Clinical Effort Against Smoke Exposure in Cystic Fibrosis

Not Applicable

Completed

• Conditions: Cystic Fibrosis
• Interventions: Behavioral: Tobacco Treatment Specialist (TTS) intervention

• Registration Number: NCT04777344
• Lead Sponsor: University of Alabama at Birmingham

Brief 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.

Detailed 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2021-02-23
• Study First Submitted QC: 2021-02-25
• Study First Posted: 2021-03-02
• Study Start: 2021-07-08
• Primary Completion: 2022-09-27
• Study Completion: 2022-09-27
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-05
• Last Update Posted: 2022-10-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 36

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

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Exclusion Criteria

• Do not report smoking at least 1 cigarette in the previous week
• Currently enrolled in a smoking cessation program.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intervention group	Tobacco Treatment Specialist (TTS) intervention	The intervention group will receive the multi-component intervention (counseling with intake assessment, follow-up, help obtaining nicotine replacement therapy, and CF-specific smoke exposure education)

Primary Outcome Measures

Name	Time	Method
Intervention feasibility	6 months	Participant drop-out rates and time added to the clinical encounter
Intervention acceptability	6 months	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

Secondary Outcome Measures

Name	Time	Method
Self-reported caregiver cessation	6 months	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
Child smoke exposure	6 months	Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months

Trial Locations

Locations (1)

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States