Survey on Lymphedema After Sentinel Lymph Node Biopsy in People With Cervical or Vulvar Cancer

Study Overview
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Brief Summary
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The purpose of this study is to collect information that may identify people who are at risk of developing lower extremity lymphedema (LEL) after sentinel lymph node biopsy (SLN) during surgery for early-stage vulvar or cervical cancer, and to improve the quality and accuracy of the information that is given to people who have this procedure. Please note that, during this study, the researchers will collect information from a questionnaire completed by people who had SLN and LND+/- SLN during surgery for early-stage cervical or vulvar cancer. No form of treatment will be provided as part of the study, and no investigational tests or procedures will be performed.

Official Title
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RELEVANT Prevalence of Patient-Reported Lymphedema Following Surgical Management of Cervical or Vulvar Cancer

Conditions
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Cervical Cancer, Vulvar Cancer

Intervention / Treatment
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* Other: Questionnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Presented to MSK with newly diagnosed early-stage cervical cancer of any histologic profile or early stage squamous cell carcinoma of the vulva. °Early stage: Stage 1-2 Underwent primary surgery at our institution between January 2006 and December 2019. Alive at the time of study activation English comprehension Capable of providing informed consent Exclusion Criteria: Had documented macroscopic evidence of metastatic disease at the time of initial diagnosis

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)<br>Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned. | Other: Questionnaires<br>* A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic. The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. The EORTC Quality of Life - Cervical Cancer Module.<br>|
| Standard lymphadenectomy(LND) alone<br>Patients will receive up to two mailings or messages and two phone calls if they do not respond. Self-addressed, stamped envelopes will be provided for return of questionnaires. No other interventions are planned. | Other: Questionnaires<br>* A 13-item questionnaire specific to LEL, developed and validated by investigators at the Mayo Clinic. The EORTC QLQ-C30 is a 30-item questionnaire designed to assess the quality of life of cancer patients. The EORTC Quality of Life - Cervical Cancer Module.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| prevalence of patient-reported lower extremity lymphedema | Prevalence will be measured using the 13-item questionnaire as reported by the patient. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Questionnaire, Sentinel Lymph Node Biopsy, Lymphedema, 22-002