A Stepped-Care Telehealth Approach to Treat Distress in Rural Cancer Survivors
18 Years and older, Male and Female
This randomized clinical trial studies how well a stepped-care telehealth approach works in decreasing distress such as anxiety and / or depressive symptoms in cancer survivors. A stepped-care mental health intervention may help to decrease emotional distress in post-treatment cancer survivors.
I. To determine feasibility (recruitment, accrual, retention, adherence) of a randomized controlled trial (RCT) of a stepped-care telehealth 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).
I. To obtain preliminary data on the efficacy and variability of a stepped-care telehealth 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.
II. To obtain preliminary data on the efficacy and variability of a stepped-care telehealth mental health intervention (tailored to symptom level) versus enhanced usual care for secondary outcomes (sleep disturbance, fatigue, fear of recurrence, cancer-related distress, and quality of life [QOL]) in 90 post-treatment cancer survivors.
III. To determine costs associated with both stepped-care telehealth and enhanced usual care interventions from the perspective of a healthcare provider.
I. 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.
II. To examine mediating effects of expectancy ratings of the intervention on anxiety and depression.
OUTLINE: Patients with moderate symptoms only are randomized into Group I or III, and patients with severe symptoms are randomized into Group II or III.
GROUP I: Patients receive a workbook with lessons designed to help manage anxiety, depression, and distress. Patients review the information in the workbook, complete the written exercises, and practice the techniques over 1 hour and 45 minutes per week or 15 minutes daily for 12 weeks.
GROUP II: Patients receive a workbook and complete exercises as in Group I. Patients also attend 12 weekly therapy sessions over 45 minutes each.
GROUP III: Patients receive information about referrals/resources in the local area, including support groups and mental health providers. Patients also receive a book to assist with the transition from active treatment to survivorship.
After completion of study, patients are followed up for 15 weeks.
Treatment Sites in Georgia