Oncology PatientsNCT04406844
Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic
An observational study of Oncology Patients, run by Max Healthcare Insititute Limited at 1 site in India.
Trial summary
In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic. Read more about this study
- Who is it for?
- Ages 12 to 98 years
- Conditions the study is for
- Oncology Patients
- How many people
- 150 participants
- Where
- 1 siteIndia
- Study dates
- 9 May 2020to 30 Jun 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 12 to 98 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: The study population will comprise all the cancer patients who are registered in the Max Superspeciality hospital, Patparganj between Nov 1st 2019 to Jan 31st 2020
Who may be able to join
- Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020
- Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
India1 site, 1 recruiting
- Recruiting
Max Superspeciality hospital, A Unit of Balaji Medical and Diagnostic Centre
New Delhi, 110092
Rajesh Saxena, 9818474003, rajesh.saxena@maxhealthcare.com
About this study
Official title: An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown
In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.
Read the detailed description
Protocol No: Onco_Covid-19
Version no:1.0
Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown.
Collection of data will be done through telephonic communication. Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and Hindi both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the participant or attendant during telephonic verbal consent.
- Conditions
- Oncology Patients
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncology patients
To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc
Measured: 4-8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 May 2020
- Study start9 May 2020
- Primary completion30 Jun 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oncology PatientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Max Healthcare Insititute Limited
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geeta Kadayaprath, Principal investigator, Max Hospital, Patparganj
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04406844
- Sponsor's protocol ID
- Onco_Covid-19
- Status last verified
- Jul 2020
- First submitted
- 25 May 2020
- Last updated
- 22 Jul 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study to Identify the Issues and Challenges in Cancer Patients on Active Treatment During the COVID-19 Pandemic and the Resulting Lockdown
- ClinicalTrials.gov ID
- NCT04406844
- Acronym / sponsor ID
- Onco_Covid-19
- Conditions
- Oncology Patients
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Max Healthcare Insititute LimitedUniversity, hospital or other
- Study start
- 9 May 2020 (actual)
- Primary completion
- 30 Jun 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 28 May 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
In view of increasing cases of SARS-CoV-2 leading to the COVID-19 Pandemic in India,there has been unprecedented restrictions on travel, work and other aspects of daily life. Our study has been designed to collect data of cancer patients to analyze their issues and challenges during Covid-19 Pandemic.
Detailed description
Protocol No: Onco_Covid-19
Version no:1.0
Objectives: Firstly the patients recently diagnosed with cancer will be selected for enrollment who are on active treatment during lockdown based on the date of their registration in the hospital. This is followed by a telephonic interview with patients or their attendant to carry out a prospective, cross-sectional, observational study in order to address the issues and challenges faced by them during Lockdown.
Collection of data will be done through telephonic communication. Participation in this study will be entirely voluntary. Telephonic verbal consent will be taken from the patients or their attendants before collection of their response on the study questionnaire and then will be asked questions accordingly based on the questionnaire which is available in English and Hindi both. Data and general information regarding participants will only be collected in questionnaire. No personal data of the participants will be taken which will also be conveyed to the participant or attendant during telephonic verbal consent.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 12 to 98 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- The study population will comprise all the cancer patients who are registered in the Max Superspeciality hospital, Patparganj between Nov 1st 2019 to Jan 31st 2020
Key inclusion criteria (2 listed)
- Registered with the Max Institute of Cancer Care between Nov 1st 2019 to Jan 31st 2020
- Were scheduled to receive one or more modalities of treatment (chemotherapy, surgery, radiation therapy, immunotherapy) during the period Feb 1st 2020 to April 30th 2020
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oncology patients
Time frame: 4-8 weeks
To focus on basic issues encountered by oncology patients such as transportation, medical facility, healthcare support, disease apprehension etc
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2020.
- Individual participant dataSharing planned: Undecided. IPD sharing protocol is undecided at this stage. We may, however, provide the data if requested.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Geeta Kadayaprath principal investigator
Max Hospital, Patparganj
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Oncology Patients, run by Max Healthcare Insititute Limited at 1 site in India.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in India. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Rajesh Saxena (9818474003, rajesh.saxena@maxhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncology patients (time frame: 4-8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2020.