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Tobacco Use Intervention Among Radiation Oncology Patients

Primary Purpose

Tobacco Use Disorder

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Behavioral and pharmacologic tobacco use intervention

About this trial

This is an interventional treatment trial for Tobacco Use Disorder focused on measuring tobacco use cessation, radiation oncology, smoking

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Mayo Clinic

Outcomes

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.

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.

Full Information

NCT ID

NCT00587353

First Posted

December 21, 2007

Last Updated

May 1, 2012

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT00587353

Brief Title

Tobacco Use Intervention Among Radiation Oncology Patients

Official Title

Tobacco Use Intervention Among Radiation Oncology Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2012

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

November 2009 (Actual)

Study Completion Date

December 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Mayo Clinic

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Tobacco Use Disorder

Keywords

tobacco use cessation, radiation oncology, smoking

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

26 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Behavioral and pharmacologic tobacco use intervention

Intervention Description

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 Outcome Measure Information:

Title

Time Frame

6 months

Secondary Outcome Measure Information:

Title

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

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Yolanda I Garces, MD

Organizational Affiliation

Mayo Clinic

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Tobacco Use Intervention Among Radiation Oncology Patients

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