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出境医 / 临床实验 / COVID-19 Pandemic: Effect on Management of Patients With Breast Cancer (COVID-19)

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

Study Description
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

Condition or disease Intervention/treatment
Covid19 Breast Cancer Stage Isolation, Social Locally Advanced Breast Cancer 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 Design
Layout table for study information
Study Type : Observational [Patient Registry]
Actual Enrollment : 87 participants
Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration: 18 Months
Official Title: COVID 19 Pandemic: Effect on Management of Patients With Breast Cancer; Single Center Study
Actual Study Start Date : January 1, 2020
Actual Primary Completion Date : January 31, 2021
Actual Study Completion Date : January 31, 2021
Arms 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

Outcome Measures
Primary Outcome Measures :
  1. Duration of delay in presentation to hospital [ Time Frame: 18 months ]
    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

  2. Duration of delay in definitive treatment [ Time Frame: 18 months ]
    It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)

  3. Cancer upstaging [ Time Frame: 18 months ]
    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 .


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   25 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast cancer incidence is more in females as compare to male population
Accepts Healthy Volunteers:   No
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.

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)
Contacts and Locations

Locations
Layout table for location information
Pakistan
Bahria University Medical and Dental College Karachi
Karachi, Sindh, Pakistan, 74800
Sponsors and Collaborators
Mehwish Mooghal , MBBS
Investigators
Layout table for investigator information
Study Chair: Waseem Ahmad Khan, MBBS, FCPS PNS Shifa Hospital Karachi , HOD department of Surgery
Tracking Information
First Submitted Date June 13, 2021
First Posted Date June 18, 2021
Last Update Posted Date August 11, 2021
Actual Study Start Date January 1, 2020
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: August 4, 2021)
  • Duration of delay in presentation to hospital [ Time Frame: 18 months ]
    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
  • Duration of delay in definitive treatment [ Time Frame: 18 months ]
    It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)
  • Cancer upstaging [ Time Frame: 18 months ]
    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 .
Original Primary Outcome Measures
 (submitted: June 16, 2021)
  • Duration of delay in presentation to hospital [ Time Frame: 13 months ]
    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
  • Duration of delay in definitive treatment [ Time Frame: 13 months ]
    It was counted from the day of first presentation to hospital till the day of initiation of definitive treatment (chemo/surgery)
  • Cancer upstaging [ Time Frame: 13 months ]
    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 .
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title COVID-19 Pandemic: Effect on Management of Patients With Breast Cancer
Official Title COVID 19 Pandemic: Effect on Management of Patients With Breast Cancer; Single Center Study
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.

Study Type Observational [Patient Registry]
Study Design Observational Model: Case-Only
Time Perspective: Other
Target Follow-Up Duration 18 Months
Biospecimen Not Provided
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.

Condition
  • Covid19
  • Breast Cancer Stage
  • Isolation, Social
  • Locally Advanced Breast Cancer
Intervention Procedure: MRM , Toilet Mastectomy , BCS
MRM , modified radical mastectomy : removing breast and axilla toilet mastectomy : palliative removal of tumor load BCS ,Breast conservative surgery
Study Groups/Cohorts Breast cancer
Intervention: Procedure: MRM , Toilet Mastectomy , BCS
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.
  • 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. Review.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 4, 2021)
87
Original Actual Enrollment
 (submitted: June 16, 2021)
29
Actual Study Completion Date January 31, 2021
Actual Primary Completion Date January 31, 2021   (Final data collection date for primary outcome measure)
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)
Sex/Gender
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast cancer incidence is more in females as compare to male population
Ages 25 Years to 71 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Pakistan
Removed Location Countries  
 
Administrative Information
NCT Number NCT04929964
Other Study ID Numbers COV-19 BUMDC
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: impact of present covid 19 pandemic on presentation of breast cancer stage and disease upstaging status if patients are covid positive
Supporting Materials: Study Protocol
Supporting Materials: Statistical Analysis Plan (SAP)
Responsible Party Mehwish Mooghal , MBBS, Bahria University
Study Sponsor Mehwish Mooghal , MBBS
Collaborators Not Provided
Investigators
Study Chair: Waseem Ahmad Khan, MBBS, FCPS PNS Shifa Hospital Karachi , HOD department of Surgery
PRS Account Bahria University
Verification Date June 2021