Effectiveness of Smoking Cessation Program in a Community Health System

Smoking Cessation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05107687
• Other study ID #: IRB-2021-02
• Status: Enrolling by invitation
• Start date: May 10, 2021
• Est. completion date: December 30, 2025

Study information

• Verified date: March 2024
• Source: Virtua Health, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 76
• Est. completion date: December 30, 2025
• Est. primary completion date: May 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Smoking Cessation

Intervention

Behavioral:
• Smoking cessation
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.

Locations

Country	Name	City	State
United States	Virtua Health	Voorhees	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Virtua Health, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System	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	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	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