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

The CF Wellness Program to Treat Fatigue

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.

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.

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