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A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors

2017-06-19 02:51:12 | BioPortfolio

Summary

Noting the need for evidence-based cancer survivorship care, the American Society of Clinical Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial distress (anxiety, depression) in adults with cancer. These guidelines recommend screening all adults with cancer for distress and treating those with moderate or severe symptoms using a stepped-care approach tailored to distress severity.

The purpose of this study is to test a method of implementing this stepped-care approach in community oncology practices caring for rural survivors, using self-directed and telehealth approaches based on cognitive-behavioral theory.

Description

Primary Objectives: To determine feasibility (recruitment, accrual, retention, adherence) of a Randomized Control Trial (RCT) of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care in 90 post-treatment cancer survivors with moderate or severe levels of emotional distress (anxiety and/or depressive symptoms).

Secondary Objectives:

1. To obtain preliminary data on the efficacy and variability of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care for reducing emotional distress (anxiety and/or depressive symptoms) in 90 post-treatment cancer survivors.

2. To obtain preliminary data on the efficacy and variability of a stepped-care mental health intervention (tailored to symptom level) versus enhanced usual care for secondary outcomes (sleep disturbance, fatigue, fear of recurrence, and Quality of Life (QOL)) in 90 post-treatment cancer survivors.

3. To determine costs associated with both stepped-care and enhanced usual care interventions from the perspective of a healthcare provider. We will determine costs of intervention implementation and health care utilization in all arms over the course of the interventions.

4. To examine potential differential effects of the intervention on anxiety, depression, sleep disturbance, fatigue, fear of recurrence, and QOL, by gender, age, race/ethnicity, stratification arm (moderate, severe), and psychotropic medication use at baseline.

Study Design

Conditions

Anxiety Depression

Intervention

Stepped Care: Low Intensity, Enhanced Usual Care, Stepped Care: High Intensity

Location

Wake Forest School of Medicine
Winston-Salem
North Carolina
United States
27157

Status

Not yet recruiting

Source

Wake Forest University Health Sciences

Results (where available)

View Results

Links

Published on BioPortfolio: 2017-06-19T02:51:12-0400

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