CancerNCT01889511
Text Messaging to Improve Adherence to Oral Chemotherapy Agents
A study testing Intervention group - texts in people with Cancer, run by Michigan State University at 6 sites in United States.
Trial summary
The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale health-related research project on text messages to improve adherence to oral chemotherapy agents. Michigan State University College of Nursing has not been a major recipient of National Institute of Health grant funding. Read more about this study
- Who is it for?
- Ages 21 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Intervention group - texts
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 6 sitesUnited States
- Study dates
- Jun 2013to Jun 2015
- 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 21 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with cancer
- Prescribed an oncolytic or therapeutic oral agent (non-hormonal)
- Able to speak, read, and understand English
- Able and willing to receive phone calls
- Has a personal cell phone, and able and willing to receive and send a text message
Who cannot join
- Deaf, blind, or unable hear, or unable to accept phone calls
- Prescribed hormonal therapy for cancer treatment
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Diplomat Specialty Pharmacy
Flint, Michigan, 48507
McLaren Cancer Institute
Flint, Michigan, 48532
Allegiance Health
Jackson, Michigan, 49201
Sparrow Hospital
Lansing, Michigan, 48912
Yale University
New Haven, Connecticut, 06520-8034
Huron Medical Center
Port Huron, Michigan, 48060
About this study
The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale health-related research project on text messages to improve adherence to oral chemotherapy agents. Michigan State University College of Nursing has not been a major recipient of National Institute of Health grant funding. As a result, the overall objective of this proposal is to strengthen the research environment in the College of Nursing so that it can develop into a significant health-related scientific research enterprise. This project would involve undergraduate and graduate students, and thus, generate student interest in research as a career. The importance of the research planned for this proposal is as follows. More than 50 oral chemotherapy agents in pill form are currently on the market, with projections that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. To date, empirical research in the area of improving adherence to oral agents is underdeveloped. The goal of this research is to improve adherence to oral chemotherapy agents through a technology based strategy, tailored SMS text messages. This prospective randomized controlled trial will examine the feasibility, acceptability, and satisfaction with a 3-week tailored text message intervention for oral agent adherence. Descriptive statistics, generalized linear modeling, and generalized estimating equations will be used for analysis. In this proposal, preliminary data will be collected to examine efficacy of the text message intervention to promote adherence to oral agents. Data will then be used to further inform the development of an intervention to improve adherence to oral agents for an R01 application to conduct a larger randomized trial to test this innovative intervention. This study can have a transformative impact on oral agent adherence by developing a technology-based strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This type of novel intervention also has the potential to transform and impact many other ill populations that require adherence to a medication regimen.
Read the detailed description
The therapeutic outcome of cancer treatment for patients taking oral chemotherapy agents depends heavily on adherence to the oral agent regimen. Yet recent research indicated that patients miss one-third of oral chemotherapy agent doses. With more than 50 oral anti-cancer agents on the market, it is projected that within 3 years, 25% of cancer treatment will be delivered in pill form. In this new treatment paradigm, care is moved from the clinics to home settings. This means that patients are seen less frequently by oncologists and greater responsibility is placed on the patients. Complicating this further, 75% of those with cancer also have comorbid conditions that require them to perform other self-care management (SCM) responsibilities. In addition, many have low self-efficacy, which may interfere with their ability to adhere to the oral agent. The therapeutic outcome for patients taking oral agents depends heavily on engaging patients to adhere to the regimen. Thus, a critical need exists to test novel interventions that promote adherence in patients taking oral chemotherapy agents.
The long-term goal of this research is to develop novel interventions to improve bio-behavioral outcomes of patients with cancer who have treatment in pill form. The objective of this study is to determine the feasibility, acceptability, satisfaction and efficacy of a short message service (SMS) text message intervention to promote adherence among cancer patients prescribed oral agents. The strategy to achieve this objective is to examine how technology can be used to improve adherence and to explore translation of these technologies to the clinical setting by deploying the following research plan.
This 10-week, 2-group, prospective randomized controlled trial will enroll 75 patients (50 in the intervention group and 25 in the control group), from 2 cancer centers, to test the feasibility and efficacy of a tailored intervention using text messages delivered to patient's cell phones to promote oral agent adherence. As these patients are newly prescribed an oral agent, they will be randomly assigned to either the intervention or the control group. At baseline (week 1), we will assess age, sex, race, cancer type and stage, self-efficacy, comorbid conditions and their SCM, and symptoms. For 21 days (week 2-4) the intervention group will receive a tailored text message for oral agent adherence plus usual care and the control group will receive only usual care. Each week (week 2-9) and at exit (week 10) an assessment of oral agent adherence and symptoms will occur. Satisfaction with the intervention will also be evaluated during the exit interview.
Specific Aims
Aim #1. To determine feasibility, defined as patient acceptance, retention in the study, and satisfaction, of a tailored text message intervention among patients who are on oral agents. Hypotheses to be tested are:
Hypothesis 1a: 80% of participants recruited will enroll in the study.
Hypothesis 1b: 80% of patients in the intervention group will complete 21 days of tailored text messages.
Hypothesis 1c: 90% of the intervention group will be satisfied with the tailored text messages.
Aim #2. To determine preliminary efficacy of the tailored text message intervention on adherence to oral agents. Hypotheses to be tested are:
Hypothesis 2a: The intervention group will have significantly higher rates of oral agent adherence than the control group.
Hypothesis 2b: There will be a large effect size of the intervention for group differences in adherence rates.
Exploratory aim: To explore the effect of oral agent complexity, low self-efficacy, symptom severity, comorbid conditions, and SCM of comorbid conditions on adherence to oral agents. We expect that adherence will be greater for patients with higher self-efficacy, simple oral agents, for those with fewer comorbid conditions, for those with fewer SCM responsibilities for their comorbid conditions, and for those with lower symptom severity.
This study can have a transformative impact on oral agent adherence by developing an easy-to-use, technology-based intervention to promote adherence among the increasing number of cancer patients whom receive treatment in this manner.
The significance of this study is that it targets a difficult clinical problem among patients who are very sick with a life threatening disease and must adhere to complex treatment protocols. This innovative intervention involves a readily available technology that can be used to interact with patients on a regular, consistent basis that would otherwise not be possible, feasible, or cost effective if done in a one-by-one interaction with a health care provider. The number of cancer patients who receive chemotherapy in pill form is increasing and this intervention will enable them to adhere and complete their cancer treatment. Thus, the intervention has high generalizability and the potential to transform care.
- Conditions
- Cancer
- Being tested
- Intervention group - texts
- Keywords
- Text Messaging, Medication Adherence, Oral Agents
- Medical subject headings
- Neoplasms, Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group - textsBehavioural
Patients will be instructed to respond to the text message by sending a text stating if the oral agent was "taken". If there is no response after 15 minutes, a second text message will be sent out, again requesting a response. Satisfaction surveys will occur in the intervention group at week 5 when the text messages end; and will take five minutes.
| Study group | Role | What they receive |
|---|---|---|
| Intervention group - texts | Experimental | The intervention group will receive text messages for 21 days that are tailored to their oral agent regimen. Receives: Behavioral: Intervention group - texts |
| Control group | No intervention | The control group will receive usual care, which consists of standard care and materials provided by the oncology office or pharmacy. In general, this includes instructions and information on the oral agent regimen (i.e., amount and timing), common side effects, how to manage symptoms, general ways to remember to take your pill (e.g., calendar or pill box), medication safety (i.e., storage), and how to contact a clinician for problems that arise. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility, defined as patient acceptance of a text message intervention among patients who are on oral agents.
Feasibility of adherence to tailored text messages will be measured by the number of text messages delivered and any discontinuation of text messages during the course of the study while treatment with the oral agent is ongoing.
Measured: Baseline to week-10.
Feasibility, defined as retention in the study, among patients who are on oral agents.
Acceptability of tailored text messaging will be measured by the number of patients who accept enrollment in the study compared to the number of patients who were offered to participate and by the percent of patients who complete the study. Acceptability will be assessed qualitatively by examining the reasons for attrition in the intervention group.
Measured: Baseline.
Feasibility defined as satisfaction with a text message intervention among patients who are on oral agents.
Satisfaction with tailored text messages for adherence will be measured using a tool previously developed by this research team and administered in several previous studies that had Likert-scaled items. These Likert-scaled items will be modified for this study, adding items describing dimensions of satisfaction with the text messages. Satisfaction will be deemed high if the scores exceed 80%.
Measured: At week-4 after completion of text messages.
Secondary outcomes (3)
Preliminary efficacy of the text message intervention on adherence to oral agents.
Patients will be asked to recall and report the number pills taken (pill count) in the past 7 days at exit.
Measured: Calculated weekly from baseline to week 10; cumulative for the 10-week study period; and then intervention and control group are compared..
Preliminary efficacy of the text message intervention on adherence to oral agents.
The proportion of oral agent pills taken compared to what was prescribed will be calculated to determine the rate of adherence. Adherence will be examined at 3 levels: under-adherent (taking less than 85% of the prescribed dose); over-adherent (taking more than 100% of the prescribed dose in AM, PM, or both, or taking during rest periods); and adherent (taking between 85% and 100% of the medication); and cumulative.
Measured: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared.
Preliminary efficacy of the text message intervention on adherence to oral agents.
The relative dose intensity (RDI) will be calculated by examining the dose taken divided by standard dose intensity (prescribed number of pills) x 100.
Measured: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared..
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2013 (estimated)
- Study startJun 2013
- Primary completionDec 2014
- Study completionJun 2015
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 CancerStudies of the same condition, open and under way.
- 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Michigan State University
- Sponsor type
- University, hospital or other
- Collaborators
- Yale University, Sparrow Health System, Diplomat Pharmacy, Huron Medical Center, Allegiance Health, McLaren Cancer Institute
- Responsible party
- Principal investigator, Sandra Spoelstra, Michigan State University
- Investigators
- Sandra L Spoelstra, PhD, RN, Principal investigator, Michigan State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01889511
- Sponsor's protocol ID
- 1R15CA176595
- Status last verified
- Sep 2015
- First submitted
- 24 Jun 2013
- Last updated
- 21 Sep 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spoelstra SL, Given CW, Sikorskii A, Coursaris CK, Majumder A, DeKoekkoek T, Schueller M, Given BA. A randomized controlled trial of the feasibility and preliminary efficacy of a texting intervention on medication adherence in adults prescribed oral anti-cancer agents: study protocol. J Adv Nurs. 2015 Dec;71(12):2965-76. doi: 10.1111/jan.12714. Epub 2015 Jun 23.
PubMed 26100719
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Text Messaging to Improve Adherence to Oral Chemotherapy Agents
- ClinicalTrials.gov ID
- NCT01889511
- Acronym / sponsor ID
- 1R15CA176595
- Conditions
- Cancer
- Keywords
- Text Messaging, Medication Adherence, Oral Agents
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Michigan State UniversityUniversity, hospital or other
- Collaborators
- Yale University, Sparrow Health System, Diplomat Pharmacy, Huron Medical Center, Allegiance Health, McLaren Cancer Institute
- Study start
- Jun 2013
- Primary completion
- Dec 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 28 Jun 2013 (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.
The purpose of this Academic Research Enhancement Award proposal is to conduct a small-scale health-related research project on text messages to improve adherence to oral chemotherapy agents. Michigan State University College of Nursing has not been a major recipient of National Institute of Health grant funding. As a result, the overall objective of this proposal is to strengthen the research environment in the College of Nursing so that it can develop into a significant health-related scientific research enterprise. This project would involve undergraduate and graduate students, and thus, generate student interest in research as a career. The importance of the research planned for this proposal is as follows. More than 50 oral chemotherapy agents in pill form are currently on the market, with projections that in 3 years, 25% of cancer treatments will be delivered in pill form. For oral agents to achieve a therapeutically effective level for cancer treatment, patients must strictly adhere to the regimen. Adherence to oral cancer agents is often less than 80%, which may be inadequate for treating the cancer. To date, empirical research in the area of improving adherence to oral agents is underdeveloped. The goal of this research is to improve adherence to oral chemotherapy agents through a technology based strategy, tailored SMS text messages. This prospective randomized controlled trial will examine the feasibility, acceptability, and satisfaction with a 3-week tailored text message intervention for oral agent adherence. Descriptive statistics, generalized linear modeling, and generalized estimating equations will be used for analysis. In this proposal, preliminary data will be collected to examine efficacy of the text message intervention to promote adherence to oral agents. Data will then be used to further inform the development of an intervention to improve adherence to oral agents for an R01 application to conduct a larger randomized trial to test this innovative intervention. This study can have a transformative impact on oral agent adherence by developing a technology-based strategy to promote adherence among the increasing number of cancer patients who receive their cancer treatment in pill form. This type of novel intervention also has the potential to transform and impact many other ill populations that require adherence to a medication regimen.
Detailed description
The therapeutic outcome of cancer treatment for patients taking oral chemotherapy agents depends heavily on adherence to the oral agent regimen. Yet recent research indicated that patients miss one-third of oral chemotherapy agent doses. With more than 50 oral anti-cancer agents on the market, it is projected that within 3 years, 25% of cancer treatment will be delivered in pill form. In this new treatment paradigm, care is moved from the clinics to home settings. This means that patients are seen less frequently by oncologists and greater responsibility is placed on the patients. Complicating this further, 75% of those with cancer also have comorbid conditions that require them to perform other self-care management (SCM) responsibilities. In addition, many have low self-efficacy, which may interfere with their ability to adhere to the oral agent. The therapeutic outcome for patients taking oral agents depends heavily on engaging patients to adhere to the regimen. Thus, a critical need exists to test novel interventions that promote adherence in patients taking oral chemotherapy agents.
The long-term goal of this research is to develop novel interventions to improve bio-behavioral outcomes of patients with cancer who have treatment in pill form. The objective of this study is to determine the feasibility, acceptability, satisfaction and efficacy of a short message service (SMS) text message intervention to promote adherence among cancer patients prescribed oral agents. The strategy to achieve this objective is to examine how technology can be used to improve adherence and to explore translation of these technologies to the clinical setting by deploying the following research plan.
This 10-week, 2-group, prospective randomized controlled trial will enroll 75 patients (50 in the intervention group and 25 in the control group), from 2 cancer centers, to test the feasibility and efficacy of a tailored intervention using text messages delivered to patient's cell phones to promote oral agent adherence. As these patients are newly prescribed an oral agent, they will be randomly assigned to either the intervention or the control group. At baseline (week 1), we will assess age, sex, race, cancer type and stage, self-efficacy, comorbid conditions and their SCM, and symptoms. For 21 days (week 2-4) the intervention group will receive a tailored text message for oral agent adherence plus usual care and the control group will receive only usual care. Each week (week 2-9) and at exit (week 10) an assessment of oral agent adherence and symptoms will occur. Satisfaction with the intervention will also be evaluated during the exit interview.
Specific Aims
Aim #1. To determine feasibility, defined as patient acceptance, retention in the study, and satisfaction, of a tailored text message intervention among patients who are on oral agents. Hypotheses to be tested are:
Hypothesis 1a: 80% of participants recruited will enroll in the study.
Hypothesis 1b: 80% of patients in the intervention group will complete 21 days of tailored text messages.
Hypothesis 1c: 90% of the intervention group will be satisfied with the tailored text messages.
Aim #2. To determine preliminary efficacy of the tailored text message intervention on adherence to oral agents. Hypotheses to be tested are:
Hypothesis 2a: The intervention group will have significantly higher rates of oral agent adherence than the control group.
Hypothesis 2b: There will be a large effect size of the intervention for group differences in adherence rates.
Exploratory aim: To explore the effect of oral agent complexity, low self-efficacy, symptom severity, comorbid conditions, and SCM of comorbid conditions on adherence to oral agents. We expect that adherence will be greater for patients with higher self-efficacy, simple oral agents, for those with fewer comorbid conditions, for those with fewer SCM responsibilities for their comorbid conditions, and for those with lower symptom severity.
This study can have a transformative impact on oral agent adherence by developing an easy-to-use, technology-based intervention to promote adherence among the increasing number of cancer patients whom receive treatment in this manner.
The significance of this study is that it targets a difficult clinical problem among patients who are very sick with a life threatening disease and must adhere to complex treatment protocols. This innovative intervention involves a readily available technology that can be used to interact with patients on a regular, consistent basis that would otherwise not be possible, feasible, or cost effective if done in a one-by-one interaction with a health care provider. The number of cancer patients who receive chemotherapy in pill form is increasing and this intervention will enable them to adhere and complete their cancer treatment. Thus, the intervention has high generalizability and the potential to transform care.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group - texts | Experimental | Behavioral: Intervention group - textsThe intervention group will receive text messages for 21 days that are tailored to their oral agent regimen. |
| Control group | No intervention | –The control group will receive usual care, which consists of standard care and materials provided by the oncology office or pharmacy. In general, this includes instructions and information on the oral agent regimen (i.e., amount and timing), common side effects, how to manage symptoms, general ways to remember to take your pill (e.g., calendar or pill box), medication safety (i.e., storage), and how to contact a clinician for problems that arise. |
Who may qualify
- Ages
- 21 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Diagnosed with cancer
- Prescribed an oncolytic or therapeutic oral agent (non-hormonal)
- Able to speak, read, and understand English
- Able and willing to receive phone calls
- Has a personal cell phone, and able and willing to receive and send a text message
Key exclusion criteria (2 listed)
- Deaf, blind, or unable hear, or unable to accept phone calls
- Prescribed hormonal therapy for cancer treatment
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 |
|---|---|---|
| Intervention group - textsPatients will be instructed to respond to the text message by sending a text stating if the oral agent was "taken". If there is no response after 15 minutes, a second text message will be sent out, again requesting a response. Satisfaction surveys will occur in the intervention group at week 5 when the text messages end; and will take five minutes. | Behavioural | Intervention group - texts |
Primary outcome
Feasibility, defined as patient acceptance of a text message intervention among patients who are on oral agents.
Time frame: Baseline to week-10.
Feasibility of adherence to tailored text messages will be measured by the number of text messages delivered and any discontinuation of text messages during the course of the study while treatment with the oral agent is ongoing.
Feasibility, defined as retention in the study, among patients who are on oral agents.
Time frame: Baseline.
Acceptability of tailored text messaging will be measured by the number of patients who accept enrollment in the study compared to the number of patients who were offered to participate and by the percent of patients who complete the study. Acceptability will be assessed qualitatively by examining the reasons for attrition in the intervention group.
Feasibility defined as satisfaction with a text message intervention among patients who are on oral agents.
Time frame: At week-4 after completion of text messages.
Satisfaction with tailored text messages for adherence will be measured using a tool previously developed by this research team and administered in several previous studies that had Likert-scaled items. These Likert-scaled items will be modified for this study, adding items describing dimensions of satisfaction with the text messages. Satisfaction will be deemed high if the scores exceed 80%.
3 secondary outcomes
Preliminary efficacy of the text message intervention on adherence to oral agents.
Time frame: Calculated weekly from baseline to week 10; cumulative for the 10-week study period; and then intervention and control group are compared..
Preliminary efficacy of the text message intervention on adherence to oral agents.
Time frame: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared.
Preliminary efficacy of the text message intervention on adherence to oral agents.
Time frame: Cumulative over the baseline to 10-weeks of the study then control and intervention groups are compared..
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 21 Sep 2015.
- Derived from this study: PubMed 26100719Spoelstra SL, Given CW, Sikorskii A, Coursaris CK, Majumder A, DeKoekkoek T, Schueller M, Given BA. A randomized controlled trial of the feasibility and preliminary efficacy of a texting intervention on medication adherence in adults prescribed oral anti-cancer agents: study protocol. J Adv Nurs. 2015 Dec;71(12):2965-76. doi: 10.1111/jan.12714. Epub 2015 Jun 23.
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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.
Sandra L Spoelstra, PhD, RN principal investigator
Michigan State University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention group - texts in people with Cancer, run by Michigan State University at 6 sites 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 5 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 21 Sep 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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?
Feasibility, defined as patient acceptance of a text message intervention among patients who are on oral agents. (time frame: Baseline to week-10.). The study lists 3 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 NCT01889511, 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 21 Sep 2015.