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AzTrials

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.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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
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
  • MedStar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

    Keith Unger, MD, 202-444-2223, KXU2@gunet.georgetown.edu

    Recruiting

Other trials in United States

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:

  1. Reducing the cognitive or time burden (or both) of navigation-related tasks performed by either patient navigators (PNs) or patients;
  2. Integrating seamlessly into the workflow of PNs and existing health information technology (IT) architecture; and
  3. 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:

  1. 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.
  2. 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.
  3. 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
Medical subject headings
Pancreatic Neoplasms, Patient Participation

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Patient Anxiety and Cognitive Burden

    Patient Health Questionnaire-2 (PHQ-2)

    Measured: Up to 24 weeks

  2. Patient Anxiety and Cognitive Burden

    Patient Health Questionnaire-9 (PHQ-9)

    Measured: Up to 24 weeks

  3. Time Burden

    Duration of task completion -- data within the app (time stamps)

    Measured: Through study completion, an average of 6 weeks

  4. Improved information sharing

    Presence/absence of critical information in app (e.g., imaging)

    Measured: Through study completion, an average of 8 weeks

  5. 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.

  1. First posted19 May 2021
  2. Study start3 May 2021
  3. Primary completion26 May 2021 (estimated)
  4. Study completion30 Jun 2021 (estimated)

Resources

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
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

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.

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