Clinical trial NCT06606457: PACE CF, a 3-session Mind-body Pain Management Program for Adults with Cystic Fibrosis
Official title: Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults with CF
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Cystic Fibrosis (CF)
Pain Management
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: University of Kansas Medical Center
First posted: 2024-09-23
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: Inclusion Criteria:

1. diagnosis of CF;
2. age \> 18 years;
3. report of pain affecting them at least moderately (score ≥ 2) on the IPOS item;
4. pain lasting at least one month;
5. English-speaking;
6. participant willing and able to give informed consent.

Exclusion Criteria:

Presenting an acute safety risk to self or others at baseline. Participants will not be excluded for the following reasons:

1. CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT;
2. Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions;
3. 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.

Primary outcomes:
measure: Acceptability - measured by treatment acceptability interview
timeFrame: End of intervention, up to 2 months
measure: Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)
timeFrame: End of intervention, up to 2 months
measure: Feasibility - participant attrition during the intervention period.
timeFrame: From date of baseline assessment to completion of intervention, up to 2 months
Secondary outcomes:
measure: Change in pain catastrophizing, measured by the Coping Strategies Questionnaire (CSQ-CAT)
timeFrame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
measure: Change in depressive symptoms, measured by the Patient Health Questionnaire-9 (PHQ-9)
timeFrame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
measure: Change in anxiety symptoms, measured by the Generalized Anxiety Disorder-7 item scale (GAD-7)
timeFrame: From baseline assessment to post-intervention assessment, up to 2 months
measure: Change in Health-Related Quality of Life, measured by the Cystic Fibrosis Questionnaire-Revised (CFQ-R)
timeFrame: From baseline assessment to post-intervention assessment, up to 2 months
measure: Change in sleep quality, measured by the PROMIS Sleep Disturbance Scale short form
timeFrame: From baseline assessment to post-intervention assessment, up to 2 months
measure: Change in pain intensity, measured by the PROMIS(r) Pain Intensity Instrument
timeFrame: From date of baseline assessment to date of post-intervention, up to 2 months
measure: Change in pain interference, measured by the PROMIS(r) Pain Interference Scale adult short form
timeFrame: From date of baseline assessment to date of post-intervention assessment, up to 2 months
measure: Coping Self-Efficacy as measured by the Cystic Fibrosis Coping Self-Efficacy Scale (CF-CSE)
timeFrame: From baseline assessment to post-intervention assessment, up to 2 months
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: University of Kansas Medical Center
name: Amanda Bruce, PhD
role: PRINCIPAL_INVESTIGATOR
References: