Implementation of a System-level Tobacco Treatment Intervention

Not Applicable

Active, not recruiting

• Conditions: Lung Cancer; Smoking Cessation
• Interventions: Other: CEASE; Other: Usual Care Tobacco Treatment Services

• Registration Number: NCT02816697
• Lead Sponsor: Dana-Farber Cancer Institute

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.

Detailed Description

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)

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2016-06
• Study First Submitted: 2016-06-23
• Study First Submitted QC: 2016-06-24
• Study First Posted: 2016-06-28
• Primary Completion: 2022-12-01
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-28
• Last Update Posted: 2024-05-29
• Study Completion: 2025-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 263

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Cease-Aim 1	CEASE	* Cease Implementation * 100 Patients after CEASE Implementation * Exit Interview and Tobacco Use Survey
Usual Care-Aim 1	Usual Care Tobacco Treatment Services	Usual Care Tobacco Treatment Services * 100 patients in usual care * Exit Interview and Tobacco Use Survey
Pre Cease Implementation Aim 2	Usual Care Tobacco Treatment Services	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
After Cease Implementation Aim 2	CEASE	50 Current or former smokers (3 months +/-2 month) * Tobacco Use Survey (Baseline,1- 6 Months) * Biochemical verification

Primary Outcome Measures

Name	Time	Method
Smoking cessation Rate	6 Months	Biochemical verification of smoking cessation

Secondary Outcome Measures

Name	Time	Method
Documentation of tobacco treatment	2 months after CEASE	Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)

Trial Locations

Locations (2)

Dana Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States