- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04575402
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients (DigiPRO)
July 27, 2021 updated by: Gillian Gresham, Cedars-Sinai Medical Center
Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors
Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
Physical function is a known predictor of QOL in advanced prostate cancer patients and key measure of treatment tolerability.
While treatment with Androgen Deprivation Therapy (ADT) improves survival, it is associated with significant toxicities that lead to physical function (PF) decline.
The average age of incident prostate cancer is 66 years, and in this older group of men, chronic comorbid conditions often co-occur with diagnosis, further adding to the risk for PF decline.
With over 2.9 million prostate cancer survivors in the US, there is an increasing demand for adequate symptom monitoring and PF assessment throughout cancer care.
However, there are currently no validated methods to systematically evaluate and predict PF decline.
Thus, the overarching objective of this proposal is to determine whether the use of wearable technology to monitor objective daily activity combined with routine symptom reporting can predict PF decline.
To accomplish this, we propose a mixed-methods approach that will provide quantitative information to help identify PC survivors at higher risk for PF decline as well as a qualitative aim gain a deeper understanding of the perceived relationships that PC survivors have with their physical activity levels and treatment symptoms.
Study Type
Observational
Enrollment (Anticipated)
40
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
California
-
Los Angeles, California, United States, 90048
- Recruiting
- Cedars Sinai Medical Center
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Sampling Method
Probability Sample
Study Population
Prostate cancer patients receiving ADT (+/- radiation) being seen for treatment at Cedars-Sinai Medical Center or the VA (Durham)
Description
Inclusion Criteria:
- Prostate cancer patients receiving ADT (+/- radiation) or planning to receive ADT. Start date of ADT must be planned for no more 7 days after baseline, or patients must have started ADT within 6 months prior to enrollment.
- 18 years or older
- Ambulatory (use of walking aids, such as cane and rollator, is acceptable)
- Access to a device that has the capability to sync to the Fitbit
- Have an understanding, ability, and willingness to fully comply with study procedures and restrictions
- English or Spanish speaking
- Informed consent obtained from subject and ability for subject to comply with the requirements of the study.
Exclusion Criteria:
- Using a pacemaker, implantable cardiac defibrillator, neurostimulator, implantable hearing aids, cochlear implants, or other electronic medical equipment. However, removable hearing aids are permitted.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
---|---|
CSMC prostate cancer patients receiving ADT
Prostate cancer patients recruited from oncology clinic at Cedars-Sinai Medical Center.
|
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)
Other Names:
|
Veterans with prostate cancer
Prostate cancer patients recruited from the Veteran Affairs Oncology Clinic (Durham, NC).
|
Continuous monitoring of physical activity including step counts, sleep, heart rate, with consumer-based wearable activity monitor (Fitbit Charge HR4 or similar model)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Physical function decline within 3 months from baseline
Time Frame: 3 months
|
Patient-reported physical function defined as 5-point change in standardized NIH PROMIS t-scores (mean 50, SD: 10), where higher scores represent higher physical function)
|
3 months
|
Absolute change in average step counts at 3 months from baseline
Time Frame: 3 months
|
Change will be calculated based on difference in average weekly step count at baseline from the average weekly step count at end-of-study visit as measured using a Fitbit activity monitor where mean weekly Fitbit activity values will be calculated
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean change in Fitbit 24-hour activity
Time Frame: 3 months
|
Change will be calculated based on difference in 24 hour activity as defined as periods of active minutes, sedentary time, and sleep at baseline and end-of-study
|
3 months
|
Key themes and concepts surrounding the relationships patients have with their treatment symptoms and how they affect their daily activity, as assessed in qualitative interviews.
Time Frame: 3 months
|
This is a qualitative endpoint assessed in individual patient interviews at end of study.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Collaborators
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
February 19, 2021
Primary Completion (ANTICIPATED)
September 30, 2022
Study Completion (ANTICIPATED)
December 31, 2022
Study Registration Dates
First Submitted
September 29, 2020
First Submitted That Met QC Criteria
September 29, 2020
First Posted (ACTUAL)
October 5, 2020
Study Record Updates
Last Update Posted (ACTUAL)
July 29, 2021
Last Update Submitted That Met QC Criteria
July 27, 2021
Last Verified
July 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IIT2020-15-GRESH-DIGIPRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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