PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
2 other identifiers
interventional
260
1 country
1
Brief Summary
This research study is to learn about breast cancer patients' opinions about screening for lymphedema (a side effect of breast cancer treatment in which the arm can become heavy, painful, and/or swollen) and their satisfaction with the lymphedema screening program.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Nov 2017
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 17, 2017
CompletedFirst Submitted
Initial submission to the registry
September 15, 2021
CompletedFirst Posted
Study publicly available on registry
September 24, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 17, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 17, 2026
March 5, 2026
March 1, 2026
9 years
September 15, 2021
March 3, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
through study completion, an average of 1 year
Study Arms (2)
Cohort I (patients receiving annual lymphedema screening)
OTHERWe will retrospectively retrieve information on patients who previously underwent preoperative perometer lymphedema screening during the past year who were treated definitively for their breast cancer with an ALND, and for whom no follow-up postoperative lymphedema screening was done.
Cohort II (patients followed intensively for lymphedema)
OTHERWe will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening.
Interventions
patientns who previously underwent preoperative perometer lymphedema screening
patients who have recently undergone ALND
Eligibility Criteria
You may qualify if:
- a Cohort A:
- Breast cancer patients with a baseline (preoperative perometer measurements) who have undergone axillary lymph node dissection
- English speaker
- Patients who participate in Cohort A will be eligible for enrollment in Cohort
- b Cohort I:
- Breast cancer patients who have undergone axillary lymph node dissection who have a clinic visit in the Nellie B. Connally Breast Center approximately 12 months (+/- 4 months) following axillary lymph node dissection
- English speaker
- c Cohort II:
- Breast cancer patients who have undergone axillary lymph node dissection who are having a follow-up visit in the Nellie B. Connally Breast Center within 0-6 months following surgery who intend to continue follow-up care at MD Anderson
- English speaker
You may not qualify if:
- Inability to complete a self-administered questionnaire
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
M D Anderson Cancer Center
Houston, Texas, 77030, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Simona Shaitelman
M.D. Anderson Cancer Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SCREENING
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 15, 2021
First Posted
September 24, 2021
Study Start
November 17, 2017
Primary Completion (Estimated)
November 17, 2026
Study Completion (Estimated)
November 17, 2026
Last Updated
March 5, 2026
Record last verified: 2026-03