enCompass Carolina: A Social Support and Coaching Program for Cancer Caregivers
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 111
- 试验地点
- 1
- 主要终点
- Study feasibility - caregiver enrollment
研究概览
简要总结
This study explores the feasibility, acceptability, and preliminary efficacy of a social support intervention in cancer caregivers who live in rural communities. Cancer caregivers need support, especially when they live at a distance from healthcare centers. enCompass Carolina is a social support intervention, that supports caregivers by helping them find and use new sources of support. The purpose of this study is to test and receive feedback about the program.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non 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
- •Inclusion criteria for caregivers In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •English-speaking.
- •Ability to provide written or electronic informed consent to participate in the study.
- •Subject is willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- •Age ≥ 18 years at the time of consent. Identify as an informal (unpaid) caregiver for a rural-dwelling adult with a stage II-IV solid tumor or any hematologic malignancy in active treatment (see eligibility criteria for patients).
- •Inclusion criteria for subjects with cancer In order to participate in this study a subject must meet all of the eligibility criteria outlined below.
- •Their identified caregiver is enrolled in the study
- •English-speaking.
- •Ability to provide written or electronic informed consent to participate in the study.
- •Subjects are willing and able to comply with study procedures based on the judgment of the investigator or protocol designee.
- •Age ≥ 18 years at the time of consent. Have a diagnosis of stage II-IV solid tumor or any hematologic malignancy receiving active treatment s, not including hormonal therapy
- •7. Live in a rural area according to the USDA's Rural/Urban Commuting Area (RUCA) score of >4.
排除标准
- •Exclusion criteria for caregivers
- •Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- •Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
- •Participation in the intervention development phase of this intervention.
- •Exclusion criteria for subjects with cancer
- •Unable to complete self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- •Existence of another co-morbid disease, which in the opinion of the investigator, prohibits participation in the protocol;
- •Their caregiver does not enroll in the study or withdraws consent
研究组 & 干预措施
Caregiver of subject with cancer
Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.
干预措施: Eco-mapping tool (Behavioral)
Caregiver of subject with cancer
Adults who identify as a primary unpaid caregiver for a rural-dwelling adult with cancer.
干预措施: Caregiver-coach study visits (Behavioral)
Subject with Cancer
Subjects is with cancer and receive care from caregivers.
结局指标
主要结局
Study feasibility - caregiver enrollment
时间窗: 8 weeks
Study feasibility will be measured by caregiver enrollment rates, defined as the proportion of eligible caregivers approached about the study who consent to participate.
Study feasibility - Caregiver intervention engagement
时间窗: 8 weeks
Study feasibility will be measured by caregiver intervention engagement, defined as the proportion of enrolled caregiver subjects who receive at least one intervention visit.
次要结局
- Intervention acceptability-quantitative(4 weeks, 8 weeks)
- Caregiver self-efficacy(Baseline, 4 weeks, 8 weeks)
- Intervention acceptability-qualitative(4 weeks, 8 weeks)