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Implementation of a System-level Tobacco Treatment Intervention

Sponsor
Dana-Farber Cancer Institute (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT02816697
Collaborator
Brigham and Women's Hospital (Other), Massachusetts General Hospital (Other)
263
Enrollment
2
Locations
5
Arms
78
Anticipated Duration (Months)
131.5
Patients Per Site
1.7
Patients Per Site Per Month

Study Details

Study Description

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
  • Other: CEASE
  • Other: Usual Care Tobacco Treatment Services
 N/A

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

Study Type:
Interventional
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 :
Jun 1, 2016
Anticipated Primary Completion Date :
Dec 1, 2022
Anticipated Study Completion Date :
Dec 1, 2022

Arms and Interventions

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

Primary Outcome Measures

  1. Smoking cessation Rate [6 Months]

    Biochemical verification of smoking cessation

Secondary Outcome Measures

  1. Documentation of tobacco treatment [2 months after CEASE]

    Assess documentation of smoking assessment and provision of treatment ( medication and referral for behavioral counseling)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Locations

Site City State Country Postal Code
1 Brigham and Women's Hospital Boston Massachusetts United States 02115
2 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

  • Principal Investigator: Mary E Cooley, PhD, RN, Dana-Farber Cancer Institute

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
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:
Jun 28, 2016
Last Update Posted:
Jun 8, 2022
Last Verified:
Jun 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Keywords provided by Mary E. Cooley, Phd, Mary E. Cooley MD, Dana-Farber Cancer Institute
Smoking Habits

Study Results

No Results Posted as of Jun 8, 2022