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

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.

Study Overview

• Status: Completed
• Conditions: Cancer
• Intervention / Treatment: Behavioral: Use of TOGETHERCare app

• Study Type: Interventional
• Enrollment (Actual): 14
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rachel Mesia; Phone Number: 650-723-7119; Email: rmesia@stanford.edu

Study Locations

• United States
  • California
    • Stanford, California, United States, 94304
      • Stanford University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Sequential Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Beta Testing; For the beta testing, input will be provided by cancer patient/survivor, caregivers, and clinicians. 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.	Behavioral: Use of TOGETHERCare app; TOGETHERCare (Medable Inc.) is a mobile software application on a smart software system that informal caregivers can use to develop and implement home-based care for cancer patients/survivors. It is intended to improve the care experience by helping to alleviate the cancer care-giving burden and facilitate communication with patients' healthcare teams by centering the conversation around a care plan.
Experimental: Usability testing; For the usability testing, caregivers will be the primary type of stakeholder providing input. 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.	Behavioral: Use of TOGETHERCare app; TOGETHERCare (Medable Inc.) is a mobile software application on a smart software system that informal caregivers can use to develop and implement home-based care for cancer patients/survivors. It is intended to improve the care experience by helping to alleviate the cancer care-giving burden and facilitate communication with patients' healthcare teams by centering the conversation around a care plan.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Assess user experience with TOGETHER app	User experiences will be assessed by measuring overall experiences.	1 year
Assess user experience with TOGETHER app	User experiences will be assessed by measuring module recommendation.	1 year
Assess user experience with TOGETHER app	User experiences will be assessed by measuring dynamics/flow of app use, module recommendation, and general demographics.	1 year
Assess user experience with TOGETHER app	User experiences will be assessed by measuring problems with app use.	1 year
Assess caregiver's experience with TOGETHER app	Caregiver's experience with TOGETHER app will be assessed for clarity of documentation.	1 year
User documentation feedback	General feedback/recommendations for the app, including user documentation feedback.	1 year

Collaborators and Investigators

• Sponsor: Stanford University
• Collaborators: National Institutes of Health (NIH); Medable Inc.
• Investigators: Principal Investigator: Vasu Divi, MD, Stanford University

Publications and helpful links

General Publications

• Oakley-Girvan I, Davis SW, Kurian A, Rosas LG, Daniels J, Palesh OG, Mesia RJ, Kamal AH, Longmire M, Divi V. Development of a Mobile Health App (TOGETHERCare) to Reduce Cancer Care Partner Burden: Product Design Study. JMIR Form Res. 2021 Aug 13;5(8):e22608. doi: 10.2196/22608.

Study record dates

Study Major Dates

• Study Start (Actual): May 7, 2019
• Primary Completion (Actual): July 21, 2021
• Study Completion (Actual): June 25, 2022

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: July 11, 2019
• First Posted (Actual): July 12, 2019

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 22, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: IRB-44783 (Other Identifier: Stanford IRB); VAR0182 (Other Identifier: OnCore)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No