Ignite Creation Date:
2024-10-25 @ 7:52 PM
Last Modification Date:
2024-10-26 @ 3:40 PM
Study NCT ID:
NCT06606457
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-09-10
Brief Title:
PACE CF a 3-session Mind-body Pain Management Program for Adults with Cystic Fibrosis
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Pilot of PACE CF a 3-session Mind-body Pain Management Program for Adults with CF
Status:
RECRUITING
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
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:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None