Recruiting

Mobile Application

Sponsor:

GMG Arcdata LLC

Code:

NCT04892927

Conditions

Pancreas Cancer

Hepatobiliary Cancer

Patient Engagement

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

Brief summary:

GMG ArcData will create a mobile-based application to improve communications and data exchange among patients and navigators involved in new pancreas surgery oncology episodes of care. Functionality will align with care processes using smartphone and the EHR patient portal. GMG will apply user-centered design theory and behavioral psychology approaches to co-design, develop, and test usability of features that optimize patient navigators-patient encounters on scheduling issues, nutrition guidance, pain management, wellbeing assessments, and activity tracking. Evaluation endpoints will reflect how the application improves the efficiency of workflows and lessens cognitive burden. Study will assess how patients and navigators perceive the tool's ability to provide more control and easier access to information about surgical care. The key project innovations are based on Fast Healthcare Interoperability Resources (FHIR)-based engineering standards that enable interoperability among digital health platforms, apply 'recommender' functions based on similar patients' experiences, and exploit microeducation tools to enhance patient understanding about their surgical care. The research team has partnered with MedStar Health and Georgetown University Lombardi Comprehensive Cancer Center to co-design the software and access patients for usability testing. Successful implementation will lead to exploring a joint venture for scaling to other care episodes, expanded functionality, and co-creating business models for commercialization.

Conditions

Pancreas Cancer

Hepatobiliary Cancer

Patient Engagement

Study ID

NCT04892927

Start date

May 3, 2021

Status verified date

May, 2021

Completion date

Jun 30, 2021

Anticipated

Primary completion date

May 26, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Hepatobiliary surgery patients seeking care at research location
  • A sufficient level of comfort with personal computers or smart phone devices

Exclusion Criteria:

-

Study Design

Enrollment

25 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • Patient Anxiety and Cognitive Burden [ Time Frame: Up to 24 weeks ]
  • Patient Anxiety and Cognitive Burden [ Time Frame: Up to 24 weeks ]
  • Time Burden [ Time Frame: Through study completion, an average of 6 weeks ]
  • Improved information sharing [ Time Frame: Through study completion, an average of 8 weeks ]
  • Improved information sharing [ Time Frame: Through study completion, an average of 8 weeks ]

Central Contacts and Locations

Central contacts

Locations

MedStar Georgetown University Hospital

Recruiting

Washington, District of Columbia, United States, 20007

Contacts

More Information

Sponsor

GMG Arcdata LLC

Last update posted

May 19, 2021

Last verified

May, 2021

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by GMG Arcdata LLC on 2021-05-19.