Clinical trial NCT05107687: Effectiveness of Smoking Cessation Program in a Community Health System
Official title: The Effectiveness of a Structured Smoking Cessation Program Versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
Study type: OBSERVATIONAL
Overall status: ENROLLING_BY_INVITATION
Conditions: Smoking Cessation
Lead sponsor: Virtua Health, Inc.
Sponsor class: OTHER
First posted: 2021-11-04
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
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.

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: The Effectiveness of a Structured Smoking Cessation Program versus Unassisted Smoking Cessation Methods in Cancer Patients Managed in a Community Health System
timeFrame: 6 and 12 month intervals
Secondary outcomes:
measure: 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
timeFrame: 6 and 12 month intervals
Other outcomes:
Locations:
city: Voorhees
country: United States
facility: Virtua Health
state: New Jersey
Study officials:
affiliation: Virtua Health
name: Theresa Carducci, MSN, RN, CCRP
role: PRINCIPAL_INVESTIGATOR
References: