The COMFORT Caregiver Intervention (CCI)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Change in caregiver psychological distress, measured using the Distress Thermometer
研究概览
简要总结
This pilot clinical trial studies the COMFORT (C-Communication, O-Orientation and opportunity, M-Mindful presence, F-Family, O-Openings, R-Relating, and T-Team) caregiver intervention in improving communication and reducing distress in caregivers of patients with lung cancer. Caregivers of patients with cancer may experience stress and anxiety due to difficulty communicating with family, friends, and healthcare providers, or feeling unable to communicate openly. A communication intervention that improves the caregiver's ability to communicate with patients and healthcare providers may help reduce caregivers' psychological distress and improve the health outcomes of patients.
详细描述
PRIMARY OBJECTIVES:
I. To assess the feasibility of the COMFORT Caregiver Intervention (CCI) for family caregivers.
II. To explore common family caregiver communication concerns in oncology and their impact.
III. Estimate the effects of the CCI on family caregivers' psychological distress (primary outcome) and caregiver confidence with communication (secondary outcome).
OUTLINE:
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
- 是
入选标准
- •Family caregivers will need to be the primary family caregiver as identified by the lung cancer patient (ten caregivers from each of the following cancer care continuum points will be recruited)
- •English-speaking
- •Cancer care continuum points are defined as follows:
- •Diagnosis: A lung cancer patient who has received diagnosis within the last 45 days but has not yet started treatment
- •Treatment: A lung cancer patients who has started initial treatment (chemotherapy, radiation, surgery) for diagnosis within the last 30 days, is actively receiving treatment, and has a prognosis of more than one year
- •Survivorship: A lung cancer patient who has completed treatment and who is clinically disease free at the time of caregiver enrollment to study
- •End of Life: A lung cancer patient who is estimated to have 6 months or less to live
- •All subjects must have the ability to understand and the willingness to participate in the informed consent process
排除标准
- •Research participants who do not speak or read English
- •Subjects, who in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study
结局指标
主要结局
Change in caregiver psychological distress, measured using the Distress Thermometer
时间窗: Baseline to 1 month post-intervention
Data will be summarized using descriptive statistics, including means for normally distributed continuous data, medians for non-normally distributed continuous data or proportions for categorical data. The established instruments will be scored according to standard instructions, and appropriate descriptive statistics will be computed. Outcomes will be compared pre- and post-intervention without full effectiveness analysis, as this is a pilot study.
Retention rate
时间窗: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Recruitment rate
时间窗: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Attrition rate
时间窗: Up to 18 months
An electronic recruitment database will be created to document accrual, attrition, and retention rates.
Themes derived from qualitative content analysis
时间窗: Up to 18 months
Qualitative review of recruitment procedures and evaluation of research nurse feedback about intervention calls will be conducted. Content analysis will be conducted on the transcribed qualitative data. A qualitative summary of themes derived from study documents will be used. The intervention will be refined based on study results, and improvements made for it to be suited to a larger randomized, controlled trial.
次要结局
- Change in caregiver communication confidence, measured using the Caregiver Communication Survey(Baseline to 1 month post-intervention)