Clinical trial · Observational
NCI SBIR Contract for Patient Navigation Tool Prototype Development
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hepatobiliary Cancer | Malignant Hepatobiliary Neoplasm | ALIAS | 0.90 |
| Pancreas Cancer | Pancreatic Carcinoma | ALIAS | 0.90 |
| Patient Engagement | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (5)
- measure
- Patient Anxiety and Cognitive Burden
- timeFrame
- Up to 24 weeks
- description
- Patient Health Questionnaire-2 (PHQ-2)
- measure
- Patient Anxiety and Cognitive Burden
- timeFrame
- Up to 24 weeks
- description
- Patient Health Questionnaire-9 (PHQ-9)
- measure
- Time Burden
- timeFrame
- Through study completion, an average of 6 weeks
- description
- Duration of task completion -- data within the app (time stamps)
- measure
- Improved information sharing
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Hepatobiliary surgery patients seeking care at research location * A sufficient level of comfort with personal computers or smart phone devices Exclusion Criteria: \-
References
Publications (0)
Data not yet available