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

Part of paid clinical trials in Boston, Massachusetts.

Sponsor
Massachusetts General Hospital
Study ID
NCT04872738
Status
Completed

Conditions

  • Breast Cancer Related Lymphedema
  • Covid19

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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.

Key Dates

Start date
May 7, 2021
Status verified
Oct 2025
Primary completion
Mar 17, 2023
Completion
Mar 17, 2023

Study Design

Enrollment
714 participants (actual)

Arms

  • Arm: Vaccinated Breast Cancer Patients [mRNA vaccine - Moderna, Pfizer]
    Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson \& Johnson).
  • Arm: Vaccinated Breast Cancer Patients [non-mRNA vaccine - Johnson & Johnson]
    Patients who enroll in the trial and decided to get the COVID-19 vaccine will complete surveys to indicate their experiences, side effects, location of vaccination (i.e. right arm, left arm, or leg). This information will be analyzed in conjunction with their breast cancer treatment history and lymphedema measurements. Participants were separated into two different cohorts for analysis, Cohort 1 being those who received an mRNA vaccine for their primary vaccination series (two doses of Moderna or Pfizer) and Cohort 2 being those who received a non-mRNA vaccination for their primary vaccination series (one dose of Johnson \& Johnson).

Primary Outcome Measure

COVID-19 Vaccination on Contralateral vs Ipsilateral Arm [ Time Frame: This was a survey study of patients with breast surgery for breast cancer. Participants replied to the online survey up to 361.5 months post their breast surgery (median 69.0 months). This was the study's reported timeframe in the published manuscript. ]

Locations (1)

FacilityCityStateZIP
Massachusetts General Hospital Cancer CenterBostonMassachusetts02114

Find similar trials in Boston, MA

By condition
COVID-19 / long COVID
By specialty
Infectious disease
By research site
Massachusetts General Hospital Cancer Center· Boston, MA

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