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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05107687
Other study ID # IRB-2021-02
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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