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NCT Number: NCT05417438

Survivor mHealth: Wearable Devices 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.

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Key information

Conditions

Cancer Behavior Cardiovascular Diseases Communication Motor Activity Neoplasms

Age range

18 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wearable device deployment

Behavioral

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.

Primary outcomes

  1. 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.

Secondary outcomes

  1. 3-month Daily Step Count

    Time frame: At study completion, within 3-months of enrollment

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

  2. 1-Month Usability Overall APP Rating

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Massachusetts, Worcester

Other

Collaborators

  • National Cancer Institute (NCI)
  • National Heart, Lung, and Blood Institute (NHLBI)

Registry information

Official study title

Survivor mHealth: Assessing Feasibility of a Wearable Device and App in Cancer Survivors

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2022
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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