NCT04872738

Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 714 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

* Hypothesis 1: Patients will choose to receive the vaccine on the arm contralateral to axillary lymph node removal, or in the lower extremity if they have had bilateral axillary lymph node removal * Hypothesis 2: Patients with a history of breast cancer will experience axillary lymph node swelling after receiving the COVID-19 vaccine at the same rate as the general population * Hypothesis 3: Patients with axillary surgery who develop lymph nodes swelling in the ipsilateral side might be at increased risk of developing lymphedema

Conditions

• Breast Cancer Related Lymphedema
• Covid19

Interventions

Type	Name	Description
OTHER	Survey	Patients in all groups will complete surveys about their experience with the vaccination and any side effects they may have experienced.

Timeline

• Start date: 2021-05-07
• Primary completion: 2023-03-17
• Completion: 2023-03-17
• First posted: 2021-05-04
• Last updated: 2026-01-06
• Results posted: 2026-01-06

Locations

1 site across 1 country: United States