A Stepped-Care Telehealth Approach in Decreasing Distress in Cancer Survivors

Summary

Objectives

PRIMARY OBJECTIVE:
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).

SECONDARY OBJECTIVES:
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.

EXPLORATORY OBJECTIVES:
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, rural versus (v.) urban status, 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.