Expired Study
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Durham, North Carolina 27710


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).


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.


Study is Available At:


Original ID:

Pro00063108


NCT ID:

NCT02457715


Secondary ID:


Study Acronym:


Brief Title:

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


Official Title:

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


Overall Status:

Completed


Study Phase:

N/A


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

N/A


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Duke University


Oversight Authority:

United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Observational


Study Design:


Number of Arms:

0


Number of Groups:

4


Total Enrollment:

40


Enrollment Type:

Actual


Overall Contact Information

Official Name:Michael Harrison, MD
Principal Investigator
Duke University

Study Dates

Start Date:July 2015
Completion Date:October 2017
Completion Type:Actual
Primary Completion Date:October 2017
Primary Completion Type:Actual
Verification Date:December 2017
Last Changed Date:December 8, 2017
First Received Date:May 20, 2015

Study Outcomes

Outcome Type:Secondary Outcome
Measure:Karnofsky performance status in cancer patients.
Time Frame:14 weeks
Safety Issues:False
Outcome Type:Secondary Outcome
Measure:Number of steps per day in cancer patients.
Time Frame:14 weeks
Safety Issues:False
Outcome Type:Primary Outcome
Measure:Compliance rate of cancer and ALS patients using the device during a 14 week period.
Time Frame:14 weeks
Safety Issues:False

Study Interventions

There are no available Study Interventions

Study Arms

Study Arm Type:Other
Arm Name:Amyotrophic Lateral Sclerosis (ALS)
Description:Subjects will use a Jawbone Up24 for 14 weeks.
Study Arm Type:Other
Arm Name:Brain Cancer
Description:Subjects will use a Jawbone Up24 for 14 weeks.
Study Arm Type:Other
Arm Name:Renal Cancer
Description:Subjects will use a Jawbone Up24 for 14 weeks.
Study Arm Type:Other
Arm Name:Prostate Cancer
Description:Subjects will use a Jawbone Up24 for 14 weeks.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Duke University

Samples and Retentions

Study Population: This is a parallel group, single institution, prospective clinical study.
Sample Method:Non-Probability Sample

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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