Stepped-Care Telehealth for Distress in Rural Cancer Survivors



Status:Recruiting
Conditions:Anxiety, Anxiety, Cancer, Cancer, Depression, Insomnia Sleep Studies, Other Indications
Therapuetic Areas:Oncology, Psychiatry / Psychology, Other
Healthy:No
Age Range:18 - Any
Updated:8/4/2018
Start Date:July 19, 2018
End Date:May 2019
Contact:Karen Craver, MT, MHA
Email:kcraver@wakehealth.edu
Phone:(336) 713-4394

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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.


Inclusion Criteria:

- 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

Exclusion Criteria:

- 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 )
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