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

Wake Forest University (WFU)

Status: Completed

Conditions: Depression, Anxiety; Survivorship; Cancer

Treatments: Behavioral: Cognitive Behavioral Therapy; Behavioral: Telephone interview

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04430335

P30CA012197 (U.S. NIH Grant/Contract)

WFBCCC 01220 (Other Identifier)

IRB00066444

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 8 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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8 participants in 1 patient group

Telephone-Based Cognitive Behavioral Therapy

Other group

Description:

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).

Treatment:

Behavioral: Cognitive Behavioral Therapy

Behavioral: Telephone interview