- ICH GCP
- US Clinical Trials Registry
- Klinisk forsøg NCT00412490
Smoking Status and Body Image in Oral Cancer Patients
A Prospective Examination of Smoking Status and Body Image in Surgical Patients With Cancer of the Oral Cavity
Primary Objectives:
- To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
- To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
- To examine the influence of smoking status and body image on quality of life outcomes.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
If you agree to take part in this study, researchers will first perform a test to check the level of carbon monoxide (CO) in your blood. To do this test, you will be asked to blow into a cardboard tube attached to a machine. You will then be asked to fill out some questionnaires and complete a one-on-one interview. All of these things combined will take about an hour to complete. You will be asked basic questions such as your age, education level, and smoking history. You will also be asked questions about your mood, quality of life, and how you feel about your appearance.
If you do not have surgery, your participation in this study will end after this visit. If you have surgery, you will be asked to come back for 2 more study visits, 1 month and 6 months after your surgery. During these evaluations, you will be asked once again to blow into the cardboard tube, fill out questionnaires, and a complete a one-on-one interview. Each visit will last about an hour. You will again be asked questions about your smoking behaviors, mood, quality of life, and how you feel about your appearance. Your participation in this study will be finished after the 6-month evaluation.
This is an investigational study. About 75 people will take part in this research study. All will be enrolled at M. D. Anderson.
Undersøgelsestype
Tilmelding (Faktiske)
Kontakter og lokationer
Studiesteder
-
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Texas
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Houston, Texas, Forenede Stater, 77030
- University of Texas MD Anderson Cancer Center
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Prøveudtagningsmetode
Studiebefolkning
Beskrivelse
Inclusion Criteria:
- 18 years of age or older
- Able to provide written informed consent to participate
- Diagnosis of head and neck malignancy involving an oral cavity site without previous treatment
- Current treatment plan includes surgical intervention
- English speaking
Exclusion Criteria:
- Previous treatment for malignancy in the head and neck region
- Significant preexisting facial disfigurement from a previous trauma or congenital defect
- Diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
Kohorter og interventioner
Gruppe / kohorte |
Intervention / Behandling |
---|---|
Smoking Behavior Group
Individuals Having Surgery for Oral Cavity Cancer.
|
Written survey at 1 Month & 6 Months post surgery.
One-on-One meeting lasting about one hour, at 1 Month & 6 Months post surgery.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
---|---|---|
Primary analysis involve multiple linear regression of body image on gender, age and ethnicity while adjusting for disease and treatment related factors.
Tidsramme: Baseline, 1 Month and 6 Months Post Surgery
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Preliminary analyses involve two-sample t-tests of difference in body image between male and female, one-way ANOVA to compare body image across ethnicity groups, and calculation of Pearson product moment correlation coefficients between body image and age.
|
Baseline, 1 Month and 6 Months Post Surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Ledende efterforsker: Ellen R. Gritz, PhD, M.D. Anderson Cancer Center
Publikationer og nyttige links
Hjælpsomme links
Datoer for undersøgelser
Studer store datoer
Studiestart
Primær færdiggørelse (Faktiske)
Studieafslutning (Faktiske)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Skøn)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Skøn)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- 2005-0126
- 5R25CA057730-11 (U.S. NIH-bevilling/kontrakt)
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Kliniske forsøg med Mundhulekræft
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Danish Head and Neck Cancer GroupAfsluttetHNSCC, Larynx, Pharynx og Oral CavityDanmark
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