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Trial record 7 of 75 for:    Recruiting, Not yet recruiting, Available Studies | "Lymphedema"

A Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management

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ClinicalTrials.gov Identifier: NCT03248310
Recruitment Status : Recruiting
First Posted : August 14, 2017
Last Update Posted : March 16, 2018
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Brief Summary:
This study is being done to see the long-term results for patients who choose to have surgery for lymphedema (with the vascularized lymph node transfer), compared to patients who choose not to have surgery.

Condition or disease Intervention/treatment
Lymphedema Behavioral: Quality of Life Assessments

Study Type : Observational
Estimated Enrollment : 300 participants
Observational Model: Case-Control
Time Perspective: Prospective
Official Title: A Prospective Study Comparing Quality of Life in Patients With Lymphedema Who Undergo Surgical Treatment Versus Non-Surgical Management
Actual Study Start Date : August 9, 2017
Estimated Primary Completion Date : August 2022
Estimated Study Completion Date : August 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Lymphedema
U.S. FDA Resources

Group/Cohort Intervention/treatment
vascularized lymph node transfer (VLNT)
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Behavioral: Quality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.
non-surgical treatment
This is an observational study to assess QOL in patients who have elected to undergo or considered undergoing VLNT. There is no therapeutic intervention involved during the follow-up study period.
Behavioral: Quality of Life Assessments
Upper Limb Lymphedema (ULL-27), Lymphedema Life Impact Scale, version 2 (LLISv2), LYMQOL-Leg.



Primary Outcome Measures :
  1. Quality of Life [ Time Frame: up to 40 months ]
    Questionnaire to assess quality of life changes



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients who present for consultation of their lymphedema and who meet eligibility criteria will be offered the option of enrolling in this study at the time of their initial consultation.
Criteria

Inclusion Criteria:

  • Patients aged 18-80 years
  • Secondary lymphedema of the upper or lower extremity
  • International Society of Lymphology (ISL) Stage 1 or 2 lymphedema
  • BMI <30
  • Proficiency in English language

Exclusion Criteria:

  • Patients with clotting disorders, venous insufficiency, end-stage lymphedema
  • Additionally, if the patient refuses to complete questionnaires, the patient will be excluded from the study and replaced at the discretion of the principal or co-principal investigator.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03248310


Contacts
Contact: Joseph Dayan, MD 212-639-8095 dayanj@mskcc.org
Contact: Andrea Barrio, MD 646-888-5118

Locations
United States, New York
Memorial Sloan Kettering Westchester Recruiting
Harrison, New York, United States, 10604
Contact: Joseph Dayan, MD    212-639-8095      
Contact: Andrea Barrio, MD    646-888-5118      
Principal Investigator: Joseph Dayan, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Joseph Dayan, MD    212-639-8095      
Contact: Andrea Barrio, MD    646-888-5118      
Principal Investigator: Joseph Dayan, MD         
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Investigators
Principal Investigator: Joseph Dayan, MD Memorial Sloan Kettering Cancer Center

Additional Information:
Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT03248310     History of Changes
Other Study ID Numbers: 17-377
First Posted: August 14, 2017    Key Record Dates
Last Update Posted: March 16, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Memorial Sloan Kettering Cancer Center:
Quality of Life (QoL)
17-377

Additional relevant MeSH terms:
Lymphedema
Lymphatic Diseases