Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis



Status:Completed
Conditions:Prostate Cancer, Cancer, Cancer, Cancer, Cancer, Brain Cancer, Neurology, ALS
Therapuetic Areas:Neurology, Oncology, Other
Healthy:No
Age Range:18 - Any
Updated:12/14/2017
Start Date:July 2015
End Date:October 2017

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This is a parallel group, single institution, prospective clinical study. The purpose of this
study is to assess whether the Jawbone Up 24, a consumer based accelerometer, can be a
feasible tool to study physical activity in cancer patients and patients with Amyotrophic
Lateral Sclerosis (ALS).


Inclusion Criteria:

- 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:

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
- 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:

- 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.
We found this trial at
1
site
2301 Erwin Rd
Durham, North Carolina 27710
919-684-8111
Duke Univ Med Ctr As a world-class academic and health care system, Duke Medicine strives...
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