Acceptability, Feasibility and Preliminary Efficacy of CFWP to Treat Clinically Elevated Fatigue in Adults With CF

NCT ID: NCT04809207

Last Updated: 2023-08-28

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-01
• Study Completion Date: 2023-07-25

Brief Summary

This research is being done to learn more ways to treat non-respiratory symptoms in people with CF including fatigue, pain, mood, sleep problems and the use of a wellness program to treat them.

Detailed Description

This study aims to test the acceptability, feasibility and preliminary efficacy of a tailored intervention known as the CF Wellness Program (CFWP) to treat clinically elevated fatigue in adults with CF. This is a pre-post pilot intervention study of the CF-Wellness Program. This study is needed because fatigue negatively affects health-related quality of life and has been identified by those with CF as a symptom that needs to be addressed. The study will include approximately 50 participants and the intervention will last approximately 13 weeks.

Conditions

Cystic Fibrosis; Fatigue

Study Design

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

Study Groups

CF Wellness Program

Participants will receive CF Wellness Program sessions.

Group Type: EXPERIMENTAL

CF Wellness Program Sessions

Intervention Type: OTHER

The intervention will last approximately 12 weeks. During this time, up to 9 coaching sessions will be delivered. Each will last approximately 45 - 60 minutes. Sessions will be delivered either by web-based video chat (e.g., Zoom) or by telephone. Sessions will cover content such as understanding the physiological, cognitive, affective, behavioral contributors to CF fatigue; understanding the role of physical activity/exercise and fatigue including the importance of balancing activity and rest periods; cognitive restructuring; addressing attention and interpretation processes contributing to fatigue; teaching techniques such as mindfulness meditation relaxation strategies, good sleep hygiene, and activity scheduling and behavioral activation; and engaging social support. Physical activity goals will be set each session. Participants will be encouraged to use the provided fitness tracker and to sync weekly prior the coaching session so that the results can inform session content.

Interventions

CF Wellness Program Sessions

The intervention will last approximately 12 weeks. During this time, up to 9 coaching sessions will be delivered. Each will last approximately 45 - 60 minutes. Sessions will be delivered either by web-based video chat (e.g., Zoom) or by telephone. Sessions will cover content such as understanding the physiological, cognitive, affective, behavioral contributors to CF fatigue; understanding the role of physical activity/exercise and fatigue including the importance of balancing activity and rest periods; cognitive restructuring; addressing attention and interpretation processes contributing to fatigue; teaching techniques such as mindfulness meditation relaxation strategies, good sleep hygiene, and activity scheduling and behavioral activation; and engaging social support. Physical activity goals will be set each session. Participants will be encouraged to use the provided fitness tracker and to sync weekly prior the coaching session so that the results can inform session content.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• ≥18 years old
• Documentation of CF diagnosis in the medical record
• If prescribed a modulator (i.e., ivacaftor, lumacaftor/ivacaftor, tezacaftor/ivacaftor, & elexacaftor/tezacaftor/ivacaftor), have been on treatment for at least 4 weeks
• If prescribed medicine for psychiatric purpose, must be on treatment for at least 8 weeks
• Has access to a smartphone, tablet, and/or computer with access to internet
• Ability to understand/read/speak English
• Receives CF care at a participating CF Center
• Has a score of >4 on the Fatigue Severity Scale
• Not likely to start and/or change modulator treatments during the intervention period

Exclusion Criteria

• Receiving antibiotic treatment for a pulmonary exacerbation 14 days prior to the screening or expected to start within 14 days after screening visit
• Is pregnant or less than 6 months postpartum (self-reported)
• Is currently participating in another interventional trial
• Contraindication for aerobic exercise (determined by treating physician including cardiovascular, pulmonary and/or musculoskeletal contraindications)
• Forced Expiratory Volume in 1 second percent predicted (FEV1pp) is <25% within last year
• Planning to transfer care to a non-participating CF Center before the post-intervention visit could be completed
• Will not be available to complete CF-Wellness sessions in a timely fashion (e.g., will be on extended travel)
• Has already participated in the CF Wellness Program

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

Sponsors

University of Washington

OTHER

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

Johns Hopkins University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Kristin Riekert, PhD

Role: PRINCIPAL_INVESTIGATOR

Johns Hopkins University

Chris Goss, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Locations

Johns Hopkins University

Baltimore, Maryland, United States

University of Washington Medical Center

Seattle, Washington, United States

Countries

United States

Other Identifiers

IRB00202780

Identifier Type: -

Identifier Source: org_study_id