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|NCT02457715 : Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis|
|Ages||Min: 18 Years Max: N/A|
- Patients > = 18 years of age.
- Patient must be able to ambulate and complete the 6 minute walk test without use of a
walker, cane, or any assist devices.
- Cancer patients or ALS patients who meet the following criteria:
- Histologically confirmed prostate cancer.
- Patients who are initiating any hormone directed treatment for prostate cancer.
Examples include GnRH agonist or antagonists (such as leuprolide, goserlin,
triptorelin, histrelin and degarelix), androgen receptor blockers (such as
bicalutamide or enzalutamide), or androgen biosynthesis inhibitors (such as
- Histologically confirmed renal cell carcinoma (RCC).
- Metastatic disease, in the opinion of the treating provider.
- No prior systemic therapy for metastatic RCC.
- Starting systemic therapy with an anti-VEGF agent (ie, sunitinib, pazopanib, etc.).
- Histologically confirmed high grade glioma.
- Status post concurrent radiation therapy and daily temozolomide.
- Starting adjuvant temozolomide therapy.
ALS patients who are:
- Already on a stable dose of Riluzole for at least one month.
- ALSFRS-R with
- Must have ALSFRS-R walking score of at least 3 or 4 and FVC at least 50% (to ensure
patients are fit enough for ambulation and physical activity).
- Technology requirement:
- Patients will need to own a smart phone that can interface with the Jawbone Up 24.
- Patients willing to provide their own internet access for this study. This will
include either a data plan or Wi-Fi access on the patient's smart phone for use of
the Jawbone App. They will also need internet access (through their smart phone or
home computer) for setting up a SGHIx account. Patients are welcome to use the free
guest Wi-Fi access within the Duke Outpatient clinic area for the purpose of this
- Patients will need a home computer or adaptor with USB port to charge the Jawbone Up
- Non-English Speaking or inability to read and understand English
- Presence of cardiovascular disease that would make physical activity risky at the
discretion of the provider.
- Any patient who is unable to comprehend and operate the activity tracker at the
discretion of the enrolling provider.
|Links||Permanent Link to THIS page: https://virtualtrials.com/nct/display1trial.cfm?nct=NCT02457715
| Link to official Clinicaltrials.gov listing