A Feasibility Study of Smoking Cessation Program in Radiation Oncology

This study has been completed.
Sponsor:
Collaborator:
Walther Cancer Institute
Information provided by:
Indiana University
ClinicalTrials.gov Identifier:
NCT00236288
First received: October 7, 2005
Last updated: October 29, 2007
Last verified: October 2007
  Purpose

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


Condition Intervention
Cancer and Tobacco Abuse
Drug: Bupropion and intensive behavioral therapy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Feasibility Study of Smoking Cessation Program in Radiation Oncology

Resource links provided by NLM:


Further study details as provided by Indiana University:

Primary Outcome Measures:
  • To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic. [ Time Frame: 1 year from enrollment ]

Secondary Outcome Measures:
  • 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. [ Time Frame: 1 year from enrollment ]

Estimated Enrollment: 36
Study Start Date: October 2005
Study Completion Date: April 2007
Intervention Details:
    Drug: Bupropion and intensive behavioral therapy
    To prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation.
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% 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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  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: NCT00236288

Locations
United States, Indiana
Indiana University, Department of Radiation Oncology
Indianapolis, Indiana, United States, 46202
Sponsors and Collaborators
Indiana University School of Medicine
Walther Cancer Institute
Investigators
Principal Investigator: Anna McDaniel, DNS, RN, FAAN Department of Environments for Health, Indiana University School of Nursing
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00236288     History of Changes
Other Study ID Numbers: 0508-12, Walther Cancer Institute, Inc
Study First Received: October 7, 2005
Last Updated: October 29, 2007
Health Authority: United States: Food and Drug Administration
United States: Institutional Review Board
United States: Federal Government

Keywords provided by Indiana University:
Cancer treatment and tobacco abuse

Additional relevant MeSH terms:
Tobacco Use Disorder
Chemically-Induced Disorders
Mental Disorders
Substance-Related Disorders
Bupropion
Antidepressive Agents
Antidepressive Agents, Second-Generation
Central Nervous System Agents
Dopamine Agents
Dopamine Uptake Inhibitors
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Neurotransmitter Uptake Inhibitors
Pharmacologic Actions
Physiological Effects of Drugs
Psychotropic Drugs
Therapeutic Uses

ClinicalTrials.gov processed this record on October 30, 2014