Prostate CancerNCT02457715
Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
An observational study of Prostate Cancer and Renal Cancer, run by Duke University at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Prostate Cancer, Renal Cancer, Brain Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Oct 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: This is a parallel group, single institution, prospective clinical study.
Who may be able to join
- 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).
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- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Medical Center
Durham, North Carolina, 27710
About this study
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).
- Conditions
- Prostate Cancer, Renal Cancer, Brain Cancer, ALS
- Medical subject headings
- Prostatic Neoplasms, Kidney Neoplasms, Brain Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Compliance rate of cancer and ALS patients using the device during a 14 week period.
Measured: 14 weeks
Secondary outcomes (2)
Number of steps per day in cancer patients.
Measured: 14 weeks
Karnofsky performance status in cancer patients.
Measured: 14 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2015 (estimated)
- Study startJul 2015
- Primary completionOct 2017
- Study completionOct 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michael Harrison, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02457715
- Sponsor's protocol ID
- Pro00063108
- Status last verified
- Dec 2017
- First submitted
- 20 May 2015
- Last updated
- 12 Dec 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of a Consumer Based Accelerometer in Monitoring Outpatient Physical Activity: A Study in Patients With Cancer and Amyotrophic Lateral Sclerosis
- ClinicalTrials.gov ID
- NCT02457715
- Acronym / sponsor ID
- Pro00063108
- Conditions
- Prostate Cancer, Renal Cancer, Brain Cancer, ALS
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- Jul 2015
- Primary completion
- Oct 2017 (actual)
- Study completion
- Oct 2017 (actual)
- First posted
- 29 May 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- This is a parallel group, single institution, prospective clinical study.
Key inclusion criteria (22 listed)
- 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:
- 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).
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Compliance rate of cancer and ALS patients using the device during a 14 week period.
Time frame: 14 weeks
2 secondary outcomes
Number of steps per day in cancer patients.
Time frame: 14 weeks
Karnofsky performance status in cancer patients.
Time frame: 14 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michael Harrison, MD principal investigator
Duke University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Prostate Cancer and Renal Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 22 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Compliance rate of cancer and ALS patients using the device during a 14 week period. (time frame: 14 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2017.