CancerATANDECNCT04936139
Art Therapy Effectiveness in the Level of Anxiety and Depression of Cancer Patients
A study testing Art Therapy in people with Cancer, run by Elisenda Campreciós Suñol at 1 site in Spain.
Trial summary
Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Art Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 224 participants
- Where
- 1 siteSpain
- Study dates
- 21 Feb 2021to 3 Nov 2023
- 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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Over 18 years of age
- Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months
- Have internet access in case the intervention is done online
- Agree to participate and sign informed consent
Who cannot join
- Patient with active diagnosis or personal history of severe psychological / psychiatric illness
- Patient who has participated in an art therapy program structured in the context of the oncological process
Trial locations and contacts
1 site in 1 country.
Spain1 site
Althaia Xarxa Assistencial Universitària de Manresa
Manresa, Barcelona, 08243
About this study
Official title: Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)
Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered.
Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.
Read the detailed description
Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered.
Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.
Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies.
Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions.
Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language.
Assessing anxiety and depression with the HAD scale, coping strategies with the Mini-MAC scale, and WHOQOL-BREF for quality of life will be used. Statistical analysis will be for treatment purposes. IBM SPSS Statistics v.24 and STATA v.14 will be used.
- Conditions
- Cancer
- Being tested
- Art Therapy
- Keywords
- Art Therapy, Depression, Anxiety, Quality of Life, Coping Skills
- Medical subject headings
- Neoplasms, Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Art TherapyBehavioural
During the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression.
Each session is structured in 3 phases:
- A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes). ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes). iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes).
| Study group | Role | What they receive |
|---|---|---|
| Art Therapy | Experimental | Patients assigned to the intervention group will participate in 12 weekly group therapy workshop sessions. Receives: Behavioral: Art Therapy |
| Control group | No intervention | Patients assigned to the control group will receive the usual follow-up care of each center provided for the cancer patient and will not perform art therapy workshops. They will be offered the opportunity to participate in the workshops once they have completed their participation in the study, putting them on a waiting list. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital Anxiety and Depression Scale (HAD scale)
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Measured: 3 months
Hospital Anxiety and Depression Scale (HAD scale)
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Measured: 6 months
Secondary outcomes (4)
World Health Organization Quality of Life (WHOQOL-BREF scale)
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
Measured: 3 months
World Health Organization Quality of Life (WHOQOL-BREF scale)
The questionnaire contains a total of 26 questions, two global quality of life and general health questions, and one question from each of the 24 facets contained in the WHOQOL-100. It also consists of 4 areas or dimensions: physical health, psychological, social relationships and environment. Each item has 5 ordinary Likert-type response options and the time it takes is two weeks. Higher scores indicate better quality of life
Measured: 6 months
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.
Measured: 3 months
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
MINI-MAC is a 29-item instrument on a 4-choice Likert scale that assesses cognitive and behavioral responses to cancer. Differentiate 5 modes of coping: helplessness / hopelessness (ID), anxious worry (PA), cognitive avoidance (EN), fighting spirit (EL), and fatalism (FAE). Results are calculated for each of the examined strategies. Each strategy includes seven relevant statements. Every analysed subscale result range may be from 7 to 28. The higher the score, the stronger the behaviour typical for a given strategy of coping with càncer.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2021
- Study start21 Feb 2021
- Primary completion3 Nov 2023
- Study completion3 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial
- Masking
- None (open label)
- Enrolment
- 224 participants (actual)
Sponsor and investigators
- Lead sponsor
- Elisenda Campreciós Suñol
- Sponsor type
- University, hospital or other
- Collaborators
- Fundació privada Nous Cims, Althaia Xarxa Assistencial Universitària de Manresa
- Responsible party
- Sponsor-investigator, Elisenda Campreciós Suñol, Althaia Xarxa Assistencial Universitària de Manresa
- Investigators
- Pau Gomes, MsC, Study chair, Fundació Nou Cims
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04936139
- Sponsor's protocol ID
- CEI 20/69
- Acronym
- ATANDEC
- Status last verified
- Feb 2024
- First submitted
- 14 Jun 2021
- Last updated
- 5 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
PubMed 24953449Andreu Vaillo Y, Murgui Perez S, Martinez Lopez P, Romero Retes R. Mini-Mental Adjustment to Cancer Scale: Construct validation in Spanish breast cancer patients. J Psychosom Res. 2018 Nov;114:38-44. doi: 10.1016/j.jpsychores.2018.09.004. Epub 2018 Sep 15.
PubMed 30314577Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
PubMed 16889324Krikorian A, Limonero JT, Mate J. Suffering and distress at the end-of-life. Psychooncology. 2012 Aug;21(8):799-808. doi: 10.1002/pon.2087. Epub 2011 Oct 11.
PubMed 21990213Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
PubMed 16288447Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
PubMed 23699646Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
PubMed 19473224Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
PubMed 19619378Xu L, Cheng P, Wu Y, Zhang J, Zhu J, Cui J, Yu R. The effects of art therapy on anxiety and depression in breast cancer patients: An updated meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13266. doi: 10.1111/ecc.13266. Epub 2020 May 25.
PubMed 32452121Zhang MF, Wen YS, Liu WY, Peng LF, Wu XD, Liu QW. Effectiveness of Mindfulness-based Therapy for Reducing Anxiety and Depression in Patients With Cancer: A Meta-analysis. Medicine (Baltimore). 2015 Nov;94(45):e0897-0. doi: 10.1097/MD.0000000000000897.
PubMed 26559246Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
PubMed 6880820
Study at a glance
From the registry record, last updated by the sponsor on 5 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Art Therapy in the Level of Anxiety and Depression of Cancer Patients. Multicentric Random Clinical Trial (ATANDEC)
- ClinicalTrials.gov ID
- NCT04936139
- Acronym / sponsor ID
- ATANDEC / CEI 20/69
- Conditions
- Cancer
- Keywords
- Art Therapy, Depression, Anxiety, Quality of Life, Coping Skills
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 224 participants (actual)
- Lead sponsor
- Elisenda Campreciós SuñolUniversity, hospital or other
- Collaborators
- Fundació privada Nous Cims, Althaia Xarxa Assistencial Universitària de Manresa
- Study start
- 21 Feb 2021 (actual)
- Primary completion
- 3 Nov 2023 (actual)
- Study completion
- 3 Nov 2023 (actual)
- First posted
- 23 Jun 2021 (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.
Having a diagnosis of cancer leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve the emotional well-being is considered.
Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.
Detailed description
Introduction: The passage of a cancer through a person leaves a great emotional impact when it comes to strategies for coping with illness and life after illness. Participation in an art therapy program to forge and improve your emotional well-being is considered.
Research Project Hypothesis: Art therapy can be an effective intervention to help cancer patients lower their levels of anxiety and depression and in return improve their quality of life and their ability to cope with the disease.
Objectives: To evaluate the effectiveness of art therapy in reducing the levels of anxiety and depression in cancer patients, as well as in improving the quality of life and coping strategies.
Methodology: Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial. Eight centers will participate in the study with an N of 423 patients. Patients older than 18 years of age who are diagnosed with cancer at any stage of treatment with the intention of radical treatment or palliative treatment with a life expectancy of more than 12 months will be included. If it is carried out in an online format, the person must have access to the internet. Patients who suffer from a current or previous serious psychological / psychiatric illness or those who have participated in an art therapy program structured in the context of oncological process will be excluded. Patients will be assigned to the control group (they will receive the usual follow-up from the center) or to the intervention group (art therapy program). Patients assigned to the intervention group will participate in an art therapy workshop once a week for 12 weeks, which will be done in person / online depending on the epidemiological situation of covid-19 and the needs of each center, The group will maintain the format (online / face-to-face) with which it has started throughout all the sessions.
Art therapy is a discipline that offers a space to meet with oneself, where one can dialogue with different artistic languages, with the aim of promoting emotional integration and looking for new ways to integrate difficult experiences through creative language.
Assessing anxiety and depression with the HAD scale, coping strategies with the Mini-MAC scale, and WHOQOL-BREF for quality of life will be used. Statistical analysis will be for treatment purposes. IBM SPSS Statistics v.24 and STATA v.14 will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized, controlled, parallel and multi-centric non-pharmacological clinical trial
| Arm | Type | Receives |
|---|---|---|
| Art Therapy | Experimental | Behavioral: Art TherapyPatients assigned to the intervention group will participate in 12 weekly group therapy workshop sessions. |
| Control group | No intervention | –Patients assigned to the control group will receive the usual follow-up care of each center provided for the cancer patient and will not perform art therapy workshops. They will be offered the opportunity to participate in the workshops once they have completed their participation in the study, putting them on a waiting list. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age
- Intention for radical treatment or palliative treatment with a life expectancy of more than 12 months
- Have internet access in case the intervention is done online
- Agree to participate and sign informed consent
Key exclusion criteria (2 listed)
- Patient with active diagnosis or personal history of severe psychological / psychiatric illness
- Patient who has participated in an art therapy program structured in the context of the oncological process
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 |
|---|---|---|
| Art TherapyDuring the 12 planned sessions, different artistic disciplines will be used: visual arts, music, play, narrative, dramatization, movement and body expression. Each session is structured in 3 phases: i. A first part of encounter and contextualization, to make contact with oneself, with the art therapist and with the group through a relaxation or meditation activity (35 minutes). ii. A second part, where the session continues with the work of artistic elaboration and production with the different materials and the different artistic languages (50 minutes). iii. A third part where the participants will be invited to make a closing, a moment to welcome and share whoever wishes, the experiences that have been experienced. A dialogue is created between Work-Patient-Art Therapist (35 minutes). | Behavioural | Art Therapy |
Primary outcome
Hospital Anxiety and Depression Scale (HAD scale)
Time frame: 3 months
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
Hospital Anxiety and Depression Scale (HAD scale)
Time frame: 6 months
The scale consists of 14 items that assess symptoms of anxiety and depression on a Likert scale of 4 response options. Scores between 0 and 7 are considered normal; between 8 and 10 doubtful, and scores above 11 for clinical problem of depression or anxiety.
4 secondary outcomes
World Health Organization Quality of Life (WHOQOL-BREF scale)
Time frame: 3 months
World Health Organization Quality of Life (WHOQOL-BREF scale)
Time frame: 6 months
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
Time frame: 3 months
Mini-Mental Adjustment to Cancer Scale (MINI-MAC)
Time frame: 6 months
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 Feb 2024.
- Results publication: PubMed 24953449Archer S, Buxton S, Sheffield D. The effect of creative psychological interventions on psychological outcomes for adult cancer patients: a systematic review of randomised controlled trials. Psychooncology. 2015 Jan;24(1):1-10. doi: 10.1002/pon.3607. Epub 2014 Jun 21.
- Results publication: PubMed 30314577Andreu Vaillo Y, Murgui Perez S, Martinez Lopez P, Romero Retes R. Mini-Mental Adjustment to Cancer Scale: Construct validation in Spanish breast cancer patients. J Psychosom Res. 2018 Nov;114:38-44. doi: 10.1016/j.jpsychores.2018.09.004. Epub 2018 Sep 15.
- Results publication: PubMed 16889324Oster I, Svensk AC, Magnusson E, Thyme KE, Sjodin M, Astrom S, Lindh J. Art therapy improves coping resources: a randomized, controlled study among women with breast cancer. Palliat Support Care. 2006 Mar;4(1):57-64. doi: 10.1017/s147895150606007x.
- Results publication: PubMed 21990213Krikorian A, Limonero JT, Mate J. Suffering and distress at the end-of-life. Psychooncology. 2012 Aug;21(8):799-808. doi: 10.1002/pon.2087. Epub 2011 Oct 11.
- Results publication: PubMed 16288447Monti DA, Peterson C, Kunkel EJ, Hauck WW, Pequignot E, Rhodes L, Brainard GC. A randomized, controlled trial of mindfulness-based art therapy (MBAT) for women with cancer. Psychooncology. 2006 May;15(5):363-73. doi: 10.1002/pon.988.
- Results publication: PubMed 23699646Puetz TW, Morley CA, Herring MP. Effects of creative arts therapies on psychological symptoms and quality of life in patients with cancer. JAMA Intern Med. 2013 Jun 10;173(11):960-9. doi: 10.1001/jamainternmed.2013.836.
- Results publication: PubMed 19473224Svensk AC, Oster I, Thyme KE, Magnusson E, Sjodin M, Eisemann M, Astrom S, Lindh J. Art therapy improves experienced quality of life among women undergoing treatment for breast cancer: a randomized controlled study. Eur J Cancer Care (Engl). 2009 Jan;18(1):69-77. doi: 10.1111/j.1365-2354.2008.00952.x.
- Results publication: PubMed 19619378Thyme KE, Sundin EC, Wiberg B, Oster I, Astrom S, Lindh J. Individual brief art therapy can be helpful for women with breast cancer: a randomized controlled clinical study. Palliat Support Care. 2009 Mar;7(1):87-95. doi: 10.1017/S147895150900011X.
- Results publication: PubMed 32452121Xu L, Cheng P, Wu Y, Zhang J, Zhu J, Cui J, Yu R. The effects of art therapy on anxiety and depression in breast cancer patients: An updated meta-analysis. Eur J Cancer Care (Engl). 2020 Sep;29(5):e13266. doi: 10.1111/ecc.13266. Epub 2020 May 25.
- Results publication: PubMed 26559246Zhang MF, Wen YS, Liu WY, Peng LF, Wu XD, Liu QW. Effectiveness of Mindfulness-based Therapy for Reducing Anxiety and Depression in Patients With Cancer: A Meta-analysis. Medicine (Baltimore). 2015 Nov;94(45):e0897-0. doi: 10.1097/MD.0000000000000897.
- Results publication: PubMed 6880820Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.
- Individual participant dataSharing planned: No
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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.
Pau Gomes, MsC study chair
Fundació Nou Cims
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Art Therapy in people with Cancer, run by Elisenda Campreciós Suñol at 1 site in Spain.
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 4 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 5 Feb 2024. 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 Spain. 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?
Hospital Anxiety and Depression Scale (HAD scale) (time frame: 3 months). The study lists 2 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 NCT04936139, which also lists 11 linked publications.
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 Feb 2024.