Clinical trial NCT04430335: Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
Official title: Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Survivorship
Cancer
Depression, Anxiety
Lead sponsor: Wake Forest University Health Sciences
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2020-06-12
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

Detailed 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Participation Rate - Percentage Who Agreed to Participate
timeFrame: 12 weeks after start of intervention
measure: Accrual Rate
timeFrame: 12 weeks after start of intervention
measure: Retention Rate - Percentage of Completed Visits
timeFrame: 13 weeks after the start of intervention
measure: Adherence - Percentage of Completed Therapy Sessions
timeFrame: 12 weeks after start of intervention
Secondary outcomes:
measure: Anxiety Questionnaire - General Anxiety Disorder (GAD)-7
timeFrame: At baseline, 7 weeks and 13 weeks after start of intervention
measure: Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9
timeFrame: At baseline, 7 weeks and 13 weeks after start of intervention
measure: Fear of Cancer Recurrence Inventory Questionnaire
timeFrame: At baseline and 13 weeks after start of intervention
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: Wake Forest University Health Sciences
name: Suzanne C Danhauer, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: