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Impact of the Coronavirus (COVID-19) on Patients With Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04330521
Recruitment Status : Recruiting
First Posted : April 1, 2020
Last Update Posted : November 8, 2022
Sponsor:
Information provided by (Responsible Party):
Manali Indravadan Patel, Stanford University

Study Description
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Brief Summary:
The purpose of this study is to understand the impact of COVID-19 on patients with cancer through a survey.

Condition or disease
Cancer COVID-19

Detailed Description:
The global spread of coronavirus (COVID-19) is affecting cancer patients and their treatments. Cancer patients are among those at high risk of developing serious illness from an infection because their immune systems are often weakened by cancer and its treatments. Due to the growing coronavirus outbreak, patients clinic visits are being cancelled and many are facing social isolation and strict restrictions on their daily lives. We want to evaluate the impact of the coronavirus on the patient's well-being and their cancer care by assessing the delays in their medical care and any other unmet needs. We have created a survey that is available online for any patient with cancer to fill out voluntarily regarding their experiences to date. The survey is available at: https://stanforduniversity.qualtrics.com/jfe/form/SV_ctKS6ZSMYdEYoXX
Study Design
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Study Type : Observational
Estimated Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Impact of the Coronavirus (COVID-19) on Patients With Cancer
Actual Study Start Date : April 8, 2020
Estimated Primary Completion Date : May 2024
Estimated Study Completion Date : May 2024

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  1. Number of participants who fill out the survey and participate in the semi-structured interviews. [ Time Frame: 12 Months ]
    We will track the number of participants who fill out the survey for the 12 month duration of the study and the number of participants who participate in the semi-structured telephone interviews.


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Individuals who are diagnosed with any cancer diagnosis . We plan to enroll as many patients as possible in the survey portion of the study - we have no limitation of the numbers and do not require a specific number to participate although we hope to achieve at least 50 participants who fill out the survey.

Among survey participants, we plan to enroll 18-30 participants in semi-structured telephone interviews. These participants will be randomly selected among those who filled out the survey.

The research procedures are as followed:

  1. Survey: An online survey link will include questions regarding the impact patients with cancer are experiencing during the coronavirus outbreak.
  2. Semi-structured Interviews (18-30 participants): For those participants who state that they would like to participate in an interview, a random sample will be contacted.
Criteria

Inclusion Criteria:

  1. The patients must be 18 years or older.
  2. Patients who opt in to complete the survey.
  3. Patients must have the capacity to verbally consent for the interview.

Exclusion Criteria:

1.Patients who under the age of 18 years old.

Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04330521


Locations
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United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Manali I Patel, MD MPH MS    650-723-4000    manalip@stanford.edu   
Principal Investigator: Manali I Patel, MD MPH MS         
Sponsors and Collaborators
Stanford University
More Information
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Additional Information:

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Responsible Party: Manali Indravadan Patel, Assistant Professor, Stanford University
ClinicalTrials.gov Identifier: NCT04330521    
Other Study ID Numbers: 55596
First Posted: April 1, 2020    Key Record Dates
Last Update Posted: November 8, 2022
Last Verified: November 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Manali Indravadan Patel, Stanford University:
Coronavirus
COVID-19
Cancer
Life Change Events
Additional relevant MeSH terms:
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COVID-19
Coronavirus Infections
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
 Virus Diseases
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases