Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: C509- Malignant neoplasm of breast of unspecified site
Conditions
Interventions
None listed
Sponsors
None listed
Eligibility
Inclusion criteria
Inclusion criteria: INCLUSION CRITERIA COVID Case Cohort 1. Histologically confirmed breast cancer 2. Age more than 18years, female or male 3. Registered at TMC during the COVID-19 Mumbai lockdown starting from 25th March 2020 Or Registered in TMC after 1st May 2019 and still receiving or expected to be receiving active treatment (except oral hormone therapy) during the lockdown in Mumbai INCLUSION CRITERIA Control Cohort: 1. Histologically confirmed primary breast cancer 2. Age more than 18years, female or male 3. Registered at TMC during the period 1st February to 30th April 2019
Exclusion criteria
Exclusion criteria: EXCLUSION CRITERIA CASES 1. Registered in TMC after partial or full treatment outside (except incision/excision biopsy) 2. Not willing and providing consent for telephonic interview EXCLUSION CRITERIA CONTROLS 1. Registered in TMC after partial or full treatment outside (except incision/excision biopsy) 2. Not willing and providing consent for telephonic interview
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the proportion of breast cancer patients who could not receive the TMC Standard of Care (SOC) multimodality treatment in the COVID and Pre-COVID cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Proportion of patients who could not receive the TMC Standard of Care surgical or reconstructive treatment in the two cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years;10. Incidence of COVID-19 in the breast cancer cohort during the study period and their COVID / Cancer outcomesTimepoint: 6 months - initial analysis and then 2 and 5 years;11. Challenges in follow up visits and compliance during the pandemicTimepoint: 6 months - initial analysis and then 2 and 5 years;12. Patientâ??s awareness about the TMC Pandemic tele-consultation system and patient satisfaction with teleconsultation if they had attempted to use itTimepoint: 6 months - initial analysis and then 2 and 5 years;13. Two year clinical outcome in terms of Loco-regional control, Disease free survival and overall survival in the two cohortsTimepoint: 2 year;13.Five-year clinical outcome in terms of Loco-regional control, Disease free survival and overall survival in the two cohortsTimepoint: 5 year;2. Proportion of patients who could not receive the TMC Standard of Care radiotherapy treatment in the two cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years;3. Proportion of patients who could not receive the TMC Standard of Care systemic therapy in the two cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years;4. Proportion of patients in the two cohorts who received the TMC Standard of Care systemic multi-modality therapy but not within the optimum timelines for sequential treatment as defined laterTimepoint: 6 months - initial analysis and then 2 and 5 years;5. Factors associated with deviation from Standard of Care management or beyond the optimum timelines, as defined below, in two cohortsTimepoint: 6 months - initial analysis and then 2 and 5 years;6. To determine the proportion of patients with planned versus unplanned deviation from SOC, where the deviation will be considered as â??plannedâ?? if it was recommended by the oncologist.Timepoint: 6 mont | — |
Countries
India
Contacts
Public ContactDr Jince Mary Mathew
Tata Memorial hospital
Outcome results
None listed