Breast CancerNCT03350854
Improving Decision Role Concordance in Newly Diagnosed Breast Cancer Patients
A study testing Patient Preference in Treatment Decision Making in people with Breast Cancer, run by University of Utah.
Trial summary
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Patient Preference in Treatment Decision Making
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- No sites listed yet
- Study dates
- 7 Mar 2016to 9 Aug 2017
- Phase
- Interventional
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Who cannot join
- Men with breast cancer.
- Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
About this study
Official title: An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.
Read the detailed description
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.
The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:
Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:
- Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.
- The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.
- Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments
- Conditions
- Breast Cancer
- Being tested
- Patient Preference in Treatment Decision Making
- Keywords
- early stage breast cancer;, treatment decision making, newly diagnosed breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Patient Preference in Treatment Decision MakingBehavioural
The roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group.
| Study group | Role | What they receive |
|---|---|---|
| The non-intervention control group | No intervention | In the non-intervention control group, providers are blind to the patient's preferred decision making role. |
| The intervention group | Experimental | The provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group. Receives: Behavioral: Patient Preference in Treatment Decision Making |
What is being measured
The primary outcome is the main question the study is designed to answer.
Decision role concordance before and after a surgical consultation
The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.
Measured: The estimated period is 3 hours (before and immediately after a surgical consultation)
Decision role concordance of provider and patient
It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.
Measured: This is an one-time measurement (Immediately after a surgical consultation)
Secondary outcomes (5)
Patient's satisfaction with the decision making process
Satisfaction with the decision making process will be measured directly after the clinic encounter using a modified version of the Holmes-Rovner Satisfaction with Decision scale. The scale uses a Likert-type ranking of 6 items related to decision making, with 1 being strongly disagree and 5 being strongly agree.
Measured: immediately after a surgical consultation
Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups
Quality of life will be assessed using the (FACT-B) questionnaire. FACT-B measures 27 items in five different areas: physical well-being, social/family well-being, emotional well-being, functional well-being, and additional concerns specific to this patient population. FACT-B is measured on the scale from 0 to 4, with a total minimum score of 0 and maximum score of 144.
Measured: This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
The Decision Regret outcome
The decision regret outcome will be measured using the Decision Regret Scale. The Decision Regret Scale is is a 5 item scale with items ranked on a 5-point Likert-type scale and added together with higher score indicating more regret.
Measured: The scale will be administered at 2 weeks and 6 months after initial clinic visit.
Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement
The outcome of patient involvement at the clinic encounter will be measured using the OPTION scale. This scale measures 12 item from 0 to 4, with 0 being "this behavior is not observed" to 4 "This behavior is exhibited to a very high standard"
Measured: 4 months after initial clinic visit
completion or intention to complete therapies
Group differences in completion or intention to complete recommended therapies will be assessed at 6 months after the clinic visit through chart review of all participants' charts.
Measured: 6 months after initial clinic visit
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2017
- Study start7 Mar 2016
- Primary completion31 Jan 2017
- Study completion9 Aug 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (36)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cindy Matsen, University of Utah
- Investigators
- Cindy Matsen, MD, Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03350854
- Sponsor's protocol ID
- IRB_00081898
- Status last verified
- Nov 2017
- First submitted
- 13 Oct 2017
- Last updated
- 22 Nov 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Sepucha K, Ozanne EM. How to define and measure concordance between patients' preferences and medical treatments: A systematic review of approaches and recommendations for standardization. Patient Educ Couns. 2010 Jan;78(1):12-23. doi: 10.1016/j.pec.2009.05.011. Epub 2009 Jun 30.
PubMed 19570647Sepucha KR, Barry MJ. Making patient-centered cancer care a reality. Cancer. 2009 Dec 15;115(24):5610-1. doi: 10.1002/cncr.24824. No abstract available.
PubMed 19957353Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, Lewin S, Smith RC, Coffey J, Olomu A. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD003267. doi: 10.1002/14651858.CD003267.pub2.
PubMed 23235595Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.
PubMed 26215573Livaudais JC, Franco R, Fei K, Bickell NA. Breast cancer treatment decision-making: are we asking too much of patients? J Gen Intern Med. 2013 May;28(5):630-6. doi: 10.1007/s11606-012-2274-3. Epub 2012 Nov 15.
PubMed 23229908Katz SJ, Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Salem B, Lakhani I, Morrow M. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5526-33. doi: 10.1200/JCO.2005.06.217.
PubMed 16110013Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
PubMed 21474265Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF, Huschka MM, Rummans TA, Clark MM, Diekmann B, Degner LF. Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the Control Preferences Scale. Am J Manag Care. 2010 Sep;16(9):688-96.
PubMed 20873956Frongillo M, Feibelmann S, Belkora J, Lee C, Sepucha K. Is there shared decision making when the provider makes a recommendation? Patient Educ Couns. 2013 Jan;90(1):69-73. doi: 10.1016/j.pec.2012.08.016. Epub 2012 Sep 20.
PubMed 22999786Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
PubMed 9505581Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.
PubMed 9145723Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.
PubMed 15284259Tariman JD, Berry DL, Cochrane B, Doorenbos A, Schepp K. Preferred and actual participation roles during health care decision making in persons with cancer: a systematic review. Ann Oncol. 2010 Jun;21(6):1145-1151. doi: 10.1093/annonc/mdp534. Epub 2009 Nov 25.
PubMed 19940010Johnson JD, Roberts CS, Cox CE, Reintgen DS, Levine JS, Parsons M. Breast cancer patients' personality style, age, and treatment decision making. J Surg Oncol. 1996 Nov;63(3):183-6. doi: 10.1002/(SICI)1096-9098(199611)63:33.0.CO;2-9.
PubMed 8944063Almyroudi A, Degner LF, Paika V, Pavlidis N, Hyphantis T. Decision-making preferences and information needs among Greek breast cancer patients. Psychooncology. 2011 Aug;20(8):871-9. doi: 10.1002/pon.1798. Epub 2010 Jul 11.
PubMed 20623805
Study at a glance
From the registry record, last updated by the sponsor on 22 Nov 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Intervention to Improve Decision Role Concordance Amongst Newly Diagnosed Breast Cancer Patients
- ClinicalTrials.gov ID
- NCT03350854
- Acronym / sponsor ID
- IRB_00081898
- Conditions
- Breast Cancer
- Keywords
- early stage breast cancer;, treatment decision making, newly diagnosed breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 7 Mar 2016 (actual)
- Primary completion
- 31 Jan 2017 (actual)
- Study completion
- 9 Aug 2017 (actual)
- First posted
- 22 Nov 2017 (actual)
- 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.
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process.
Detailed description
The goal of this project is to test the effects of the Patient Preference Scale as the basis for a clinical intervention for role negotiation in breast cancer surgery decisions and the Patient Perception Scale to measure role concordance. The investigators hypothesize that better role concordance will be achieved with a simple provider-based intervention. In addition, role concordance will be associated with improved short-term and longer-term improvements in outcomes of the following parameters: a) satisfaction with decision process b) breast specific QOL, and c) decision regret.
The investigators propose a mixed methods, interventional study with concurrent controls performed in a breast cancer surgery clinic at a comprehensive cancer center. The Patient Preference Scale will be used to identify the preferred involvement in decision making of newly diagnosed breast cancer patients prior to their first clinic visit. The Patient Perception Scale will be used after the encounter in order to evaluate role concordance. The Provider Perception Scale will also be used to assess the perception of the achieved role by the provider. In the first half of the study, providers will be blind to the patient's preferred role. In the second half, providers will be made aware of the preferred role prior to the encounter and will have a brief conversation with the patient about their desired role in the decision making process. Clinical encounters will be audiotaped, transcribed, and scored for patient involvement. The investigators propose the following aims and hypotheses:
Investigate the impact of a brief provider-led intervention about the patients' preferred role in treatment decision making on role concordance. The investigators hypothesize that:
- Role concordance will be improved when the preferred role is discussed with the patient at the beginning of the encounter.
- The provider's perception of the role achieved will be more concordant with the patient's perception when the preferred role is discussed. 3. Investigate the impact of role concordance in the treatment decision making process on short term and long term quality of life and decision outcomes. The investigators hypothesize that: Patients who achieve role concordance will be more satisfied with the decision process.
- Patients who achieve role concordance will have better QOL and less decision regret at early (2 to 6 weeks) and later (6 months) time points after the clinic visit.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments.
- Patients who achieve concordance will be more likely to complete or plan to complete recommended treatments
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| The non-intervention control group | No intervention | –In the non-intervention control group, providers are blind to the patient's preferred decision making role. |
| The intervention group | Experimental | Behavioral: Patient Preference in Treatment Decision MakingThe provider will be informed of the patient preference in treatment decision making (preferred role) and have a discussion about this with the patient in the intervention group. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients who present to Huntsman Cancer Hospital/University of Utah for a newly diagnosed breast cancer surgical consultation.
Key exclusion criteria (2 listed)
- Men with breast cancer.
- Patients who have previously seen another medical provider to discuss treatment for newly diagnosed breast cancer.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Patient Preference in Treatment Decision MakingThe roles are divided into two active roles, a collaborative (or shared) role, and two passive roles in the Patient Preference scale questionnaire. Once the questionnaire is administered, the patient will then proceed to original surgical appointment. The provider is informed of the patient's preferred role and has a discussion with them patient about this in the intervention group, but not in the control group. | Behavioural | The intervention group |
Primary outcome
Decision role concordance before and after a surgical consultation
Time frame: The estimated period is 3 hours (before and immediately after a surgical consultation)
The primary outcome measures the changes from patient's preferred role in baseline (before a surgical consultation) to the perception of whether the patient achieved the preferred role (immediately after a surgical consultation) in the surgical consultation.
Decision role concordance of provider and patient
Time frame: This is an one-time measurement (Immediately after a surgical consultation)
It measures the difference in the patient's perception of the achieved role and provider's perception of the patient's preferred role.
5 secondary outcomes
Patient's satisfaction with the decision making process
Time frame: immediately after a surgical consultation
Comparing Reliability and Validity of the Functional Assessment of Cancer Therapy-Breast (FACT-B) assessment of short-term quality of life between the groups
Time frame: This scale will be used prior to the first consultation to establish a baseline for each patient and will subsequently be used at 2 weeks and 6 months after initial clinic visit.
The Decision Regret outcome
Time frame: The scale will be administered at 2 weeks and 6 months after initial clinic visit.
Observing Patient Involvement in Decision Making (OPTION) assessment of patient involvement
Time frame: 4 months after initial clinic visit
completion or intention to complete therapies
Time frame: 6 months after initial clinic visit
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 22 Nov 2017.
- Background: PubMed 19570647Sepucha K, Ozanne EM. How to define and measure concordance between patients' preferences and medical treatments: A systematic review of approaches and recommendations for standardization. Patient Educ Couns. 2010 Jan;78(1):12-23. doi: 10.1016/j.pec.2009.05.011. Epub 2009 Jun 30.
- Background: PubMed 19957353Sepucha KR, Barry MJ. Making patient-centered cancer care a reality. Cancer. 2009 Dec 15;115(24):5610-1. doi: 10.1002/cncr.24824. No abstract available.
- Background: PubMed 23235595Dwamena F, Holmes-Rovner M, Gaulden CM, Jorgenson S, Sadigh G, Sikorskii A, Lewin S, Smith RC, Coffey J, Olomu A. Interventions for providers to promote a patient-centred approach in clinical consultations. Cochrane Database Syst Rev. 2012 Dec 12;12(12):CD003267. doi: 10.1002/14651858.CD003267.pub2.
- Background: PubMed 26215573Stiggelbout AM, Pieterse AH, De Haes JC. Shared decision making: Concepts, evidence, and practice. Patient Educ Couns. 2015 Oct;98(10):1172-9. doi: 10.1016/j.pec.2015.06.022. Epub 2015 Jul 15.
- Background: PubMed 23229908Livaudais JC, Franco R, Fei K, Bickell NA. Breast cancer treatment decision-making: are we asking too much of patients? J Gen Intern Med. 2013 May;28(5):630-6. doi: 10.1007/s11606-012-2274-3. Epub 2012 Nov 15.
- Background: PubMed 16110013Katz SJ, Lantz PM, Janz NK, Fagerlin A, Schwartz K, Liu L, Deapen D, Salem B, Lakhani I, Morrow M. Patient involvement in surgery treatment decisions for breast cancer. J Clin Oncol. 2005 Aug 20;23(24):5526-33. doi: 10.1200/JCO.2005.06.217.
- Background: PubMed 21474265Chewning B, Bylund CL, Shah B, Arora NK, Gueguen JA, Makoul G. Patient preferences for shared decisions: a systematic review. Patient Educ Couns. 2012 Jan;86(1):9-18. doi: 10.1016/j.pec.2011.02.004. Epub 2011 Apr 6.
- Background: PubMed 20873956Singh JA, Sloan JA, Atherton PJ, Smith T, Hack TF, Huschka MM, Rummans TA, Clark MM, Diekmann B, Degner LF. Preferred roles in treatment decision making among patients with cancer: a pooled analysis of studies using the Control Preferences Scale. Am J Manag Care. 2010 Sep;16(9):688-96.
- Background: PubMed 22999786Frongillo M, Feibelmann S, Belkora J, Lee C, Sepucha K. Is there shared decision making when the provider makes a recommendation? Patient Educ Couns. 2013 Jan;90(1):69-73. doi: 10.1016/j.pec.2012.08.016. Epub 2012 Sep 20.
- Background: PubMed 9505581Degner LF, Sloan JA, Venkatesh P. The Control Preferences Scale. Can J Nurs Res. 1997 Fall;29(3):21-43.
- Background: PubMed 9145723Degner LF, Kristjanson LJ, Bowman D, Sloan JA, Carriere KC, O'Neil J, Bilodeau B, Watson P, Mueller B. Information needs and decisional preferences in women with breast cancer. JAMA. 1997 May 14;277(18):1485-92.
- Background: PubMed 15284259Janz NK, Wren PA, Copeland LA, Lowery JC, Goldfarb SL, Wilkins EG. Patient-physician concordance: preferences, perceptions, and factors influencing the breast cancer surgical decision. J Clin Oncol. 2004 Aug 1;22(15):3091-8. doi: 10.1200/JCO.2004.09.069.
- Individual participant dataSharing planned: Undecided
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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.
Cindy Matsen, MD principal investigator
University of Utah
Questions about this trial
What is this clinical trial studying?
A study testing Patient Preference in Treatment Decision Making in people with Breast Cancer, run by University of Utah.
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 1 inclusion and 2 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 22 Nov 2017. Status can change between updates, so confirm with the study contact before making plans.
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?
Decision role concordance before and after a surgical consultation (time frame: The estimated period is 3 hours (before and immediately after a surgical consultation)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03350854, which also lists 36 linked publications.
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 22 Nov 2017.