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A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03434535
Recruitment Status : Completed
First Posted : February 15, 2018
Last Update Posted : December 13, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date  ICMJE February 6, 2018
First Posted Date  ICMJE February 15, 2018
Last Update Posted Date December 13, 2019
Actual Study Start Date  ICMJE July 11, 2018
Actual Primary Completion Date October 16, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 13, 2018)
  • Health-Related Quality of Life [ Time Frame: Baseline ]
    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.
  • Health-Related Quality of Life [ Time Frame: 1 month after baseline ]
    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.
  • Health-Related Quality of Life [ Time Frame: 2 months after baseline ]
    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.
  • Health-Related Quality of Life [ Time Frame: 3 months after baseline ]
    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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
Official Title  ICMJE A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
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.
Detailed Description 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. All participants will complete a health-related quality of life survey each month for 3 months. The digital survey will be administered on a programmed tablet. The participants in the intervention group 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. Health-related quality of life will be compared between participants in the intervention group, who receive (1) tools to monitor their activity and weight and (2) personalized feedback, versus participants in the control group, who receive standard of care. The potential improved adherence to healthy behaviors of the participants receiving personalized feedback may translate to to improved health-related quality of life.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Other
Condition  ICMJE Health-Related Quality Of Life
Intervention  ICMJE Device: Technology Intervention
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.
Other Names:
  • Fitbit Alta HR
  • Fitbit Aria
Study Arms  ICMJE
  • Experimental: 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. 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.
    Intervention: Device: Technology Intervention
  • No Intervention: Control
    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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 25, 2019)
9
Original Estimated Enrollment  ICMJE
 (submitted: February 13, 2018)
20
Actual Study Completion Date  ICMJE October 16, 2019
Actual Primary Completion Date October 16, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • Anyone who is unable to give informed consent will be excluded
  • Anyone who is physically unable to participate in physical activity will be excluded.
Sex/Gender  ICMJE
Sexes Eligible for Study: Male
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03434535
Other Study ID Numbers  ICMJE IRB00156374
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Johns Hopkins University
Study Sponsor  ICMJE Johns Hopkins University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Peter Searson, PhD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date December 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP