Bupropion and intensive behavioral therapy w Cancer and Tobacco Abuse - Rejestr badań klinicznych

Przegląd badań

Status

Zakończony

Warunki

Cancer and Tobacco Abuse

Interwencja / Leczenie

Lek: Bupropion and intensive behavioral therapy

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Oczekiwany)

36

Faza

Nie dotyczy

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Lokalizacje studiów

Stany Zjednoczone
- Indiana
  - Indianapolis, Indiana, Stany Zjednoczone, 46202
    - Indiana University, Department of Radiation Oncology

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

18 lat i starsze (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

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 studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

Przydział: Nielosowe
Model interwencyjny: Zadanie dla jednej grupy
Maskowanie: Brak (otwarta etykieta)

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku	Ramy czasowe
To test the feasibility of using the medication bupropion and behavioral therapy to help people stop smoking in the radiation oncology clinic. Ramy czasowe: 1 year from enrollment	1 year from enrollment

Miary wyników drugorzędnych

Miara wyniku	Ramy czasowe
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. Ramy czasowe: 1 year from enrollment	1 year from enrollment

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Indiana University School of Medicine

Współpracownicy

Walther Cancer Institute

Śledczy

Główny śledczy: Anna McDaniel, DNS, RN, FAAN, Department of Environments for Health, Indiana University School of Nursing

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów

1 października 2005

Ukończenie studiów (Rzeczywisty)

1 kwietnia 2007

Daty rejestracji na studia

Pierwszy przesłany

7 października 2005

Pierwszy przesłany, który spełnia kryteria kontroli jakości