Clinical trial NCT03434535: A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
Official title: A Pilot Study of Remote Monitoring to Improve Health Related Quality of Life of Men Following Prostate Cancer Treatment.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Health-Related Quality Of Life
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
First posted: 2018-02-15
Enrollment: 9
Sex: MALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Health-Related Quality of Life
timeFrame: Baseline
measure: Health-Related Quality of Life
timeFrame: 1 month after baseline
measure: Health-Related Quality of Life
timeFrame: 2 months after baseline
measure: Health-Related Quality of Life
timeFrame: 3 months after baseline
Secondary outcomes:
Other outcomes:
Locations:
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
Study officials:
affiliation: Johns Hopkins University
name: Peter Searson, PhD
role: PRINCIPAL_INVESTIGATOR
References: