Cultural and Linguistic Adaptation of a Telephone-Based Intervention to Treat Depression and Anxiety in Hispanic Cancer Survivors
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 8
- 试验地点
- 2
- 主要终点
- Accrual Rate
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Accrual Rate
时间窗: 12 weeks after start of intervention
Accrual rates will be calculated by calculating the mean number of participants recruited per month.
Retention Rate - Percentage of Completed Visits
时间窗: 13 weeks after the start of intervention
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 %
Adherence - Percentage of Completed Therapy Sessions
时间窗: 12 weeks after start of intervention
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.
Participation Rate - Percentage Who Agreed to Participate
时间窗: 12 weeks after start of intervention
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.
次要结局
- 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)