Tobacco Use Intervention Among Radiation Oncology Patients

NCT ID: NCT00587353

Last Updated: 2012-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-12-31

Brief Summary

Tobacco prevention and intervention strategies in the general population are ongoing and evolving. However, strategies to help cancer patients overcome tobacco dependence have been limited. Radiation oncology patients who continue to smoke despite their cancer diagnosis have a lower quality of life (QOL), increased frequency and severity of side effects during their cancer treatment, higher risks of developing a smoking-related primary cancer, and may have a poorer survival rate than their non-smoking counterparts. These are all compelling reasons to be more pro-active in helping cancer patients stop smoking. The overall objective of this project is to adapt a model of an effective tobacco use intervention that can be delivered by any trained radiation oncologist and their staff.

Conditions

Tobacco Use Disorder

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

Behavioral and pharmacologic tobacco use intervention

A novel approach to providing an intervention for tobacco users who are receiving radiation therapy is to provide an individual tobacco use intervention that utilizes concepts of motivational interviewing strategies to facilitate self-exploration of the reasons for continued smoking and a treatment plan that is comprehensive and builds self-efficacy, provides one-on-one counseling, and includes tobacco treatment pharmacotherapies. The pharmacotherapies will be tailored to the patients needs. One could utilize varenicline, bupropion, and/or nicotine replacement therapies.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• at least 18 years of age;
• current cigarette smoker (smoked any cigarettes within the previous 7 days prior to their first visit) or recent ex-smoker (last cigarette smoked was >7 but ≤ 30 days);
• planning to undergo radiation therapy (RT) that is to be delivered by the members of the Department of Radiation Oncology in Rochester, MN;
• be receiving a minimum of 5 weeks of RT and/or be willing to return for all 5 sessions.

Exclusion Criteria

• patient is currently (in previous 30 days) using other formal behavioral tobacco cessation program [i.e., behavioral therapy (Nicotine Dependence Consultation and treatment) or telephone quitline];
• daily use of tobacco products other than cigarettes;
• hospitalized patients;
• Karnofsky Performance Status (KPS) score of < 60 (KPS = 60 corresponds to a person who requires occasional assistance but is able to care for most of their own needs;
• presence of an unstable or untreated psychiatric disorder.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mayo Clinic

OTHER

Sponsor Role: lead

Responsible Party

Mayo Clinic

Principal Investigators

Yolanda I Garces, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic

Locations

Mayo Clinic

Rochester, Minnesota, United States

Countries

United States

Other Identifiers

07-006180

Identifier Type: -

Identifier Source: org_study_id