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Sponsored by: |
M.D. Anderson Cancer Center |
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Information provided by: | M.D. Anderson Cancer Center |
ClinicalTrials.gov Identifier: | NCT00495950 |
Primary Objective:
Secondary Objectives:
Condition | Intervention |
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Melanoma |
Behavioral: Questionnaire |
Study Type: | Observational |
Study Design: | Case-Only, Prospective |
Official Title: | Prospective Measurement of Post-Treatment Lymphedema in Patients With Melanoma |
Estimated Enrollment: | 250 |
Study Start Date: | May 2006 |
Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
Groups/Cohorts | Assigned Interventions |
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1
Questionnaire
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Behavioral: Questionnaire
Questionnaires relating to symptoms experienced during and following standard cancer treatment.
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If you choose to take part in this study, you will have measurements taken of your arms or legs using a Perimeter and a bioimpedance machine. The Perimeter 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, every 3-6 months for 30 months (up to 6 total visits). You will complete the additional questionnaires using a laptop computer. 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 M. D. Anderson.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
Study participants with a confirmed diagnosis (M.D. Anderson pathology) of invasive cutaneous melanoma (stages I-III).
Inclusion Criteria:
Exclusion Criteria:
Contact: Janice N. Cormier, MD | 713-792-9640 |
United States, Texas | |
U.T.M.D. Anderson Cancer Center | Recruiting |
Houston, Texas, United States, 77030 | |
Principal Investigator: Janice N. Cormier, MD |
Principal Investigator: | Janice N. Cormier, MD | U.T.M.D. Anderson Cancer Center |
Responsible Party: | U.T.M.D. Anderson Cancer Center ( Janice N. Cormier, MD/Associate Professor ) |
Study ID Numbers: | 2004-0787 |
Study First Received: | July 2, 2007 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00495950 |
Health Authority: | United States: Institutional Review Board |
Melanoma Lymphedema Limb Swelling Questionnaire |
Quality of Life Physical Function Survey |
Lymphedema Neuroectodermal Tumors Lymphatic Diseases Nevus, Pigmented Neoplasms, Germ Cell and Embryonal Neuroepithelioma |
Quality of Life Edema Nevus Neuroendocrine Tumors Melanoma |
Neoplasms Neoplasms by Histologic Type Neoplasms, Nerve Tissue Nevi and Melanomas |