PACE CF, a 3-session Mind-body Pain Management Program for Adults With Cystic Fibrosis

NCT ID: NCT06606457

Last Updated: 2025-12-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-09-10
• Study Completion Date: 2025-04-09

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.

Conditions

Cystic Fibrosis (CF); Pain Management

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

PACE CF Intervention

Participants will complete an baseline series of questionnaires, and then meet with the psychologist on their cystic fibrosis care team for 3 weekly meetings to complete the PACE CF program and learn mind-body strategies for pain management. Following completion of the program, they will complete a second assessment that includes another set of questionnaires and a brief qualitative interview to provide feedback about the program.

Group Type: EXPERIMENTAL

Pain Acknowledgment Coping and Empowerment in CF (PACE CF)

Intervention Type: BEHAVIORAL

The Pain Acknowledgment Coping and Empowerment in CF (PACE CF) program is a newly developed 3-session mind-body pain management intervention for adults with cystic fibrosis (CF), developed with CF community input. The sessions are delivered by the the CF care team psychologist. Each session will teach mind-body strategies to increase comfort and reduce the impact of pain on the participant\'s life. These strategies include understanding pain in CF from a mind-body perspective, learning relaxation and mindfulness-based skills, identifying and practicing individualized cognitive and behavioral strategies that improve comfort and well-being, and discussing communication skills that empower people living with CF and pain. Participants will receive a workbook that will provide related education and resources and reinforce skill practice.

Interventions

Pain Acknowledgment Coping and Empowerment in CF (PACE CF)

The Pain Acknowledgment Coping and Empowerment in CF (PACE CF) program is a newly developed 3-session mind-body pain management intervention for adults with cystic fibrosis (CF), developed with CF community input. The sessions are delivered by the the CF care team psychologist. Each session will teach mind-body strategies to increase comfort and reduce the impact of pain on the participant\'s life. These strategies include understanding pain in CF from a mind-body perspective, learning relaxation and mindfulness-based skills, identifying and practicing individualized cognitive and behavioral strategies that improve comfort and well-being, and discussing communication skills that empower people living with CF and pain. Participants will receive a workbook that will provide related education and resources and reinforce skill practice.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Kansas Medical Center

OTHER

Sponsor Role: collaborator

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Deborah Friedman

Clinical Psychologist; Assistant Professor of Psychology (Psychiatry), Harvard Medical School; Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Amanda Bruce, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Kansas Medical Center

Locations

Massachusetts General Hospital

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2024P001312

Identifier Type: -

Identifier Source: org_study_id