Implementation of a System-level Tobacco Treatment Intervention

Lung Cancer Clinical Trial

Official title:

Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02816697
• Other study ID #: 16-208
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 2016
• Est. completion date: January 2025

Study information

• Verified date: May 2024
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 263
• Est. completion date: January 2025
• Est. primary completion date: December 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Cancer
• Smoking Cessation

Intervention

Other:
• 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
• Usual Care Tobacco Treatment Services

Locations

Country	Name	City	State
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Dana Farber Cancer Institute	Boston	Massachusetts

Sponsors (3)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute	Brigham and Women's Hospital, Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Smoking cessation Rate	Biochemical verification of smoking cessation	6 Months
Secondary	Documentation of tobacco treatment	Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)	2 months after CEASE