Psychological implications of kaftrio for patients with CF (Part 1)
Research type
Research Study
Full title
Exploring the Psychological Implications of Triple-Combination Therapy, Kaftrio, for Patients with Cystic Fibrosis (CF); Part 1
IRAS ID
295947
Contact name
Daniel Peckham
Contact email
Sponsor organisation
University of Leeds
Clinicaltrials.gov Identifier
n/a, n/a
Duration of Study in the UK
0 years, 8 months, 20 days
Research summary
Patients with cystic fibrosis (CF) are at an increased risk of experiencing anxiety and depression compared to the general population. While conventional treatments target the symptoms of CF (e.g. antibiotics fight infections), modulator therapy drugs target the underlying genetic mutations that cause CF by helping to make the protein work effectively. At present, there are 4 modulator therapy drugs for people with certain CFTR mutations available on the NHS.
There is mixed evidence about whether modulator therapies have a positive or negative effect on mental health and quality of life. Improvements in health are often linked to positive psychological outcomes (improved mood, overall wellbeing and quality of life, reduced anxiety etc), however improved health can also introduce its own challenges as patients also adapt to changes in their routines, roles and relationships as a result. Some patient’s may also be faced with the prospect of no longer being eligible for certain forms of financial and practical support, and being well enough to return to work, or plan for a future that they had not necessarily expected to be able to live to see.
One-to-one interviews will be performed with patients within the first few months of commencing Kaftrio (a modulator therapy) to identify and better understand the psychological implications of this therapy, and what changes in a patient’s physical health might mean for their mental health and quality of life. Themes identified will help inform the choice of questionnaires to be used in a subsequent longitudinal study which will quantitatively measure the impact of Kaftrio (and COVID-19) on mental health and quality of life in a larger number of patients with CF.
REC name
North West - Greater Manchester West Research Ethics Committee
REC reference
21/NW/0144
Date of REC Opinion
1 Jul 2021
REC opinion
Further Information Favourable Opinion