MDACC Study Summary 2003-0652

Study Summary
No. 2003-0652:.......Melanoma......Janice N. Cormier......Surgical Oncology

Study Summary Title



Study Summary Number:	2003-0652

Study Title:	MEASURING QUALITY OF LIFE (QOL) IN PATIENTS WITH MELANOMA: DEVELOPMENT AND VALIDATION OF A DISEASE-SPECIFIC MODULE FOR THE FUNCTIONAL ASSESSMENT OF CANCER THERAPY (FACT-G)

Physician

New Patient Referral



Name:	Janice N. Cormier	Patients Call:	800-392-1611 (in U.S.A.) 713-792-6161 (outside U.S.A.)

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

Phone:	713-792-6949 Contact us about clinical trials

General Information



Disease Group:	Melanoma	Supported By:	N/A

Phase of Study:	N/A	Return Visit:	Patients will complete administrations of the questionnaires via telephone or personal (face-to-face) interviews 1 week after enrollment, and approximately 3, 6, and 12 months after enrollment.

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 research study is to develop and validate a quality of life (QOL) questionnaire for melanoma patients for future use in clinical studies. Researchers eventually want to use the melanoma QOL questionnaire to evaluate the QOL of patients with moderate to severe lymphedema which is a symptom that some melanoma patients experience.

Study Objectives / Outcomes

1. Primary Objective:
The primary objective of the study is to develop and validate a melanoma specific quality of life (QOL) instrument for future use in clinical trials.

2. Secondary Objectives:
2.1 Examine the criterion validity of the melanoma subscale in a subset of patients with stage III disease. Our a priori hypothesis is that patients with moderate to severe lymphedema will have poorer QOL scores than patients of similar disease stage without lymphedema.

2.2 Prospectively collect utilities for melanoma related health states to be used in decision analytic models related to treatment.

Study Status Information



Study Activation / Registration Date:	09/29/2003

IRB Review and Approval Date:	09/17/2003

Study Type:	Not Applicable

Recruitment Status:	Closed

Projected Accrual:	300 over 9 months

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) Patients with a confirmed diagnosis of melanoma (M.D.Anderson pathology) within the past 3 years, who present for appointments to the University of Texas M.D. Anderson Melanoma Skin Center will be recruited for participation.

2) Patients with all stages of melanoma, American Joint Commission on Cancer (AJCC) stages I, II, III, IV (6th edition, 2002) who may currently be receiving or have previously received treatment for melanoma.

3) Patients who can knowledgeably and voluntarily provide an informed consent to participate. The informed consent will be signed, dated and witnessed.

4) Fluent in English.

5) At least 18 years of age.

6) Eastern Cooperative Oncology Group Performance Status Rating (ECOG-PSR) < 3 at the time of recruitment. (Appendix A).

Exclusion Criteria:

1) Patients who are unable to consent due to other medical illnesses or disorientation to person, place or time.

Links

Registration Number: Not Registered