Status:
COMPLETED
A Feasibility Study of Smoking Cessation Program in Radiation Oncology
Lead Sponsor:
Indiana University School of Medicine
Collaborating Sponsors:
Walther Cancer Institute
Conditions:
Cancer and Tobacco Abuse
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions.
Detailed Description
There is overwhelming evidence to support tobacco use as the number one cause of preventable cancer and cardiovascular death. Smoking is responsible for at least 30% of all cancer deaths and nearly 90...
Eligibility Criteria
Inclusion
- Eligibility for Radiotherapy Patients
- age 18 years or older
- receiving three weeks or more of external beam radiotherapy
- report smoking one or more cigarettes in the past 30 days or self-identify as a smoker
- Cancer Stage:
- Stage I-III
- IVa Head and Neck Malignancy is allowed
- Stage I-IV breast, prostate, testis or lymphoma also allowed
- at least one year life expectancy
- have given written informed consent
- KPS 70-100
- Eligibility for Family/Companions of Radiotherapy Patients (Note: Family members/companions are eligible for this protocol regardless of whether the index radiotherapy patient is eligible or willing to participate.)
- age 18 years or older
- at least one year life expectancy
- radiotherapy patient is receiving three weeks or more of external beam radiotherapy
- Person is committed to bringing/accompanying the patient to radiotherapy at least three days per week.
- report smoking one or more cigarettes in the past 30 days or self-identify as a smoker
- Family member/companion of patients under radiotherapy treatment for any stage of cancer
- have given written informed consent
- KPS 70-100
Exclusion
- Exclusion Criteria for both Radiotherapy Patients and their Families/Companions
- serious or unstable cardiac, renal, hypertensive, pulmonary, endocrine, or neurologic disorders, as assessed by the study-site physician
- a current diagnosis of major depressive episode or a history of panic disorder, psychosis, bipolar disorder, or eating disorders
- pregnancy or lactation
- any history of allergy/intolerance or adverse reaction to bupropion
- history of seizure disorder, bulimia or anorexia nervosa
- use of an MAOi within 14 days
- current use of another antidepressant
- abrupt discontinuation of alcohol or sedatives
- unwilling/unable to meet with the behavioral interventionalist for 20 minutes, at least 3 days per week during the course of radiotherapy
Key Trial Info
Start Date :
October 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2007
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT00236288
Start Date
October 1 2005
End Date
April 1 2007
Last Update
October 31 2007
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Indiana University, Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202