N/A
Completed N=8
Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
Survivorship · Cancer · Depression, Anxiety
Source: ClinicalTrials.gov NCT04430335 ↗
Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Aug 2023
Primary outcomePrimary: Participation Rate - Percentage Who Agreed to Participate — 88.9 percentage of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Participation Rate - Percentage Who Agreed to Participate |
88.9 | — |
| PRIMARY Accrual Rate |
1.1 | — |
| PRIMARY Retention Rate - Percentage of Completed Visits |
87.5 | — |
| PRIMARY Adherence - Percentage of Completed Therapy Sessions |
87.5 | — |
| SECONDARY Anxiety Questionnaire - General Anxiety Disorder (GAD)-7 |
12.9; 4.3; 4.1 | — |
| SECONDARY Depressive Symptoms Questionnaire - Patient Health Questionnaire (PHQ)-9 |
11.9; 4.3; 4.1 | — |
| SECONDARY Fear of Cancer Recurrence Inventory Questionnaire |
15.5; 11.6 | — |
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.
Data sourced from ClinicalTrials.gov (NCT04430335). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.