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

Cancer Clinical Trial

Official title:

Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04430335
• Other study ID #: IRB00066444
• Secondary ID: WFBCCC 01220P30C
• Status: Completed
• Phase: N/A
• Start date: January 4, 2021
• Est. completion date: February 1, 2022

Study information

• Verified date: July 2023
• Source: Wake Forest University Health Sciences
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: February 1, 2022
• Est. primary completion date: August 15, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Anxiety Disorders
• Cancer
• Depression
• Depression, Anxiety
• Depressive Disorder
• Survivorship

Intervention

Behavioral:
• 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.

Locations

Country	Name	City	State
United States	Wake Forest Baptist Comprehensive Cancer Center	Winston-Salem	North Carolina

Sponsors (2)

Lead Sponsor	Collaborator
Wake Forest University Health Sciences	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Accrual Rate	Accrual rates will be calculated by calculating the mean number of participants recruited per month.	12 weeks after start of intervention
Primary	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
Primary	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	Anxiety Questionnaire - General Anxiety Disorder (GAD)-7	The General Anxiety Disorder (GAD)-7 is a self-report measure of DSM-IV symptoms of general anxiety disorder. Participants rate 7 questions on a scale of 0 (not at all), 1 (several days), 2 (more than half the days) and 3 (nearly every day); one additional question assesses the interference of these symptoms with functioning. The first 7 questions are summed to create a total score. Scoring range is 0-21 with the higher score indicating a higher level of anxiety (scores 0 to less than or equal to 9 = no/mild anxiety; scores greater than or equal to 10 to less than or equal to 14 = moderate anxiety; scores greater than or equal to 15 to 21 = severe anxiety).	At baseline, 7 weeks and 13 weeks after start of intervention
Secondary	Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9	The Patient Health Questionnaire (PHQ)-9 is a self-report measure of DSM-IV symptoms of Major Depressive Disorder. Participants rate how often they have experienced nine symptoms over the past 2 weeks on a scale of 0 (not at all); 1 (several days), 2 (more than half the days) and 3 (nearly every day). Responses are summed, with higher scores indicating greater depressive symptomatology. Scoring scale = 0-27 (scores 0 to less than or equal to 7 = no/mild depressive symptoms; scores greater than or equal to 8 to less than or equal to 14 = moderate depressive symptoms; scores greater than or equal to 15 to 27 = severe depressive symptoms)	At baseline, 7 weeks and 13 weeks after start of intervention
Secondary	Fear of Cancer Recurrence Inventory Questionnaire	The Fear of Cancer Recurrence Inventory (FCRI; severity subscale) will be used to measure self-reported fear of recurrence. This 9-item subscale measures the presence and severity of the intrusive thoughts or images associated with the fear of recurrence. Scoring scale ranges from 0 (not at all or never) to 4 (a great deal or all of the time). Score ranges from 0-36. The higher the score, the greater the participants' fear of recurrence.	At baseline and 13 weeks after start of intervention