Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults With CF
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Acceptability - measured by treatment acceptability interview
研究概览
简要总结
Many people living with cystic fibrosis (CF) experience pain. However, pain is sometimes unrecognized and under-managed in people with CF. Both medication and non-medication interventions can be used to treat pain and ideally, there is a multicomponent management approach.
The goal of this study is to pilot a new 3-session non-medication mind-body pain management intervention specifically designed for adults with cystic fibrosis (CF). The intervention is titled Pain Acknowledgement Coping and Empowerment in CF (PACE CF).
PACE CF will be administered by a member of the CF care team via telehealth visits to participants at home or during a hospitalization.
The aim of the study is to evaluate the feasibility and patient acceptability of the intervention as well as preliminary evidence of the impact of the intervention on pain and its interference in daily life.
The study will also examine outcomes such as perceived coping, quality of life, symptoms of depression or anxiety, and use of prescribed pain medication, in an exploratory manner.
详细描述
This study is a multi-center collaboration of a psychological approach to pain treatment in CF. This is the first study to elicit input from the CF community and CF care team members to develop a brief, focused psychological treatment for pain in adults with CF (MGB IRB exempt protocol# 2022P003370). Utilizing the development phase of the grant (protocol# 2022P003370), the investigators developed a brief (3-session) structured intervention manual and patient workbook based on CF community feedback (PACE CF). The intervention will be highly accessible, delivered by a member of the CF care team via telehealth in both inpatient and outpatient settings. The workbook will provide education and resources for patients and reinforce skill practice. Resources will facilitate future training and dissemination, standardization, and evaluation of feasibility, acceptability, and efficacy of the intervention in a larger trial.
The PACE CF intervention integrates the well-established science of behavioral pain management with CF-specific content drawn from feedback from community stakeholders to develop an intervention specific to pain in CF. The investigators anticipate that integration of this intervention into the existing CF model of care will positively impact people with CF by increasing access to best practices in pain treatment, while minimizing additional cost and burden of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 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
- •diagnosis of CF;
- •age > 18 years;
- •report of pain affecting them at least moderately (score ≥ 2) on the IPOS item;
- •pain lasting at least one month;
- •English-speaking;
- •participant willing and able to give informed consent.
排除标准
- •Presenting an acute safety risk to self or others at baseline. Participants will not be excluded for the following reasons:
- •CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT;
- •Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions;
- •psychosocial treatments (with the exception of another formal CBT for pain) or psychopharmacologic treatments at baseline. All concomitant psychosocial and pain-directed treatments will be tracked and considered in analysis.
结局指标
主要结局
Acceptability - measured by treatment acceptability interview
时间窗: End of intervention, up to 2 months
During visit 5, post-intervention, participants will be asked to complete a brief qualitative interview conducted by a research coordinator regarding treatment acceptability that will be recorded. Interviews will be qualitatively coded utilizing content analysis to summarize feedback regarding intervention acceptability.
Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)
时间窗: End of intervention, up to 2 months
Feedback on the intervention will be obtained from pilot subjects at both sites to assess acceptability of the pain management program. At the end of visit 4, after the participant has completed the PACE CF program, participants will complete the Client Satisfaction Questionnaire (CSQ), an 8-item empirically-derived, validated, self-report measure assessing patient satisfaction with health services, rated on a 4-point scale from 1= lowest to 4 = highest satisfaction. The scale has a minimum score of 0, maximum score of 32, with higher scores indicating greater satisfaction.
Feasibility - participant attrition during the intervention period.
时间窗: From date of baseline assessment to completion of intervention, up to 2 months
Completion rates will be a key indicator of feasibility. Completion rate will be calculated as the percentage of intervention sessions completed out of the total number of possible sessions (the intervention is 3 sessions) among those enrolled.
次要结局
- Change in pain catastrophizing, measured by the Coping Strategies Questionnaire (CSQ-CAT)(From date of baseline assessment to date of post-intervention assessment, up to 2 months)
- Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)(From date of baseline assessment to date of post-intervention assessment, up to 2 months)
- Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)(From baseline assessment to post-intervention assessment, up to 2 months)
- Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)(From baseline assessment to post-intervention assessment, up to 2 months)
- Change in sleep quality, measured by the PROMIS Sleep Disturbance Scale short form(From baseline assessment to post-intervention assessment, up to 2 months)
- Change in pain intensity, measured by the PROMIS(r) Pain Intensity Instrument(From date of baseline assessment to date of post-intervention, up to 2 months)
- Change in pain interference, measured by the PROMIS(r) Pain Interference Scale adult short form(From date of baseline assessment to date of post-intervention assessment, up to 2 months)
- Coping Self-Efficacy as measured by the Cystic Fibrosis Coping Self-Efficacy Scale (CF-CSE)(From baseline assessment to post-intervention assessment, up to 2 months)
研究者
Deborah Friedman
Clinical Psychologist; Assistant Professor of Psychology (Psychiatry), Harvard Medical School; Principal Investigator
Massachusetts General Hospital