Clinical trial NCT02457715: Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
Official title: Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Prostate Cancer
Renal Cancer
Brain Cancer
ALS
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2015-05-29
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: This is a parallel group, single institution, prospective clinical study.

Brief summary: 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).


Eligibility criteria: 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 \<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:

* 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.

Primary outcomes:
measure: Compliance rate of cancer and ALS patients using the device during a 14 week period.
timeFrame: 14 weeks
Secondary outcomes:
measure: Number of steps per day in cancer patients.
timeFrame: 14 weeks
measure: Karnofsky performance status in cancer patients.
timeFrame: 14 weeks
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke University Medical Center
state: North Carolina
Study officials:
affiliation: Duke University
name: Michael Harrison, MD
role: PRINCIPAL_INVESTIGATOR
References: