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TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources

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ClinicalTrials.gov Identifier: NCT04018677
Recruitment Status : Recruiting
First Posted : July 12, 2019
Last Update Posted : July 12, 2019
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Medable, Inc.
Information provided by (Responsible Party):
Stanford University

Brief Summary:

The goal of this project is to iteratively develop and test a TOGETHER pilot mobile app product in preparation for commercialization. TOGETHER is a mobile application on a smart software system that informal caregivers can use to develop and implement home-based care for cancer patients/survivors.

The Technical Objectives are to:

  1. Establish the project team and obtain stakeholder feedback on what to include in the product.
  2. Evaluate IT customization requirements and HIPAA compliance security, and privacy protocols.
  3. Develop a prototype to show NCI and then a pilot version for beta and usability testing among stakeholders.
  4. Enhance interoperability and test integration into health system(s) - if feasible.
  5. Develop user support documentation for stakeholders.

Condition or disease Intervention/treatment Phase
Cancer Device: TOGETHER Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 58 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources
Actual Study Start Date : May 7, 2019
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : May 2021

Arm Intervention/treatment
Experimental: TOGETHER app users
TOGETHER app will be downloaded on smart phone. Subjects will be asked to answer questions and/or perform activities on his/her smartphone device. Project information will include responses to surveys and giving additional feedback on app user experience.
Device: TOGETHER
TOGETHER is a mobile application software by Medable Inc.




Primary Outcome Measures :
  1. Assess user experience with TOGETHER app [ Time Frame: 1 year ]
    User experiences will be assessed by measuring overall experiences.

  2. Assess user experience with TOGETHER app [ Time Frame: 1 year ]
    User experiences will be assessed by measuring module recommendation.

  3. Assess user experience with TOGETHER app [ Time Frame: 1 year ]
    User experiences will be assessed by measuring dynamics/flow of app use, module recommendation, and general demographics.

  4. Assess user experience with TOGETHER app [ Time Frame: 1 year ]
    User experiences will be assessed by measuring problems with app use.

  5. Assess caregiver's experience with TOGETHER app [ Time Frame: 1 year ]
    Caregiver's experience with TOGETHER app will be assessed for clarity of documentation.

  6. User documentation feedback [ Time Frame: 1 year ]
    General feedback/recommendations for the app, including user documentation feedback.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Adults (aged 18 years or older) who are either:

    • Cancer patient/survivor receiving care or with plans to transition to care in the community setting.
    • Caregiver of cancer patient/survivor receiving care or with plans to transition to care in the community setting.
    • Clinician of cancer patient/survivor receiving care or with plans to transition to care in the community setting.
  • Cancer patient is a patient of Stanford Health Care.
  • Patient, Caregiver, and Clinician are willing to be connected on the app.
  • Have a smartphone and data plan that allows for app installation and usage.
  • Must speak, read and write in English, because all study materials and communication will be in English.

Exclusion Criteria:

  • Patient does not have a cancer diagnosis.
  • Cancer patient/survivor is not receiving care or does not have plans to transition to care in the community setting.
  • Cancer patient is not a patient of Stanford Health Care.
  • Patient, Caregiver, and Clinician are not willing to be connected on the app.
  • Unable to speak, read and write in English.
  • Does not have a smartphone nor data plan that allows for app installation and usage

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04018677


Contacts
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Contact: Rachel Mesia 650-723-7119 rmesia@stanford.edu

Locations
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United States, California
Stanford University Recruiting
Stanford, California, United States, 94304
Contact: Rachel Mesia         
Principal Investigator: Vasu Divi, MD         
Sponsors and Collaborators
Stanford University
National Institutes of Health (NIH)
Medable, Inc.
Investigators
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Principal Investigator: Vasu Divi, MD Stanford University

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Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT04018677     History of Changes
Other Study ID Numbers: IRB-44783
VAR0182 ( Other Identifier: OnCore )
IRB-44783 ( Other Identifier: Stanford IRB )
First Posted: July 12, 2019    Key Record Dates
Last Update Posted: July 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No