Implementation of a System-level Tobacco Treatment Intervention

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Smoking Cessation; Lung Cancer
• Intervention / Treatment: Other: CEASE; Other: Usual Care Tobacco Treatment Services

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)

• Study Type: Interventional
• Enrollment (Actual): 263
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Brigham and Women's Hospital
    • Boston, Massachusetts, United States, 02115
      • Dana Farber Cancer Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Cease-Aim 1; Cease Implementation; 100 Patients after CEASE ImplementationExit Interview and Tobacco Use Survey	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
Active Comparator: 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	Other: Usual Care Tobacco Treatment Services
Experimental: After Cease Implementation Aim 2; 50 Current or former smokers (3 months +/-2 month); Tobacco Use Survey (Baseline,1- 6 Months); Biochemical verification	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
Active Comparator: Usual Care-Aim 1; Usual Care Tobacco Treatment Services; 100 patients in usual care; Exit Interview and Tobacco Use Survey	Other: Usual Care Tobacco Treatment Services
No Intervention: Clinician and Staff Survey; - Interview clinicians and support staff (40)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Smoking cessation Rate	Biochemical verification of smoking cessation	6 Months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Documentation of tobacco treatment	Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)	2 months after CEASE

Collaborators and Investigators

• Sponsor: Dana-Farber Cancer Institute
• Collaborators: Massachusetts General Hospital; Brigham and Women's Hospital
• Investigators: Principal Investigator: Mary E Cooley, PhD, RN, Dana-Farber Cancer Institute

Study record dates

Study Major Dates

• Study Start (Actual): June 1, 2016
• Primary Completion (Actual): December 1, 2022
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: June 23, 2016
• First Submitted That Met QC Criteria: June 24, 2016
• First Posted (Estimated): June 28, 2016

Study Record Updates

• Last Update Posted (Actual): January 9, 2024
• Last Update Submitted That Met QC Criteria: January 8, 2024
• Last Verified: January 1, 2024

More Information

Terms related to this study

• Keywords: Smoking Habits
• Other Study ID Numbers: 16-208

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO