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| Tracking Information | |||||||||
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| First Received Date ICMJE | March 8, 2004 | ||||||||
| Last Updated Date | May 9, 2009 | ||||||||
| Start Date ICMJE | February 2004 | ||||||||
| Primary Completion Date | |||||||||
| Current Primary Outcome Measures ICMJE | |||||||||
| Original Primary Outcome Measures ICMJE | |||||||||
| Change History | Complete list of historical versions of study NCT00079469 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE | |||||||||
| Original Secondary Outcome Measures ICMJE | |||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Bupropion and Counseling With or Without Contingency Management to Enhance Smoking Cessation in Treating Cancer Survivors Who Continue to Smoke | ||||||||
| Official Title ICMJE | Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial | ||||||||
| Brief Summary | RATIONALE: Contingency management is a behavioral treatment approach that provides immediate rewards for positive change in behavior such as quitting smoking. In this protocol, contingency management will be in the form of a cash reward. A smoking cessation (stop-smoking) program that combines contingency management with bupropion and counseling may be effective in helping cancer survivors stop smoking. PURPOSE: Randomized clinical trial to compare the effectiveness of bupropion and counseling with or without contingency management in helping cancer survivors stop smoking. |
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| Detailed Description | OBJECTIVES: Primary
Secondary
OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms.
In both arms, treatment continues in the absence of unacceptable toxicity. Patients are followed at 12 and 24 weeks after the completion of the smoking cessation interventions. PROJECTED ACCRUAL: A total of 100 patients (50 per intervention arm) will be accrued for this study within 8 months. |
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| Study Phase | |||||||||
| Study Type ICMJE | Interventional | ||||||||
| Study Design ICMJE | Prevention, Randomized, Active Control | ||||||||
| Condition ICMJE |
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| Intervention ICMJE |
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| Study Arms / Comparison Groups | |||||||||
| Publications * | |||||||||
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* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Active, not recruiting | ||||||||
| Enrollment ICMJE | |||||||||
| Completion Date | |||||||||
| Primary Completion Date | |||||||||
| Eligibility Criteria ICMJE | DISEASE CHARACTERISTICS:
PATIENT CHARACTERISTICS: Age
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Biologic therapy
Chemotherapy
Endocrine therapy
Radiotherapy
Surgery
Other
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||||
| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT ID ICMJE | NCT00079469 | ||||||||
| Responsible Party | |||||||||
| Study ID Numbers ICMJE | CDR0000356037, NCI-03-C-N308 | ||||||||
| Study Sponsor ICMJE | National Cancer Institute (NCI) | ||||||||
| Collaborators ICMJE | |||||||||
| Investigators ICMJE |
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| Information Provided By | National Cancer Institute (NCI) | ||||||||
| Verification Date | July 2004 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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