Metastatic Breast CancerLIBERATENCT04173897
Living Better With Advanced Breast Cancer: Feasibility Evaluation of an Online Supportive Intervention.
A study testing LIBERATE website in people with Metastatic Breast Cancer, run by University of Leeds at 1 site in United Kingdom.
Trial summary
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- LIBERATE website
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jun 2020to 31 Mar 2021
- 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
- Adult females (aged 18 and over).
- Diagnosed with secondary (metastatic, stage IV) breast cancer.
- Access to the internet.
Who cannot join
- Exhibiting signs of overt psychopathology or cognitive dysfunction.
- Current involvement in other clinical trials involving completion of QoL or other patient reported outcome measures.
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
St James University Hospital
Leeds, West Yorkshire, LS97TF
About this study
Official title: Living Better With Advanced Breast Cancer (LIBERATE) Phase II: Evaluating the Feasibility of a Supportive, Self-management Website in Women Living With Secondary Breast Cancer.
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support.
This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.
Read the detailed description
Despite ongoing treatment advances for women living with secondary (metastatic, stage IV, advanced) breast cancer, quality of life (QoL) remains a crucial concern. Patients' diverse psycho-social and supportive needs are widely reported to be poorly understood and inadequately addressed.
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer.
Phase I of the LIBERATE project informed intervention development though several strands:
- Semi-structured interviews with patients and health \& charity professionals explored the supportive needs and factors affecting the quality of life of women living with secondary breast cancer. This guided the components and content of the online intervention.
- A systematic review of online interventions in the context of advanced cancer was also conducted. This guided the design and delivery of the online intervention.
The final intervention comprises five components delivered via an interactive website;
- A wide range of holistic health information specific to secondary breast cancer.
- Online symptom monitoring questionnaire generating tailored self-management advice with results available for clinician review.
- Case studies of a diverse range of women living with secondary breast cancer.
- Signposting to services and resources specific to secondary breast cancer.
- Support for others affected by a diagnosis of secondary breast cancer. The overall aims of the LIBERATE intervention are to better address the supportive needs and to improve the quality of life of women living with secondary breast cancer.
Aims and objectives: In this feasibility randomised controlled trial, the investigators plan to test the complete LIBERATE intervention, including the clinical integration of users' symptom monitoring questionnaire results with their electronic medical records.
The investigators aim to examine the feasibility, acceptability and adherence to the online intervention from the perspective of women living with secondary breast cancer and to explore the effect of the intervention on their quality of life and self-efficacy in managing their cancer. The investigators aim to determine effect sizes to inform a potential future larger scale randomised controlled trial.
Eligibility and study design:
Adult females with a diagnosis of secondary breast cancer and access to the internet who are receiving their care at St James' University Hospital, Leeds, will be eligible to take part in this study.
This study will be a prospective randomised controlled feasibility trial using a waiting list control design, repeated measures and mixed methods. Participants will be randomised (following a 1:1 randomisation strategy) to either receive the intervention or to be assigned to a waiting list to receive access to the intervention following study completion. Those on the waiting list will receive care and support as usual during the study period. The investigators aim to recruit a maximum of 30 patients to the study.
Participants in the intervention arm will receive training to navigate the LIBERATE website and complete the online symptom monitoring questionnaires from home. They will be free to use the website as much or as little as they choose over the 12 week study period. They will be reminded to complete a symptom monitoring questionnaire at least once per week. Their health professionals will be able to view the results of their symptom monitoring questionnaires and act on the information accordingly. Alerts will also be sent out to the relevant clinician when patients report any severe symptoms.
All participants (within both the intervention and the waiting list control arm) will complete paper-based self-report questionnaires measuring quality of life and self-efficacy at baseline and at 12 weeks.
A separate single-arm sub study will also recruit approximately 15 women with secondary breast cancer (bringing the overall recruitment target to 45) who are being cared for outside of the Leeds Teaching Hospitals Trust. The aim of this study is to explore whether participants outside of Leeds find symptom monitoring and the overall website useful without the function for linking to their medical records. Participants will fill in questionnaires asking about their QoL and confidence in self-managing their cancer before and after the study.
Study measures:
This study will use a range outcome measures to compare the LIBERATE intervention with care as usual (waiting list control):
Patient reported outcome measures: Validated questionnaires will be used to measure quality of life (EQ-5D-5L and FACT-B) and self-efficacy (CBI-B and SEMCD-6).
Clinical process measures: including number of clinician alerts generated, number of Clinical Nurse Specialist contacts in intervention period, calls to hospital and number of visits to hospital during intervention period.
End of study interviews: semi-structured interviews with participants and health professionals will explore acceptance and experiences of using the LIBERATE intervention.
Overall findings will determine the feasibility and value of a self-management, symptom-monitoring and signposting website as a supportive intervention for women living with and being treated for secondary breast cancer.
- Conditions
- Metastatic Breast Cancer
- Being tested
- LIBERATE website
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LIBERATE websiteOther
The LIBERATE intervention is a self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Components include; holistic health information specific to secondary breast cancer, symptom monitoring and self-management advice, case studies, signposting to services \& support and support for family \& loved ones.
| Study group | Role | What they receive |
|---|---|---|
| Intervention arm | Experimental | 12 weeks access to LIBERATE online supportive intervention (dose not specified) including symptom monitoring questionnaire component, with questionnaire results integrated within electronic medical records for clinician review. Receives: Other: LIBERATE website |
| Waiting list control arm | No intervention | Care and support as usual; no access to intervention. Placed on waiting list to receive intervention following study completion. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with self-reported outcome data at 12 weeks.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Measured: 12 weeks.
Proportion of missing data in self-report outcome questionnaires.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Measured: 12 weeks.
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (EQ-5D-5L).
Descriptive statistics of returned EQ-5D-5L questionnaires.
The standardised EQ-5D-5L measures health outcomes through a descriptive profile and a visual analogue scale (VAS). The descriptive profile encompasses 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
Measured: 12 weeks
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (FACT-B).
Descriptive statistics of returned FACT-B questionnaires.
Measured: 12 weeks
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (B-CBI).
Descriptive statistics of returned B-CBI questionnaires.
The 12-item questionnaire Cancer Behaviour Inventory - brief version measures patients' self-efficacy for coping with cancer by asking them to rate their confidence to perform certain behaviours on a scale of 1 (not at all confident) to 9 (totally confident). CBI-B is a single score measure (minimum score = 12, maximum score = 108) with higher scores indicative of greater self-efficacy.
Measured: 12 weeks
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (SEMCD-6).
Descriptive statistics of returned SEMCD-6 questionnaires.
This 6-item SEMCD-6 measures self-efficacy to manage chronic disease, asking patients to rate their confidence in their abilities to perform a range of self-management tasks. Each of the 6 items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores for the scale are calculated as a mean of the 6 items (minimum score = 1, maximum score = 10), with higher scores indicating greater self-efficacy.
Measured: 12 weeks
Acceptability & use of intervention: Number of symptom monitoring reports generated and qualitative interview data.
Number of symptom monitoring reports generated and qualitative interview data.
Measured: 12 weeks
Secondary outcomes (4)
Estimation of effect size for QOL using participant scores for EQ-5D-5L.
Calculation of mean and standard deviation of questionnaire scores to allow for estimation of effect size for QOL.
[EuroQoL Health Related Quality of Life - 5 Dimensions - 5 Levels (EQ-5D-5L). Descriptive profile minimum score 11111 (no problems across all 5 dimensions), maximum score 55555 (extreme problems). Visual analogue scale rating health from 0 ('worst health imaginable') to 100 ('best health imaginable)].
Measured: 12 weeks
Estimation of effect size for QOL using participant scores for FACT-B.
Calculation of mean and standard deviation of questionnaire scores to allow for estimation of effect size for QOL.
[Functional Assessment of Cancer Therapy-Breast (FACT-B). Total score ranges from 0 to 123, calculated by adding the scores from each of the 5 subscales. Higher scores reflect better quality of life.]
Measured: 12 weeks
Estimation of effect size for self-efficacy using participant scores for B-CBI.
Calculation of mean and standard deviation of questionnaire scores to allow for estimation of effect size for self-efficacy in managing cancer.
[Cancer Behaviour Inventory - brief version (B-CBI). Items rated on a scale of 1 (not at all confident) to 9 (totally confident). Single score measure (minimum score =12, maximum score =108), with higher scores indicative of greater self-efficacy].
Measured: 12 weeks
Estimation of effect size for self-efficacy using participant scores for SEMCD-6.
Calculation of mean and standard deviation of questionnaire scores to allow for estimation of effect size for self-efficacy in managing cancer.
[Self-Efficacy for Managing Chronic Disease scale (SEMCD-6). Items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores are calculated as a mean of the 6 items (minimum score =1, maximum score =10), higher scores indicating greater self-efficacy].
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2019
- Study start6 Jun 2020
- Primary completion11 Jan 2021
- Study completion31 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel group, two-arm randomised model using a waiting list control design. \[A separate single arm study (non-randomised, pre-post design) will run in parallel, recruiting via online channels.\]
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Breast Cancer Now
- Responsible party
- Principal investigator, Galina Velikova, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04173897
- Sponsor's protocol ID
- NOV2016PhD818
- Acronym
- LIBERATE
- Status last verified
- Apr 2021
- First submitted
- 30 Oct 2019
- Last updated
- 30 Apr 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Living Better With Advanced Breast Cancer (LIBERATE) Phase II: Evaluating the Feasibility of a Supportive, Self-management Website in Women Living With Secondary Breast Cancer.
- ClinicalTrials.gov ID
- NCT04173897
- Acronym / sponsor ID
- LIBERATE / NOV2016PhD818
- Conditions
- Metastatic Breast Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Breast Cancer Now
- Study start
- 6 Jun 2020 (actual)
- Primary completion
- 11 Jan 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 22 Nov 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 LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Overall, this intervention aims to improve quality of life among this growing group of patients through targeted, tailored and accessible information and support.
This randomised waiting list control trial aims to evaluate the feasibility of the clinically integrated LIBERATE intervention. Results of participants' online symptom monitoring questionnaires are integrated with their electronic patient record, enabling clinician review and follow up alongside participants' own self-management activities.
Detailed description
Despite ongoing treatment advances for women living with secondary (metastatic, stage IV, advanced) breast cancer, quality of life (QoL) remains a crucial concern. Patients' diverse psycho-social and supportive needs are widely reported to be poorly understood and inadequately addressed.
The LIBERATE intervention is a multi-component self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer.
Phase I of the LIBERATE project informed intervention development though several strands:
- Semi-structured interviews with patients and health \& charity professionals explored the supportive needs and factors affecting the quality of life of women living with secondary breast cancer. This guided the components and content of the online intervention.
- A systematic review of online interventions in the context of advanced cancer was also conducted. This guided the design and delivery of the online intervention.
The final intervention comprises five components delivered via an interactive website;
- A wide range of holistic health information specific to secondary breast cancer.
- Online symptom monitoring questionnaire generating tailored self-management advice with results available for clinician review.
- Case studies of a diverse range of women living with secondary breast cancer.
- Signposting to services and resources specific to secondary breast cancer.
- Support for others affected by a diagnosis of secondary breast cancer. The overall aims of the LIBERATE intervention are to better address the supportive needs and to improve the quality of life of women living with secondary breast cancer.
Aims and objectives: In this feasibility randomised controlled trial, the investigators plan to test the complete LIBERATE intervention, including the clinical integration of users' symptom monitoring questionnaire results with their electronic medical records.
The investigators aim to examine the feasibility, acceptability and adherence to the online intervention from the perspective of women living with secondary breast cancer and to explore the effect of the intervention on their quality of life and self-efficacy in managing their cancer. The investigators aim to determine effect sizes to inform a potential future larger scale randomised controlled trial.
Eligibility and study design:
Adult females with a diagnosis of secondary breast cancer and access to the internet who are receiving their care at St James' University Hospital, Leeds, will be eligible to take part in this study.
This study will be a prospective randomised controlled feasibility trial using a waiting list control design, repeated measures and mixed methods. Participants will be randomised (following a 1:1 randomisation strategy) to either receive the intervention or to be assigned to a waiting list to receive access to the intervention following study completion. Those on the waiting list will receive care and support as usual during the study period. The investigators aim to recruit a maximum of 30 patients to the study.
Participants in the intervention arm will receive training to navigate the LIBERATE website and complete the online symptom monitoring questionnaires from home. They will be free to use the website as much or as little as they choose over the 12 week study period. They will be reminded to complete a symptom monitoring questionnaire at least once per week. Their health professionals will be able to view the results of their symptom monitoring questionnaires and act on the information accordingly. Alerts will also be sent out to the relevant clinician when patients report any severe symptoms.
All participants (within both the intervention and the waiting list control arm) will complete paper-based self-report questionnaires measuring quality of life and self-efficacy at baseline and at 12 weeks.
A separate single-arm sub study will also recruit approximately 15 women with secondary breast cancer (bringing the overall recruitment target to 45) who are being cared for outside of the Leeds Teaching Hospitals Trust. The aim of this study is to explore whether participants outside of Leeds find symptom monitoring and the overall website useful without the function for linking to their medical records. Participants will fill in questionnaires asking about their QoL and confidence in self-managing their cancer before and after the study.
Study measures:
This study will use a range outcome measures to compare the LIBERATE intervention with care as usual (waiting list control):
Patient reported outcome measures: Validated questionnaires will be used to measure quality of life (EQ-5D-5L and FACT-B) and self-efficacy (CBI-B and SEMCD-6).
Clinical process measures: including number of clinician alerts generated, number of Clinical Nurse Specialist contacts in intervention period, calls to hospital and number of visits to hospital during intervention period.
End of study interviews: semi-structured interviews with participants and health professionals will explore acceptance and experiences of using the LIBERATE intervention.
Overall findings will determine the feasibility and value of a self-management, symptom-monitoring and signposting website as a supportive intervention for women living with and being treated for secondary breast cancer.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Parallel group, two-arm randomised model using a waiting list control design. [A separate single arm study (non-randomised, pre-post design) will run in parallel, recruiting via online channels.]
| Arm | Type | Receives |
|---|---|---|
| Intervention arm | Experimental | Other: LIBERATE website12 weeks access to LIBERATE online supportive intervention (dose not specified) including symptom monitoring questionnaire component, with questionnaire results integrated within electronic medical records for clinician review. |
| Waiting list control arm | No intervention | –Care and support as usual; no access to intervention. Placed on waiting list to receive intervention following study completion. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Adult females (aged 18 and over).
- Diagnosed with secondary (metastatic, stage IV) breast cancer.
- Access to the internet.
Key exclusion criteria (2 listed)
- Exhibiting signs of overt psychopathology or cognitive dysfunction.
- Current involvement in other clinical trials involving completion of QoL or other patient reported outcome measures.
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 |
|---|---|---|
| LIBERATE websiteThe LIBERATE intervention is a self-management, symptom monitoring and signposting website tailored to the supportive needs of women living with secondary breast cancer. Components include; holistic health information specific to secondary breast cancer, symptom monitoring and self-management advice, case studies, signposting to services \& support and support for family \& loved ones. | Other | Intervention arm |
Primary outcome
Number of participants with self-reported outcome data at 12 weeks.
Time frame: 12 weeks.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Proportion of missing data in self-report outcome questionnaires.
Time frame: 12 weeks.
Patients will complete paper based questionnaires relating to quality of life (FACT-B \& EQ-5D-5L) and self-efficacy (B-CBI \& SEMCD-6).
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (EQ-5D-5L).
Time frame: 12 weeks
Descriptive statistics of returned EQ-5D-5L questionnaires. The standardised EQ-5D-5L measures health outcomes through a descriptive profile and a visual analogue scale (VAS). The descriptive profile encompasses 5 dimensions of health (mobility, self-care, usual activities, pain/discomfort, and anxiety/depression). For each dimension, participants choose one of 5 levels that best describes their health on that day (from 'no problem'= 1 to 'unable/extreme'= 5). The numbers chosen for the five dimensions are combined to give a 5 digit score (minimum score = 11111 maximum score = 55555). The VAS provides participant's rating of their health on a scale from 0 ('the worst health you can imagine') to 100 ('the best health you can imagine').
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (FACT-B).
Time frame: 12 weeks
Descriptive statistics of returned FACT-B questionnaires.
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (B-CBI).
Time frame: 12 weeks
Descriptive statistics of returned B-CBI questionnaires. The 12-item questionnaire Cancer Behaviour Inventory - brief version measures patients' self-efficacy for coping with cancer by asking them to rate their confidence to perform certain behaviours on a scale of 1 (not at all confident) to 9 (totally confident). CBI-B is a single score measure (minimum score = 12, maximum score = 108) with higher scores indicative of greater self-efficacy.
Appropriateness of each of the self-report outcome questionnaires by assessing ceiling and floor effects (SEMCD-6).
Time frame: 12 weeks
Descriptive statistics of returned SEMCD-6 questionnaires. This 6-item SEMCD-6 measures self-efficacy to manage chronic disease, asking patients to rate their confidence in their abilities to perform a range of self-management tasks. Each of the 6 items are rated on a scale from 1 ('not at all confident') to 10 ('totally confident'). Scores for the scale are calculated as a mean of the 6 items (minimum score = 1, maximum score = 10), with higher scores indicating greater self-efficacy.
Acceptability & use of intervention: Number of symptom monitoring reports generated and qualitative interview data.
Time frame: 12 weeks
Number of symptom monitoring reports generated and qualitative interview data.
4 secondary outcomes
Estimation of effect size for QOL using participant scores for EQ-5D-5L.
Time frame: 12 weeks
Estimation of effect size for QOL using participant scores for FACT-B.
Time frame: 12 weeks
Estimation of effect size for self-efficacy using participant scores for B-CBI.
Time frame: 12 weeks
Estimation of effect size for self-efficacy using participant scores for SEMCD-6.
Time frame: 12 weeks
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 30 Apr 2021.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing LIBERATE website in people with Metastatic Breast Cancer, run by University of Leeds at 1 site in United Kingdom.
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 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 30 Apr 2021. 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 Kingdom. 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?
Number of participants with self-reported outcome data at 12 weeks. (time frame: 12 weeks.). The study lists 7 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 30 Apr 2021.