Georgia's Online Cancer Information Center

Find A Clinical Trial

A Stepped-Care Telehealth Approach to Treat Distress in Rural Cancer Survivors

Status
Active
Cancer Type
Breast Cancer
Cervical Cancer
Lymphoma
Prostate Cancer
Trial Phase
Eligibility
18 Years and older, Male and Female
Study Type
Supportive care
NCD ID
NCT03190291
Protocol IDs
WF-30917CD (primary)
WF-30917CD
WF-30917CD
NCI-2017-01840
Study Sponsor
Wake Forest NCORP Research Base

Summary

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.

Objectives

PRIMARY OBJECTIVES:
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.

TERTIARY 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, 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.
Georgia CORE

 

Hearts and Minds Dedicated to Improving Cancer Care

Georgia CORE is a public-private partnership that creates collaboration among the state’s cancer organizations and institutions to connect more Georgians to quality, personalized cancer care. We welcome you to this one-of-a-kind online information center for all things related to cancer and survivorship care in Georgia.