Prospective Measurement of Post-Treatment Lymphedema
The goal of this study is to measure the amount of limb swelling (lymphedema) that sometimes occurs after melanoma treatment, and to find out how people feel and react to the diagnosis and treatment of melanoma.
The primary objective is to estimate the incidence of lymphedema (LE), over time following the surgical treatment of stage I, II, and III cutaneous malignant melanoma.
Beginning at pre-op with follow-up over 30 months, we will examine how changes in LE affect quality of life (QOL) and physical function.
We will conduct pilot testing and validation of the Coping Efficacy with Lymphedema (CEL) questionnaire, the Lymphedema and Melanoma Questionnaire (LEMEQ), and the Lymphedema Interference Questionnaire (LIQ).
|Study Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma|
- Number of incidences of lymphedema following surgical treatment of stage I, II, and III cutaneous malignant melanoma [ Time Frame: 30 Month Period ] [ Designated as safety issue: No ]
|Study Start Date:||May 2006|
|Estimated Primary Completion Date:||May 2014 (Final data collection date for primary outcome measure)|
Questionnaires relating to symptoms experienced during and following standard cancer treatment.
Other Name: Survey
If you choose to take part in this study, you will have measurements taken of your arms or legs using a Perometer and a bioimpedance machine. The Perometer is a machine that painlessly measures the fluid in your limb using two-directional infrared lights. These lights are located in the frame of the machine that encircles the arm or leg during the measurement. The bioimpedance is a machine that measures the fluid in your arm or leg by passing a very small current through the body similar to an electrocardiogram (EKG). These very small currents are located in electrodes that are placed on the hands and feet during the measurement. Both machines are able to pick up changes in limb size.
You will also be asked to complete a set of questionnaires relating to any symptoms that you may experience in your limbs and/or trunk (chest, stomach, and hip areas) during and following your standard cancer treatment.
Additional questionnaires, along with your limb measurements, will be done at your regularly-scheduled follow-up clinic visits, 3-6 months, 9-12 months, 15-18 months, 21-24 months and 27- 30 months. You will complete the additional questionnaires using a laptop computer or a hardcopy. The measurements and questionnaires will take 45-60 minutes to complete each time.
This is an investigational study. About 250 patients will take part in this study. All patients will be enrolled at MD Anderson.
|United States, Texas|
|UT MD Anderson Cancer Center|
|Houston, Texas, United States, 77030|
|Principal Investigator:||Janice N. Cormier, MD||M.D. Anderson Cancer Center|