CancerNCT04018677
TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources
A study testing Use of TOGETHERCare app in people with Cancer, run by Stanford University at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Cancer
- What is being tested?
- Use of TOGETHERCare app
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteUnited States
- Study dates
- 7 May 2019to 25 Jun 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Cancer
- Being tested
- Use of TOGETHERCare app
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Use of TOGETHERCare appBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Behavioral: Use of TOGETHERCare app |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess user experience with TOGETHER app
User experiences will be assessed by measuring overall experiences.
Measured: 1 year
Assess user experience with TOGETHER app
User experiences will be assessed by measuring module recommendation.
Measured: 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.
Measured: 1 year
Assess user experience with TOGETHER app
User experiences will be assessed by measuring problems with app use.
Measured: 1 year
Assess caregiver's experience with TOGETHER app
Caregiver's experience with TOGETHER app will be assessed for clarity of documentation.
Measured: 1 year
User documentation feedback
General feedback/recommendations for the app, including user documentation feedback.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2019
- Study start7 May 2019
- Primary completion21 Jul 2021
- Study completion25 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medable Inc.
- Responsible party
- Sponsor
- Investigators
- Vasu Divi, MD, Principal investigator, Stanford University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04018677
- Sponsor's protocol ID
- IRB-44783
- Other IDs
- VAR0182, IRB-44783
- Status last verified
- Aug 2023
- First submitted
- 18 Jun 2019
- Last updated
- 24 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34398787
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- TOGETHER: Track Outcomes and Guidance, Technology for Health and Effective Resources
- ClinicalTrials.gov ID
- NCT04018677
- Acronym / sponsor ID
- IRB-44783
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institutes of Health (NIH), Medable Inc.
- Study start
- 7 May 2019 (actual)
- Primary completion
- 21 Jul 2021 (actual)
- Study completion
- 25 Jun 2022 (actual)
- First posted
- 12 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Beta Testing | Experimental | Behavioral: Use of TOGETHERCare appFor 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. |
| Usability testing | Experimental | Behavioral: Use of TOGETHERCare appFor 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Adults (aged 18 years or older) who are either:
- 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.
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Use of TOGETHERCare appTOGETHERCare (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. | Behavioural | Beta Testing, Usability testing |
Primary outcome
Assess user experience with TOGETHER app
Time frame: 1 year
User experiences will be assessed by measuring overall experiences.
Assess user experience with TOGETHER app
Time frame: 1 year
User experiences will be assessed by measuring module recommendation.
Assess user experience with TOGETHER app
Time frame: 1 year
User experiences will be assessed by measuring dynamics/flow of app use, module recommendation, and general demographics.
Assess user experience with TOGETHER app
Time frame: 1 year
User experiences will be assessed by measuring problems with app use.
Assess caregiver's experience with TOGETHER app
Time frame: 1 year
Caregiver's experience with TOGETHER app will be assessed for clarity of documentation.
User documentation feedback
Time frame: 1 year
General feedback/recommendations for the app, including user documentation feedback.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2023.
- Results publication: PubMed 34398787Oakley-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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Vasu Divi, MD principal investigator
Stanford University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Use of TOGETHERCare app in people with Cancer, run by Stanford University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess user experience with TOGETHER app (time frame: 1 year). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04018677, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.