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

NCT04809207 | Completed

• 1 other identifier: IRB00202780
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

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.

Conditions

Cystic Fibrosis; Fatigue

Outcome Measures

Primary Outcomes (3)

• Proportion enrolled in the CF Wellness Program (CFWP)

  Number of participants enrolled into the CFWP Intervention among those eligible.

  Day 0

• Proportion of cognitive behavioral therapy (CBT) sessions completed

  Mean of the number of completed cognitive behavioral therapy (CBT) sessions divided by the number of sessions expected per participant.

  At approximately 13 weeks post intervention

• Proportion of weeks participant synced the fitness tracker watch to the Smartphone app

  This will be measured as the mean of the number of syncs completed divided by the number expected per participant. The fitness tracker watch with smartphone app data will be used to assess the proportion of weeks participant synced the fitness tracker watch to the Smartphone app.

  At approximately 13 weeks post intervention

Secondary Outcomes (9)

• Feasibility of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients

  At approximately 13 weeks post intervention

• Acceptability of the CF Wellness Program as assessed by the Intervention Feasibility and Acceptability questionnaire (iFAQ) for patients

  At approximately 13 weeks post intervention

• Qualitative interview as assessed by thematic analysis

  At approximately 13 weeks post intervention

• Mean change in fatigue as assessed by the Functional Assessment of Chronic Illness-Fatigue ( FACIT-F) Scale

  Day 1 to approximately 13 weeks post intervention

• Change in exercise capacity as assessed by the 1 Minute Sit to Stand Test (1MSTST) test and Fitness tracker watch

  Day 1 to approximately 13 weeks post intervention

Study Arms (1)

CF Wellness Program

EXPERIMENTAL

Participants will receive CF Wellness Program sessions.

Other: CF Wellness Program Sessions

Interventions

CF Wellness Program Sessions 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.

CF Wellness Program

Eligibility Criteria

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

You may qualify if:

• ≥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

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead
• University of Washington: collaborator
• Cystic Fibrosis Foundation: collaborator

Study Sites (2)

Johns Hopkins University

Baltimore, Maryland, 21224, United States

Location

University of Washington Medical Center

Seattle, Washington, 356522, United States

Location

MeSH Terms

Conditions

Cystic Fibrosis; Fatigue

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; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Kristin Riekert, PhD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

• Chris Goss, MD

  University of Washington

  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: SPONSOR

Study Record Dates

• First Submitted: March 18, 2021
• First Posted: March 22, 2021
• Study Start: May 1, 2021
• Primary Completion: July 25, 2023
• Study Completion: July 25, 2023
• Last Updated: August 28, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)