Clinical Effort Against Smoke Exposure in Cystic Fibrosis

Cystic Fibrosis Clinical Trial

— CEASE-CF  

Official title:

Clinical Effort Against Smoke Exposure in Cystic Fibrosis (CEASE-CF)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04777344
• Other study ID #: IRB-300006654
• Status: Completed
• Phase: N/A
• Start date: July 8, 2021
• Est. completion date: September 27, 2022

Study information

• Verified date: October 2022
• Source: University of Alabama at Birmingham
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study will test the feasibility, acceptability, and preliminary efficacy of a multi-component smoking cessation intervention tailored to the needs of caregivers of children with CF and delivered in clinical settings as part of routine CF care. The ultimate goal of this effort is to reduce the exposure of children and adolescents with CF to tobacco smoke.

Description:

This is a single-center, randomized, open-label study to test the feasibility and acceptability (primary outcomes) and preliminary efficacy (secondary outcome) of a multi-component smoking-cessation intervention delivered by a tobacco treatment specialist (TTS) integrated in the multidisciplinary CF care team.

The intervention will be tested in a two-group design with a 2:1 allocation. Participants (dyads of caregiver/CF child) will be randomized to either intervention or control group. The intervention group (N=24) will receive the multi-component intervention (intake assessment, follow-up, help with obtaining nicotine replacement therapy, and CF-specific smoke exposure education). The control group (N=12) will receive usual care plus CF-specific smoke exposure education.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: September 27, 2022
• Est. primary completion date: September 27, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 19 Years and older

Eligibility

Inclusion Criteria:

• Adult familial caregiver of a child with CF aged <18 years

• Speak English

• Report smoking at least 1 cigarette in the previous week

• Not enrolled in a smoking cessation program

Exclusion Criteria:

• Do not report smoking at least 1 cigarette in the previous week

• Currently enrolled in a smoking cessation program.

Related Conditions & MeSH terms

• Cystic Fibrosis
• Fibrosis

Intervention

Behavioral:
• Tobacco Treatment Specialist (TTS) intervention
A trained Tobacco Treatment specialist (TTS) embedded in the multi-disciplinary CF care team will provide tobacco use counseling to smoking caregivers of children with CF.

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (2)

Lead Sponsor	Collaborator
University of Alabama at Birmingham	Cystic Fibrosis Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intervention feasibility	Participant drop-out rates and time added to the clinical encounter	6 months
Primary	Intervention acceptability	Proportion of caregivers who accepted participation; Participant and provider satisfaction with the intervention on a 1-5 Likert scale; Perceived effectiveness of the intervention on a 1-5 Likert scale	6 months
Secondary	Self-reported caregiver cessation	7-day point prevalence of abstinence measured at 1, 3, and 6 months; Number of cigarettes smoked in the past 7 days, measured at 1, 3, and 6 months	6 months
Secondary	Child smoke exposure	Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months	6 months