Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
NCT ID: NCT02457715
Last Updated: 2017-12-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
40 participants
OBSERVATIONAL
2015-07-31
2017-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Prostate Cancer
Subjects will use a Jawbone Up24 for 14 weeks.
No interventions assigned to this group
Renal Cancer
Subjects will use a Jawbone Up24 for 14 weeks.
No interventions assigned to this group
Brain Cancer
Subjects will use a Jawbone Up24 for 14 weeks.
No interventions assigned to this group
Amyotrophic Lateral Sclerosis (ALS)
Subjects will use a Jawbone Up24 for 14 weeks.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* 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:
Prostate cancer:
* Histologically confirmed prostate cancer.
* Patients who are initiating any chemotherarpy (examples are docetaxel, cabazitaxel, etc.) and/or hormone directed treatment for prostate cancer. Examples of hormone directed therapy include GnRH agonist or antagonists (such as leuprolide, goserelin, triptorelin, histrelin and degarelix), androgen receptor blockers (such as bicalutamide or enzalutamide), or androgen biosynthesis inhibitors (such as abiraterone).
Renal cancer:
* Histologically confirmed renal cell carcinoma (RCC).
* Metastatic disease, in the opinion of the treating provider.
* Starting any systemic therapy for metastatic disease
Brain cancer:
* 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 \<or equal to 2 point decline in last month.
* 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 study.
* Patients will need a home computer or adaptor with USB port to charge the Jawbone Up 24.
Exclusion Criteria
* 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.
18 Years
ALL
No
Sponsors
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Duke University
OTHER
Responsible Party
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Principal Investigators
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Michael Harrison, MD
Role: PRINCIPAL_INVESTIGATOR
Duke University
Locations
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Duke University Medical Center
Durham, North Carolina, United States
Countries
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Other Identifiers
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Pro00063108
Identifier Type: -
Identifier Source: org_study_id