NCT03434535

Brief Summary

The purpose of this study is to determine the feasibility of using digital technology and remote monitoring to track health-related measures in men following prostate cancer treatment. Half of the participants will receive tools to monitor their activity and weight, as well as personalized feedback on these measures, while the other half will receive standard of care. Health related quality of life measure will be collected from both groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
9

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2018

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

February 6, 2018

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 15, 2018

Completed
5 months until next milestone

Study Start

First participant enrolled

July 11, 2018

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 16, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 16, 2019

Completed
Last Updated

December 13, 2019

Status Verified

December 1, 2019

Enrollment Period

1.3 years

First QC Date

February 6, 2018

Last Update Submit

December 11, 2019

Conditions

Health-Related Quality Of Life

Outcome Measures

Primary Outcomes (4)

  • Health-Related Quality of Life

    36-Item Short Form (SF) Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    Baseline

  • Health-Related Quality of Life

    36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    1 month after baseline

  • Health-Related Quality of Life

    36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    2 months after baseline

  • Health-Related Quality of Life

    36-Item Short Form Survey. This survey is a patient-reported survey of patient health. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section and the scores range from 0-100. A score of 0 is equivalent to maximum disability and a score of 100 is equivalent to no disability.

    3 months after baseline

Study Arms (2)

Intervention

EXPERIMENTAL

The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months. They will also receive an activity sensor and weight scale. Health state data from this group will be generated over a 3-6 month period and remotely monitored. These data will be used to provide personalized feedback regarding the participant's progress towards established goals.

Device: Technology Intervention

Control

NO INTERVENTION

The participants will complete a digital health-related quality of life survey on a programmed tablet at baseline and each month for the following 3-6 months.

Interventions

Technology InterventionDEVICE

A combination of existing technology and a new app developed by InHealth Measurement Corp to (1) remotely monitor a participant's activity level and weight and (2) remotely provide updates to the participants regarding their progress towards the goals established in the Prostate Cancer Foundation Health and Wellness guidelines.

Also known as: Fitbit Alta HR, Fitbit Aria
Intervention

Eligibility Criteria

Sexmale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Participants must have localized prostate cancer.
  • Participants must have received treatment at Johns Hopkins
  • Participants must be classified as overweight (body mass index ≥ 25).
  • Participants must have wi-fi in their homes.

You may not qualify if:

  • Anyone who is unable to give informed consent will be excluded
  • Anyone who is physically unable to participate in physical activity will be excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Study Officials

  • Peter Searson, PhD

    Johns Hopkins University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 6, 2018

First Posted

February 15, 2018

Study Start

July 11, 2018

Primary Completion

October 16, 2019

Study Completion

October 16, 2019

Last Updated

December 13, 2019

Record last verified: 2019-12

Locations

US(1)