Clinical Effort Against Smoke Exposure in Cystic Fibrosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Cystic Fibrosis

Intervention / Treatment
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* Behavioral: Tobacco Treatment Specialist (TTS) intervention


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Health Services Research
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: single-center, randomized, open-label study
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>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) | Behavioral: Tobacco Treatment Specialist (TTS) intervention<br>* 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.<br>|
| No Intervention: Control group<br>The control group will receive usual care plus CF-specific smoke exposure education. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Intervention feasibility | Participant drop-out rates and time added to the clinical encounter | 6 months | 
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| Child smoke exposure | Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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caregivers, tobacco, smoke exposure