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

Study Purpose:

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).

Disease:

Amyotrophic Lateral Sclerosis (ALS),  Familial ALS,  Sporadic ALS, Other

Study Type:

Observational Study

Study Category:

Device

Study Status:

Active, currently recruiting

Phase:

Not Applicable

Study Chair(s)/Principal Investigator(s):

Michael Harrison, MD Duke University

Clinicaltrials.gov ID (11 digit #):

NCT02457715

Neals Affiliated?

No

Coordinating Center Contact Information

Duke University Medical Center
Michael Harrison; Julia Rasmussen / .(JavaScript must be enabled to view this email address) / 919-681-9822
.(JavaScript must be enabled to view this email address) Durham, North Carolina 27710 United States

Full Study Summary:

Primary Outcome Measures:
Compliance rate of cancer and ALS patients using the device during a 14 week period. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
Number of steps per day in cancer patients. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]
Karnofsky performance status in cancer patients. [ Time Frame: 14 weeks ] [ Designated as safety issue: No ]

Study Sponsor:

Duke University

Participant Duration:

14 weeks

Estimated Enrollment:

50

Estimated Study Start Date:

06/30/2015

Estimated Study Completion Date:

06/30/2017

Posting Last Modified Date:

11/02/2016

Date Study Added to alsconsortium.org:

08/19/2015
  • More Information
  • Eligibility Criteria

    Gender:

    Female, Male

    Minimum Age:

    18

    Maximum Age:

    N/A

    Min Vital Capacity (% predicted normal):

    60

    Time since Symptom Onset:

    Time since Diagnosis:

    Can participants use Riluzole?

    Yes


    Study Population
    This is a parallel group, single institution, prospective clinical study.
    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 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 abiraterone).

    Renal cancer:
    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.).

    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 60% (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.

  • Site Contact Information

    Duke University Medical Center
    Michael Harrison; Julia Rasmussen / .(JavaScript must be enabled to view this email address) / 919-681-9822
    Durham, North Carolina 27710
    United States