PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
Primary Purpose
Lymphedema
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cohort I (patients receiving annual lymphedema screening
Cohort II (patients followed intensively for lymphedema)
Sponsored by
About this trial
This is an interventional screening trial for Lymphedema
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inability to complete a self-administered questionnaire
Sites / Locations
- M D Anderson Cancer Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Cohort I (patients receiving annual lymphedema screening)
Cohort II (patients followed intensively for lymphedema)
Arm Description
We 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.
We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening.
Outcomes
Primary Outcome Measures
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
Secondary Outcome Measures
Full Information
NCT ID
NCT05056207
First Posted
September 15, 2021
Last Updated
August 23, 2023
Sponsor
M.D. Anderson Cancer Center
1. Study Identification
Unique Protocol Identification Number
NCT05056207
Brief Title
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
Official Title
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
Study Type
Interventional
2. Study Status
Record Verification Date
August 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
November 17, 2017 (Actual)
Primary Completion Date
November 17, 2023 (Anticipated)
Study Completion Date
November 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
Primary Objectives:
To determine the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer for reducing the cumulative incidence of grade lymphedema among breast cancer patients after ALND compared to routine screening. Secondary Objectives:
To estimate the direct costs associated with the Lymphedema Screening Initiative
To determine the association of the Initiative on patient productivity
To determine patient satisfaction with the Lymphedema Initiative in the context of their cancer care
To determine patient understanding of lymphedema-associated symptoms
To determine patient self-reported compliance with treatments and measures to prevent lymphedema
To determine the incidence of breast cancer-related lymphedema among a cohort of breast cancer patients treated with ALND To analyze clinical and pathological features associated with the development of lymphedema
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphedema
7. Study Design
Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
260 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Cohort I (patients receiving annual lymphedema screening)
Arm Type
Other
Arm Description
We 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.
Arm Title
Cohort II (patients followed intensively for lymphedema)
Arm Type
Other
Arm Description
We will prospectively follow a cohort of 279 patients who have recently undergone ALND in this upcoming year with intensive lymphedema screening.
Intervention Type
Other
Intervention Name(s)
Cohort I (patients receiving annual lymphedema screening
Intervention Description
patientns who previously underwent preoperative perometer lymphedema screening
Intervention Type
Other
Intervention Name(s)
Cohort II (patients followed intensively for lymphedema)
Intervention Description
patients who have recently undergone ALND
Primary Outcome Measure Information:
Title
To establish the effectiveness of prospective, intensive lymphedema screening in the postoperative setting using a perometer.
Time Frame
through study completion, an average of 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
Inability to complete a self-administered questionnaire
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Simona Shaitelman
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
M D Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.mdanderson.org
Description
M D Anderson Cancer Center
Learn more about this trial
PREVENT: PeRomEter Visualization to ENd Treatment-related Lymphedema
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