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

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT05255393

Collaborator

(none)

1,026

Enrollment

Location

11.5

Anticipated Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Cervical Cancer Vulvar Cancer	Other: Questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

1026 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Feb 15, 2022

Anticipated Primary Completion Date :

Feb 1, 2023

Anticipated Study Completion Date :

Feb 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN) 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 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.
Standard lymphadenectomy(LND) alone 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 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.

Arm

Intervention/Treatment

Standard lymphadenectomy(LND) with sentinel lymph node mapping (SLN)

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

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.

Standard lymphadenectomy(LND) alone

Other: Questionnaires

Outcome Measures

Primary Outcome Measures

prevalence of patient-reported lower extremity lymphedema [1 year]
Prevalence will be measured using the 13-item questionnaire as reported by the patient.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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