Trial Outcomes & Findings for Survivor mHealth: Wearable Devices in Cancer Survivors (NCT NCT05417438)

NCT ID: NCT05417438

Last Updated: 2024-09-19

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Baseline
• Results posted on: 2024-09-19

Participant Flow

Participant milestones

Measure	Wearable Device Deployment Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
Overall Study STARTED	31
Overall Study COMPLETED	28
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Measure	Wearable Device Deployment Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
Overall Study Withdrawal by Subject	3

Baseline Characteristics

Survivor mHealth: Wearable Devices in Cancer Survivors

Baseline characteristics by cohort

Measure	Wearable Device Deployment n=31 Participants Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
Age, Continuous	64.7 years STANDARD_DEVIATION 11.1 • n=5 Participants
Sex: Female, Male Female	17 Participants n=5 Participants
Sex: Female, Male Male	14 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	24 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	10 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Region of Enrollment United States	31 participants n=5 Participants
Education level High school or less	7 Participants n=5 Participants
Education level Some college	7 Participants n=5 Participants
Education level Bachelor's degree	6 Participants n=5 Participants
Education level Advanced college degree	11 Participants n=5 Participants
Cancer type Gynecologic	2 Participants n=5 Participants
Cancer type Thyroid	2 Participants n=5 Participants
Cancer type Colon	1 Participants n=5 Participants
Cancer type Prostate	9 Participants n=5 Participants
Cancer type Breast	4 Participants n=5 Participants
Cancer type Throat	2 Participants n=5 Participants
Cancer type Kidney	1 Participants n=5 Participants
Cancer type Blood	2 Participants n=5 Participants
Cancer type Skin	2 Participants n=5 Participants
Cancer type Unknown	6 Participants n=5 Participants
Annual Household income <$25,000	2 Participants n=5 Participants
Annual Household income $25,000 to $50,000	5 Participants n=5 Participants
Annual Household income $50,001 to $75,000	4 Participants n=5 Participants
Annual Household income >$75,000	18 Participants n=5 Participants
Annual Household income Unknown	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Wearable Device Deployment n=31 Participants Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
Feasibility of Enrollment	30 Participants

SECONDARY outcome

Timeframe: At study completion, within 3-months of enrollment

Population: Number of participants with validated wear-time.

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

Outcome measures

Measure	Wearable Device Deployment n=28 Participants Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
3-month Daily Step Count	6687 Steps/day Standard Deviation 3183

SECONDARY outcome

Timeframe: 1-month post-enrollment

Population: Completed 1-month usability survey.

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.

Outcome measures

Measure	Wearable Device Deployment n=25 Participants Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app. Wearable device deployment: 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.
1-Month Usability Overall APP Rating	3.79 units on a scale Standard Deviation 0.82

Adverse Events

Wearable Device Deployment

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Reem Najjar

UMass Chan Medical School

Phone: 7742750890

Email: Reem.najjar@umassmed.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place