Clinical trial NCT04018677: TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources
Official title: TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cancer
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: Medable Inc.
First posted: 2019-07-12
Enrollment: 14
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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

Primary outcomes:
measure: Assess user experience with TOGETHER app
timeFrame: 1 year
measure: Assess user experience with TOGETHER app
timeFrame: 1 year
measure: Assess user experience with TOGETHER app
timeFrame: 1 year
measure: Assess user experience with TOGETHER app
timeFrame: 1 year
measure: Assess caregiver's experience with TOGETHER app
timeFrame: 1 year
measure: User documentation feedback
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
Study officials:
affiliation: Stanford University
name: Vasu Divi, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.