MDACC Study Summary 2005-0126

Study Summary
No. 2005-0126:.......Head And Neck......Ellen R. Gritz......Behavioral Science

Study Summary Title



Study Summary Number:	2005-0126

Study Title:	A Prospective Examination of Smoking Status and Body Image in Surgical Patients with Cancer of the Oral Cavity

Physician

New Patient Referral



Name:	Ellen R. Gritz	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Dept:	Behavioral Science	Referring MD Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

Phone:	713-563-8032 Contact us about clinical trials

General Information



Disease Group:	Head And Neck	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Participants will be evaluated at 3 time points: baseline (prior to surgical treatment), one month and six months following surgery. Follow-up evaluations will occur at the time of postsurgical appointments with the treating physician.

Treatment Agents:	None	Home Care:	N/A

Treatment Loc:	Only at MDACC

Estimated Length of Stay in Houston:	N/A


Description/ Intervention:	The goal of this psychosocial research study is to look at smoking behaviors and the way you feel about your appearance.

Study Objectives / Outcomes

Management of oral cavity cancer often requires surgical resection and has the potential for producing profound disfigurement and dysfunction. Smoking is widely known to be a primary risk factor in the etiology of all head and neck cancers, and continued smoking after cancer diagnosis remains an important factor in treatment outcome. The goal of the proposed study is to prospectively evaluate body image, smoking behaviors, and quality of life outcomes in a sample of individuals undergoing surgical procedures for head and neck cancer of the oral cavity. Findings from this study are essential to developing specially tailored smoking cessation interventions that address body image concerns in cancer patients and ultimately prevent second primary tumors and other adverse health and psychosocial outcomes.

Specific Aims
1. To characterize smoking behaviors and body image in patients with oral cavity cancer prior to and following surgical procedures.
2. To examine the relationship between smoking status and body image in this sample of head and neck cancer patients.
3. To examine the influence of smoking status and body image on quality of life outcomes.

Study Status Information



Study Activation / Registration Date:	12/27/2005

IRB Review and Approval Date:	04/20/2005

Study Type:	Behavioral

Recruitment Status:	Closed

Projected Accrual:	N/A

Enrollment Eligibility

If you do not meet the enrollment eligibility, there may be other treatment options for you. Please Contact the Referral Office for more information.

Inclusion Criteria:

1) 18 years of age or older

2) able to provide written informed consent to participate

3) diagnosis of head and neck malignancy involving an oral cavity site without previous treatment

4) current treatment plan includes surgical intervention

5) English speaking

Exclusion Criteria:

1) previous treatment for malignancy in the head and neck region

2) significant preexisting facial disfigurement from a previous trauma or congenital defect

3) diagnosis of a serious mental illness involving formal thought disorder (e.g., Schizophrenia) documented in medical record.

Links

Registration Number: NCT00412490
Study Information on Clinical Trials Registry (clinicaltrials.gov)