Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
NCT ID: NCT04430335
Last Updated: 2023-08-16
Study Results
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View full resultsBasic Information
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COMPLETED
NA
8 participants
INTERVENTIONAL
2021-01-04
2022-02-01
Brief Summary
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Detailed Description
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* To assess the feasibility (participation, accrual, retention, adherence) of administering the intervention in Hispanic cancer survivors.
* To culturally adapt an existing behavioral intervention for cancer survivors based on stakeholder feedback.
Exploratory Objectives
* To summarize emotional distress (anxiety, depressive symptoms) and fear of recurrence in these post-treatment Hispanic cancer survivors.
* To describe the therapy process in terms of satisfaction with treatment and the therapist-participant relationship.
Conditions
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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Telephone-Based Cognitive Behavioral Therapy
Participants with moderate or severe anxiety and/or depressive symptoms will participate in the telephone-based intervention that consists of the CBT workbook (15 minutes daily to complete exercises), plus psychotherapy delivered by telephone with a licensed bilingual mental health provider (45-50 minute sessions weekly).
Telephone interview
Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy
Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
Interventions
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Telephone interview
Interested participants will complete a telephone interview to determine eligibility for the study. If found to be eligible for the study, participants will be registered and set up a time to speak with an assigned study coach.
Cognitive Behavioral Therapy
Participants will speak with their assigned coach over the phone for 12 weeks to discuss the cognitive behavioral therapy (CBT) study workbook and provide feedback. CBT is a type of treatment that teaches people different ways to handle anxiety and/or depressive symptoms, such as by relaxing the body, changing thoughts, and solving problems. Participants will receive a workbook focused on teaching these strategies.
Eligibility Criteria
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Inclusion Criteria
* Self-identify as Hispanic ethnicity
* Score greater than or equal to 10 on the General Anxiety Disorder (GAD)-7 and/or greater than or equal to 8 on the Patient Health Questionnaire (PHQ)-9
* History of (1) treated (newly diagnosed or recurrent) solid tumor cancers (Stage I, II, or III); (2) any stage lymphoma (Hodgkin's or non-Hodgkin's); (3) acute leukemia in remission for more than a year; (4) chronic myelogenous leukemia with stable disease (chronic phase disease); or (5) chronic lymphocytic leukemia (CLL) not requiring treatment or a change in treatment for more than 6 months.
* 6-60 months post-treatment (surgery, chemotherapy, and/or radiation therapy) for cancer (If only received active surveillance for prostate cancer or lymphoma with no other cancer treatment, participant is ineligible.) The timeframe applies to the most recent completion of treatment if a participant had a cancer recurrence. It is acceptable to be on hormonal/maintenance therapies.
* Must be able to speak, read, and understand Spanish or English.
* Resides in North Carolina.
Exclusion Criteria
* 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
* Global cognitive impairment based on self-reported diagnosis of dementia.
* Self-reported psychotic symptoms in the last 30 days (Item in Screening Form: "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?")
* 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). Individuals who can compensate for hearing loss through the use of a hearing device or 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.
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
Wake Forest University Health Sciences
OTHER
Responsible Party
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Principal Investigators
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Suzanne C Danhauer, Ph.D
Role: PRINCIPAL_INVESTIGATOR
Wake Forest University Health Sciences
Locations
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Wake Forest Baptist Comprehensive Cancer Center
Winston-Salem, North Carolina, United States
Countries
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Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Document Type: Informed Consent Form
Other Identifiers
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WFBCCC 01220
Identifier Type: OTHER
Identifier Source: secondary_id
IRB00066444
Identifier Type: -
Identifier Source: org_study_id
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