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

NCT ID: NCT04929964

Last Updated: 2021-08-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 87 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-01-01
• Study Completion Date: 2021-01-31

Brief Summary

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

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.

Conditions

Covid19; Breast Cancer Stage; Isolation, Social; Locally Advanced Breast Cancer

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: OTHER

Study Groups

Breast cancer

MRM , Toilet Mastectomy , BCS

Intervention Type: PROCEDURE

MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery

Interventions

MRM , Toilet Mastectomy , BCS

MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• diagnosis of breast cancer confirmed on histo-pathological examination

Exclusion Criteria

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

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 71 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mehwish Mooghal , MBBS

OTHER

Sponsor Role: lead

Responsible Party

Mehwish Mooghal , MBBS

Resident Surgery at PNS Shifa Hospital Karachi

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Waseem Ahmad Khan, MBBS, FCPS

Role: STUDY_CHAIR

PNS Shifa Hospital Karachi , HOD department of Surgery

Locations

Bahria University Medical and Dental College Karachi

Karachi, Sindh, Pakistan

Countries

Pakistan

References

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.

Reference Type: BACKGROUND

PMID: 30774437 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 25640384 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 32460829 (View on PubMed)

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.

Reference Type: RESULT

PMID: 32715776 (View on PubMed)

Other Identifiers

COV-19 BUMDC

Identifier Type: -

Identifier Source: org_study_id