Breast CancerNCT03849573
A Web-Based Tool to Improve Breast Cancer Survivorship
A study testing "OncoTool" Intervention (MBSR + HT education) in people with Breast Cancer and Hormone Dependent Neoplasms, run by Northwestern University at 1 site in United States.
Trial summary
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Hormone Dependent Neoplasms, Adherence to Hormone Therapy
- What is being tested?
- "OncoTool" Intervention (MBSR + HT education)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 84 participants
- Where
- 1 siteUnited States
- Study dates
- 29 May 2019to 1 May 2022
- 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
- ≥ 18 years of age
- English-speaking (6th grade reading level) as required to complete assessments
- medical chart confirmed diagnosis of hormone-receptor positive non-metastatic breast cancer
- Stages I-IIIa
- completion of any combination of surgical, radiation, and chemotherapy treatment
- willingness to be randomized into study
Show all 9Show fewer
- have initiated HT within the past 6 months as data in literature indicates that the overwhelming majority of women who initiated HT are still adherent within the first 4 months
- first-time diagnosis of breast cancer
- access to a computer or tablet with Internet capabilities
Who cannot join
- Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- diagnosis of an unmanaged psychotic or psychiatric disorder (e.g., clinical depression, anxiety, or PTSD), bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., chronic severe pain, fibromyalgia)
- Alzheimer's, dementia or history of stroke
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Mindfulness-Based e-Health Intervention to Improve Medication Adherence Among Breast Cancer Survivors
The purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors.
The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period.
Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.
Read the detailed description
Breast cancer is the most commonly diagnosed cancer among women in the U.S. Approximately 75% to 80% of breast cancer survivors are prescribed HT (hormone therapy) medication for 5 to 10 years following primary treatment. Five years of adjuvant HT among women with non-metastatic cancer reduces the risk of recurrences by 50%. Adherence to HT is also an independent predictor of breast cancer mortality, reducing the risk by up to 28%. HT-side effects, however, are not only a major source of distress but also among the most robust predictors of non-adherence to HT. Therefore, effective management and ability to reduce the burden of these side effects are critically important to achieve optimal HT adherence. Because HT side effects may persist for years and are not easily managed, MBSR's mind-body approach and emphasis on non-judgmental attitudes, acceptance, and uncertainty tolerance may be an especially beneficial approach to helping cancer survivors cope with the burdensome medication-related side effects, thus improving adherence to medication. The investigators propose that a mindfulness-based stress reduction (MBSR) intervention that has been efficacious in reducing HT side effects and improving HRQoL in cancer patients may also prove beneficial in improving HT adherence. After developing a web-based MBSR intervention and refining it via a usability trial, this study will establish the feasibility of a web-delivered, group based MBSR intervention to improve HT medication adherence and HRQoL in patients being treated for breast cancer. It is hypothesized that participants assigned to the MBSR intervention will have better primary outcomes than participants in the control group, which receives standard health information.
- Being tested
- "OncoTool" Intervention (MBSR + HT education), "Oncotool" Control (health +HT education)
- Keywords
- eHealth, Adherence, Health Related Quality of Life, Symptom Burden, Breast Cancer
- Medical subject headings
- Breast Neoplasms, Neoplasms, Hormone-Dependent
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
"OncoTool" Intervention (MBSR + HT education)Behavioural
OncoTool is a website intended to improve self-management practices for helping cancer patients cope with stress and improve health-related quality of life. OncoTool provides mindfulness-based education and management for dealing with the numerous physical and mental side effects associated with hormone therapy (e.g., muscle and joint pain, vaginal dryness, depressive symptoms). OncoTool is a website designed to improve hormone therapy adherence by improving quality of life, and hormone therapy associated symptom burden. Both intervention and active comparator conditions are administered to participants for 8 weeks.
"Oncotool" Control (health +HT education)Behavioural
OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to breast cancer survivors, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar HT education content as the experimental content but without the CBT and MBSR state. Both intervention and active comparator conditions are administered to participants for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Mindfulness-based stress reduction + Hormone Therapy Education | Experimental | Not described Receives: Behavioral: "OncoTool" Intervention (MBSR + HT education) |
| Hormone Therapy Education + Overall Health Education | Active comparator | Not described Receives: Behavioral: "Oncotool" Control (health +HT education) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Self Reported Adherence to Hormone Therapy will be evaluated with the ARMS questionnaire.
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Endocrine (FACT-ES)
The FACT-ES has been used extensively to measure HRQoL. It assesses participant's wellbeing in physical, emotional, social, functional, and concerns specific to endocrine therapy in the last seven days using a five-point response scale.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Electronically Verified Hormone Therapy Adherence will be measured using medication event monitoring systems (MEMS)
A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.
Measured: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T4 (12 months post-intervention)
Pharmacy reported Adherence to Hormone Therapy will be measured using pharmacological records
Pharmacy data will be pulled once at approximately T4 when a participant finishes the study. This data will inform how frequently patients refill their hormone therapy medication.
Measured: T4 (12 months post intervention)
Secondary outcomes (10)
Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
The IES is made up of two subscales measuring the frequency of intrusion and avoidance experiences after a stressful event. The IES has been widely used among patients diagnosed with cancer.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire
This questionnaire has been tested and validated with breast cancer patients. It is made up of 16 true and false questions regarding general breast cancer knowledge.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Breast Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
The CASE-cancer questionnaire is made up various subscales measuring breast cancer related communication and attitudinal self-efficacy. Each question asks participants to use a four-point response scale to agree or disagree with statements regarding their level of confidence with different skills.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Stress Management Skills will be evaluated with the Brief COPE Inventory
The Brief COPE is made up of various subscales measuring different ways of coping. Each question as participants to rate how often they have used each coping mechanism in response to their breast cancer experience.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Perceived benefits and cost barriers to using hormone therapy will be assessed using a Beliefs about Medicines scale
The 11 point Beliefs about Medicines questionnaire assesses patients' beliefs about the efficacy of their treatment as well as their beliefs about how the benefits and side affects of hormone therapy affect their life.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Self-Reported Negative Mood is measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire
The PROMIS Depression questionnaire is a computer adaptive assessment that measures patients' self-reported level of negative mood within the past 7 days.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)
The 8 question MOS-SSS scale was developed by RAND Healthcare to assess the degree of companionship, assistance, or other types of social support that participants have access to. This study will use the 8 question emotional-informational support subsection.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
The PROMIS Self Efficacy for Managing Symptoms survey is a validated, computer adaptive survey to assess how confident participants are in their ability to manage their symptoms and side effects
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Mindfulness will be assessed using questionnaires tailored to MBSR treatment
The Intolerance of Uncertainty, Rumination and Reassure Me survey assesses participants' development in MBSR intervention targets, which will help isolate and assess the effect of MBSR treatment
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Concerns about cancer recurrence will be measured using the Concerns about Recurrence scale
The Concerns about Recurrence scale is a 4 question scale that assesses the frequency and intensity of patients' concerns about cancer recurrence.
Measured: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2019
- Study start29 May 2019
- Primary completion1 May 2022
- Study completion1 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 84 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Betina Yanez, Northwestern University
- Investigators
- Betina Yanez, PhD, Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03849573
- Sponsor's protocol ID
- STU00206180
- Status last verified
- Jul 2022
- First submitted
- 13 Feb 2019
- Last updated
- 5 Jul 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jul 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Mindfulness-Based e-Health Intervention to Improve Medication Adherence Among Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT03849573
- Acronym / sponsor ID
- STU00206180
- Keywords
- eHealth, Adherence, Health Related Quality of Life, Symptom Burden, Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 84 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- 29 May 2019 (actual)
- Primary completion
- 1 May 2022 (actual)
- Study completion
- 1 May 2022 (actual)
- First posted
- 21 Feb 2019 (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 purpose of this study is to examine the efficacy of a psychosocial eHealth intervention on the proposed primary outcomes, hormone therapy adherence and health related quality of life (HRQoL), in breast cancer survivors.
The intervention components include mindfulness-based stress reduction, breast cancer knowledge, stress awareness and management, social support, and enhanced communication. The intervention will be delivered via an online application over an 8-week period.
Participants are randomized into either an intervention application (described above) or a control application (health information and general health promotion strategies). Aside from having access to the online application for the recommended 8 weeks with weekly online focus groups, participation in this study includes four assessments: baseline (at the beginning of the research study), post-intervention (8 weeks after baseline), a 6-month follow-up and a 12-month follow-up.
Detailed description
Breast cancer is the most commonly diagnosed cancer among women in the U.S. Approximately 75% to 80% of breast cancer survivors are prescribed HT (hormone therapy) medication for 5 to 10 years following primary treatment. Five years of adjuvant HT among women with non-metastatic cancer reduces the risk of recurrences by 50%. Adherence to HT is also an independent predictor of breast cancer mortality, reducing the risk by up to 28%. HT-side effects, however, are not only a major source of distress but also among the most robust predictors of non-adherence to HT. Therefore, effective management and ability to reduce the burden of these side effects are critically important to achieve optimal HT adherence. Because HT side effects may persist for years and are not easily managed, MBSR's mind-body approach and emphasis on non-judgmental attitudes, acceptance, and uncertainty tolerance may be an especially beneficial approach to helping cancer survivors cope with the burdensome medication-related side effects, thus improving adherence to medication. The investigators propose that a mindfulness-based stress reduction (MBSR) intervention that has been efficacious in reducing HT side effects and improving HRQoL in cancer patients may also prove beneficial in improving HT adherence. After developing a web-based MBSR intervention and refining it via a usability trial, this study will establish the feasibility of a web-delivered, group based MBSR intervention to improve HT medication adherence and HRQoL in patients being treated for breast cancer. It is hypothesized that participants assigned to the MBSR intervention will have better primary outcomes than participants in the control group, which receives standard health information.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindfulness-based stress reduction + Hormone Therapy Education | Experimental | Behavioral: "OncoTool" Intervention (MBSR + HT education) |
| Hormone Therapy Education + Overall Health Education | Active comparator | Behavioral: "Oncotool" Control (health +HT education) |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- ≥ 18 years of age
- English-speaking (6th grade reading level) as required to complete assessments
- medical chart confirmed diagnosis of hormone-receptor positive non-metastatic breast cancer
- Stages I-IIIa
- completion of any combination of surgical, radiation, and chemotherapy treatment
Key exclusion criteria (3 listed)
- Visual, hearing, voice, or motor impairment that would prevent completion of study procedures
- diagnosis of an unmanaged psychotic or psychiatric disorder (e.g., clinical depression, anxiety, or PTSD), bipolar disorder, dissociative disorder, or other diagnosis for which participation in this trial is either inappropriate or dangerous - this includes patients who have life-threatening illness (e.g., end-stage kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment (e.g., chronic severe pain, fibromyalgia)
- Alzheimer's, dementia or history of stroke
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 |
|---|---|---|
| "OncoTool" Intervention (MBSR + HT education)OncoTool is a website intended to improve self-management practices for helping cancer patients cope with stress and improve health-related quality of life. OncoTool provides mindfulness-based education and management for dealing with the numerous physical and mental side effects associated with hormone therapy (e.g., muscle and joint pain, vaginal dryness, depressive symptoms). OncoTool is a website designed to improve hormone therapy adherence by improving quality of life, and hormone therapy associated symptom burden. Both intervention and active comparator conditions are administered to participants for 8 weeks. | Behavioural | Mindfulness-based stress reduction + Hormone Therapy Education |
| "Oncotool" Control (health +HT education)OncoTool is a health promotion website with health education on subjects like nutrition and exercise specific to breast cancer survivors, as well as general advice on lifestyle choices and prevention. The Oncotool control has similar HT education content as the experimental content but without the CBT and MBSR state. Both intervention and active comparator conditions are administered to participants for 8 weeks. | Behavioural | Hormone Therapy Education + Overall Health Education |
Primary outcome
Change in Self Reported Adherence to Hormone Therapy will be evaluated with the ARMS questionnaire.
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
The ARMS (Adherence to Refills and Medications Scale) survey is a previously validated patient-report measure of barriers to medication adherence and adherence-related behavior.
Change in Health Related Quality of Life will be evaluated with The Functional Assessment of Cancer Therapy-Endocrine (FACT-ES)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
The FACT-ES has been used extensively to measure HRQoL. It assesses participant's wellbeing in physical, emotional, social, functional, and concerns specific to endocrine therapy in the last seven days using a five-point response scale.
Electronically Verified Hormone Therapy Adherence will be measured using medication event monitoring systems (MEMS)
Time frame: MEMS data will be collected continuously during study participation from T1 (prior to starting intervention) to T4 (12 months post-intervention)
A MEMS cap is an electronic bottle cap that tracks when participants open their medication bottle. MEMS cap data will be collected continuously during the duration of participation in the study.
Pharmacy reported Adherence to Hormone Therapy will be measured using pharmacological records
Time frame: T4 (12 months post intervention)
Pharmacy data will be pulled once at approximately T4 when a participant finishes the study. This data will inform how frequently patients refill their hormone therapy medication.
10 secondary outcomes
Cancer-Specific Distress will be evaluated using The Impact of Event Scale (IES)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Breast Cancer Related Knowledge will be evaluated with the Knowledge about Breast Cancer Questionnaire
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Breast Cancer Related Communication and Attitudinal Self Efficacy will be evaluated using the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-cancer)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Stress Management Skills will be evaluated with the Brief COPE Inventory
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Perceived benefits and cost barriers to using hormone therapy will be assessed using a Beliefs about Medicines scale
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Self-Reported Negative Mood is measured with the Patient-Reported Outcomes Measurement Information System (PROMIS) Depression questionnaire
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Emotional Social Support is assessed using the emotional subscale portion of the Medical Outcomes Study - Social Support Survey Instrument (MOS-SSS)
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Patient Self-Efficacy in managing side effects is measured using the PROMIS Self Efficacy for Managing Symptoms
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Mindfulness will be assessed using questionnaires tailored to MBSR treatment
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
Concerns about cancer recurrence will be measured using the Concerns about Recurrence scale
Time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)
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 5 Jul 2022.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with any researchers outside Northwestern.
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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.
Betina Yanez, PhD principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing "OncoTool" Intervention (MBSR + HT education) in people with Breast Cancer and Hormone Dependent Neoplasms, run by Northwestern University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Jul 2022. 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 in Self Reported Adherence to Hormone Therapy will be evaluated with the ARMS questionnaire. (time frame: T1 (prior to starting intervention), T2 (8 weeks post intervention), T3 (6 months post-intervention), T4 (12 months post intervention)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jul 2022.