Effectiveness of Smoking Cessation Program in a Community Health System

NCT05107687 | Enrolling By Invitation

• 1 other identifier: IRB-2021-02
• Study Type: observational
• Target: 76
• Locations: 1 country
• Sites: 1

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.

Conditions

Smoking Cessation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

  6 and 12 month intervals

Study Arms (2)

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.

Behavioral: Smoking cessation

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.

Behavioral: Smoking cessation

Interventions

Smoking cessation BEHAVIORAL

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.

Assisted Smoking Cessation; Unassisted Smoking Cessation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Virtua Health, Inc.: lead

Study Sites (1)

Virtua Health

Voorhees Township, New Jersey, 08043, United States

Location

MeSH Terms

Conditions

Smoking Cessation

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Theresa Carducci, MSN, RN, CCRP

  Virtua Health

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: November 4, 2021
• Study Start: May 10, 2021
• Primary Completion: May 31, 2025
• Study Completion: December 30, 2025
• Last Updated: April 5, 2024

Record last verified: 2024-03

Locations

US (1)