Implementation of a System-level Tobacco Treatment Intervention
1 other identifier
interventional
263
1 country
2
Brief Summary
The proposed study plans to adapt and study the implementation and effectiveness of integrating Clinical and Community Effort Against Secondhand smoke Exposure (CEASE) into the thoracic oncology setting using mixed methods.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Jun 2016
Longer than P75 for not_applicable
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2016
CompletedFirst Submitted
Initial submission to the registry
June 23, 2016
CompletedFirst Posted
Study publicly available on registry
June 28, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2026
CompletedApril 16, 2026
April 1, 2026
6.5 years
June 23, 2016
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Smoking cessation Rate
Biochemical verification of smoking cessation
6 Months
Secondary Outcomes (1)
Documentation of tobacco treatment
2 months after CEASE
Study Arms (5)
Cease-Aim 1
ACTIVE COMPARATOR* Cease Implementation * 100 Patients after CEASE Implementation * Exit Interview and Tobacco Use Survey
Pre Cease Implementation Aim 2
ACTIVE COMPARATOR50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification
After Cease Implementation Aim 2
EXPERIMENTAL50 Current or former smokers (3 months +/-2 month) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification
Usual Care-Aim 1
ACTIVE COMPARATORUsual Care Tobacco Treatment Services * 100 patients in usual care * Exit Interview and Tobacco Use Survey
Clinician and Staff Survey
NO INTERVENTION\- Interview clinicians and support staff (40)
Interventions
* Clinical and Community Effort Against Secondhand Smoke Exposure (CEASE) * CEASE is a system-level intervention that integrates tobacco-use screening, cessation assistance, and referral to outside services into routine visits
Eligibility Criteria
You may qualify if:
- Age ≥ 18
- Have an actual or potential diagnosis of thoracic malignancy
- Able to read and write in English.
- Current or recent former smoker (defined as having smoked within past 6 months)
- Must have an active telephone number.
You may not qualify if:
- Former smoker greater than 6 months.
- Have any of the below conditions needing immediate medical intervention
- Hypercalcemia causing lethargy and confusion,
- Acute respiratory distress
- Dehydration
- Hypotension
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Dana-Farber Cancer Institutelead
- Brigham and Women's Hospitalcollaborator
- Massachusetts General Hospitalcollaborator
Study Sites (2)
Brigham and Women's Hospital
Boston, Massachusetts, 02115, United States
Dana Farber Cancer Institute
Boston, Massachusetts, 02115, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Mary E Cooley, PhD, RN
Dana-Farber Cancer Institute
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Mary E. Cooley MD
Study Record Dates
First Submitted
June 23, 2016
First Posted
June 28, 2016
Study Start
June 1, 2016
Primary Completion
December 1, 2022
Study Completion
April 1, 2026
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will not share