Anxiety Depression Clinical Trial
Official title:
A Stepped-Care Telehealth Approach To Treat Distress In Rural Cancer Survivors
Noting the need for evidence-based cancer survivorship care, the American Society of Clinical
Oncology (ASCO) published guidelines for screening, assessment, and care of psychosocial
distress (anxiety, depression) in adults with cancer. These guidelines recommend screening
all adults with cancer for distress and treating those with moderate or severe symptoms using
a stepped-care approach tailored to distress severity.
The purpose of this study is to test a method of implementing this stepped-care approach in
community oncology practices caring for rural survivors, using self-directed and telehealth
approaches based on cognitive-behavioral theory.
Status | Not yet recruiting |
Enrollment | 90 |
Est. completion date | February 1, 2020 |
Est. primary completion date | August 1, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: 1. Age =18 years 2. Score =10 on the Generalized Anxiety Disorder-7 (GAD-7) and/or a score =8 on the Patient Health Questionnaire-9 (PHQ-9), indicating clinically significant anxiety or depressive symptoms, respectively. 3. 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). 4. 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. 5. Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas (RUCA) Version 3.1. Residential zip codes are assigned a RUCA code based on size of its largest population center and commuting patterns. A spreadsheet with eligibility by zip code will be provided to all participating sites. 6. Must be able to speak and understand English. 7. Must have access to a telephone Exclusion Criteria: 1. Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days] 2. Self-reported active alcohol or substance abuse within the last 30 days 3. Past history of prostate cancer or non-Hodgkin's lymphoma with only active surveillance (i.e., no surgery, chemotherapy, or radiation therapy) 4. Progressive cancer (must be considered no evidence of disease or stable) 5. Global cognitive impairment based on education-adjusted scores (details below) on the Telephone Interview for Cognitive Status-modified 6. Self-reported psychotic symptoms in the last 30 days: "Have you seen things that aren't really there or have you heard voices when no one else was around within the last 30 days?") 7. Active suicidal ideation (currently reported suicidal plan and intent) 8. Any change in psychotropic medications within the last 30 days 9. Hearing loss that would preclude participating in telephone sessions (determined by brief hearing assessment administered by research staff) |
Country | Name | City | State |
---|---|---|---|
United States | Wake Forest School of Medicine | Winston-Salem | North Carolina |
Lead Sponsor | Collaborator |
---|---|
Wake Forest University Health Sciences | National Cancer Institute (NCI) |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Patient Health Questionnaire-2 (PHQ-2) | Includes a 3-item depression/anxiety screening | Pre-Screen | |
Primary | Generalized Anxiety Disorder-1 (GAD-1) | Generalized Anxiety Disorder Question | Pre-Screen | |
Primary | Telephone Interview of Cognitive Status-modified-34 (TICS-m) | Screening measure of cognitive function based on MMSE and validated for telephone administration. Assess global cognitive impairment. Eligibility will be based on education adjusted scores. Scores at the following cut-points are eligible for the study: < 8th grade: TICS-m = 23; 8-10th grade: TICS- m = 26; 11-12th grade: TICS-m = 28; > 12th grade: TICS-m = 30. | Pre-Screen | |
Primary | Generalized Anxiety Disorder-7 (GAD-7) | Incorporates DSM-IV symptoms for generalized anxiety disorder. A score = 10 indicates moderate anxiety symptoms, and a score = 15 suggests severe symptoms. | Screening | |
Primary | Patient Health Questionnaire-9 (PHQ-9) | Self-report measure used for screening, diagnosing, monitoring and measuring the severity of depression that incorporates DSM-IV depression diagnostic criteria. A score = 8 indicates moderate depressive symptoms while a score =15 suggests severe depressive symptoms. | Screening | |
Secondary | Fear of Cancer Recurrence Inventory Severity Subscale (FCRI) | Will be used to measure self-reported fear of recurrence. | Baseline, Week 13 | |
Secondary | Insomnia Severity Index | Measure of type and severity of insomnia symptoms, including problems with sleep onset, sleep maintenance, or early morning awakening; satisfaction with current sleep pattern; interference with daily functioning; noticing impairment attributed to sleep problems; and level of concern or distress caused by the sleep problem. | Baseline, Week 13 | |
Secondary | PROMIS-Fatigue Scale-Short Form 8a | Measure of the experience of fatigue and the impact of fatigue on activities across multiple domains. | Baseline, Week 13 | |
Secondary | Self-Report Quality of Life (SF-36) | Self-report measure of quality of life consisting of 36 items that form 8 subscales: physical functioning, role limitations due to physical health problems, role limitations due to emotional health problems, social functioning, freedom from pain, energy or fatigue, emotional well-being, and general health perceptions. | Baseline, Week 13 | |
Secondary | The Impact of Events Scale - Revised (IES-R) | Self-report measure of cancer-specific distress. Assesses the frequency with which respondents experience intrusive thoughts, avoidant behaviors, and autonomic arousal specific to one's thoughts and feelings about cancer over the past week. | Baseline, Week 13 | |
Secondary | Cornell Services Index | Assesses the frequency of use of medical outpatient visits, psychiatric and psychotherapeutic visits, and intensive services such as hospitalizations, emergency room visits, and home health visits. | Baseline, Week 13 |
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