Pancreas CancerNCT04892927
NCI SBIR Contract for Patient Navigation Tool Prototype Development
An observational study of Pancreas Cancer and Hepatobiliary Cancer, run by GMG Arcdata LLC at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pancreas Cancer, Hepatobiliary Cancer, Patient Engagement
- How many people
- 25 participants
- Where
- 1 siteUnited States
- Study dates
- 3 May 2021to 30 Jun 2021
- How long will I take part?
- 4 Weeks
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Pancreas cancer patients and other surgical candidates for procedures including pancreatectomy, whipple procedure.
Who may be able to join
- Hepatobiliary surgery patients seeking care at research location
- A sufficient level of comfort with personal computers or smart phone devices
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
MedStar Georgetown University Hospital
Washington D.C., District of Columbia, 20007
Keith Unger, MD, 202-444-2223, KXU2@gunet.georgetown.edu
About this study
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.
Read the detailed description
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:
- Reducing the cognitive or time burden (or both) of navigation-related tasks performed by either patient navigators (PNs) or patients;
- Integrating seamlessly into the workflow of PNs and existing health information technology (IT) architecture; and
- Transmitting information securely across a variety of IT systems.
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:
- Engineering concepts that embrace interoperability through leveraging open messaging standards and improve usability by adopting human-centered design principles at project inception. With respect to interoperability, the key facet of this work's innovation will be using interoperability standards (e.g., FHIR) to interface with an electronic health record (EHR) at an NCI-designated Comprehensive Cancer Center. Doing so will facilitate scalability and flexibility in functionality that enhances the user experience for integrated functions (patient care information delivery, patient assessment, pain assessment, nutrition and activity). The study will apply user-centered design features that will allow us to assess patient engagement, efficiency of information flow, and navigator satisfaction.
- Research, design, and potential implementation of open source solutions for recommender systems. Smart recommendations, nudges, and automation enable users, both patients and PNs, to receive certain actionable options for an interaction based on experiences from other patients and navigators with similar preferences or share similar characteristics. The adoption of this approach will address cognitive overload, diminish presentation of unnecessary or inapplicable content, and create enhanced user experiences and more efficient and effective decision making.
- Research, design, and potential implementation of enhanced content delivery using asynchronous microeducation features. The most common approach to patient education is to create flat files or pdfs that are shared with patients for instruction. The study plans to demonstrate the value of instructional design in the software application to enhance patient engagement and understanding. Video features of the patient experience can be enhanced with videography, 360 immersive videos (for instance to show the patient the inside of the operating and recovery rooms). Through these delivery platforms content can be evaluated with AB testing to assess patient's responsiveness (for example, wound care, graphic representation of the anatomical surgical approach, etc.).
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:
- Reducing the information processing burden required of patients to navigate the health care system and care plan
- Bridging inefficiencies in the multi-step and multi-stakeholder processes inherent in complex care management and coordination
- Conditions
- Pancreas Cancer, Hepatobiliary Cancer, Patient Engagement
- Medical subject headings
- Pancreatic Neoplasms, Patient Participation
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient Anxiety and Cognitive Burden
Patient Health Questionnaire-2 (PHQ-2)
Measured: Up to 24 weeks
Patient Anxiety and Cognitive Burden
Patient Health Questionnaire-9 (PHQ-9)
Measured: Up to 24 weeks
Time Burden
Duration of task completion -- data within the app (time stamps)
Measured: Through study completion, an average of 6 weeks
Improved information sharing
Presence/absence of critical information in app (e.g., imaging)
Measured: Through study completion, an average of 8 weeks
Improved information sharing
Navigator perception via survey feedback
Measured: Through study completion, an average of 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2021
- Study start3 May 2021
- Primary completion26 May 2021 (estimated)
- Study completion30 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pancreas CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 25 participants (estimated)
- Target duration
- 4 Weeks
Sponsor and investigators
- Lead sponsor
- GMG Arcdata LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Georgetown University
- Responsible party
- Sponsor
- Investigators
- Gregory Downing, Principal investigator, GMG Arcdata LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04892927
- Sponsor's protocol ID
- 75N91020C00043
- Other IDs
- 75N91020C00043-0-9999-1
- Status last verified
- May 2021
- First submitted
- 2 May 2021
- Last updated
- 19 May 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- NCI SBIR Contract for Patient Navigation Tool Prototype Development
- ClinicalTrials.gov ID
- NCT04892927
- Acronym / sponsor ID
- 75N91020C00043
- Conditions
- Pancreas Cancer, Hepatobiliary Cancer, Patient Engagement
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- GMG Arcdata LLCIndustry (pharma, biotech, devices)
- Collaborators
- National Cancer Institute (NCI), Georgetown University
- Study start
- 3 May 2021 (actual)
- Primary completion
- 26 May 2021 (estimated)
- Study completion
- 30 Jun 2021 (estimated)
- First posted
- 19 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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:
- Reducing the cognitive or time burden (or both) of navigation-related tasks performed by either patient navigators (PNs) or patients;
- Integrating seamlessly into the workflow of PNs and existing health information technology (IT) architecture; and
- Transmitting information securely across a variety of IT systems.
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:
- Engineering concepts that embrace interoperability through leveraging open messaging standards and improve usability by adopting human-centered design principles at project inception. With respect to interoperability, the key facet of this work's innovation will be using interoperability standards (e.g., FHIR) to interface with an electronic health record (EHR) at an NCI-designated Comprehensive Cancer Center. Doing so will facilitate scalability and flexibility in functionality that enhances the user experience for integrated functions (patient care information delivery, patient assessment, pain assessment, nutrition and activity). The study will apply user-centered design features that will allow us to assess patient engagement, efficiency of information flow, and navigator satisfaction.
- Research, design, and potential implementation of open source solutions for recommender systems. Smart recommendations, nudges, and automation enable users, both patients and PNs, to receive certain actionable options for an interaction based on experiences from other patients and navigators with similar preferences or share similar characteristics. The adoption of this approach will address cognitive overload, diminish presentation of unnecessary or inapplicable content, and create enhanced user experiences and more efficient and effective decision making.
- Research, design, and potential implementation of enhanced content delivery using asynchronous microeducation features. The most common approach to patient education is to create flat files or pdfs that are shared with patients for instruction. The study plans to demonstrate the value of instructional design in the software application to enhance patient engagement and understanding. Video features of the patient experience can be enhanced with videography, 360 immersive videos (for instance to show the patient the inside of the operating and recovery rooms). Through these delivery platforms content can be evaluated with AB testing to assess patient's responsiveness (for example, wound care, graphic representation of the anatomical surgical approach, etc.).
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:
- Reducing the information processing burden required of patients to navigate the health care system and care plan
- Bridging inefficiencies in the multi-step and multi-stakeholder processes inherent in complex care management and coordination
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Weeks
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Pancreas cancer patients and other surgical candidates for procedures including pancreatectomy, whipple procedure.
Key inclusion criteria (2 listed)
- Hepatobiliary surgery patients seeking care at research location
- A sufficient level of comfort with personal computers or smart phone devices
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patient Anxiety and Cognitive Burden
Time frame: Up to 24 weeks
Patient Health Questionnaire-2 (PHQ-2)
Patient Anxiety and Cognitive Burden
Time frame: Up to 24 weeks
Patient Health Questionnaire-9 (PHQ-9)
Time Burden
Time frame: Through study completion, an average of 6 weeks
Duration of task completion -- data within the app (time stamps)
Improved information sharing
Time frame: Through study completion, an average of 8 weeks
Presence/absence of critical information in app (e.g., imaging)
Improved information sharing
Time frame: Through study completion, an average of 8 weeks
Navigator perception via survey feedback
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2021.
Related trials for Pancreas Cancer
RecruitingObservational study
ctDNA Assay in Patients With Resectable Pancreatic Cancer
Pancreas Cancer
RecruitingPhase 1/2
A Study of PRMT5 Inhibitor BAY 3713372 in Participants With MTAP-deleted Solid Tumors
MTAP-deleted Solid Tumors
RecruitingPhase 1
A Phase I Study of Intra-Arterial Yttrium-90 Radioembolization for Unresectable Pancreatic Cancer
Pancreatic Cancer Non-resectable
RecruitingPhase 2/3
Zanzalintinib Versus Everolimus in Participants With Locally Advanced or Metastatic Neuroendocrine Tumors
Pancreatic Neuroendocrine Tumor (pNET), Extra-Pancreatic Neuroendocrine Tumor (epNET)
RecruitingPhase 1
A Study of LY4337713 in Participants With FAP-Positive Solid Tumors
Ovarian Neoplasms, Breast Neoplasms
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gregory Downing principal investigator
GMG Arcdata LLC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pancreas Cancer and Hepatobiliary Cancer, run by GMG Arcdata LLC at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mike Yea (30315232648, myea@gmgarcdata.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient Anxiety and Cognitive Burden (time frame: Up to 24 weeks). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2021.