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

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

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

Conditions
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Cancer

Intervention / Treatment
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* Behavioral: Use of TOGETHERCare app


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Beta Testing<br>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<br>* 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.<br>|
| Experimental: Usability testing<br>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<br>* 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.<br>|

What is the study measuring?
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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 |