CancerNCT05417438
Survivor mHealth: Wearable Devices in Cancer Survivors
A study testing Wearable device deployment in people with Cancer and Cardiovascular Diseases, run by University of Massachusetts, Worcester at 1 site in United States.
Trial summary
The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Cancer, Cardiovascular Diseases
- What is being tested?
- Wearable device deployment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2023to 15 Oct 2023
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Aims 1 and 2 Inclusion Criteria:
- Past cancer diagnosis
- At least 18 years of age
- Capacity to provide informed consent
- Medically cleared to perform physical activity (as noted by Physical Activity Readiness Questionnaire form or physician's clearance if needed)
- Owns a smartphone
Aims 1 and 2 Exclusion Criteria:
- Is a prisoner
- Non-English speaking
- Is unable to provide consent
- Under 18 years of age
- No prior cancer diagnosis
- Does not own a smartphone
Aim 3 Inclusion Criteria:
- Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist
- Consent to participate
Aim 3 Exclusion Criteria:
- Not currently employed at UMass Memorial
- Not involved in direct treatment of care coordination of cancer patients
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Massachusetts Chan Medical School
Worcester, Massachusetts, 01605
About this study
Official title: Survivor mHealth: Assessing Feasibility of a Wearable Device and App in Cancer Survivors
The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. The Fitbit will be synced to the app and participants will receive messages and notifications about their activity levels. Participants will also complete surveys through the app asking how useful it is and ways to improve it. The study team will conduct qualitative interviews at the completion of the 3 months to see how participants liked the program, and ways it can be improved and make it more specific to cancer survivors. The study team will also conduct interviews with providers and clinic staff to assess their perceptions of patient digital health programs and preferences for receiving patient-generated health data.
- Conditions
- Cancer, Cardiovascular Diseases
- Being tested
- Wearable device deployment
- Keywords
- Physical activity, Wearable, Communication
- Medical subject headings
- Neoplasms, Cardiovascular Diseases, Motor Activity, Communication
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Wearable device deploymentBehavioural
Participants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection.
| Study group | Role | What they receive |
|---|---|---|
| Wearable device deployment | Experimental | Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Receives: Behavioral: Wearable device deployment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Enrollment
Feasibility will be determined by a participant meeting all three criteria: 1) Enrollment in trial, 2) completion of baseline measures, and 3) Fitbit sync to app.
Measured: Baseline
Secondary outcomes (2)
3-month Daily Step Count
The mean number of steps taken per day during week 12 of the intervention.
Measured: At study completion, within 3-months of enrollment
1-Month Usability Overall APP Rating
Mobile Application Rating Scale (MARS). The Rating scale assesses app quality on four dimensions. All items are rated on a 5-point scale from "1.Inadequate" to "5.Excellent". The mean was taken from the overall app usability question and reported. A higher score indicates greater user acceptability of the app. The lowest possible score is a 1, and the highest possible score is a 5.
Measured: 1-month post-enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2022
- Study start15 Jan 2023
- Primary completion30 Sep 2023
- Study completion15 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by University of Massachusetts, WorcesterThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Massachusetts, Worcester
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jamie Faro, University of Massachusetts, Worcester
- Investigators
- Jamie M Faro, PhD, Principal investigator, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05417438
- Sponsor's protocol ID
- H00023545
- Other IDs
- 5P50CA244693-02, 1K12HL138049-01
- Status last verified
- Aug 2024
- First submitted
- 3 Jun 2022
- Last updated
- 19 Sep 2024
- Results posted
- Yes, on ClinicalTrials.gov
- 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 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Survivor mHealth: Assessing Feasibility of a Wearable Device and App in Cancer Survivors
- ClinicalTrials.gov ID
- NCT05417438
- Acronym / sponsor ID
- H00023545
- Conditions
- Cancer, Cardiovascular Diseases
- Keywords
- Physical activity, Wearable, Communication
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- University of Massachusetts, WorcesterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), National Heart, Lung, and Blood Institute (NHLBI)
- Study start
- 15 Jan 2023 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 15 Oct 2023 (actual)
- First posted
- 14 Jun 2022 (actual)
- Results
- Posted 19 Sep 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The Survivor mobile health (mHealth) study is testing the use of wearable devices (Fitbits) and a smartphone application in cancer survivors. The goal of the program is to increase survivor's physical activity levels. The Fitbit will be synced to the app and participants will receive messages and notifications about their activity levels. Participants will also complete surveys through the app asking how useful it is and ways to improve it. The study team will conduct qualitative interviews at the completion of the 3 months to see how participants liked the program, and ways it can be improved and make it more specific to cancer survivors. The study team will also conduct interviews with providers and clinic staff to assess their perceptions of patient digital health programs and preferences for receiving patient-generated health data.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wearable device deployment | Experimental | Behavioral: Wearable device deploymentParticipants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
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 |
|---|---|---|
| Wearable device deploymentParticipants will receive a Fitbit to be synced with a smartphone app (MyDataHelps). Participants will receive push notifications to complete surveys via the MyDataHelps app. The Fitbit will sync with the app for data collection. | Behavioural | Wearable device deployment |
Primary outcome
Feasibility of Enrollment
Time frame: Baseline
Feasibility will be determined by a participant meeting all three criteria: 1) Enrollment in trial, 2) completion of baseline measures, and 3) Fitbit sync to app.
2 secondary outcomes
3-month Daily Step Count
Time frame: At study completion, within 3-months of enrollment
1-Month Usability Overall APP Rating
Time frame: 1-month post-enrollment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- 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.
Jamie M Faro, PhD principal investigator
University of Massachusetts, Worcester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Wearable device deployment in people with Cancer and Cardiovascular Diseases, run by University of Massachusetts, Worcester 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?
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 19 Sep 2024. 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?
Yes. Results are posted in the registry (first posted 19 Sep 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Feasibility of Enrollment (time frame: Baseline). 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 19 Sep 2024.