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A Feasibility Study of Smoking Cessation Program in Radiation Oncology

29 de octubre de 2007 actualizado por: Indiana University School of Medicine
To test the feasibility of an intensive behavioral and pharmacologic tobacco cessation program for radiation oncology patients and their families/companions.

Descripción general del estudio

Estado

Terminado

Descripción detallada

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 estudio

Intervencionista

Inscripción (Anticipado)

36

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Indiana
      • Indianapolis, Indiana, Estados Unidos, 46202
        • Indiana University, Department of Radiation Oncology

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Asignación: No aleatorizado
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Periodo de tiempo
To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic.
Periodo de tiempo: 1 year from enrollment
1 year from enrollment

Medidas de resultado secundarias

Medida de resultado
Periodo de tiempo
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.
Periodo de tiempo: 1 year from enrollment
1 year from enrollment

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Colaboradores

Investigadores

  • Investigador principal: Anna McDaniel, DNS, RN, FAAN, Department of Environments for Health, Indiana University School of Nursing

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio

1 de octubre de 2005

Finalización del estudio (Actual)

1 de abril de 2007

Fechas de registro del estudio

Enviado por primera vez

7 de octubre de 2005

Primero enviado que cumplió con los criterios de control de calidad

7 de octubre de 2005

Publicado por primera vez (Estimar)

12 de octubre de 2005

Actualizaciones de registros de estudio

Última actualización publicada (Estimar)

31 de octubre de 2007

Última actualización enviada que cumplió con los criterios de control de calidad

29 de octubre de 2007

Última verificación

1 de octubre de 2007

Más información

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

Ensayos clínicos sobre Bupropion and intensive behavioral therapy

3
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