Melanoma (Skin)NCT03518229
Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
A study testing Microsoft Band 2 + UV messaging and Microsoft Band 2 in people with Melanoma (Skin), run by University of Minnesota.
Trial summary
This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Melanoma (Skin)
- What is being tested?
- Microsoft Band 2 + UV messaging and Microsoft Band 2
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2020to May 2021
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old
- Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
- Able to read/write in English
- Own a smartphone
- Able to provide voluntary informed consent
Who cannot join
- -Patients currently undergoing adjuvant therapy.
About this study
This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.
- Conditions
- Melanoma (Skin)
- Being tested
- Microsoft Band 2 + UV messaging, Microsoft Band 2
- Keywords
- cancer prevention, sunburn
- Medical subject headings
- Melanoma, Sunburn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microsoft Band 2 + UV messagingDevice
wearable device (wrist) and associated mobile application; UV sensor and messaging activated
Microsoft Band 2Device
wearable device (wrist) and associated mobile application; UV messaging not activated
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | Microsoft Band 2 application with UV messaging activated Receives: Device: Microsoft Band 2 + UV messaging |
| Control | Active comparator | Microsoft Band 2 application (UV messaging not active) Receives: Device: Microsoft Band 2 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Sunburn
Self-report of a sunburn during study period
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 May 2018
- Study startFeb 2020 (estimated)
- Primary completionSep 2020 (estimated)
- Study completionMay 2021 (estimated)
Why it stopped: Converted from a pilot into a larger study which we will enter as a new protocol
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Melanoma (Skin)Studies of the same condition, open and under way.
- More trials run by University of MinnesotaThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Minnesota
- Sponsor type
- University, hospital or other
- Collaborators
- Melanoma Research Alliance
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03518229
- Sponsor's protocol ID
- STUDY00002107
- Status last verified
- Apr 2019
- First submitted
- 25 Apr 2018
- Last updated
- 17 Apr 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study of Intervention to Reduce Sunburns in Melanoma Survivors
- ClinicalTrials.gov ID
- NCT03518229
- Acronym / sponsor ID
- STUDY00002107
- Conditions
- Melanoma (Skin)
- Keywords
- cancer prevention, sunburn
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Converted from a pilot into a larger study which we will enter as a new protocol
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of MinnesotaUniversity, hospital or other
- Collaborators
- Melanoma Research Alliance
- Study start
- Feb 2020 (estimated)
- Primary completion
- Sep 2020 (estimated)
- Study completion
- May 2021 (estimated)
- First posted
- 8 May 2018 (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.
This project will pilot test whether a wearable device that tracks sun exposure and provides alerts regarding sun exposure and protection behaviors will reduce sunburns in melanoma survivors. The use of wearable technology devices has grown quickly over the last decade and studies using these devices to promote physical activity and weight loss have been promising. The investigators will pilot test the technology device versus a similar control device in 80 melanoma survivors and compare sunburns between the two groups after the three month intervention.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Microsoft Band 2 + UV messagingMicrosoft Band 2 application with UV messaging activated |
| Control | Active comparator | Device: Microsoft Band 2Microsoft Band 2 application (UV messaging not active) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 18-75 years old
- Diagnosed with stage I-III cutaneous invasive melanoma between 2009 and 2017 and treated at the University of Minnesota
- Able to read/write in English
- Own a smartphone
- Able to provide voluntary informed consent
Key exclusion criteria (1 listed)
- -Patients currently undergoing adjuvant therapy.
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 |
|---|---|---|
| Microsoft Band 2 + UV messagingwearable device (wrist) and associated mobile application; UV sensor and messaging activated | Device | Intervention |
| Microsoft Band 2wearable device (wrist) and associated mobile application; UV messaging not activated | Device | Control |
Primary outcome
Sunburn
Time frame: 3 months
Self-report of a sunburn during study period
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2019.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Microsoft Band 2 + UV messaging and Microsoft Band 2 in people with Melanoma (Skin), run by University of Minnesota.
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 5 inclusion and 1 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: withdrawn, as of the sponsor's last update on 17 Apr 2019. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Sunburn (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Apr 2019.