A Stepped-Care Telehealth Approach in Decreasing Distress in Cancer Survivors
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.
Inclusion Criteria
- 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
Exclusion Criteria
- Current psychotherapy (regular appointment[s] with a psychologist, counselor, or therapist within the last 30 days prior to randomization)
- Self-reported active alcohol or substance abuse within the last 30 days
- Past history of prostate cancer or non-Hodgkin’s lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy)
- Progressive cancer (must be considered no evidence of disease or stable)
- Self-reported psychotic symptoms in the last 30 days prior to randomization
- Active suicidal ideation with plan and intent
- Any change in psychotropic medications within the last 30 days
- Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff at each National Cancer Institute Community Oncology Research Program [NCORP] component); individuals who can compensate for hearing loss through the use of a hearing device or telecommunication device for the deaf (TDD) phone, and through the use of such devices are able to communicate with the study therapist by telephone, will be included; if the therapist cannot communicate with the participant by telephone, the participant will be excluded
- Failure/inability/unwillingness to provide names and contact information for two family members or friends to serve as emergency contacts during the course of the study
Study sponsor and potential other locations can be found on ClinicalTrials.gov for NCT03060096.
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.
Trial PhaseNo phase specified
Trial Typehealth services research
Lead OrganizationWake Forest NCORP Research Base
Principal InvestigatorSuzanne C. Danhauer
- Primary IDWF-30917CD
- Secondary IDsNCI-2017-01840, NCT03190291
- ClinicalTrials.gov IDNCT03060096