Anxiety Depression Clinical Trial
Official title:
A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors
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.
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.
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