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Clinical Trial 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.


Clinical Trial 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


Related Conditions & MeSH terms


NCT number NCT03190291
Study type Interventional
Source Wake Forest University Health Sciences
Contact Robin Rosdhal, RN, OCN
Phone 336-713-6519
Email rosdhal@wakehealth.edu
Status Not yet recruiting
Phase N/A
Start date May 2018
Completion date February 1, 2020

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