Cystic Fibrosis Clinical Trial
— QUESTOfficial title:
Qualitative Understanding of Experiences With the SIMPLIFY Trial
Verified date | August 2023 |
Source | Boston Children's Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
This qualitative longitudinal study is designed to elicit and thematically analyze the perspectives of SIMPLIFY subjects about treatment withdrawal research and treatment burden in the context of triple combination CFTR (Cystic Fibrosis Transmembrane Conductance Regulator) modulator therapy (TCT). Cohorts will be determined based on sub-groups of the assigned treatment arms from the SIMPLIFY study. Participants will be asked to participate in two interviews; the first interview will be conducted at the completion of the SIMPLIFY study and the second interview will be conducted approximately 4 months after the first interview. Trained research staff will conduct the semi-structured interviews that will be audio-recorded and transcribed for thematic analysis. Each interview should last between 30-60 minutes.
Status | Completed |
Enrollment | 115 |
Est. completion date | September 16, 2022 |
Est. primary completion date | September 16, 2022 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 14 Years and older |
Eligibility | Inclusion Criteria: Patient Participant: 1. Participant was randomized into the SIMPLIFY study 2. Person with CF is = 14 years of age at the time of randomization into SIMPLIFY 3. Is English speaking 4. Participant has provided consent (or assent if applicable) in the SIMPLIFY study to provide contact information and share data from the SIMPLIFY study with the QUEST study team 5. Participant has provided contact information via the QUEST portal 6. Is willing and able to adhere to the study requirements 7. Provides consent (or assent if applicable) for the QUEST study 8. Completed participation in the SIMPLIFY study (i.e. completed through Visit 3 or early withdrawal, if applicable) Caregiver Participant: 1. Lives in the same household as a child with CF who is = 14 years of age but <18 years of age who meets the eligibility requirements for the QUEST study 2. Is English speaking, 3. Is willing and able to adhere to the study requirements 4. Provides consent for the QUEST study Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this study: 1. Any situation that, in the opinion of the Investigator, would compromise the safety of the patient or the quality of the data |
Country | Name | City | State |
---|---|---|---|
United States | Johns Hopkins University | Baltimore | Maryland |
United States | Boston Children's Hospital | Boston | Massachusetts |
Lead Sponsor | Collaborator |
---|---|
Boston Children's Hospital | Johns Hopkins University |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in Participant Perceptions | To determine if individuals who did not maintain treatment assignment (i.e., person randomized to discontinue treatment restarted the treatment OR person randomized to maintain treatment discontinued it) have different perceptions about treatment burden | from day one to approximately month 8 | |
Other | Change in Participant Perceptions (2) | To determine if individuals who withdrew from the SIMPLIFY study have a different perception about treatment burden and the factors that affect decisions to discontinue treatments. | from day one to approximately month 8 | |
Primary | Interview #1 | Questions to evaluate (A) attitudes and beliefs regarding participation in a withdrawal study and (B) perceptions of treatment burden in the context of having participated in a withdrawal study. | to be conducted at the time of enrollment (post SIMPLIFY study) | |
Primary | Interview #2 | Questions to evaluate pwCF's perceptions of (A) factors that affected the decision to use or not use dornase alfa and/or hypertonic saline post-trial participation and satisfaction with the decision and (B) factors that would affect decision-making about whether to withdraw treatments in the future. | to be conducted 4 months following the date of the first interview | |
Secondary | Change in Participant's Perceptions in Interviews | To determine if perceptions about treatment burden and withdrawal study participation vary by the parent study treatment arm assignment (e.g. randomized to continue or stop dornase alfa and/or hypertonic saline). | from day one to approximately month 8 | |
Secondary | Change in Participant's Decision-making in Interviews | To determine if treatment arm assignment influenced decision-making about using or not using dornase alfa and/or hypertonic saline post-trial participation | from day one to approximately month 8 | |
Secondary | Change in Participant's Level of Satisfaction in Interviews | To determine pwCF's level of satisfaction with the decision to use or not use dornase alfa and/or hypertonic saline post-trial participation | from day one to approximately month 8 |
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