A Feasibility Study of Smoking Cessation Program in Radiation Oncology

Cancer and Tobacco Abuse Clinical Trial

Official title:

A Feasibility Study of Smoking Cessation Program in Radiation Oncology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00236288
• Other study ID #: 0508-12
• Secondary ID: Walther Cancer I
• Status: Completed
• Phase: N/A
• First received: October 7, 2005
• Last updated: October 29, 2007
• Start date: October 2005
• Est. completion date: April 2007

Study information

• Verified date: October 2007
• Source: Indiana University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationUnited States: Institutional Review BoardUnited States: Federal Government
• Study type: Interventional

Clinical Trial Summary

To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions.

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% of lung cancer deaths. There is robust phase III randomized data to show improved smoking cessation with both behavioral strategies as well as pharmacologic interventions such as bupropion.

Despite significant evidence showing survival, toxicity and quality of life detriments in cancer patients who continue smoking after diagnosis, roughly one third of cancer patients continue to use tobacco. There is a relative paucity of data regarding smoking cessation programs in cancer patient populations. Several single institution, as well as cooperative group (ECOG), efforts have been published with varying results. However, to date, there are no published reports on the success of pharmacologic smoking cessation interventions in cancer patients.

Patients undergoing definitive/curative radiotherapy often receive daily treatment over the course of three to eight weeks. They are often accompanied and supported daily by family members or companions, many of whom smoke. This represents a huge exposure to the health care system and a unique opportunity for intensive intervention in both cancer patients and their families/companions during their "daily routine" of radiotherapy. To date, there is no published report on intensive tobacco cessation intervention concurrent with radiotherapy in cancer patients and their families or companions.

We propose a feasibility study of an intensive tobacco cessation program to be delivered to radiation oncology patients and/or their family/companions concurrent with planned radiotherapy. This program will feature an intensive behavioral intervention as well as the pharmacologic agent bupropion.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: April 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 Criteria:

• 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Cancer and Tobacco Abuse
• Tobacco Use Disorder

Intervention

Drug:
• Bupropion and intensive behavioral therapy
To prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation.

Locations

Country	Name	City	State
United States	Indiana University, Department of Radiation Oncology	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Indiana University School of Medicine	Walther Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic.		1 year from enrollment
Secondary	Smoking cessation status will be formally assessed by patient report, and for those reporting tobacco abstinence, confirmed by carbon monoxide breath testing concentrations of 10 ppm or less.		1 year from enrollment