Grant Number:	5R21CA198237-03 Interpret this number
Primary Investigator:	Danhauer, Suzanne
Organization:	Wake Forest University Health Sciences
Project Title:	A Stepped-Care Telehealth Approach to Treat Distress in Rural Cancer Survivors
Fiscal Year:	2018

 DESCRIPTION (provided by applicant): Psychosocial distress, including anxiety and depressive symptoms, is common in post-treatment cancer survivors and associated with multiple adverse outcomes, including sleep disturbance, fatigue and decreased quality of life (QOL). Interventions that are accessible to post-treatment cancer survivors experiencing significant distress are sorely needed, especially in rural areas where psychosocial care is scarce. Recent national guidelines recommend screening all adults with cancer for distress and treating those with moderate to severe symptoms using a stepped-care approach. The purpose of this pilot study is to implement a stepped- care approach in rural community oncology settings using a cognitive-behavioral therapy (CBT) protocol that includes both self-directed and telehealth approaches. Specific aims are to: (1) determine feasibility (accrual, retention, adherence) of a randomized controlled trial of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care (EUC) in 90 rural, post-treatment cancer survivors with moderate to severe levels of distress (anxiety and/or depressive symptoms); (2) obtain preliminary efficacy data for reducing emotional distress and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, QOL); and (3) determine intervention costs. We will recruit 90 adult (age ≥18), rural cancer survivors who are 6-24 months post-treatment for female breast, colorectal, prostate, or gynecologic cancer or non-Hodgkin's lymphoma and who report clinically significant anxiety or depressive symptoms. Participants will be stratified by symptom severity and randomized to stepped-care or EUC. For participants with moderate symptoms, low- intensity, stepped care will consist of a self-guided CBT workbook and biweekly check-in calls to assess changes in symptom severity/immediate need for psychiatric treatment and to provide minimal support. For participants with moderate to severe symptoms, high-intensity stepped care will consist of a CBT workbook and psychotherapy delivered by telephone. Participants randomized to EUC will receive survivorship resources and referral information for local mental health providers. Measures will be administered by telephone and mail at pre-, mid- and post-intervention. The proposed study efficiently builds on prior and current research and leverages the existing NCI-funded Research Base infrastructure. The innovation of this work is its focus on addressing a mental health disparity among rural cancer survivors through a stepped-care intervention. After this study is completed, we will implement a fully-powered study in the community cancer setting. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.





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