Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors

NCT ID: NCT04430335

Last Updated: 2023-08-16

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-04

Study Completion Date

2022-02-01

Brief Summary

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The purpose of this research is to assess the feasibility of administering a telephone-based intervention to treat depression and anxiety in Hispanic cancer survivors.

Detailed Description

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Primary Objectives

* 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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Survivorship Cancer Depression, Anxiety

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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).

Group Type OTHER

Telephone interview

Intervention Type BEHAVIORAL

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

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* Inclusion: age greater than or equal to 18 years;
* 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

* Current psychotherapy \[regular appointment(s) with a mental health provider within the last 30 days\]
* 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)
* 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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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National Cancer Institute (NCI)

NIH

Sponsor Role collaborator

Wake Forest University Health Sciences

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

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

Site Status

Countries

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United States

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

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WFBCCC 01220

Identifier Type: OTHER

Identifier Source: secondary_id

P30CA012197

Identifier Type: NIH

Identifier Source: secondary_id

View Link

IRB00066444

Identifier Type: -

Identifier Source: org_study_id

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