Oncology Dashboard for the Improvement of Operational Efficiency and Patients Outcomes in Patients With Sarcoma

Sponsor
M.D. Anderson Cancer Center (Other)
Overall Status
Recruiting
CT.gov ID
NCT05216029
Collaborator
National Cancer Institute (NCI) (NIH)
75
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2
87
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Study Details

Study Description

Brief Summary

This clinical trial investigates whether measuring and presenting information about a patient's cancer treatment to them, their doctor, and their radiologist using a tool called an "oncology dashboard" may help patients understand the disease better and help the patient's medical team manage their care more efficiently. The oncology dashboard tool may help patients understand the disease better and may help improve the efficiency of their medical care.

Condition or Disease Intervention/Treatment Phase
  • Other: Best Practice
  • Other: Informational Intervention
  • Other: Questionnaire Administration
N/A

Detailed Description

PRIMARY OBJECTIVE:
  1. 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:
  1. 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.

  2. 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.

  1. Assess the patient's satisfaction with physician communication during the clinic visit and with the current treatment plan at each visit for each group.

  2. 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 Design

Study Type:
Interventional
Anticipated Enrollment :
75 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Health Services Research
Official Title:
Study of Efficacy of Oncology Dashboard in Improving Operational Efficiency and Patient Outcomes
Actual Study Start Date :
Oct 1, 2015
Anticipated Primary Completion Date :
Dec 31, 2022
Anticipated Study Completion Date :
Dec 31, 2022

Arms and Interventions

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.

Other: Informational Intervention
View oncology dashboard

Other: Questionnaire Administration
Ancillary studies

Experimental: Group II (standard of care)

Patients receive standard of care.

Other: Best Practice
Receive standard of care
Other Names:
  • standard of care
  • standard therapy
  • Other: Questionnaire Administration
    Ancillary studies

    Outcome Measures

    Primary Outcome Measures

    1. Time to complete medical oncology review (oncology workflow) [through study completion, an average of 1 year]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 M D Anderson Cancer Center Houston Texas United States 77030

    Sponsors and Collaborators

    • M.D. Anderson Cancer Center
    • National Cancer Institute (NCI)

    Investigators

    • Principal Investigator: Vinod Ravi, M.D. Anderson Cancer Center

    Study Documents (Full-Text)

    None provided.

    More Information

    Additional Information:

    Publications

    None provided.
    Responsible Party:
    M.D. Anderson Cancer Center
    ClinicalTrials.gov Identifier:
    NCT05216029
    Other Study ID Numbers:
    • 2014-0707
    • NCI-2021-09453
    • 2014-0707
    First Posted:
    Jan 31, 2022
    Last Update Posted:
    Aug 24, 2022
    Last Verified:
    Aug 1, 2022
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Aug 24, 2022