Effectiveness of Smoking Cessation Program in a Community Health System

April 4, 2024 updated by: Virtua Health, Inc.

The Effectiveness of a Structured Smoking Cessation Program Versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System

Research efforts are needed to increase tobacco cessation support and to improve tobacco cessation efficacy. In addition, strategies must be identified to increase access to smoking cessation support and to develop processes to integrate smoking cessation into treatment plans for cancer patients.

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Detailed Description

The Cancer Patient Tobacco Questionnaire (C-TUQ) survey tool will be used to address the primary and secondary outcome measures. This tool is publicly available on the National Cancer Institutes Grid-Enabled Measures website and was developed by NCI and the American Association for Cancer Research. This tool is a 22-item self-report survey designed to capture information about tobacco use by cancer patients and cancer survivors. Comparisons will be made for those patients that enroll in the structured smoking cessation program versus those patients that have opted to quit on their own.

Primary:

To determine the effectiveness of an intensive structured smoking cessation program (education and support) provided by a tobacco cessation trained specialist versus unassisted smoking cessation quitting methods (no support, patients have opted to stop on their own) in cancer patients seen in a community health care system

Secondary:

  • Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking with professional support
  • Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support, participants choosing to stop smoking on their own.
  • Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.

Study Type

Observational

Enrollment (Estimated)

76

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • New Jersey
      • Voorhees, New Jersey, United States, 08043
        • Virtua Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

All cancer patients who are actively smoking receiving treatment for any type of cancer, for patients who have completed treatment and cancer survivors.

Description

Inclusion Criteria:

Any Gender

  • Over 18 years of age
  • Able to read and understand English
  • Able to sign the informed consent form
  • A current cigarette smoker defined as smoking within 30 days
  • Diagnosed with cancer and wants to quit smoking

Exclusion Criteria:

  • • Individuals with Dementia

    • ECOG Performance Status 3-4
    • Survival prognosis less than 12 months
    • Currently participating in a smoking cessation program that is not provided by Virtua
    • Individuals who do not want to quit smoking
    • Pregnant Women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Assisted Smoking Cessation

Subject participates in a structured smoking cessation program hosted at Virtua Health which may be either smoking cessation group sessions or individual sessions and/or both. All participants will be provided with a list of smoking cessation resources.

Description of Group Smoking Education and Support: These sessions are led by a Tobacco Treatment Specialist and include 2-3 sessions in-person or virtually and cover the following topics: Biological changes caused by nicotine, addiction, tips to quit smoking, health benefits to quitting smoking, types of nicotine replacement therapy, e-cigarettes and devices, aromatherapy, meditation and various resources. In addition, access to nicotine replacement therapies is optional.

Assisted Smoking Cessation- Subject is provided professional support provided by tobacco cessation specialist.

Unassisted Smoking Cessation- Subject provided resources and attempts to quit smoking without professional support.

The subject selects their preferred intervention.

Unassisted Smoking Cessation
The subject receives no professional support but is provided with a list of smoking cessation resources, in this cohort the subject engages in smoking cessation with no assistance from a provider.

Assisted Smoking Cessation- Subject is provided professional support provided by tobacco cessation specialist.

Unassisted Smoking Cessation- Subject provided resources and attempts to quit smoking without professional support.

The subject selects their preferred intervention.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
Time Frame: 6 and 12 month intervals
To determine the effectiveness of an intensive structured smoking cessation program versus unassisted smoking cessation quitting methods in cancer patients seen in a community health care system
6 and 12 month intervals

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Effectiveness of a Structured Smoking Cessation Program in Cancer Patients in a Community Health System The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessatio
Time Frame: 6 and 12 month intervals
  • Self-reported 7-day point-prevalence smoking abstinence at 6-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support.
  • Self-reported 7-day point-prevalence smoking abstinence at 12-month follow-up in patients participating in a structured smoking cessation program versus those patients that have quit smoking without professional support.
  • Examine the impact of implementing a system level smoking cessation program into the ongoing management of our cancer patients who smoke.
6 and 12 month intervals

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Theresa Carducci, MSN, RN, CCRP, Virtua Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 10, 2021

Primary Completion (Estimated)

May 31, 2025

Study Completion (Estimated)

December 30, 2025

Study Registration Dates

First Submitted

October 5, 2021

First Submitted That Met QC Criteria

October 25, 2021

First Posted (Actual)

November 4, 2021

Study Record Updates

Last Update Posted (Actual)

April 5, 2024

Last Update Submitted That Met QC Criteria

April 4, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Other Study ID Numbers

  • IRB-2021-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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