Clinical Effort Against Smoke Exposure in Cystic Fibrosis

University of Alabama at Birmingham36 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

HEALTH_SERVICES_RESEARCH

Masking

NONE

Enrollment

Conditions

Cystic Fibrosis

Interventions

Tobacco Treatment Specialist (TTS) interventionBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 19 Years

Medical Language ↔ Plain English

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.

Locations (1)

University of Alabama at Birmingham

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

Intervention feasibility

Participant drop-out rates and time added to the clinical encounter

Time frame: 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

Time frame: 6 months

Secondary Outcomes

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

Time frame: 6 months

Child smoke exposure

Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months

Time frame: 6 months

Data from ClinicalTrials.gov

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