NCT05417438

Survivor mHealth: Wearable Devices in Cancer Survivors

Completed NA Results posted Last updated 19 September 2024

What this trial tests

NA trial testing Wearable device deployment in Cancer in 31 participants. Completed in 15 October 2023.

Timeline

15 January 2023

Primary endpoint
30 September 2023

15 October 2023

Quick facts

Lead sponsor	University of Massachusetts, Worcester
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	supportive care
Enrollment	31
Start date	15 January 2023
Primary completion	30 September 2023
Estimated completion	15 October 2023
Sites	1 location across United States

Drugs / interventions tested

• Wearable device deployment

Conditions studied

• Cancer — all drugs for Cancer →
• Cardiovascular Diseases — all drugs for Cardiovascular Diseases →

Sponsor

University of Massachusetts, Worcester

Who can join

Adults 18 to 100, any sex, with Cancer or Cardiovascular Diseases. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Feasibility of Enrollment Primary · 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.

Group	Value	95% CI
Wearable Device Deployment	30

3-month Daily Step Count Secondary · At study completion, within 3-months of enrollment

The mean number of steps taken per day during week 12 of the intervention.

Group	Value	95% CI
Wearable Device Deployment	6687	± 3183

1-Month Usability Overall APP Rating Secondary · 1-month post-enrollment

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.

Group	Value	95% CI
Wearable Device Deployment	3.79	± 0.82

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrating Artificial Intelligence-Driven Wearable Technology in Oncology Decision-Making: A Narrative Review.
   Birla M, Rajan, Roy PG, Gupta I, et al · · 2025 · cited 14× · PMID 39072365 · DOI 10.1159/000540494
2. Usability and Implementation Considerations of Fitbit and App Intervention for Diverse Cancer Survivors: Mixed Methods Study.
   Dabbagh Z, Najjar R, Kamberi A, Gerber BS, et al · · 2025 · cited 2× · PMID 39993013 · DOI 10.2196/60034