Clinical trial · Observational
Digitally Captured Activity Data and PROs to Monitor Physical Function in Prostate Cancer Patients
Evaluating the Role of Wearable Technology and Patient-reported Outcomes to Monitor Physical Function Decline in Prostate Cancer Survivors
NCT04575402CI-TRIAL-00080198DigiPROunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective observational research study to evaluate the role of wearable activity monitors to predict physical function decline among prostate cancer survivors receiving ADT.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Wearable Activity Monitor | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- CSMC prostate cancer patients receiving ADT
- description
- Prostate cancer patients recruited from oncology clinic at Cedars-Sinai Medical Center.
- interventionNames
- Other: Wearable Activity Monitor
- label
- Veterans with prostate cancer
- description
- Prostate cancer patients recruited from the Veteran Affairs Oncology Clinic (Durham, NC).
- interventionNames
- Other: Wearable Activity Monitor
Primary outcomes (2)
- measure
- Physical function decline within 3 months from baseline
- timeFrame
- 3 months
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- Male
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.