A Stepped-Care Intervention to Reduce Disparities in Mental Health Services Among Underserved Lung and Head and Neck Cancer Patients and Their Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 535
- 试验地点
- 10
- 主要终点
- Change in Coping-Patients
研究概览
简要总结
Medically under-served (i.e., low-income, uninsured, underinsured) cancer patients generally encounter significant disparities in accessing care for their mental health needs while undergoing toxic treatments that provide considerable physical and emotional stress. Thus, the investigators propose to adapt evidence-based strategies to a stepped-care intervention model to address the mental health needs of under-served lung cancer (LC) and head and neck cancer (HNC) patients and their caregivers across several levels of symptom severity (e.g., mild, moderate, or severe symptoms of depression and anxiety).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- •Newly diagnosed LC and/or HNC (within a month of recruitment date from the date of 1st visit oncology, Ear Nose and Throat (ENT), or radiation clinic visit/consultation upon pathologic tissue diagnosis;
- •LC and/or HNC patients at any stage of diagnosis (Stages 0-IV);
- •Over 18 years old;
- •English and/or Spanish speaking;
- •Medically underserved, as defined by at least one or several of the following:
- •Low-income: Below 400% of the 2016 Federal poverty levels;
- •Uninsured: No health insurance (public or private insurance);
- •Underinsured: e.g.: Public insurance (Medicaid, Medicare exclusive, VA); and/or 10% of annual income on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty levels.
排除标准
- •Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish;
- •Those who refuse treatment at one of three hospital sites;
- •Decisionally-challenged adults with cognitive or personality impairment;
- •Suicidal ideation, or
- •Intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study;
- •Individuals from vulnerable populations (e.g., inmates or individuals on probation,
- •homeless,
- •pregnant women, and
- •those with auditory impairment.
- •Note: Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
- •Caregivers of LC and/or HNC patients
- •Inclusion Criteria:
- •Primary caregiver of a newly diagnosed LC and/or HNC patient (per criteria for patients);
- •Over 18 years old;
- •English and/or Spanish speaking;
- •Medically underserved, as defined by at least one or several of the following:
- •Low-income: Below 400% of the 2016 Federal poverty levels;
- •Uninsured: No health insurance (public or private insurance);
- •Underinsured:
- •(c.1) Public insurance (i.e., Medicaid, Medicare exclusive, VA);
- •(c.2) 10% of annual income spent on out-of-pocket medical expenses for individuals below 200% of the 2016 Federal poverty level.
- •Exclusion criteria:
- •Individuals who do not meet eligibility criteria, including individuals who do not speak English or Spanish [at the discretion of the Site Coordinators upon recruitment];
- •Caregivers of patients who refuse treatment at one of three hospital sites.
- •Decisionally challenged adults with:
- •cognitive or personality impairment,
- •suicidal ideation, or
- •intoxication (alcohol or drugs) that might interfere with their ability to consent or participate in the study [at the discretion of the Site Coordinators upon recruitment or the Counselor during the intervention];
- •Individuals from:
- •vulnerable populations (e.g., inmates or individuals on probation, homeless,
- •pregnant women, and
- •those with auditory impairment [at the discretion of the Site Coordinators upon recruitment]).
- •Individuals who become pregnant or develop auditory impairments after they have been randomized to study condition may remain in the study until completion.
结局指标
主要结局
Change in Coping-Patients
时间窗: 6-months
Coping Self-Efficacy (26 items). Scores can rage from 0 to 260. Higher score corresponds to better outcome.
Symptoms of Anxiety-Patients
时间窗: 6-months
Patient-Reported Outcomes Measurement Information System, Anxiety (PROMIS-Ca) Form v1.0- Anxiety (22 items). The range of scores is between 8 and 40. The raw scores were used. Higher score corresponds to worse outcome.
Symptoms of Depression-Patients
时间窗: 6-months
Patient-Reported Outcomes Measurement Information System (PROMIS)-Cancer (CA) Form v1.0 - Depression (30 items). The range is from 8 to 40. Higher score indicates worse outcome (higher depression). Raw scores were used in analyses.
次要结局
- Change in Coping-Caregivers(6-months)
- Health-Related Quality of Life-Patients(6-months)
- Perceived Stress-Patients(6-months)
- Perceived Stress-Caregivers(6-months)
- Symptoms of Depression-Caregivers(6-months)
- Caregiving Burden-Caregivers(6-months)
- Symptoms of Anxiety-Caregivers(6-months)