- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05216029
Oncology Dashboard for the Improvement of Operational Efficiency and Patients Outcomes in Patients With Sarcoma
Study of Efficacy of Oncology Dashboard in Improving Operational Efficiency and Patient Outcomes
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
PRIMARY OBJECTIVE:
I. To compare the changes in oncology workflow times from baseline to follow up visits between intervention (follow-up visit with oncology dashboard tool) and control (follow-up visit without oncology dashboard tool) groups.
SECONDARY OBJECTIVES:
I. To compare the changes in radiology workflow times from baseline to follow up visits between intervention (follow-up visit with oncology dashboard tool) and control (follow-up visit without oncology dashboard tool) groups.
II. Assess and compare the proportion of patients who correctly indicate the changes in tumor size while on therapy at the baseline and at the follow-up visit (with the oncology dashboard tool).
IIa. Compare the change in proportion of patients who correctly indicate the changes in tumor size while on therapy from baseline to follow-up visit between intervention and control groups.
III. Assess the patient's satisfaction with physician communication during the clinic visit and with the current treatment plan at each visit for each group.
IV. Assess changes in the radiology report quality with the following measures (all changes will be compared between intervention and control groups):
IVa. Whether or not the current study was compared to the imaging study that was performed at the start of current therapy.
IVb. The number of time points reviewed by the radiologist. IVc. The time interval between the earliest study reviewed and the current study.
IVd. Percentage of target lesions measured and listed in the radiology report. V. In patients who have stable disease or mildly progressive disease at the time of the baseline assessment, assess the impact of patient understand on the decision to continue and discontinue therapy.
OUTLINE: Patients are randomized to 1 of 2 groups.
GROUP I: Radiologist records information from patient's recent scan into oncology dashboard. Patients view images of how disease may have changed over time on oncology dashboard.
GROUP II: Patients receive standard of care.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Texas
-
Houston, Texas, United States, 77030
- M D Anderson Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients with sarcoma on active chemotherapy/targeted therapy
Patients must have stable to mildly progressive disease or better on baseline assessment
- Baseline measurement and follow-up measurement have to be performed on the same treatment for consistency. If patients with progressive disease are included into the study at baseline, follow-up measurement will be on a different treatment. Invariable, initiation of a new treatment, in the setting of progressive disease, lengthens oncology workflow which would affect the post measurement
- Patients must have been on the same treatment for at least 6 weeks
- Patients must have at least 3 prior imaging studies of the same body part/tracked lesion/area of interest separated by 6 weeks or more between studies
- Patients should be continuing same therapy for the next 6-8 weeks
- Patients must have plan for follow-up with imaging studies at MD Anderson Cancer Center (MDACC) while on therapy
- Patients who are receiving therapy outside of MDACC but having their follow-up imaging at MDACC are eligible
- >= 18 years of age
Exclusion Criteria:
- Expected survival of less than 8 weeks
- Patients with an Eastern Cooperative Oncology Group (ECOG) performance status of 4
- Non- English-speaking patients and patients with cognitive impairment who cannot complete the questionnaire
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Group I (oncology dashboard)
Radiologist records information from patient's recent scan into oncology dashboard.
Patients view images of how disease may have changed over time on oncology dashboard.
|
Ancillary studies
View oncology dashboard
|
|
Experimental: Group II (standard of care)
Patients receive standard of care.
|
Ancillary studies
Receive standard of care
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Time to complete medical oncology review (oncology workflow)
Time Frame: through study completion, an average of 1 year
|
through study completion, an average of 1 year
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Vinod Ravi, M.D. Anderson Cancer Center
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Neoplasms
- Neoplasms by Histologic Type
- Neoplasms, Connective and Soft Tissue
- Sarcoma
- Health Services Administration
- Health Care Quality, Access, and Evaluation
- Quality of Health Care
- Quality Indicators, Health Care
- Guidelines as Topic
- Quality Assurance, Health Care
- Standard of Care
- Practice Guidelines as Topic
Other Study ID Numbers
- 2014-0707 (Other Identifier: M D Anderson Cancer Center)
- NCI-2021-09453 (Registry Identifier: CTRP (Clinical Trial Reporting Program))
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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