A Study of Risk Factors for the COVID-19 Virus Infection

Sponsor

Memorial Sloan Kettering Cancer Center (Other)

Overall Status

Recruiting

CT.gov ID

NCT04697927

Collaborator

(none)

10,000

Enrollment

Locations

Anticipated Duration (Months)

1428.6

Patients Per Site

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The purpose of this study is to collect information that will help the reasearchers learn more about COVID-19 infections in cancer patients, and to find out about the effects of these infections on cancer treatment and outcomes. The research study involves asking people to complete a series of online questionnaires that include questions about their medical history, lifestyle, and risk factors related to the COVID-19 infection. The study will enroll both MSK patients and their household family members.

Condition or Disease	Intervention/Treatment	Phase
COVID-19 Infections in Cancer Patients	Other: Questionnaires

Study Design

Study Type:

Observational

Anticipated Enrollment :

10000 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

Ascertainment of Epidemiologic Risk Information to Assess Susceptibility to and Severity of SARS-CoV-2 Infection

Actual Study Start Date :

Dec 30, 2020

Anticipated Primary Completion Date :

Dec 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
MSK Patients Patients include those undergoing cancer screening and treatment as well as cancer survivors that received COVID-related care. Both adult and pediatric patients will be included.	Other: Questionnaires The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources. Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire. Validated questions capturing demographics, employment, risk behaviors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies. The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.
Household Members (identified by MSK Patient) Individuals over the age of 18 (i.e., individuals currently living in the same household as the MSK enrollee).	Other: Questionnaires The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources. Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire. Validated questions capturing demographics, employment, risk behaviors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies. The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.

Arm

Intervention/Treatment

MSK Patients

Patients include those undergoing cancer screening and treatment as well as cancer survivors that received COVID-related care. Both adult and pediatric patients will be included.

Other: Questionnaires

The epidemiologic questionnaires used in this study are a composite of validated questions from multiple sources. Many of the questions are an expansion of the MSK General Medical Health clinical questionnaire. Validated questions capturing demographics, employment, risk behaviors, family history, as well as, specific research domains including psychosocial, food security, and financial toxicity have already been utilized in other MSK minimal risk studies. The COVID-19 symptom and history tracker questions were largely drawn from the COronavirus Pandemic Epidemiology (COPE) consortium study.

Household Members (identified by MSK Patient)

Individuals over the age of 18 (i.e., individuals currently living in the same household as the MSK enrollee).

Other: Questionnaires

Outcome Measures

Primary Outcome Measures

develop a comprehensive registry database [2 years]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Inclusion Criteria:

MSK Patients

All individuals who have had at least one point of contact since January 1st 2019 as a patient, including visiting an MSK facility for treatment, clinical evaluation, follow-up or screening, COVID-related screening, or a telehealth visit. Household Members of MSK Patients
Individuals aged 18 or older
Currently reside in the same household of MSK patients enrolled onto this protocol
Have an email account

Exclusion Criteria:

Impaired decision-making capacity as noted in EHR
Current MSK employee

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Memoral Sloan Kettering Basking Ridge	Basking Ridge	New Jersey	United States	07920
2	Memorial Sloan Kettering Monmouth	Middletown	New Jersey	United States	07748
3	Memorial Sloan Kettering Bergen	Montvale	New Jersey	United States	07645
4	Memorial Sloan Kettering Commack	Commack	New York	United States	11725
5	Memorial Sloan Kettering Westchester	Harrison	New York	United States	10604
6	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
7	Memorial Sloan Kettering Nassau	Rockville Centre	New York	United States	11553