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Trial record 1 of 9 for:    ALS Duke | Recruiting, Not yet recruiting, Available Studies
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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

This study is currently recruiting participants.
Verified April 2017 by Duke University
Sponsor:
ClinicalTrials.gov Identifier:
NCT02457715
First Posted: May 29, 2015
Last Update Posted: May 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Duke University
  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).

Condition
Prostate Cancer Renal Cancer Brain Cancer ALS

Study Type: Observational
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Duke University:

Primary Outcome Measures:
  • Compliance rate of cancer and ALS patients using the device during a 14 week period. [ Time Frame: 14 weeks ]

Secondary Outcome Measures:
  • Number of steps per day in cancer patients. [ Time Frame: 14 weeks ]
  • Karnofsky performance status in cancer patients. [ Time Frame: 14 weeks ]

Estimated Enrollment: 50
Study Start Date: July 2015
Estimated Study Completion Date: July 2017
Estimated Primary Completion Date: July 2017 (Final data collection date for primary outcome measure)
Groups/Cohorts
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.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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 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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02457715


Contacts
Contact: Michael Harrison, MD michael.harrison@duke.edu
Contact: Julia Rasmussen 919-681-9822 julia.rasmussen@dm.duke.edu

Locations
United States, North Carolina
Duke University Medical Center Recruiting
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Investigators
Principal Investigator: Michael Harrison, MD Duke University
  More Information

Responsible Party: Duke University
ClinicalTrials.gov Identifier: NCT02457715     History of Changes
Other Study ID Numbers: Pro00063108
First Submitted: May 20, 2015
First Posted: May 29, 2015
Last Update Posted: May 4, 2017
Last Verified: April 2017

Additional relevant MeSH terms:
Amyotrophic Lateral Sclerosis
Sclerosis
Motor Neuron Disease
Brain Neoplasms
Kidney Neoplasms
Carcinoma, Renal Cell
Pathologic Processes
Neurodegenerative Diseases
Nervous System Diseases
Neuromuscular Diseases
Spinal Cord Diseases
Central Nervous System Diseases
TDP-43 Proteinopathies
Proteostasis Deficiencies
Metabolic Diseases
Central Nervous System Neoplasms
Nervous System Neoplasms
Neoplasms by Site
Neoplasms
Brain Diseases
Urologic Neoplasms
Urogenital Neoplasms
Kidney Diseases
Urologic Diseases
Adenocarcinoma
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type