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Completed

NCT Number: NCT00587353

Tobacco Use Intervention Among Radiation Oncology Patients

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.

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Key information

Conditions

Tobacco Use Disorder Behavior Chemically-Induced Disorders Health Behavior Mental Disorders Smoking Substance-Related Disorders Tobacco Use Cessation

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Behavioral and pharmacologic tobacco use intervention

Other

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.

Primary outcomes

  1. The primary aim is to pilot test the intervention in radiation oncology patients (N=30). The primary dependent measure is self-reported 7-day point prevalence tobacco abstinence confirmed with expired air carbon monoxide.

    Time frame: 6 months

Secondary outcomes

  1. We will be collecting data on QOL and psychosocial measures. This data will be reported descriptively and will be collected on our future study with appropriate statistical analyses.

    Time frame: 6 months

Sponsors and collaborators

Lead sponsor

Mayo Clinic

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Jan 7, 2008
Registry last updated
May 2, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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