Cancer and Tobacco AbuseNCT00236288
A Feasibility Study of Smoking Cessation Program in Radiation Oncology
A study testing Bupropion and intensive behavioral therapy in people with Cancer and Tobacco Abuse, run by Indiana University at 1 site in United States.
Trial summary
To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer and Tobacco Abuse
- What is being tested?
- Bupropion and intensive behavioral therapy
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2005to Apr 2007
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 20Show fewer
- 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
Who cannot join
- 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
Show all 10Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Indiana University, Department of Radiation Oncology
Indianapolis, Indiana, 46202
About this study
To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions.
Read the 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.
- Conditions
- Cancer and Tobacco Abuse
- Being tested
- Bupropion and intensive behavioral therapy
- Keywords
- Cancer treatment and tobacco abuse
- Medical subject headings
- Neoplasms, Tobacco Use Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupropion and intensive behavioral therapyDrug
To prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation.
What is being measured
The primary outcome is the main question the study is designed to answer.
To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic.
Measured: 1 year from enrollment
Secondary outcomes (1)
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.
Measured: 1 year from enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2005 (estimated)
- Study startOct 2005
- Study completionApr 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cancer and Tobacco AbuseStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Collaborators
- Walther Cancer Institute
- Investigators
- Anna McDaniel, DNS, RN, FAAN, Principal investigator, Department of Environments for Health, Indiana University School of Nursing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00236288
- Sponsor's protocol ID
- 0508-12
- Other IDs
- Walther Cancer Institute, Inc
- Status last verified
- Oct 2007
- First submitted
- 7 Oct 2005
- Last updated
- 31 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Feasibility Study of Smoking Cessation Program in Radiation Oncology
- ClinicalTrials.gov ID
- NCT00236288
- Acronym / sponsor ID
- 0508-12
- Conditions
- Cancer and Tobacco Abuse
- Keywords
- Cancer treatment and tobacco abuse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Collaborators
- Walther Cancer Institute
- Study start
- Oct 2005
- Study completion
- Apr 2007 (actual)
- First posted
- 12 Oct 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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% 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.
Study design
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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:
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupropion and intensive behavioral therapyTo prescribe bupropion and behavioral therapy to patients and/or their families, who are currently receiving radiation. | Drug | – |
Primary outcome
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
1 secondary outcome
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna McDaniel, DNS, RN, FAAN principal investigator
Department of Environments for Health, Indiana University School of Nursing
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Bupropion and intensive behavioral therapy in people with Cancer and Tobacco Abuse, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2007.