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

Sponsor
Duke University (Other)
Overall Status
Completed
CT.gov ID
NCT02457715
Collaborator
(none)
40
Enrollment
1
Location
27
Duration (Months)
1.5
Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    40 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
    Study Start Date :
    Jul 1, 2015
    Actual Primary Completion Date :
    Oct 1, 2017
    Actual Study Completion Date :
    Oct 1, 2017

    Arms and Interventions

    Arm Intervention/Treatment
    Prostate Cancer

    Subjects will use a Jawbone Up24 for 14 weeks.
    Renal Cancer

    Subjects will use a Jawbone Up24 for 14 weeks.
    Brain Cancer

    Subjects will use a Jawbone Up24 for 14 weeks.
    Amyotrophic Lateral Sclerosis (ALS)

    Subjects will use a Jawbone Up24 for 14 weeks.

    Outcome Measures

    Primary Outcome Measures

    1. Compliance rate of cancer and ALS patients using the device during a 14 week period. [14 weeks]

    Secondary Outcome Measures

    1. Number of steps per day in cancer patients. [14 weeks]

    2. Karnofsky performance status in cancer patients. [14 weeks]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Duke University Medical Center Durham North Carolina United States 27710

    Sponsors and Collaborators

    • Duke University

    Investigators

    • Principal Investigator: Michael Harrison, MD, Duke University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Duke University
    ClinicalTrials.gov Identifier:
    NCT02457715
    Other Study ID Numbers:
    • Pro00063108
    First Posted:
    May 29, 2015
    Last Update Posted:
    Dec 12, 2017
    Last Verified:
    Dec 1, 2017
    Additional relevant MeSH terms:
    Brain Neoplasms
    Kidney Neoplasms
    Motor Neuron Disease
    Amyotrophic Lateral Sclerosis

    Study Results

    No Results Posted as of Dec 12, 2017