Bupropion and intensive behavioral therapy i Cancer and Tobacco Abuse - Kliniske forsøgsregister

Studieoversigt

Status

Afsluttet

Betingelser

Cancer and Tobacco Abuse

Intervention / Behandling

Medicin: Bupropion and intensive behavioral therapy

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Forventet)

36

Fase

Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

Forenede Stater
- Indiana
  - Indianapolis, Indiana, Forenede Stater, 46202
    - Indiana University, Department of Radiation Oncology

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Tildeling: Ikke-randomiseret
Interventionel model: Enkelt gruppeopgave
Maskning: Ingen (Åben etiket)

Hvad måler undersøgelsen?

Primære resultatmål

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

Sekundære resultatmål

Resultatmål	Tidsramme
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. Tidsramme: 1 year from enrollment	1 year from enrollment

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Indiana University School of Medicine

Samarbejdspartnere

Walther Cancer Institute

Efterforskere

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

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. oktober 2005

Studieafslutning (Faktiske)

1. april 2007

Datoer for studieregistrering

Først indsendt

7. oktober 2005

Først indsendt, der opfyldte QC-kriterier