Contingency Management to Enhance Smoking Cessation for Cancer Survivors: A Proof of Concept Trial
Collecte de données
Étude de prévention
Résumé
Date de début de l'étude : 1 février 2004
Date à laquelle le premier participant a commencé l'étude.OBJECTIVES: Primary * Compare the feasibility of a multi-component smoking cessation intervention comprising bupropion and counseling with or without contingency management (cash reward) for cancer survivors who continue to smoke. * Compare 7-day point-prevalence abstinence rates in patients treated with these smoking cessation interventions. Secondary * Determine the characteristics of these patients that predict success at quitting smoking. OUTLINE: This is a randomized, multicenter study. Patients are randomized to 1 of 2 smoking cessation intervention arms. * Arm I: Patients receive oral bupropion twice daily on weeks 1-12 and brief practical counseling (i.e., problem-solving strategies, stimulus control, stress management, and social support) on weeks 1-6. * Arm II: Patients receive treatment as in arm I and contingency management (i.e., monetary reinforcement for not smoking) on weeks 1-6. 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.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.Prévention
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.À partir de 18 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Critères
DISEASE CHARACTERISTICS: * Diagnosis of cancer at least 6 months before study entry * No carcinoma in situ of the cervix, basal cell or squamous cell skin cancer, or CNS tumor * Smoking history of at least 2 years * Smoked cigarettes daily for the past 30 days * Completed prior cancer treatment at least 6 months, but no more than 5 years before study entry * Concurrent tamoxifen allowed PATIENT CHARACTERISTICS: Age * 18 and over Performance status * Not specified Life expectancy * Not specified Hematopoietic * Platelet count ≥ 100,000 - 450,000/mm\^3 * WBC ≥ 3,000/mm\^3 Hepatic * AST and ALT ≤ 2 times upper limit of normal * Bilirubin ≤ 2.0 mg/dL Renal * Creatinine \< 2.0 mg/dL Cardiovascular * No unstable cardiovascular disease, including any of the following: * High-grade atrioventricular block * Neurocardiogenic syncope * Unstable angina * Uncompensated congestive heart failure * Poorly controlled hypertension Other * Not pregnant or nursing * Negative pregnancy test * Able to undergo peripheral blood draw * No port-a-cath or Hickman catheters * Planning to reside in the Washington D.C. metro area for at least 1 year after study entry * Willing to undergo urine testing for cotinine levels and breath testing for carbon monoxide monitoring * No significant physical or psychological disability that would preclude study participation * No known allergy to bupropion * Baseline urine drug screen negative * Prescribed pain medication allowed * None of the following predisposing factors that may increase the risk of seizures with bupropion use: * History of seizures * Alcohol use \> 4 oz/day * History of closed head injury * History of an eating disorder * CNS infection * No poorly controlled diabetes PRIOR CONCURRENT THERAPY: Biologic therapy * Not specified Chemotherapy * Not specified Endocrine therapy * See Disease Characteristics Radiotherapy * Not specified Surgery * Not specified Other * At least 2 years since prior alcohol abuse or substance abuse therapy (except for tobacco use or dependence) * More than 14 days since prior monoamine oxidase (MAO) inhibitor * No concurrent MAO inhibitor * No concurrent bupropion (Wellbutrin® or Wellbutrin SR®) * No concurrent alcohol or substance abuse disorder treatment * No concurrent nicotine replacement therapy * No concurrent medications that lower seizure threshold (e.g., theophylline or short-acting benzodiazepines) * No use of tobacco products (more than 1 time per week) other than cigarettes
Centres d'étude
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