search
Back to results

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

Primary Purpose

Cystic Fibrosis

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Tobacco Treatment Specialist (TTS) intervention
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Cystic Fibrosis focused on measuring caregivers, tobacco, smoke exposure

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • University of Alabama at Birmingham

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Intervention group

Control group

Arm 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)

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 23, 2021
Last Updated
October 5, 2022
Sponsor
University of Alabama at Birmingham
Collaborators
Cystic Fibrosis Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT04777344
Brief Title
Clinical Effort Against Smoke Exposure in Cystic Fibrosis
Acronym
CEASE-CF
Official Title
Clinical Effort Against Smoke Exposure in Cystic Fibrosis (CEASE-CF)
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
July 8, 2021 (Actual)
Primary Completion Date
September 27, 2022 (Actual)
Study Completion Date
September 27, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham
Collaborators
Cystic Fibrosis Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cystic Fibrosis
Keywords
caregivers, tobacco, smoke exposure

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
single-center, randomized, open-label study
Masking
None (Open Label)
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intervention group
Arm Type
Experimental
Arm 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)
Arm Title
Control group
Arm Type
No Intervention
Arm Description
The control group will receive usual care plus CF-specific smoke exposure education.
Intervention Type
Behavioral
Intervention Name(s)
Tobacco Treatment Specialist (TTS) intervention
Intervention Description
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 Outcome Measure Information:
Title
Intervention feasibility
Description
Participant drop-out rates and time added to the clinical encounter
Time Frame
6 months
Title
Intervention acceptability
Description
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 Outcome Measure Information:
Title
Self-reported caregiver cessation
Description
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
Title
Child smoke exposure
Description
Biochemically verified with a hair nicotine sample at baseline, 3 months, and 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35233
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Clinical Effort Against Smoke Exposure in Cystic Fibrosis

We'll reach out to this number within 24 hrs