COMPLETED

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Pilot of PACE CF, a 3-session Mind-body Pain Management Program for Adults With CF

Quick Facts

Study Start:2024-09-10
Study Completion:2025-04-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT06606457

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. diagnosis of CF;
  2. 2. age \> 18 years;
  3. 3. report of pain affecting them at least moderately (score ≥ 2) on the IPOS item;
  4. 4. pain lasting at least one month;
  5. 5. English-speaking;
  6. 6. participant willing and able to give informed consent.
  1. 1. CF severity or lung/liver transplant status, if they are otherwise able to participate in CBT;
  2. 2. Participation in concomitant pain treatments (e.g., pain medications), as ideally, patients will engage in multi-component pain interventions;
  3. 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.

Contacts and Locations

Principal Investigator

Amanda Bruce, PhD
PRINCIPAL_INVESTIGATOR
University of Kansas Medical Center

Study Locations (Sites)

Massachusetts General Hospital
Boston, Massachusetts, 02114
United States

Collaborators and Investigators

Sponsor: Massachusetts General Hospital

  • Amanda Bruce, PhD, PRINCIPAL_INVESTIGATOR, University of Kansas Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-09-10
Study Completion Date2025-04-09

Study Record Updates

Study Start Date2024-09-10
Study Completion Date2025-04-09

Terms related to this study

Additional Relevant MeSH Terms

  • Cystic Fibrosis (CF)
  • Pain Management