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OpenTrials
Completed

NCT Number: NCT04777344

Clinical Effort Against Smoke Exposure in Cystic Fibrosis

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.

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Key information

Conditions

Cystic Fibrosis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Digestive System Diseases Genetic Diseases, Inborn Infant, Newborn, Diseases Lung Diseases Pancreatic Diseases Respiratory Tract Diseases

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tobacco Treatment Specialist (TTS) intervention

Behavioral

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.

Primary outcomes

  1. Intervention feasibility

    Time frame: 6 months

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

  2. Intervention acceptability

    Time frame: 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 outcomes

  1. Self-reported caregiver cessation

    Time frame: 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

  2. Child smoke exposure

    Time frame: 6 months

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

Sponsors and collaborators

Lead sponsor

University of Alabama at Birmingham

Other

Collaborators

  • Cystic Fibrosis Foundation

Registry information

Official study title

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

Acronym: CEASE-CF

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Mar 2, 2021
Registry last updated
Oct 6, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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