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NCT04872738 · ClinicalTrials.gov registry record
Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
A clinical trial, sponsored by Massachusetts General Hospital.
- Completed
- Registry status
- 714
- Enrollment target
NCT04872738: Completed study, sponsored by Massachusetts General Hospital.
NCT04872738 is a clinical trial that has completed, run by Massachusetts General Hospital. The registered enrollment target is 714 participants. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04872738 has completed, sponsored by Massachusetts General Hospital.
- COMPLETED
- Registry status
- 714 participants
- Enrollment target
Study Summary
This study aims to elicit patient experiences, choices, and side effects associated with the COVID-19 vaccine after breast cancer surgery. Lymph node swelling is a known and common side effect of both the Moderna and Pfizer COVID-19 vaccines. This is the body's normal reaction to the vaccine. It is worrisome that lymph node swelling after the vaccine mimics that found in breast cancer which has spread to the lymph nodes. This side effect will cause worry and anxiety amongst patients as a result. For patients who have had lymph node removal (axillary lymph node dissection or sentinel lymph node biopsy) and are at risk of lymphedema, the investigators are concerned that the lymph node swelling may tax the lymphatic system and incite lymphedema in those at risk or worsen it in those with BCRL. Fear of lymphedema is high in this population and the investigators need to better understand what risk, if any, lymph node swelling after the COVID-19 vaccine imparts to BCRL risk.
Primary Outcome
The investigators expect 90% of participants to receive the COVID-19 vaccine on their contralateral (unaffected) arm. This outcome measure is looking at the number of participants who received the COVID-19 vaccine on the side of breast cancer treatment vs those who received the vaccine on the opposite side of breast cancer treatment. Patients with bilateral cancer were excluded from this analysis due to the nature of breast cancer laterality categorization.
Interventions
- OTHER Survey
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 714 participants |
| Start Date | 2021-05-07 |
| Est. Completion | 2023-03-17 |
What the finished NCT04872738 record still lists
NCT04872738 is an observational study that tracks outcomes without assigning an intervention. The registered 714 participants enrollment target is mid-sized for trials with a published cap.
The record links to 0 conditions, and to 1 intervention - of which Survey is the first listed.
NCT04872738 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04872738 about?
NCT04872738 is a clinical study titled "Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment". This study aims to elicit patient experiences, choices, and side effects associated with the COVID-19 vaccine after breast cancer surgery. Lymph node swelling is a known and common side effect of both the Moderna and Pfizer COVID-19 vaccines. This is the body's normal reaction to the vaccine. It is ...
What is the current status of trial NCT04872738?
This trial is currently completed. The enrollment target is 714 participants. The study started on 2021-05-07. Estimated completion is 2023-03-17.
What interventions are being tested in trial NCT04872738?
The interventions under investigation include: Survey (OTHER).
Who is sponsoring clinical trial NCT04872738?
This trial is sponsored by Massachusetts General Hospital, which has 2,032 total clinical trials registered on ClinicalTrials.gov.
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