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

NCT06606457 | Completed

• 1 other identifier: 2024P001312
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Cystic Fibrosis (CF)

Outcome Measures

Primary Outcomes (3)

• Acceptability - measured by treatment acceptability interview

  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.

  End of intervention, up to 2 months

• Acceptability -Client Satisfaction Questionnaire-8 (CSQ-8)

  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.

  End of intervention, up to 2 months

• Feasibility - participant attrition during the intervention period.

  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.

  From date of baseline assessment to completion of intervention, up to 2 months

Secondary Outcomes (8)

• 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

Study Arms (1)

PACE CF Intervention

EXPERIMENTAL

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.

Behavioral: Pain Acknowledgment Coping and Empowerment in CF (PACE CF)

Interventions

Pain Acknowledgment Coping and Empowerment in CF (PACE CF) 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.

PACE CF Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Kansas Medical Center: collaborator
• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Agnosia

Condition Hierarchy (Ancestors)

Pancreatic Diseases; Digestive System Diseases; Lung Diseases; Respiratory Tract Diseases; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Amanda Bruce, PhD

  University of Kansas Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Psychologist; Assistant Professor of Psychology (Psychiatry), Harvard Medical School; Principal Investigator

Study Record Dates

• First Submitted: September 10, 2024
• First Posted: September 23, 2024
• Study Start: September 10, 2024
• Primary Completion: April 9, 2025
• Study Completion: April 9, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)