Integrating Supportive Care in Cystic Fibrosis: A Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Intervention fidelity
研究概览
简要总结
Individuals living with cystic fibrosis (CF) commonly report high symptom burden, poor quality of life, and additional psychosocial stressors; these burdens are particularly heightened in advanced stages of the disease. Although supportive care (aka palliative care) has been shown to improve many of these outcomes among patients with illnesses such as cancer, no clinical trials to date have tested the impact of supportive care for patients with CF. The purpose of this pilot randomized clinical trial study is to evaluate the feasibility, acceptability, and perceived effectiveness of an embedded supportive care intervention, whereby a supportive care specialist will be integrated within the usual care experience of patients with advanced CF. The investigators will enroll 50 patients with advanced CF, who will be equally randomized to receive this embedded supportive care intervention or usual care. Secondary measures include: patient quality of life, mood, coping style, satisfaction with care, and symptom burden. This study will provide preliminary data to support the development of a larger, definitive, Phase III randomized clinical trial.
详细描述
As described above.
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
- •Ability to comprehend English
- •Advanced CF
- •(Any of the following criteria will be indicative of "Advanced CF")
- •Baseline supplemental oxygen requirement
- •FEV1 ≤ 50%
- •Baseline non-invasive mechanical ventilation requirement
- •≥ 2 hospitalizations in the past 12 months for respiratory complications related to CF
排除标准
- •Prisoners
- •Females who are pregnant
- •Prior receipt of specialist SC services
- •Cognitive impairments
- •Patients younger than 18 years of age
结局指标
主要结局
Intervention fidelity
时间窗: Up to 9 months (+/- 4 weeks)
Evaluate the fidelity of intervention delivery using structured visit checklists to be completed by the interventionist and research staff.
Feasibility of intervention
时间窗: Up to 9 months (+/- 4 weeks)
Measured by: eligibility rate, approach-to-consent rate, approach-to-enroll rate, rate of missed intervention sessions, rate of missing data on patient-reported outcomes.
Acceptability of intervention
时间窗: Up to 9 months (+/- 4 weeks)
Measured by: proportion of participants who endorse the intervention as acceptable.
Perceived effectiveness of intervention
时间窗: Up to 9 months (+/- 4 weeks)
Measured by: proportion of participants who endorse that they believe the intervention to have been beneficial.
次要结局
- Patient quality of life: Cystic Fibrosis Questionnaire-Revised (CFQ-R)(Up to 9 months (+/- 4 weeks))
- Coping style(Up to 9 months (+/- 4 weeks))
- Symptom burden(Up to 9 months (+/- 4 weeks))
- Patient mood(Up to 9 months (+/- 4 weeks))
- Satisfaction with care(Up to 9 months (+/- 4 weeks))
研究者
Dio Kavalieratos, PhD
Assistant Professor of Medicine
University of Pittsburgh