Central Nervous System NeoplasmNCT04988009
Patient Perceptions Around Quality of Care Through Telemedicine in Neuro-Oncology
An observational study of Central Nervous System Neoplasm and Leptomeningeal Neoplasm, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Central Nervous System Neoplasm, Leptomeningeal Neoplasm, Metastatic Malignant Neoplasm in the Brain
- What is being tested?
- Electronic Health Record Review and Survey Administration
- How many people
- 200 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Aug 2020to 31 Dec 2026
- Phase
- Observational
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 encounters at the Brain and Spine Center between 4/20/2020 and either (1) 8/30/2020 or (2) date that the state of emergency secondary to the COVID-19 pandemic is declared terminated in the United States of America- whichever date is earlier
Who may be able to join
- Patients with a CNS tumors: this includes patients with primary brain tumors, brain metastases, and leptomeningeal disease
- Established patients with a follow up encounter with Neuro-Oncology at the Brain and Spine Center at the University of Texas MD Anderson Cancer Center; this encounter can be
- An in-person visit
- A telemedicine appointment
Who cannot join
- Encounter occurred with the assistance of official language translation support
- Patients with telephone encounters (without interactive video)
- New patient or consult visits
- Neither patient nor caregiver present during the visit are available or able to answer survey questions
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
M D Anderson Cancer Center
Houston, Texas, 77030
Barbara J O'Brien, MD, 713-794-4380, bjobrien@mdanderson.org
Barbara J O'Brien, MD
About this study
This study evaluates patient perceptions around quality of care through telemedicine in neuro-oncology. Studying questionnaires related to perceptions quality of care through telemedicine in patients with brain cancer may help doctors to improve the delivery of care through this modality.
Read the detailed description
PRIMARY OBJECTIVE:
- To evaluate the patient-perceived quality of care by group (telemedicine versus in-person visits) in patients with central nervous system (CNS) cancer.
SECONDARY OBJECTIVES:
- To characterize the visits provided by telemedicine compared to those in-person.
II. To contrast the average time spent on telemedicine visits compared to in-person visits, and the delay between visit order placement and visit occurring.
III. To evaluate the domains of patient care addressed on a telemedicine visit versus in-person visit per documentation, including (1) treatment planning, (2) symptom burden, (3) goals of care.
IV. To evaluate frequency of acute care sought (through emergency room or urgent care clinic) within 30 days of encounter in telemedicine visit versus (vs) in-person visit.
- The impact of patient and clinical characteristics on perceived quality of care in the context of covariate-adjusted modeling.
OUTLINE:
Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively.
- Conditions
- Central Nervous System Neoplasm, Leptomeningeal Neoplasm, Metastatic Malignant Neoplasm in the Brain, Primary Brain Neoplasm
- Being tested
- Electronic Health Record Review, Survey Administration
- Medical subject headings
- Central Nervous System Neoplasms, Meningeal Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Electronic Health Record ReviewOther
Review of medical chart
Survey AdministrationOther
Complete survey
| Study group | Role | What they receive |
|---|---|---|
| Observational (survey, medical chart review) | Patients complete a survey related to their perceived quality of care via telephone and have their medical chart reviewed prospectively. Receives: Other: Electronic Health Record Review; Other: Survey Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Survey response to question 6 of the quality of care survey ("I felt I received good medical care during this encounter")
Survey responses will be summarized by ordinal category as counts with percentages, separately by group. Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval.
Measured: through study completion, an average of 1 year
Secondary outcomes (6)
Quality of Care Survey
Will separately estimate the proportion of each ordinal level of each group with 95% confidence interval.
Measured: through study completion, an average of 1 year
Patients and clinical characteristics
Differences between groups will be assessed by 2-sample 2-sided t-test and Mann-Whitney test, Fisher's exact test, or chi-square test.
Measured: Baseline
Interactive time spent during visit
Will be summarized by group per mean, median, standard deviation, and range. Differences between groups will be assessed by t-test and Mann-Whitney test.
Measured: through study completion, an average of 1 year
Time from visit order placement to visit occurring
Will be summarized by group per mean, median, standard deviation, and range. Differences between groups will be assessed by t-test and Mann-Whitney test.
Measured: through study completion, an average of 1 year
Domains of patient care addressed during a visit, including treatment planning, symptom burden, and goals of care
Will be summarized as counts with percentages by group. Differences between groups will be assessed by chi-square test.
Measured: through study completion, an average of 1 year
Incidence of acute care sought (through emergency room or urgent care clinic)
Will be summarized as counts with percentages by group. Differences between groups will be provisionally assessed by Fisher's exact test.
Measured: Within 30 days of encounter
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Aug 2021
- Study start20 Aug 2020
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Central Nervous System 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Barbara J O'Brien, MD, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04988009
- Sponsor's protocol ID
- 2020-0493
- Other IDs
- NCI-2020-07493, 2020-0493
- Status last verified
- Sep 2026
- First submitted
- 7 Oct 2020
- Last updated
- 14 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No