- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05107687
Effectiveness of Smoking Cessation Program in a Community Health System
The Effectiveness of a Structured Smoking Cessation Program Versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
Study Overview
Status
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
Enrollment (Estimated)
Contacts and Locations
Study Locations
-
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New Jersey
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Voorhees, New Jersey, United States, 08043
- Virtua Health
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
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
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
|
|
6 and 12 month intervals
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Theresa Carducci, MSN, RN, CCRP, Virtua Health
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
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
Studies a U.S. FDA-regulated device product
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