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

The University of Alabama at Birmingham

Status: Completed

Conditions: Cystic Fibrosis

Treatments: Behavioral: Tobacco Treatment Specialist (TTS) intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT04777344

IRB-300006654

Details and patient eligibility

About

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.

Full 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.

Enrollment: 36 patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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36 participants in 2 patient groups

Intervention group

Experimental group

Description:

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)

Treatment:

Behavioral: Tobacco Treatment Specialist (TTS) intervention

Control group

No Intervention group

Description:

The control group will receive usual care plus CF-specific smoke exposure education.