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Implementation of a System-level Tobacco Treatment Intervention

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ClinicalTrials.gov Identifier: NCT02816697
Recruitment Status : Active, not recruiting
First Posted : June 28, 2016
Last Update Posted : February 3, 2023
Sponsor:
Collaborators:
Brigham and Women's Hospital
Massachusetts General Hospital
Information provided by (Responsible Party):
Mary E. Cooley, Phd, Dana-Farber Cancer Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Smoking Cessation Lung Cancer Other: CEASE Other: Usual Care Tobacco Treatment Services Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 263 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Implementation of a System-level Tobacco Treatment Intervention in Thoracic Oncology
Actual Study Start Date : June 2016
Actual Primary Completion Date : December 1, 2022
Estimated Study Completion Date : December 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Cease-Aim 1
  • Cease Implementation

  • 100 Patients after CEASE Implementation

    • Exit 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)


Outcome Measures
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Primary Outcome Measures :
  1. Smoking cessation Rate [ Time Frame: 6 Months ]
    Biochemical verification of smoking cessation


Secondary Outcome Measures :
  1. Documentation of tobacco treatment [ Time Frame: 2 months after CEASE ]
    Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02816697


Locations
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United States, Massachusetts
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Dana Farber Cancer Institute
Boston, Massachusetts, United States, 02115
Sponsors and Collaborators
Dana-Farber Cancer Institute
Brigham and Women's Hospital
Massachusetts General Hospital
Investigators
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Principal Investigator: Mary E Cooley, PhD, RN Dana-Farber Cancer Institute
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Mary E. Cooley, Phd, Mary E. Cooley MD, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT02816697    
Other Study ID Numbers: 16-208
First Posted: June 28, 2016    Key Record Dates
Last Update Posted: February 3, 2023
Last Verified: February 2023
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by Mary E. Cooley, Phd, Dana-Farber Cancer Institute:
Smoking Habits