A Stepped-Care Telehealth Approach in Decreasing Distress in Cancer Survivors
Breast Cancer
Cervical Cancer
Colon/Rectal Cancer
Hodgkin Lymphoma
Lymphoma
Non-Hodgkin Lymphoma
Prostate Cancer
Solid Tumor
Uterine Cancer
18 Years and older, Male and Female
WF-30917CD (primary)
WF-30917CD
WF-30917CD
NCI-2017-01840
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 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.
Eligibility
- Score >= 10 on the Generalized Anxiety Disorder-7 Questionnaire (GAD-7) and/or a score >= 8 on the Patient Health Questionnaire-9 Item (PHQ-9), indicating clinically significant anxiety or depressive symptoms, respectively
- Past history of treated (newly diagnosed or recurrent) breast, colorectal, prostate, gynecologic (only uterine and cervical) cancers (stage I, II, or III) or any stage lymphoma (Hodgkin’s or non-Hodgkin’s)
- 6-60 months post-treatment (surgery, chemotherapy, radiation therapy, and/or maintenance therapies) for cancer; time frame applies to most recent completion of treatment if participant had a cancer recurrence; it is acceptable to be on hormonal therapies
- Participant resides in California, Georgia, Illinois, Kansas, Michigan, Minnesota, Missouri, New Mexico, North Carolina, North Dakota, South Carolina, Virginia, Tennessee, or Wisconsin
- Study-trained therapist in the state where the participant resides
- Must be able to speak and understand English
- Must have access to a telephone; if a patient does not have access to a phone or has difficulty paying for minutes for a mobile phone, the research team should contact the Wake Forest investigators or site coordinators to arrange for assistance
**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts...
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