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

NCT04018677 | Completed

• 2 other identifiers: IRB-44783VAR0182
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

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

Conditions

Cancer

Outcome Measures

Primary Outcomes (6)

• 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

Study Arms (2)

Beta Testing

EXPERIMENTAL

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

Usability testing

EXPERIMENTAL

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

Interventions

Use of TOGETHERCare app BEHAVIORAL

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.

Beta Testing; Usability testing

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Stanford University: lead
• National Institutes of Health (NIH): collaborator
• Medable Inc.: collaborator

Study Sites (1)

Stanford University

Stanford, California, 94304, United States

Location

Related 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):e22608. doi: 10.2196/22608.

  PMID: 34398787 RESULT

MeSH Terms

Conditions

Neoplasms

Study Officials

• Vasu Divi, MD

  Stanford University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: July 12, 2019
• Study Start: May 7, 2019
• Primary Completion: July 21, 2021
• Study Completion: June 25, 2022
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)