Patient Experiences With the COVID-19 Vaccination After Breast Cancer Treatment
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 714
- 试验地点
- 1
- 主要终点
- COVID-19 Vaccination on Contralateral vs Ipsilateral Arm
研究概览
简要总结
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.
详细描述
- 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
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients who are
- •≥18 years of age and have a
- •History of breast cancer For the MGH site, patients must have
- •Received some breast cancer treatment at MGH or its affiliates
- •Received perometry measurements to measure arm volume at MGH
排除标准
- 未提供
研究组 & 干预措施
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).
干预措施: Survey (Other)
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).
干预措施: Survey (Other)
结局指标
主要结局
COVID-19 Vaccination on Contralateral vs Ipsilateral Arm
时间窗: 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.
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.
Lymph Node (LN) Swelling After COVID-19 Vaccine
时间窗: 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.
The investigators expect 10-15% of participants to experience lymph node swelling after receiving the Pfizer or Moderna vaccines. The outcome measure analyzes the number of participants who experienced LN swelling after receiving each dose of their COVID-19 vaccines. The analysis looked at what location on the body lymph node swelling occurred (axilla vs supraclavicular region), which side of the body this swelling occurred in relation to the side of the body that received the vaccine (ipsilateral vs contralateral), and which side of the body this swelling occurred in relation to the side of the body the patient has/had breast cancer (ipsilateral vs contralateral). Patients with bilateral cancer were excluded from the analysis of LN swelling in relation to both the vaccine and breast cancer laterality due to the nature of BC laterality categorization. Analysis on breast cancer laterality and LN swelling was not conducted for the non-mRNA vaccine (Johnson \& Johnson) group.
Duration of Lymph Node Swelling as a Side Effect of mRNA and Non-mRNA Vaccines
时间窗: 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.
The outcome measure will be analyzing the reported duration of lymph node swelling, categorized by the location at which lymph node swelling occurred (the axilla vs supraclavicular region) and which side of the body this swelling occurred in relation to the side of the body that received the vaccine injection (ipsilateral vs contralateral). The main aim of this paper was to report the side effects of the mRNA COVID-19 vaccines in patients treated for breast cancer.
Reported Side Effects of the mRNA and Non-mRNA Vaccines
时间窗: 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.
Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations \[Moderna, Pfizer\]. A separate analysis is presented on results from participants who received the Johnson \& Johnson (J\&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine.
Duration of Side Effects of mRNA and Non-mRNA Vaccines
时间窗: 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.
Due to the inherent activity of mRNA vaccines and the immune system, as well as the role of the lymph nodes in breast cancer (BC) and in breast cancer-related lymphedema (BCRL), this study analyzed the side effect profile in patients treated for BC and who received up to three doses of the COVID-19 vaccinations \[Moderna, Pfizer\]. A separate analysis is presented on results from participants who received the Johnson \& Johnson (J\&J) vaccine as lymph node swelling is not a listed side effect of this non-mRNA vaccine and only a small proportion of the population received this vaccine. This outcome analyzes the duration of side effects associated with each dose of the vaccine.
次要结局
未报告次要终点
研究者
Alphonse Taghian
Director, Lymphedema Research Program
Massachusetts General Hospital