Tobacco Use Intervention Among Radiation Oncology Patients

This study has been completed.
Sponsor:
Information provided by:
Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00587353
First received: December 21, 2007
Last updated: May 1, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Tobacco Use Disorder
Other: Behavioral and pharmacologic tobacco use intervention
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Tobacco Use Intervention Among Radiation Oncology Patients

Resource links provided by NLM:


Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 26
Study Start Date: January 2008
Study Completion Date: December 2009
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: 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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00587353

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States, 55905
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Yolanda I Garces, MD Mayo Clinic
  More Information

No publications provided

Responsible Party: Yolanda I. Garces, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00587353     History of Changes
Other Study ID Numbers: 07-006180
Study First Received: December 21, 2007
Last Updated: May 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
tobacco use cessation
radiation oncology
smoking

Additional relevant MeSH terms:
Tobacco Use Disorder
Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders

ClinicalTrials.gov processed this record on September 18, 2014