NCI SBIR Contract for Patient Navigation Tool Prototype Development

NCT04892927 | Unknown

• 2 other identifiers: 75N91020C0004375N91020C00043-0-9999-1
• Study Type: observational
• Target: 25
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (5)

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Pancreas cancer patients and other surgical candidates for procedures including pancreatectomy, whipple procedure.

You may qualify if:

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

Sponsors & Collaborators

• GMG Arcdata LLC: lead
• National Cancer Institute (NCI): collaborator
• Georgetown University: collaborator

Study Sites (1)

MedStar Georgetown University Hospital

Washington D.C., District of Columbia, 20007, United States

RECRUITING

MeSH Terms

Conditions

Pancreatic Neoplasms; Patient Participation

Condition Hierarchy (Ancestors)

Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Endocrine Gland Neoplasms; Digestive System Diseases; Pancreatic Diseases; Endocrine System Diseases; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Study Officials

• Gregory Downing

  GMG Arcdata LLC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Mike Yea

CONTACT

30315232648; myea@gmgarcdata.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Weeks
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2021
• First Posted: May 19, 2021
• Study Start: May 3, 2021
• Primary Completion: May 26, 2021
• Study Completion: June 30, 2021
• Last Updated: May 19, 2021

Record last verified: 2021-05

Locations

US (1)