Expanding the Support of Family Caregivers of Diverse Patients With Cancer and Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 162
- 试验地点
- 5
- 主要终点
- Acceptability of the Intervention Measure (AIM)
研究概览
简要总结
This study investigates the feasibility, acceptability, and preliminary efficacy of enCompass Humana, a social support intervention for caregivers of patients with cancer and diabetes. The enCompass program aims to improve support for these caregivers through a randomized feasibility study of a pilot-tested coaching and navigation program.
Caregiver services and system-level support are essential, but successful interventions for cancer caregivers are rarely standardized or systematically disseminated. Consequently, many programs do not reach the most underserved caregivers. Challenges to implementation include substantial clinical staff involvement, lack of dissemination and implementation information, and failure to tailor interventions to rural contexts. Despite the lack of standardized supportive interventions, national reports and legislative efforts increasingly recognize the need to support caregivers.
Caregivers reported unmet needs in all domains of social support, including instrumental help (e.g., in-home help, housekeeping), logistical and coordination support (e.g., food delivery, accompanying patients to appointments), information about illness and progression, emotional support, self-care guidance, and financial assistance (e.g., parking costs, lost wages). Caregivers show high interest in services but cited uncertainty and lack of strategies for accessing resources. Many are unaware of existing services. Interviews with oncology clinicians and healthcare administrators revealed similar findings: resources exist, but there is no system to match them with caregivers' needs.
Preliminary data suggest the intervention improves caregiver coping self-efficacy and reduces anxiety and depression in patients. With input from stakeholders, including caregivers, patients, family caregiving experts, and clinical care experts, the study team adapted the CARING application into enCompass to mitigate structural barriers and normalize support-seeking. The long-term goal is to adapt this psychosocial support program to increase self-efficacy, support-seeking, and reduce loneliness among caregivers. It is hypothesized that enCompass will build self-efficacy and coping skills, serving caregivers throughout the patient's illness and complications.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Inclusion Criteria for Caregivers
- •English-speaking.
- •Ability to provide written or verbal informed consent to participate in the study;
- •Willing and able to comply with study procedures based on the judgment of the investigator or protocol designee;
- •Be at least 18 years of age at the time of consent; and
- •Identify as an informal (unpaid) caregiver for an adult with a stage II-IV cancer AND diabetes.
- •Inclusion Criteria for patients
- •English-speaking
- •Ability to provide informed consent.
- •Be at least 18 years of age at the time of consent; and
- •Their identified caregiver is enrolled in the study
- •Diagnoses: (must have cancer and diabetes)
- •Have a cancer diagnosis for which they are being actively treated at one of the study sites
- •Have a cancer diagnosis, stage II-IV solid tumor or any hematologic malignancy
- •Receiving active cancer treatment s, not including hormonal therapy
- •Concurrent history of diabetes with need for ongoing management
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 other than diabetes, which in the opinion of the investigator, prohibits participation in the protocol;
- •Participation in the intervention development phase of this intervention
- •Exclusion Criteria for patients
- •Self-report instruments due to illiteracy, neurologic illness, inability to speak or read English, or other causes;
- •Existence of other 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
caregivers
Caregivers of patients with cancer and comorbid diabetes will receive the intervention, enCompass contains two components: (1) an web-based eco-mapping tool that encourages the cognitive process of identifying, organizing, and visualizing a person's social network, and (2) a manualized, one-to-one 8-week coaching intervention to develop problem-solving skills for specific support needs.
Caregivers will also receive a resource booklet from the American Cancer Society.
干预措施: Survey (Behavioral)
caregiver
Caregivers of patients with cancer and comorbid diabetes will not receive the intervention.
干预措施: the resource booklet from the American Cancer Society (Other)
结局指标
主要结局
Acceptability of the Intervention Measure (AIM)
时间窗: 8 weeks
The AIM is a 4-item, 5-point Likert scale that measures intervention acceptability. The scale measures each statement from 1, "Completely disagree," to 5, "Completely agree." Scale items are averaged to produce a mean score. The AIM takes approximately 2 minutes to complete by caregivers.
次要结局
- Coping Self-Efficacy Scale (CSES)(Baseline, 8 weeks, 6 months)
- Zarit Burden Assessment - Revised(Baseline, 8 weeks, 6 months)
- Duke-UNC Functional Support Questionnaire (FSSQ)(Baseline, 8 weeks, 6 months)
- Hospital Anxiety and Depression Scale (HADS) - Caregivers(Baseline, 8 weeks, 6 months)
- Exit interview for Acceptability(6 months)
- Karnovsky Performance Score(Baseline, 8 weeks, 6 months)
- NCCN Distress Thermometer(Baseline, 8 weeks, 6 months)
- Hospital Anxiety and Depression Scale (HADS) - Patients(Baseline, 8 weeks, 6 months)