- ICH GCP
- Registro de ensaios clínicos dos EUA
- Ensaio Clínico NCT00236288
A Feasibility Study of Smoking Cessation Program in Radiation Oncology
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Descrição detalhada
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.
Tipo de estudo
Inscrição (Antecipado)
Estágio
- Não aplicável
Contactos e Locais
Locais de estudo
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Indiana
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Indianapolis, Indiana, Estados Unidos, 46202
- Indiana University, Department of Radiation Oncology
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Alocação: Não randomizado
- Modelo Intervencional: Atribuição de grupo único
- Mascaramento: Nenhum (rótulo aberto)
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Prazo |
|---|---|
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To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic.
Prazo: 1 year from enrollment
|
1 year from enrollment
|
Medidas de resultados secundários
Medida de resultado |
Prazo |
|---|---|
|
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.
Prazo: 1 year from enrollment
|
1 year from enrollment
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Anna McDaniel, DNS, RN, FAAN, Department of Environments for Health, Indiana University School of Nursing
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo
Conclusão do estudo (Real)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Estimativa)
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
- Transtornos Mentais, Desordem Mental
- Distúrbios induzidos quimicamente
- Transtornos Relacionados a Substâncias
- Transtorno do Uso de Tabaco
- Efeitos Fisiológicos das Drogas
- Agentes Neurotransmissores
- Mecanismos Moleculares de Ação Farmacológica
- Inibidores Enzimáticos
- Drogas Psicotrópicas
- Inibidores de Captação de Neurotransmissores
- Moduladores de transporte de membrana
- Antidepressivos
- Agentes de Dopamina
- Inibidores da enzima citocromo P-450
- Agentes antidepressivos de segunda geração
- Inibidores do citocromo P-450 CYP2D6
- Inibidores de Captação de Dopamina
- Bupropiona
Outros números de identificação do estudo
- 0508-12
- Walther Cancer Institute, Inc
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