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| ID | Type | Description | Link |
|---|---|---|---|
| 75N91020C00043-0-9999-1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
| Georgetown University | OTHER |
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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.
The objective of this Phase I Small Business Innovation Research project is to determine the scientific or technical feasibility of R&D efforts. The requirements that will be addressed include:
The study's proposed approach for developing software to support pancreatic cancer patient navigation across the care continuum will be addressed through research addressing these three Specific Aims:
While Phase I is primarily focused on the technical feasibility and commercial merit of the tool, the research team seeks to concurrently develop an evaluation design that can robustly assess the impact of the tool along key dimensions that the tool is designed to address:
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| Measure | Description | Time Frame |
|---|---|---|
| Patient Anxiety and Cognitive Burden | Patient Health Questionnaire-2 (PHQ-2) | Up to 24 weeks |
| Patient Anxiety and Cognitive Burden | Patient Health Questionnaire-9 (PHQ-9) | Up to 24 weeks |
| Time Burden | Duration of task completion -- data within the app (time stamps) | Through study completion, an average of 6 weeks |
| Improved information sharing | Presence/absence of critical information in app (e.g., imaging) | Through study completion, an average of 8 weeks |
| Improved information sharing | Navigator perception via survey feedback | Through study completion, an average of 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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Pancreas cancer patients and other surgical candidates for procedures including pancreatectomy, whipple procedure.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mike Yea | Contact | 30315232648 | myea@gmgarcdata.com |
| Name | Affiliation | Role |
|---|---|---|
| Gregory Downing | GMG Arcdata LLC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MedStar Georgetown University Hospital | Recruiting | Washington D.C. | District of Columbia | 20007 | United States |
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| ID | Term |
|---|---|
| D010190 | Pancreatic Neoplasms |
| D010358 | Patient Participation |
| ID | Term |
|---|---|
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D004701 | Endocrine Gland Neoplasms |
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| D004066 |
| Digestive System Diseases |
| D010182 | Pancreatic Diseases |
| D004700 | Endocrine System Diseases |
| D010342 | Patient Acceptance of Health Care |
| D000074822 | Treatment Adherence and Compliance |
| D015438 | Health Behavior |
| D001519 | Behavior |