome domains include depressive symptoms and implementation evaluation. Discussion: This study may provide valuable data on the effectiveness of our depressive symptom management digital health intervention linked to the EHR and the scalability of digital health interventions in general.
Original language | English (US) |
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Article number | 107121 |
Journal | Contemporary Clinical Trials |
Volume | 127 |
DOIs | |
State | Published - Apr 2023 |
Funding
This project is funded by the National Cancer Institute (1R37CA255875–01) and is registered on ClinicalTrials.gov , NCT05369429 . The study procedures described in this protocol were approved by the Institutional Review Board. Funding for this study is provided by the National Cancer Institute award #R37CA255875 awarded to Dr. Betina Yanez. Dr. Chloe Taub was supported by the National Cancer Institute award # 5T32CA193193 . REDCap is supported at FSM by the Northwestern University Clinical and Translational Science (NUCATS) Institute, Research reported in this publication was supported, in part, by the National Institutes of Health's National Center for Advancing Translational Sciences, Grant Number UL1TR001422. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health.
Keywords
- Cancer
- Depression
- Digital health
- Implementation science
- Psychosocial
ASJC Scopus subject areas
- Pharmacology (medical)