Stepped-Care Telehealth for Distress in Cancer Survivors

Completed · Not applicable

Conditions studied: Anxiety, Depressive Symptoms, Sleep Disturbance, Recurrent Disease, Fatigue, Quality of Life, Cancer

In brief

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 facts

Study ID

NCT03060096

Run by

Wake Forest University Health Sciences

People needed

68

Starts

2018-07-19

Expected to finish

2022-07-29

Last updated by the study team

2026-02-27

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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) 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.
• 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

You may not qualify if…

• 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).
• 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.
• Self -reported psychotic symptoms in the last 30 days prior to randomization
• 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)
• 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.

Where it is running

• Kaiser Permanente-Fresno — Fresno, California, United States
• Kaiser Permanente-Modesto — Modesto, California, United States
• Kaiser Permanente-South Sacramento — Sacramento, California, United States
• Pacific Central Coast Health Center-San Luis Obispo — San Luis Obispo, California, United States
• Kaiser San Rafael-Gallinas — San Rafael, California, United States
• Kaiser Permanente-Santa Rosa — Santa Rosa, California, United States
• Kaiser Permanente-Stockton — Stockton, California, United States
• Augusta University Medical Center — Augusta, Georgia, United States
• Lewis Cancer and Research Pavilion at Saint Joseph's/Candler — Savannah, Georgia, United States
• Low Country Cancer Care Associates PC — Savannah, Georgia, United States
• Summit Cancer Care-Candler — Savannah, Georgia, United States
• Rush - Copley Medical Center — Aurora, Illinois, United States
• Illinois CancerCare-Bloomington — Bloomington, Illinois, United States
• Illinois CancerCare-Canton — Canton, Illinois, United States
• Memorial Hospital of Carbondale — Carbondale, Illinois, United States
• SIH Cancer Institute — Carterville, Illinois, United States
• Illinois CancerCare-Carthage — Carthage, Illinois, United States
• Centralia Oncology Clinic — Centralia, Illinois, United States
• Carle on Vermilion — Danville, Illinois, United States
• Cancer Care Specialists of Illinois - Decatur — Decatur, Illinois, United States
• Decatur Memorial Hospital — Decatur, Illinois, United States
• Illinois CancerCare-Dixon — Dixon, Illinois, United States
• Carle Physician Group-Effingham — Effingham, Illinois, United States
• Crossroads Cancer Center — Effingham, Illinois, United States
• Mercy Hospital Fort Smith — Fort Smith, Arkansas, United States

Full record on ClinicalTrials.gov

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