A Stepped-Care Telehealth Approach to Treat Distress In Rural cancer Survivors
Overview
Mental health issues in post-treatment adult cancer survivors are associated with multiple adverse outcomes and may represent a cancer health disparity for rural survivors. The purpose of this study is to test a stepped-care approach tailored to symptom severity based on recent American Society of Clinical Oncology guidelines for reducing emotional distress (anxiety and/or depressive symptoms) and improving secondary outcomes (sleep disturbance, fatigue, fear of recurrence, quality of life) in rural, post-treatment cancer survivors in community oncology settings and to examine intervention costs. The resultant intervention will have great potential for widespread dissemination since it will be manualized, delivered by telephone, and comprised of modules to allow customized treatments for individuals with different cancer types.
Key Inclusion Criteria
For a patient to be eligible for participation in this study, all of the following criteria must apply.
- Age ≥18 years
- Score ≥10 on the GAD-7 and/or a score ≥8 on the PHQ-9, indicating clinically significant anxiety or depressive symptoms, respectively.
- Past history of treated Stage I, II, or III (newly diagnosed or recurrent)28,29 breast, colorectal, prostate, gynecologic (to include uterine and cervical) cancers and non-Hodgkin's lymphoma.
- 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer. Time frame applies to most recent completion of treatment if participant had a cancer recurrence. It is acceptable to be on maintenance or hormonal therapies.
- Residency in a rural zip code defined as below by the Rural-Urban Commuting Areas (RUCA) Version 3.1. Residential zip codes are assigned an RUCA code based on size of its largest population center and commuting patterns. Urban: 1.0, 1.1, 2.0, 2.1, 3.0, 4.1, 5.1, 7.1, 8.1, and 10.1 Rural: 4.0, 4.2, 5.0, 5.2, 6.0, 6.1, 7.0, 7.2, 7.3, 7.4, 8.0, 8.2, 8.3, 8.4, 9.0, 9.1, 9.2, 10.0, 10.2, 10.3, 10.4, 10.5, and 10.6
- Must be able to speak and understand English.
- Must have access to a telephone
Key Exclusion Criteria
A patient will not be eligible for participation in this study if any of the following criteria apply.
- Current psychotherapy [regular appointment(s) with a psychologist, counselor, or therapist within the last 30 days].
- 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).
- Diagnosis of a second malignancy (except for non-melanoma skin cancers) after a previous diagnosis of breast, colorectal, gynecologic cancers and non-Hodgkin's lymphoma
- Progressive cancer (must be considered no evidence of disease or stable)
- Self -reported history of a diagnosis of dementia from a healthcare provider.
- Global cognitive impairment based on education-adjusted scores on the Telephone Interview for Cognitive Status-modified
- Self -reported psychotic symptoms in the last 30 days
- Active suicidal ideation (currently reported suicidal 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 )
Learn More
To learn more, visit ClinicalTrials.Gov
Study Type
Interventional
Principal Investigator(s)
Amarinthia Curtis, MD
Sponsor(s)
Wake Forest University Health Sciences