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

NCT04430335 | Completed Results DMC

• 3 other identifiers: IRB00066444WFBCCC 01220P30CA012197
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Survivorship; Cancer; Depression, Anxiety

Outcome Measures

Primary Outcomes (4)

• Participation Rate - Percentage Who Agreed to Participate

  To determine participation rate, investigators will track the total number of individuals approached, the number of individuals who met all eligibility criteria and percent who agree to participate.

  12 weeks after start of intervention

• Accrual Rate

  Accrual rates will be calculated by calculating the mean number of participants recruited per month.

  12 weeks after start of intervention

• Retention Rate - Percentage of Completed Visits

  Study retention will be estimated by the proportion of participants who complete the Week 13 visit. Drop-out is defined as 100% minus the dropout %

  13 weeks after the start of intervention

• Adherence - Percentage of Completed Therapy Sessions

  Intervention adherence will be estimated as the mean percentage of therapy or check-in sessions each participant completes. Participants must complete at least 9 of the 12 sessions (75%) to be considered adherent.

  12 weeks after start of intervention

Secondary Outcomes (3)

• Anxiety Questionnaire - General Anxiety Disorder (GAD)-7

  At baseline, 7 weeks and 13 weeks after start of intervention

• Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9

  At baseline, 7 weeks and 13 weeks after start of intervention

• Fear of Cancer Recurrence Inventory Questionnaire

  At baseline and 13 weeks after start of intervention

Study Arms (1)

Telephone-Based Cognitive Behavioral Therapy

OTHER

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).

Behavioral: Telephone interview; Behavioral: Cognitive Behavioral Therapy

Interventions

Telephone interview 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.

Telephone-Based Cognitive Behavioral Therapy

Cognitive Behavioral Therapy 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.

Telephone-Based Cognitive Behavioral Therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Wake Forest University Health Sciences: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Wake Forest Baptist Comprehensive Cancer Center

Winston-Salem, North Carolina, 27157, United States

Location

MeSH Terms

Conditions

Neoplasms; Depression; Anxiety Disorders

Interventions

Interviews as Topic; Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Results Point of Contact

• Title: Study Coordinator
• Organization: Wake Forest Baptist Comprehensive Cancer Center

megreen@wakehealth.edu

336-716-9055

Study Officials

• Suzanne C Danhauer, Ph.D

  Wake Forest University Health Sciences

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 9, 2020
• First Posted: June 12, 2020
• Study Start: January 4, 2021
• Primary Completion: August 15, 2021
• Study Completion: February 1, 2022
• Last Updated: August 16, 2023
• Results First Posted: August 16, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)