Preventive ScreeningNCT01694784
Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
A study testing Quantitative Information Sheet, Qualitative Information Sheet and Narrative Information Sheet in people with Preventive Screening and Prostate Cancer, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Most prevention efforts focus on promoting services (e.g. vaccination, screening tests). While some of these services have clear net benefit, many instead have possible or clear net harm. Currently, three quarters of services graded by the U.S. Read more about this study
- Who is it for?
- Ages 50 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Preventive Screening, Prostate Cancer, Osteoporosis
- What is being tested?
- Quantitative Information Sheet, Qualitative Information Sheet and Narrative Information Sheet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 775 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Jun 2014
- 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 50 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Women between ages 50 to 85
- Men between ages 50 to 85
- Eligible for exemplar service of interest (see below for specifics of inclusion/exclusion for specific services)
Who cannot join
- Current treatment of psychosis
- History of alcohol or substance abuse within the last 2 years
- Dementia or other severe cognitive dysfunction
- serious medical illnesses with a life expectancy of less than 2 years (e.g., metastatic cancer)
- inability to speak and understand English
- blindness
Show all 23Show fewer
- presentation for an acute medical visit
- no telephone number
- Osteoporosis Screening (women aged 50-64)
- a personal history of osteoporosis
- a personal history of moderate or severe osteopenia
- BMI (body mass index) < 18.5
- personal history of non-traumatic fracture
- family history of hip fracture
- current smoking
- current use of prednisone (>30 consecutive days)
- alcohol use of 3 or more drinks/day.
- Prostate Cancer screening (men aged 50-69)
- a prior history of prostate cancer
- Colorectal Cancer Screening (men and women aged 76-85)
- prior history of colorectal cancer
- adenomatous colon polyps > 6mm (or 2 or more < 6mm)
- symptoms referable to colorectal cancer
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke Primary Care Research Consortium
Durham, North Carolina, 27704
About this study
Most prevention efforts focus on promoting services (e.g. vaccination, screening tests). While some of these services have clear net benefit, many instead have possible or clear net harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are delivered in healthcare settings at higher rates than what might be expected based on their potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to deliver more quality care. An important issue in delivering prevention messages is how to shift toward a focus on the appropriateness of prevention: encouraging services with clear net benefit and either discouraging or reducing demand for services with possible or clear net harm. Unfortunately, little is known about what drives overuse of potentially harmful screening services or how to make harms relevant to patients.
This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1) assess factors associated with intent to receive possibly or clearly harmful screening services and 2) determine whether and how patients' plans to get screened change with various presentations of information about harms (e.g. qualitative, quantitative, narrative, framed). The investigators will focus on three types of screening services: osteoporosis screening (previous C recommendation and now no recommendation for women < 65 years old with no fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).
- Conditions
- Preventive Screening, Prostate Cancer, Osteoporosis, Colorectal Cancer
- Being tested
- Quantitative Information Sheet, Qualitative Information Sheet, Narrative Information Sheet, Framed Information Sheet
- Medical subject headings
- Prostatic Neoplasms, Osteoporosis, Colorectal Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quantitative Information SheetBehavioural
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the quantitative information sheet, harms will be communicated in absolute risks with accompanying fact box (i.e. box containing key facts and rates). In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and the screening test, a description of the possible benefits of the service, and a statement encouraging decision. As an adjunct to numerical information in paragraph form, fact boxes engage individuals to process information and improve understanding.
Qualitative Information SheetBehavioural
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the qualitative information sheet, harms will be communicated using verbal descriptors. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
Narrative Information SheetBehavioural
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the narrative information sheet, harms will be communicated using patient narratives with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
Framed Information SheetBehavioural
Patients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the framed information sheet, harms will be communicated using a gain frame (as described in the arm section above) with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision.
| Study group | Role | What they receive |
|---|---|---|
| Quantitative | Experimental | In the quantitative arm, we will present harms as absolute risks in the Quantitative Information Sheet. Compared with other risk formats, absolute risks have been shown to improve understanding relative to other common risk formats. Receives: Behavioral: Quantitative Information Sheet |
| Qualitative | Active comparator | In the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet. Receives: Behavioral: Qualitative Information Sheet |
| Narrative | Experimental | In the narrative arm, we will present harms using patient narratives (i.e. descriptions in which patients describe their experience with decision making about potentially harmful screening services)in the Narrative Information Sheet. To address concerns in the literature that characteristics of the narrator independently influence narrative effect, we will present narratives in paper format with a banner of culturally diverse age-appropriate pictures shown at the top. Receives: Behavioral: Narrative Information Sheet |
| Framed | Experimental | In the framed arm, we will frame not screening with potentially harmful services as beneficial (i.e. use a gain frame). In the Framed Information Sheet, we will highlight the harms that could be avoided by not getting screened. Receives: Behavioral: Framed Information Sheet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Intent to Accept Screening Immediately Post-intervention
Following the example of others, we will measure intent to accept screening services with possible or clear net harm with a single item "I plan to get screened for (name of screening test) in the next year." Because the recommended screening intervals for services under study are variable and not all participants will be due for screening in the next year, we will additionally query participants about plans for screening within the recommended screening interval (e.g. osteoporosis screening--5 years; CRC--10 years). Responses will range from "strongly disagree" to strongly agree". All outcomes will be measured before and after participants receive the information sheet. All data will be collected at the one study visit.
Measured: Pre and Post Intervention (same visit - Day 1)
Secondary outcomes (8)
Change from Baseline in Perceived Disease Risk Immediately Post-Intervention
Perceived risk or susceptibility of disease will be measured for each disease state under study using one item that reads, "How likely is that you will get (insert prostate cancer, osteoporosis, or colon cancer) in the next 10 years?" Answers will be on a likert scale from "not at all likely" to "very likely."
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Perceived Disease Severity Immediately Post-Intervention
Perceived Disease Severity will be measured for each disease state under study using the Revised Illness Perceptions Questionnaire for Healthy People. It includes the following four questions: 1) x (insert prostate cancer, osteoporosis, or colon cancer) has serious financial consequences; 2) x strongly affects the way the patient sees himself as a person; 3) x causes difficulties to those close to the patient; 4) x is very serious. Answers will be on a 5-point scale from "strongly disagree" to "strongly agree."
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention
Two questions central to understanding each exemplar service (i.e. prostate cancer screening, osteoporosis screening, colon cancer screening) were selected to assess specific knowledge. Response options include true, false, or don't know.
Questions for prostate cancer screening are:
- Some men can live long, normal lives with untreated prostate cancer.
- Problems with sexual function and urination are common side effects of prostate cancer treatments.
Questions for colon cancer screening are:
- Most polyps in the bowel never become cancer.
- Bleeding and perforations are complications of a colonoscopy.
Questions for Osteoporosis screening are:
- Broken hip bones are uncommon before age 65.
- Treatments for osteoporosis can sometimes result in bone damage.
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention
Six questions will assess participants' attitudes about each screening service under study.
Questions include:
- Screening for x(insert prostate cancer, colon cancer, osteoporosis) in healthy persons my age is a good idea.
- There is little harm to screening for x.
- I owe it to people close to me to get screened for x.
- I owe it to my doctor to get screened for x.
- I would regret not being screened for x.
- I do not feel any special responsibility to get screened for x.
Response options range from "strongly disagree" to "strongly agree".
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Decisional Balance Immediately Post-Intervention
Decisional balance will be measured by a single item for each screening service under study. Participants will be asked, "Which best describes how you feel right now?" Participants will select one of the following answers: 1) The benefits of X (insert prostate cancer, colon cancer, osteoporosis) screening greatly outweigh the harms; 2) The benefits of X screening somewhat outweigh the harms; 3) The benefits and harms of X screening are about the same; 4) The harms of X screening somewhat outweigh the benefits; and 5) The harms of X screening greatly outweigh the benefits.
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Values Clarity Immediately Post-Intervention
Values Clarity will be measured with three items for the values subscale of the decisional conflict scale.
Items include:
- I am clear about which benefits matter most to me;
- I am clear about which harms and side effects matter most to me;
- I am clear about which is more important to me (the benefits or the harms);
Response options range from strongly disagree to strongly agree.
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Knowledge Immediately Post-Intervention
General screening knowledge will be assessed using 8 items developed by investigators.
Questions include:
- Screening means detecting disease before someone can see or feel any problem.
- Some diseases detected by screening won't cause any problems in a person's lifetime.
- In some cases, screening can lead to treatment that is not necessary.
- Screening never harms anyone.
- An abnormal screening test means I have the health condition for sure.
- A normal screening test means that I have am free of the health condition for sure.
- Screening can only decrease your chances of getting sick or dying if effective treatments are available.
- Screening can only decrease your chances of getting sick or dying if you live long enough for treatments to work.
Response options are true, false, or don't know.
Measured: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Attitudes Immediately Post-Intervention
General Screening Attitudes will be assessed at baseline by 38 questions that were developed by investigators and assessed for content validity by panel of experts. Questions assess the following sub-constructs:
General approach to screening, Value of Screening, Need to Know about Disease, Early Detection/Treatment, Benefits, Harms, Anticipated Regret in Choosing for/against screening, Duty/Responsibility to be screened, Effect on screening on MD/patient relationship.
Response options range from "strongly disagree" to "strongly agree" on a 5-point scale.
At post intervention, a subset of 12 of the 38 questions (1-2 from each subconstruct) will be used to assess changes in general screening attitudes.
Measured: Pre and Post Intervention (same visit - Day 1))
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Preventive ScreeningStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 775 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Duke University
- Responsible party
- Principal investigator, Stacey Sheridan, MD, University of North Carolina, Chapel Hill
- Investigators
- Stacey Sheridan, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01694784
- Sponsor's protocol ID
- 12-1338
- Status last verified
- Apr 2016
- First submitted
- 13 Sep 2012
- Last updated
- 19 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Sheridan SL, Sutkowi-Hemstreet A, Barclay C, Brewer NT, Dolor RJ, Gizlice Z, Lewis CL, Reuland DS, Golin CE, Kistler CE, Vu M, Harris R. A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jan;176(1):31-41. doi: 10.1001/jamainternmed.2015.7339.
PubMed 26720730
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Understanding and Discouraging Overuse of Potentially Harmful Screening Tests
- ClinicalTrials.gov ID
- NCT01694784
- Acronym / sponsor ID
- 12-1338
- Conditions
- Preventive Screening, Prostate Cancer, Osteoporosis, Colorectal Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 775 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- Agency for Healthcare Research and Quality (AHRQ), Duke University
- Study start
- Sep 2012
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 27 Sep 2012 (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.
Most prevention efforts focus on promoting services (e.g. vaccination, screening tests). While some of these services have clear net benefit, many instead have possible or clear net harm. Currently, three quarters of services graded by the U.S. Preventive Services Task Force (USPSTF) have possible or clear net harm (C, I, and D services). Many of these services are delivered in healthcare settings at higher rates than what might be expected based on their potential for harm. This leads to adverse outcomes, excess costs, and missed opportunities to deliver more quality care. An important issue in delivering prevention messages is how to shift toward a focus on the appropriateness of prevention: encouraging services with clear net benefit and either discouraging or reducing demand for services with possible or clear net harm. Unfortunately, little is known about what drives overuse of potentially harmful screening services or how to make harms relevant to patients.
This randomized controlled trial (RCT) of 775 patients at 4 primary care practices aims to 1) assess factors associated with intent to receive possibly or clearly harmful screening services and 2) determine whether and how patients' plans to get screened change with various presentations of information about harms (e.g. qualitative, quantitative, narrative, framed). The investigators will focus on three types of screening services: osteoporosis screening (previous C recommendation and now no recommendation for women < 65 years old with no fracture risk factors), prostate-specific antigen (PSA) screening (D recommendation for all men, regardless of age), and colorectal cancer (CRC) screening (C for ages 76-85).
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Quantitative | Experimental | Behavioral: Quantitative Information SheetIn the quantitative arm, we will present harms as absolute risks in the Quantitative Information Sheet. Compared with other risk formats, absolute risks have been shown to improve understanding relative to other common risk formats. |
| Qualitative | Active comparator | Behavioral: Qualitative Information SheetIn the qualitative arm, we will describe harms using verbal descriptors (such as rare, uncommon, fairly common, and common) in the Qualitative Information Sheet. |
| Narrative | Experimental | Behavioral: Narrative Information SheetIn the narrative arm, we will present harms using patient narratives (i.e. descriptions in which patients describe their experience with decision making about potentially harmful screening services)in the Narrative Information Sheet. To address concerns in the literature that characteristics of the narrator independently influence narrative effect, we will present narratives in paper format with a banner of culturally diverse age-appropriate pictures shown at the top. |
| Framed | Experimental | Behavioral: Framed Information SheetIn the framed arm, we will frame not screening with potentially harmful services as beneficial (i.e. use a gain frame). In the Framed Information Sheet, we will highlight the harms that could be avoided by not getting screened. |
Who may qualify
- Ages
- 50 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Women between ages 50 to 85
- Men between ages 50 to 85
- Eligible for exemplar service of interest (see below for specifics of inclusion/exclusion for specific services)
Key exclusion criteria (23 listed)
- Current treatment of psychosis
- History of alcohol or substance abuse within the last 2 years
- Dementia or other severe cognitive dysfunction
- serious medical illnesses with a life expectancy of less than 2 years (e.g., metastatic cancer)
- inability to speak and understand English
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 |
|---|---|---|
| Quantitative Information SheetPatients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the quantitative information sheet, harms will be communicated in absolute risks with accompanying fact box (i.e. box containing key facts and rates). In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and the screening test, a description of the possible benefits of the service, and a statement encouraging decision. As an adjunct to numerical information in paragraph form, fact boxes engage individuals to process information and improve understanding. | Behavioural | Quantitative |
| Qualitative Information SheetPatients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the qualitative information sheet, harms will be communicated using verbal descriptors. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision. | Behavioural | Qualitative |
| Narrative Information SheetPatients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the narrative information sheet, harms will be communicated using patient narratives with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision. | Behavioural | Narrative |
| Framed Information SheetPatients will read an information sheet about one of the three exemplar services in one of four presentations: quantitative, qualitative, narrative, or framed. In the framed information sheet, harms will be communicated using a gain frame (as described in the arm section above) with accompanying fact box. In addition to information about harms, the information sheet will include the following information: a description of the disease to be detected and screening test, a description of the possible benefits of the service, and a statement encouraging decision. | Behavioural | Framed |
Primary outcome
Change from Baseline in Intent to Accept Screening Immediately Post-intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Following the example of others, we will measure intent to accept screening services with possible or clear net harm with a single item "I plan to get screened for (name of screening test) in the next year." Because the recommended screening intervals for services under study are variable and not all participants will be due for screening in the next year, we will additionally query participants about plans for screening within the recommended screening interval (e.g. osteoporosis screening--5 years; CRC--10 years). Responses will range from "strongly disagree" to strongly agree". All outcomes will be measured before and after participants receive the information sheet. All data will be collected at the one study visit.
8 secondary outcomes
Change from Baseline in Perceived Disease Risk Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Perceived Disease Severity Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease Specific Knowledge Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Disease-Specific Screening Attitudes Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Decisional Balance Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in Values Clarity Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Knowledge Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1)
Change from Baseline in General Screening Attitudes Immediately Post-Intervention
Time frame: Pre and Post Intervention (same visit - Day 1))
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 19 Apr 2016.
- Derived from this study: PubMed 26720730Sheridan SL, Sutkowi-Hemstreet A, Barclay C, Brewer NT, Dolor RJ, Gizlice Z, Lewis CL, Reuland DS, Golin CE, Kistler CE, Vu M, Harris R. A Comparative Effectiveness Trial of Alternate Formats for Presenting Benefits and Harms Information for Low-Value Screening Services: A Randomized Clinical Trial. JAMA Intern Med. 2016 Jan;176(1):31-41. doi: 10.1001/jamainternmed.2015.7339.
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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.
Stacey Sheridan, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Quantitative Information Sheet, Qualitative Information Sheet and Narrative Information Sheet in people with Preventive Screening and Prostate Cancer, run by University of North Carolina, Chapel Hill 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 3 inclusion and 23 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 19 Apr 2016. 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?
Change from Baseline in Intent to Accept Screening Immediately Post-intervention (time frame: Pre and Post Intervention (same visit - Day 1)). 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 NCT01694784, which also lists 1 linked publication.
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 19 Apr 2016.