Acute Lymphoblastic LeukemiaNCT02847130
Identifying, Understanding, and Overcoming Barriers to the Use of Clinical Practice Guidelines in Pediatric Oncology
An observational study of Acute Lymphoblastic Leukemia and B-Cell Non-Hodgkin Lymphoma, run by Children's Oncology Group at 33 sites in 2 countries.
Trial summary
This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. Read more about this study
- Who is it for?
- Ages Up to 20 years
- Conditions the study is for
- Acute Lymphoblastic Leukemia, B-Cell Non-Hodgkin Lymphoma, Childhood Acute Myeloid Leukemia
- What is being tested?
- Informational Intervention, Interview and Medical Chart Review
- How many people
- 530 participants
- Where
- 33 sitesin 2 countries
- Study dates
- 21 Nov 2016to 30 Jun 2023
- 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 Up to 20 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: Patients < 21 years old at cancer diagnosis who received care as an inpatient or outpatient at a participating COG NCORP site between January 1, 2014 and December 31, 2015
Who may be able to join
- Site willingness to participate in all 3 aims
- AIM 1 - ELIGIBILITY CRITERIA FOR INCLUSION IN RETROSPECTIVE CENTRALIZED CHART REVIEW
- Received care as an inpatient or outpatient at a participating COG NCORP site during the time period between January 1, 2014 and December 31, 2015
- Ever enrolled on any COG trial (episode does not have to occur while on trial and the COG trial may be therapeutic or non-therapeutic)
- Has at least one episode eligible for FN, CINV or FP review
- CPG-Specific Eligibility
Show all 26Show fewer
- FN
- Has any of the following diagnoses:
- Newly diagnosed acute lymphoblastic leukemia
- Relapsed acute lymphoblastic leukemia
- Any acute myeloid leukemia
- Burkitt's or mature B cell non-Hodgkin's lymphoma
- Any myeloablative autologous or allogeneic hematopoietic stem cell transplantation
- Developed FN at least once
- CINV
- Diagnosis of cancer
- Received moderately emetogenic chemotherapy as an inpatient
- < 12 years of age at the start of a CINV episode and received highly emetogenic chemotherapy as an in-patient
- FP
- Newly diagnosed cancer
- >= 15 years of age at cancer diagnosis
- Note: a single patient may contribute data for multiple episodes
- AIM 2 AND AIM 3 INCLUSION CRITERIA
- Healthcare professional currently employed at a participating COG NCORP institution
- Eligible healthcare providers include but are not limited to: physicians, nurses, nurse practitioners, pharmacists, social workers, dieticians, psychologists, and physical therapists/physiotherapists
- Provides direct care for children with cancer as part of current position at NCORP site
Who cannot join
- AIM 2 AND AIM 3 EXCLUSION CRITERIA
- Trainees are excluded
- Previous participation in this study either for Aim 2 or Aim 3
- Each health care provider can only be involved in one event (focus group or interview)
Trial locations and contacts
33 sites in 2 countries.
33 sites in 2 countries
United States31 sites
University of New Mexico Cancer Center
Albuquerque, New Mexico, 87102
Dell Children's Medical Center of Central Texas
Austin, Texas, 78723
Driscoll Children's Hospital
Corpus Christi, Texas, 78411
Blank Children's Hospital
Des Moines, Iowa, 50309
Sanford Broadway Medical Center
Fargo, North Dakota, 58122
Golisano Children's Hospital of Southwest Florida
Fort Myers, Florida, 33908
Helen DeVos Children's Hospital at Spectrum Health
Grand Rapids, Michigan, 49503
BI-LO Charities Children's Cancer Center
Greenville, South Carolina, 29605
Memorial Regional Hospital/Joe DiMaggio Children's Hospital
Hollywood, Florida, 33021
Kapiolani Medical Center for Women and Children
Honolulu, Hawaii, 96826
Nemours Children's Clinic-Jacksonville
Jacksonville, Florida, 32207
Bronson Methodist Hospital
Kalamazoo, Michigan, 49007
University Medical Center of Southern Nevada
Las Vegas, Nevada, 89102
Alliance for Childhood Diseases/Cure 4 the Kids Foundation
Las Vegas, Nevada, 89135
Summerlin Hospital Medical Center
Las Vegas, Nevada, 89144
Children's Hospital New Orleans
New Orleans, Louisiana, 70118
Ochsner Medical Center Jefferson
New Orleans, Louisiana, 70121
NYP/Columbia University Medical Center/Herbert Irving Comprehensive Cancer Center
New York, New York, 10032
Kaiser Permanente-Oakland
Oakland, California, 94611
Nemours Children's Hospital
Orlando, Florida, 32827
Nemours Children's Clinic - Pensacola
Pensacola, Florida, 32504
Virginia Commonwealth University/Massey Cancer Center
Richmond, Virginia, 23298
Methodist Children's Hospital of South Texas
San Antonio, Texas, 78229
University of Texas Health Science Center at San Antonio
San Antonio, Texas, 78229
Sanford USD Medical Center - Sioux Falls
Sioux Falls, South Dakota, 57117-5134
Mercy Hospital Saint Louis
St Louis, Missouri, 63141
Mary Bridge Children's Hospital and Health Center
Tacoma, Washington, 98405
Tampa General Hospital
Tampa, Florida, 33606
Saint Joseph's Hospital/Children's Hospital-Tampa
Tampa, Florida, 33607
Montefiore Medical Center - Moses Campus
The Bronx, New York, 10467
Alfred I duPont Hospital for Children
Wilmington, Delaware, 19803
Puerto Rico2 sites
San Jorge Children's Hospital
San Juan, 00912
University Pediatric Hospital
San Juan, 00926
About this study
Official title: Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology
This research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.
Read the detailed description
PRIMARY OBJECTIVES:
- To measure the rate of adherence to selected Children's Oncology Group (COG)-endorsed supportive care clinical practice guidelines (CPG) recommendations at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites. (Aim 1) II. To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. (Aim 1a) III. To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care. (Aim 1b) IV. To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. (Aim 2) V. To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. (Aim 3)
OUTLINE:
AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.
AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.
AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.
- Conditions
- Acute Lymphoblastic Leukemia, B-Cell Non-Hodgkin Lymphoma, Childhood Acute Myeloid Leukemia, Childhood Burkitt Lymphoma, Childhood Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm
- Being tested
- Informational Intervention, Interview, Medical Chart Review, Questionnaire Administration
- Keywords
- Clinical practice guidelines, supportive care, pediatrics
- Medical subject headings
- Precursor Cell Lymphoblastic Leukemia-Lymphoma, Lymphoma, B-Cell, Burkitt Lymphoma, Neoplasms, Hematologic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Informational InterventionOther
Participate in focus group
InterviewOther
Undergo one-on-one interviews
Medical Chart ReviewOther
Also called Chart Review
Review of medical chart
Questionnaire AdministrationOther
Ancillary studies
| Study group | Role | What they receive |
|---|---|---|
| Observational (chart review, focus group, interviews) | AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.
AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.
AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing. Receives: Other: Informational Intervention; Other: Interview; Other: Medical Chart Review; Other: Questionnaire Administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes
FN will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent versus (vs.) CPG inconsistent care for each FN episode.
Measured: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes
CINV will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each CINV episode (separately for high and moderate emetogenicity risk chemotherapy).
Measured: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
The proportion of CPG-consistent care of fertility preservation (FP) episodes
FP will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each FP episode.
Measured: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a)
Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.
Measured: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Key coding categories (Aim 2)
Will be identified by the Framework for Clinical Practice Guideline Implementability. Operational definitions of each category will be determined. The implementation barriers and facilitators identified by focus group members will be coded using these categories independently by two investigators. New categories and sub-categories will be used to code concepts that do not fall within the pre-determined categories. Themes of commonality will be sought especially within the newly developed categories that fall outside the framework adapted from Gagliardi et al. Facilitators of and barriers to CPG implementation will be described.
Measured: Data collected from March 28, 2017 through October 15, 2018 will be evaluated
CPG format which is well understood by pediatric oncology healthcare providers (Aim 3)
The issues identified via the interviews, changes made to the formatting, and rationale for the changes will be documented between each round in a tracking matrix. The proportion of interviewees who select the correct course of action when presented with four possible courses of action will be described for each iteration of the CPG format including the final version. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
Measured: Data collected from a minimum of 25 interviews starting from February 1, 2019 to the timepoint where a format that is well understood by participants is developed will be evaluated
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2016 (estimated)
- Study start21 Nov 2016
- Primary completion31 Mar 2023
- Study completion30 Jun 2023
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 Acute Lymphoblastic LeukemiaStudies of the same condition, open and under way.
- More trials run by Children's Oncology GroupThe 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
- Case only
- Time perspective
- Retrospective
- Enrolment
- 530 participants (actual)
Sponsor and investigators
- Lead sponsor
- Children's Oncology Group
- Sponsor type
- Research network
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- L. Lee Dupuis, Principal investigator, Children's Oncology Group
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02847130
- Sponsor's protocol ID
- ACCL15N1CD
- Other IDs
- NCI-2016-00980, ACCL15N1CD, COG-ACCL15N1CD, ACCL15N1CD, UG1CA189955
- Status last verified
- Apr 2023
- First submitted
- 25 Jul 2016
- Last updated
- 19 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Sugalski AJ, Lo T, Beauchemin M, Grimes AC, Robinson PD, Walsh AM, Santesso N, Dang H, Fisher BT, Wrightson AR, Yu LC, Sung L, Dupuis LL. Facilitators and barriers to clinical practice guideline-consistent supportive care at pediatric oncology institutions: a Children's Oncology Group study. Implement Sci Commun. 2021 Sep 16;2(1):106. doi: 10.1186/s43058-021-00200-2.
PubMed 34530933
Study at a glance
From the registry record, last updated by the sponsor on 19 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Use of Evidence-Based Supportive Care Clinical Practice Guidelines in Pediatric Oncology
- ClinicalTrials.gov ID
- NCT02847130
- Acronym / sponsor ID
- ACCL15N1CD
- Conditions
- Acute Lymphoblastic Leukemia, B-Cell Non-Hodgkin Lymphoma, Childhood Acute Myeloid Leukemia, Childhood Burkitt Lymphoma, Childhood Neoplasm, Hematopoietic and Lymphoid Cell Neoplasm
- Keywords
- Clinical practice guidelines, supportive care, pediatrics
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 530 participants (actual)
- Lead sponsor
- Children's Oncology GroupResearch network
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 21 Nov 2016 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 28 Jul 2016 (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 research trial studies the use of clinical practice guidelines by pediatric oncology healthcare providers in order to identify, understand, and overcome barriers to them. The treatments for childhood cancers are intense and result in a high rate of symptoms which require support by healthcare providers. By reviewing patients' medical chart records, meeting in focus groups and in one-on-one interviews, healthcare providers may improve how clinical practice guidelines are used to support children undergoing cancer treatment.
Detailed description
PRIMARY OBJECTIVES:
- To measure the rate of adherence to selected Children's Oncology Group (COG)-endorsed supportive care clinical practice guidelines (CPG) recommendations at National Cancer Institute (NCI) Community Oncology Research Program (NCORP) sites. (Aim 1) II. To describe the possible influence of NCORP site size and the number of patients enrolled in COG studies per site on the delivery of CPG-consistent care. (Aim 1a) III. To describe the clinical outcome of episodes during which patients receive CPG-consistent or CPG-inconsistent care. (Aim 1b) IV. To describe facilitators of and barriers to the use of CPGs elicited via focus group interviews with a diverse set of potential users (physician, nurse, nurse practitioner and pharmacists) who provide pediatric cancer care at NCORP sites. (Aim 2) V. To improve how well CPG recommendations are understood by health care providers by refining the CPG recommendation format based on an iterative process of cognitive interviewing and formatting revisions. (Aim 3)
OUTLINE:
AIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs.
AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed.
AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Observational (chart review, focus group, interviews) | – | Other: Informational Intervention, Other: Interview, Other: Medical Chart Review, Other: Questionnaire AdministrationAIM 1 (CHART REVIEW): Patients are separated for each CPG evaluated (fever and neutropenia [FN], chemotherapy induced nausea and vomiting [CINV], fertility preservation [FP]) and are randomly selected for medical chart review. Patients with eligible episodes of FN, CINV or FP within the health records are selected and have the data from their records abstracted and reviewed by COG for adherence to COG endorsed CPGs. AIM 2 (FOCUS GROUPS): Health care providers who provide direct care to pediatric oncology patients are identified and separated to participate in three types of focus groups: physician-only, non-physician, and mixed. AIM 3 (INTERVIEWS): Health care providers undergo one-on-one interviews consisting of think aloud technique (TAL) of cognitive interviewing. |
Who may qualify
- Ages
- Up to 20 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- Patients < 21 years old at cancer diagnosis who received care as an inpatient or outpatient at a participating COG NCORP site between January 1, 2014 and December 31, 2015
Key inclusion criteria (26 listed)
- Site willingness to participate in all 3 aims
- AIM 1 - ELIGIBILITY CRITERIA FOR INCLUSION IN RETROSPECTIVE CENTRALIZED CHART REVIEW
- Received care as an inpatient or outpatient at a participating COG NCORP site during the time period between January 1, 2014 and December 31, 2015
- Ever enrolled on any COG trial (episode does not have to occur while on trial and the COG trial may be therapeutic or non-therapeutic)
- Has at least one episode eligible for FN, CINV or FP review
Key exclusion criteria (4 listed)
- AIM 2 AND AIM 3 EXCLUSION CRITERIA
- Trainees are excluded
- Previous participation in this study either for Aim 2 or Aim 3
- Each health care provider can only be involved in one event (focus group or interview)
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 |
|---|---|---|
| Informational InterventionParticipate in focus group | Other | Observational (chart review, focus group, interviews) |
| InterviewUndergo one-on-one interviews | Other | Observational (chart review, focus group, interviews) |
| Medical Chart ReviewAlso: Chart ReviewReview of medical chart | Other | Observational (chart review, focus group, interviews) |
| Questionnaire AdministrationAncillary studies | Other | Observational (chart review, focus group, interviews) |
Primary outcome
The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes
Time frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
FN will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent versus (vs.) CPG inconsistent care for each FN episode.
The proportion of CPG-consistent care of chemotherapy induced nausea and vomiting (CINV) episodes
Time frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
CINV will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each CINV episode (separately for high and moderate emetogenicity risk chemotherapy).
The proportion of CPG-consistent care of fertility preservation (FP) episodes
Time frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
FP will be identified by chart review. Outcome variable will be the binary endpoint of CPG-consistent vs. CPG inconsistent care for each FP episode.
Possible influence of National Cancer Institute Community Oncology Research Program site size (Aim 1a)
Time frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated
Will be estimated and examined as fixed effect covariates in these generalized linear mixed effect models described above.
Key coding categories (Aim 2)
Time frame: Data collected from March 28, 2017 through October 15, 2018 will be evaluated
Will be identified by the Framework for Clinical Practice Guideline Implementability. Operational definitions of each category will be determined. The implementation barriers and facilitators identified by focus group members will be coded using these categories independently by two investigators. New categories and sub-categories will be used to code concepts that do not fall within the pre-determined categories. Themes of commonality will be sought especially within the newly developed categories that fall outside the framework adapted from Gagliardi et al. Facilitators of and barriers to CPG implementation will be described.
CPG format which is well understood by pediatric oncology healthcare providers (Aim 3)
Time frame: Data collected from a minimum of 25 interviews starting from February 1, 2019 to the timepoint where a format that is well understood by participants is developed will be evaluated
The issues identified via the interviews, changes made to the formatting, and rationale for the changes will be documented between each round in a tracking matrix. The proportion of interviewees who select the correct course of action when presented with four possible courses of action will be described for each iteration of the CPG format including the final version. Understanding is defined as the correct interpretation of the course of action recommended or suggested by a CPG.
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 Jul 2023.
- Derived from this study: PubMed 34530933Sugalski AJ, Lo T, Beauchemin M, Grimes AC, Robinson PD, Walsh AM, Santesso N, Dang H, Fisher BT, Wrightson AR, Yu LC, Sung L, Dupuis LL. Facilitators and barriers to clinical practice guideline-consistent supportive care at pediatric oncology institutions: a Children's Oncology Group study. Implement Sci Commun. 2021 Sep 16;2(1):106. doi: 10.1186/s43058-021-00200-2.
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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.
L. Lee Dupuis principal investigator
Children's Oncology Group
33 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Acute Lymphoblastic Leukemia and B-Cell Non-Hodgkin Lymphoma, run by Children's Oncology Group at 33 sites in 2 countries.
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 26 inclusion and 4 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 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 33 sites in United States, Puerto Rico. 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?
The proportion of clinical practice guidelines (CPG)-consistent care of fever and neutropenia (FN) episodes (time frame: Care delivered from January 1, 2014 through December 31, 2015 will be evaluated). The study lists 6 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 NCT02847130, 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 Jul 2023.