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

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).

Study Overview

• Status: Completed
• Conditions: Prostate Cancer; Brain Cancer; ALS; Renal Cancer

• Study Type: Observational
• Enrollment (Actual): 40

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

This is a parallel group, single institution, prospective clinical study.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Compliance rate of cancer and ALS patients using the device during a 14 week period.	14 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Number of steps per day in cancer patients.	14 weeks
Karnofsky performance status in cancer patients.	14 weeks

Collaborators and Investigators

• Sponsor: Duke University

Study record dates

Study Major Dates

• Study Start: July 1, 2015
• Primary Completion (Actual): October 1, 2017
• Study Completion (Actual): October 1, 2017

Study Registration Dates

• First Submitted: May 20, 2015
• First Submitted That Met QC Criteria: May 27, 2015
• First Posted (Estimate): May 29, 2015

Study Record Updates

• Last Update Posted (Actual): December 12, 2017
• Last Update Submitted That Met QC Criteria: December 8, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neoplasms; Urologic Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Kidney Diseases; Urologic Diseases; Neuromuscular Diseases; Neurodegenerative Diseases; Spinal Cord Diseases; TDP-43 Proteinopathies; Proteostasis Deficiencies; Central Nervous System Neoplasms; Nervous System Neoplasms; Kidney Neoplasms; Motor Neuron Disease; Amyotrophic Lateral Sclerosis; Brain Neoplasms
• Other Study ID Numbers: Pro00063108