Implementation of a System-level Tobacco Treatment Intervention

NCT ID: NCT02816697

Last Updated: 2026-01-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

263 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-06-30

Study Completion Date

2026-02-28

Brief Summary

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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.

Detailed Description

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In particular the study aims to see if participants are asked about their smoking status and what services are offered if someone indicates being a former or current smoker. Findings from this study will help improve a standard of care at this clinic and allow us to understand what type of tobacco treatment services are preferred by patients.

* Adaption of CEASE will entail exit interviews with patients and individual interviews with clinical staff to identify and address facilitators and barriers to the implementation process.
* Effectiveness of CEASE will be measured through questionnaires \& biochemical verification of smoking status using a pre-test/post-test study design before (usual care)and after implementation (CEASE)

Conditions

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Smoking Cessation Lung Cancer

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Cease-Aim 1

* Cease Implementation
* 100 Patients after CEASE Implementation

* Exit Interview and Tobacco Use Survey

Group Type ACTIVE_COMPARATOR

CEASE

Intervention Type OTHER

* 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

Pre Cease Implementation Aim 2

50 Current or former smokers (3 months +/-2 month) patients in usual care (before CEASE implementation)

* Tobacco Use Survey (Baseline,1- 6 Months)
* Biochemical verification

Group Type ACTIVE_COMPARATOR

Usual Care Tobacco Treatment Services

Intervention Type OTHER

After Cease Implementation Aim 2

50 Current or former smokers (3 months +/-2 month)

* Tobacco Use Survey (Baseline,1- 6 Months)
* Biochemical verification

Group Type EXPERIMENTAL

CEASE

Intervention Type OTHER

* 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

Usual Care-Aim 1

Usual Care Tobacco Treatment Services

* 100 patients in usual care
* Exit Interview and Tobacco Use Survey

Group Type ACTIVE_COMPARATOR

Usual Care Tobacco Treatment Services

Intervention Type OTHER

Clinician and Staff Survey

\- Interview clinicians and support staff (40)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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CEASE

* 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

Intervention Type OTHER

Usual Care Tobacco Treatment Services

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Brigham and Women's Hospital

OTHER

Sponsor Role collaborator

Massachusetts General Hospital

OTHER

Sponsor Role collaborator

Dana-Farber Cancer Institute

OTHER

Sponsor Role lead

Responsible Party

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Mary E. Cooley, Phd

Mary E. Cooley MD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Mary E Cooley, PhD, RN

Role: PRINCIPAL_INVESTIGATOR

Dana-Farber Cancer Institute

Locations

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Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Dana Farber Cancer Institute

Boston, Massachusetts, United States

Site Status

Countries

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United States

Other Identifiers

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16-208

Identifier Type: -

Identifier Source: org_study_id

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