Advanced Malignant Solid NeoplasmNCT05058339
Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer
An observational study of Advanced Malignant Solid Neoplasm and COVID-19 Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Malignant Solid Neoplasm, COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm
- What is being tested?
- Survey Administration
- How many people
- 223 participants
- Where
- 1 siteUnited States
- Study dates
- 27 Apr 2021to 6 Sep 2024
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with advanced cancer seen at the University of Texas MD Anderson Supportive Care Outpatient Clinic
Who may be able to join
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Age 18 or greater
- Patient presenting for at least two follow-up visits with Supportive Care visit since the COVID19 pandemic (after March 23, 2020), consisting of either in-person, or virtual
- For patients who have had two consecutive video visits, or consecutive telephone visits with supportive care, they will be asked to complete additional questions regarding telehealth visits
Who cannot join
- Memorial Delirium Assessment Scale (MDAS) of 7 or more or if determined to be of impaired cognition by the clinician at the time of clinic visit as documented in the visit either by history or exam. Providers routinely note screening for mental status with routine administration of the MDAS or history of altered cognition or noted on exam
- Non-English-speaking participants
- Unwilling or unable to provide informed consent
Trial locations and contacts
1 site in 1 country.
About this study
This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Information from this study may help doctors better understand how COVID-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.
Read the detailed description
PRIMARY OBJECTIVES:
- Assess advanced cancer patients' level of distress due to the COVID-19 pandemic.
II. Assess patients' overall preference towards palliative telemedicine vs in person visits during the COVID-19 pandemic.
SECONDARY OBJECTIVES:
- Assess associations between patient characteristics and perceptions of overall distress due to the COVID-19 pandemic.
II. Assess associations between patient characteristics and their attitudes and beliefs towards palliative telemedicine during the COVID-19 pandemic.
III. Compare the attitudes and beliefs towards palliative telemedicine between patients who completed visits via video vs telephone.
OUTLINE:
Patients complete survey over 20 minutes.
- Conditions
- Advanced Malignant Solid Neoplasm, COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy
- Being tested
- Survey Administration
- Medical subject headings
- COVID-19, Hematologic Neoplasms, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey) | Patients complete survey over 20 minutes. Receives: Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey.
[Survey (COVID Distress Survey) will evaluate overall distress level with degree of increase or decrease assessed on a 7-point Likert scale, with higher scores indicating high distress levels.
Measured: through study completion, an average of 1 year
Assessment of patients' overall preference and perceptions towards palliative telemedicine vs in person visits during the COVID-19 pandemic.
[Survey (Attitudes and beliefs towards telehealth) will evaluate participant preference level with degree of increase or decrease assessed by 5-point Likert scale from "strongly prefer virtual visits" to "strongly prefer in person visits", with high scores indicating preference for in-person visits..
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2021
- Study start27 Apr 2021
- Primary completion6 Sep 2024
- Study completion6 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Advanced Malignant Solid NeoplasmStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 223 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- David Hui, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05058339
- Sponsor's protocol ID
- 2020-1196
- Other IDs
- NCI-2021-09080, 2020-1196
- Status last verified
- Sep 2024
- First submitted
- 14 Sep 2021
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Distress Associated with Coronavirus Disease 2019 and Telehealth on Supportive Care Patients with Advanced Cancer
- ClinicalTrials.gov ID
- NCT05058339
- Acronym / sponsor ID
- 2020-1196
- Conditions
- Advanced Malignant Solid Neoplasm, COVID-19 Infection, Hematopoietic and Lymphoid Cell Neoplasm, Locally Advanced Malignant Solid Neoplasm, Metastatic Malignant Solid Neoplasm, Recurrent Hematologic Malignancy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 223 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- 27 Apr 2021 (actual)
- Primary completion
- 6 Sep 2024 (actual)
- Study completion
- 6 Sep 2024 (actual)
- First posted
- 27 Sep 2021 (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.
This study assesses the level of distress felt by cancer patients due to the coronavirus disease 2019 (COVID-19) pandemic. Researchers also want to learn if patients prefer to receive supportive care (palliative care) in person or through telemedicine (visits by phone or video call, such as Zoom). Information from this study may help doctors better understand how COVID-19 has affected patients with advanced cancer, patients' perceptions of telehealth, and may help clinicians tailor care to patients' needs during the pandemic.
Detailed description
PRIMARY OBJECTIVES:
- Assess advanced cancer patients' level of distress due to the COVID-19 pandemic.
II. Assess patients' overall preference towards palliative telemedicine vs in person visits during the COVID-19 pandemic.
SECONDARY OBJECTIVES:
- Assess associations between patient characteristics and perceptions of overall distress due to the COVID-19 pandemic.
II. Assess associations between patient characteristics and their attitudes and beliefs towards palliative telemedicine during the COVID-19 pandemic.
III. Compare the attitudes and beliefs towards palliative telemedicine between patients who completed visits via video vs telephone.
OUTLINE:
Patients complete survey over 20 minutes.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (survey) | – | Other: Survey AdministrationPatients complete survey over 20 minutes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with advanced cancer seen at the University of Texas MD Anderson Supportive Care Outpatient Clinic
Key inclusion criteria (4 listed)
- Diagnosis of advanced cancer, defined as locally advanced, recurrent or metastatic disease
- Age 18 or greater
- Patient presenting for at least two follow-up visits with Supportive Care visit since the COVID19 pandemic (after March 23, 2020), consisting of either in-person, or virtual
- For patients who have had two consecutive video visits, or consecutive telephone visits with supportive care, they will be asked to complete additional questions regarding telehealth visits
Key exclusion criteria (3 listed)
- Memorial Delirium Assessment Scale (MDAS) of 7 or more or if determined to be of impaired cognition by the clinician at the time of clinic visit as documented in the visit either by history or exam. Providers routinely note screening for mental status with routine administration of the MDAS or history of altered cognition or noted on exam
- Non-English-speaking participants
- Unwilling or unable to provide informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Survey AdministrationComplete survey | Other | Observational (survey) |
Primary outcome
Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey.
Time frame: through study completion, an average of 1 year
[Survey (COVID Distress Survey) will evaluate overall distress level with degree of increase or decrease assessed on a 7-point Likert scale, with higher scores indicating high distress levels.
Assessment of patients' overall preference and perceptions towards palliative telemedicine vs in person visits during the COVID-19 pandemic.
Time frame: through study completion, an average of 1 year
[Survey (Attitudes and beliefs towards telehealth) will evaluate participant preference level with degree of increase or decrease assessed by 5-point Likert scale from "strongly prefer virtual visits" to "strongly prefer in person visits", with high scores indicating preference for in-person visits..
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- M D Anderson Cancer CenterLink provided by the sponsor.
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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.
David Hui, MD principal investigator
M.D. Anderson Cancer Center
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 Advanced Malignant Solid Neoplasm and COVID-19 Infection, run by M.D. Anderson Cancer Center at 1 site in United States.
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 4 inclusion and 3 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: finished, as of the sponsor's last update on 19 Sep 2024. 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 United States. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of attitudes and beliefs of patients' level of distress and incidence of stressors due to the COVID-19 pandemic, measured by survey. (time frame: through study completion, an average of 1 year). The study lists 2 primary outcomes in all. 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 19 Sep 2024.