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

Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04018677
• Other study ID #: IRB-44783
• Secondary ID: VAR0182IRB-44783
• Status: Completed
• Phase: N/A
• Start date: May 7, 2019
• Est. completion date: June 25, 2022

Study information

• Verified date: August 2023
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 14
• Est. completion date: June 25, 2022
• Est. primary completion date: July 21, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Cancer

Intervention

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.

Locations

Country	Name	City	State
United States	Stanford University	Stanford	California

Sponsors (3)

Lead Sponsor	Collaborator
Stanford University	Medable Inc., National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

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):e226 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Assess user experience with TOGETHER app	User experiences will be assessed by measuring overall experiences.	1 year
Primary	Assess user experience with TOGETHER app	User experiences will be assessed by measuring module recommendation.	1 year
Primary	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
Primary	Assess user experience with TOGETHER app	User experiences will be assessed by measuring problems with app use.	1 year
Primary	Assess caregiver's experience with TOGETHER app	Caregiver's experience with TOGETHER app will be assessed for clarity of documentation.	1 year
Primary	User documentation feedback	General feedback/recommendations for the app, including user documentation feedback.	1 year