NCT05417438

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at below P25 for not_applicable cancer

Timeline
Completed

Started Jan 2023

Shorter than P25 for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 3, 2022

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 14, 2022

Completed
7 months until next milestone

Study Start

First participant enrolled

January 15, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2023

Completed
15 days until next milestone

Study Completion

Last participant's last visit for all outcomes

October 15, 2023

Completed
11 months until next milestone

Results Posted

Study results publicly available

September 19, 2024

Completed
Last Updated

September 19, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

June 3, 2022

Results QC Date

April 18, 2024

Last Update Submit

August 23, 2024

Conditions

CancerCardiovascular Diseases

Keywords

Physical activityWearableCommunication

Outcome Measures

Primary Outcomes (1)

  • 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.

    Baseline

Secondary Outcomes (2)

  • 3-month Daily Step Count

    At study completion, within 3-months of enrollment

  • 1-Month Usability Overall APP Rating

    1-month post-enrollment

Study Arms (1)

Wearable device deployment

EXPERIMENTAL

Participants will be enrolled in the experimental trial to receive Fitbits and a smartphone app.

Behavioral: Wearable device deployment

Interventions

Wearable device deploymentBEHAVIORAL

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.

Wearable device deployment

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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
  • Are a current UMass Memorial Cancer Clinic patient navigator, oncologist, radiologist, or cardiologist
  • Consent to participate
  • Not currently employed at UMass Memorial
  • Not involved in direct treatment of care coordination of cancer patients

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Massachusetts Chan Medical School

Worcester, Massachusetts, 01605, United States

Location

MeSH Terms

Conditions

NeoplasmsCardiovascular DiseasesMotor ActivityCommunication

Condition Hierarchy (Ancestors)

Behavior

Results Point of Contact

Title
Reem Najjar
Organization
UMass Chan Medical School
Reem.najjar@umassmed.edu
7742750890

Study Officials

  • Jamie M Faro, PhD

    University of Massachusetts Chan Medical School

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 3, 2022

First Posted

June 14, 2022

Study Start

January 15, 2023

Primary Completion

September 30, 2023

Study Completion

October 15, 2023

Last Updated

September 19, 2024

Results First Posted

September 19, 2024

Record last verified: 2024-08

Data Sharing

IPD Sharing
Will not share

Locations

US(1)