Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
Study NCT ID:
NCT06606457
Status:
COMPLETED
Last Update Posted:
2025-12-12
First Post:
2024-09-10
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
PACE CF, a 3-session Mind-body Pain Management Program for Adults With Cystic Fibrosis
Sponsor:
Massachusetts General Hospital
Organization:
Study Overview
Official Title:
Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults With CF
Status:
COMPLETED
Status Verified Date:
2025-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: