COVID-19 Pandemic: Effect on Management of Patients With Breast Cancer (COVID-19)

COVID 19 Pandemic: Effect on Management of Patients With Breast Cancer; Single Center Study

The objective was to find out the impact of COVID-19 on stage of breast cancer at presentation and its effects on overall onco-surgical management. The investigator carried out this research to see the presenting stage of breast cancer in the participants in this pandemic and correlate its effect on stage of breast cancer and upstaging of disease

Study Overview

• Status: Completed
• Conditions: Covid19; Locally Advanced Breast Cancer; Breast Cancer Stage; Isolation, Social
• Intervention / Treatment: Procedure: MRM , Toilet Mastectomy , BCS

Detailed Description

This retrospective observational study was conducted at department of surgery PNS Shifa hospital Karachi after obtaining permission from ethical review committee. Participant's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021 was retrieved. Out of these only those participants were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Participants who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records. Participant presentation time was calculated as the time interval between the appearance of the first symptoms of breast cancer (day 0) and the date of initial presentation to hospital by patient and consultation for breast symptoms. Time taken for start of treatment was calculated by counting number of days from the first presentation day to hospital until the date when definitive treatment for Carcinoma Breast was initiated (chemo/radio/surgery). Time duration for definitive surgery was counted from the day of first presentation to the hospital till the date surgery was conducted(modified radical mastectomy (MRM)/breast conserving surgery (BCS)/toilet mastectomy).

Presentation 'Delay' was defined as a patient reporting to the hospital for medical advice 30 days after noticing the first possible symptoms of breast cancer while time taken for start of treatment was calculated form time of first presentation to hospital (day 0) till the first day of start of definitive first treatment for breast cancer. The investigator labelled delay in treatment if it was initiated later than 62days .

The questionnaire inquired about the symptoms, date of presentation of the first symptoms, date of first reporting to hospital, reasons for the delayed presentation.

All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol. If the patient turned out COVID positive, their symptoms were noted and the COVID team (infectious disease department) was notified. The quarantine protocol at investigating hospital was, complete isolation for 14 days with one PCR-negative report after completing quarantine, with no residual respiratory symptoms of cough, fever, and shortness of breath. This protocol was followed for all elective breast surgery patients admitted in the hospital. All COVID-positive patients underwent the same treatment protocol as non-COVID patients with regards to management of breast cancer. Patients with early breast cancer (upto stage 2A) underwent modified radical mastectomy/breast conservative surgery first, followed by chemotherapy/radiotherapy, locally advanced cases (stage 2B and above) had neo-adjuvant treatment first followed by surgery, and advanced cases(stage 4/metastatic) underwent palliative treatment.

All the data obtained were analyzed using IBM SPSS 23.0. Descriptive statistics like age were presented as range and means. Categorical data were analyzed using fisher exact test and t-test was applied to numerical data. In all cases, a 95% confidence interval was used and p value <0.05 was considered significant.

• Study Type: Observational
• Enrollment (Actual): 87

Contacts and Locations

Study Locations

• Pakistan
  • Sindh
    • Karachi, Sindh, Pakistan, 74800
      • Bahria University Medical and Dental College Karachi

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 71 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

Patient's data of all operated cases for suspicious lump breast (abnormal findings on ultrasound and mammogram, BIRAD III or above and abnormal FNAC results;C3 or above) from January1,2020 to 31 January 2021was retrieved. Out of these only those patients were included in whom the diagnosis of breast cancer was confirmed on histo-pathological examination. Patients who had already had their surgery pre covid (December 2019), were excluded. Data were collected on standard pre-designed questionnaire and from paper documents retrieved from patient records.

All patients who were admitted and underwent pre anesthesia assessment underwent COVID testing according to the protocol.

Description

Inclusion Criteria:

• diagnosis of breast cancer confirmed on histo-pathological examination

Exclusion Criteria:

• Patients who had already had their surgery pre covid (December 2019)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Breast cancer	Procedure: MRM , Toilet Mastectomy , BCS; MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Duration of delay in presentation to hospital	It was time counted from the day when the participant first felt breast symptom on self assessment or during diagnostic workup and than presented for the first time to hospital for diagnostic or treatment workup purpose	18 months
Duration of delay in definitive treatment	It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)	18 months
Cancer upstaging	It was assessed by reassessing the patient by comparison of disease stage on first time diagnostic workup results and than reassessing the stage of cancer during consecutive visits to hospital , and the effect of delay in treatment and presentation on cancer upstaging of participants related to covid 19 pandemic is evaluated .	18 months

Collaborators and Investigators

• Sponsor: Mehwish Mooghal , MBBS
• Investigators: Study Chair: Waseem Ahmad Khan, MBBS, FCPS, PNS Shifa Hospital Karachi , HOD department of Surgery

Publications and helpful links

General Publications

• Gulzar F, Akhtar MS, Sadiq R, Bashir S, Jamil S, Baig SM. Identifying the reasons for delayed presentation of Pakistani breast cancer patients at a tertiary care hospital. Cancer Manag Res. 2019 Jan 29;11:1087-1096. doi: 10.2147/CMAR.S180388. eCollection 2019.
• Khan MA, Shafique S, Khan MT, Shahzad MF, Iqbal S. Presentation delay in breast cancer patients, identifying the barriers in North Pakistan. Asian Pac J Cancer Prev. 2015;16(1):377-80. doi: 10.7314/apjcp.2015.16.1.377.
• Vuagnat P, Frelaut M, Ramtohul T, Basse C, Diakite S, Noret A, Bellesoeur A, Servois V, Hequet D, Laas E, Kirova Y, Cabel L, Pierga JY; Institut Curie Breast Cancer and COVID Group; Bozec L, Paoletti X, Cottu P, Bidard FC. COVID-19 in breast cancer patients: a cohort at the Institut Curie hospitals in the Paris area. Breast Cancer Res. 2020 May 28;22(1):55. doi: 10.1186/s13058-020-01293-8.
• Elghazawy H, Bakkach J, Zaghloul MS, Abusanad A, Hussein MM, Alorabi M, Eldin NB, Helal T, Zaghloul TM, Venkatesulu BP, Elghazaly H, Al-Sukhun S. Implementation of breast cancer continuum of care in low- and middle-income countries during the COVID-19 pandemic. Future Oncol. 2020 Nov;16(31):2551-2567. doi: 10.2217/fon-2020-0574. Epub 2020 Jul 27.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2020
• Primary Completion (Actual): January 31, 2021
• Study Completion (Actual): January 31, 2021

Study Registration Dates

• First Submitted: June 13, 2021
• First Submitted That Met QC Criteria: June 16, 2021
• First Posted (Actual): June 18, 2021

Study Record Updates

• Last Update Posted (Actual): August 11, 2021
• Last Update Submitted That Met QC Criteria: August 4, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: Breast Cancer; Covid-19; Modified Radical Mastectomy; Breast Conservation Surgery
• Additional Relevant MeSH Terms: Skin Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Neoplasms; Pneumonia, Viral; Pneumonia; Lung Diseases; Neoplasms by Site; Breast Diseases; COVID-19; Breast Neoplasms
• Other Study ID Numbers: COV-19 BUMDC

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: impact of present covid 19 pandemic on presentation of breast cancer stage and disease upstaging status if patients are covid positive
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No