Clinical Effort Against Smoke Exposure in Cystic Fibrosis
Purpose
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.
Condition
- Cystic Fibrosis
Eligibility
- Eligible Ages
- Over 19 Years
- Eligible Genders
- All
- Accepts Healthy Volunteers
- No
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.
Study Design
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- single-center, randomized, open-label study
- Primary Purpose
- Health Services Research
- Masking
- None (Open Label)
Arm Groups
Arm | Description | Assigned Intervention |
---|---|---|
Experimental Intervention group |
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) |
|
No Intervention Control group |
The control group will receive usual care plus CF-specific smoke exposure education. |
|
More Details
- Status
- Completed
- Sponsor
- University of Alabama at Birmingham
Study Contact
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.