Lymphoma, Large B-Cell, DiffuseNCT05199961
Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
A study testing Digital Health Coaching in people with Lymphoma, Large B-Cell, Diffuse, run by Pack Health at 1 site in United States.
Trial summary
The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Lymphoma, Large B-Cell, Diffuse
- What is being tested?
- Digital Health Coaching
- Type of treatment
- Injection or infusion, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Jan 2022to 13 Sep 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adults aged 18 and older
- Able to read, speak and consent in English
- Diagnosis of diffuse large b-cell lymphoma
- Confirmed treatment with tisagenlecleucel (Kymriah)
- Internet access via smartphone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
Who cannot join
- Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
- Individuals for whom there is documentation of inability to provide consent in the medical record
Trial locations and contacts
1 site in 1 country.
United States1 site
Ohio State University Comprehensive Cancer Center
Columbus, Ohio, 43210
About this study
The aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Being tested
- Digital Health Coaching
- Keywords
- Quality of Life, Digital Health Coaching, adult, Receptors, Chimeric Antigen
- Medical subject headings
- Lymphoma, Large B-Cell, Diffuse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Digital Health CoachingBehavioural
The digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Single Arm Cohort Receiving Digital Health Coaching | Experimental | A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of whom will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center. Receives: Behavioral: Digital Health Coaching |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.
Measured: Change across Enrollment, Months 1,2,3,4,5,6
Secondary outcomes (3)
SF-36
The SF-36 is a validated measure for the assessment of health-related quality of life for individuals with diverse chronic conditions, including individuals with hematologic malignancies. It consists of 36-items assessing 8 health domains, including physical functioning, bodily pain, role limitations due to physical health problems, role limitations due to personal or emotional problems, emotional well-being, social functioning, energy/fatigue, and general health. The instrument is scored on a scale of 0-100 for each of the 8 health domains. It was recently used in a study of quality-of-life following treatment with tisagenlecleucel.
Measured: Enrollment, Months 3,6
Cancer Behavior Inventory- Brief (CBI-B)
This 12-item instrument measures self-efficacy in coping with cancer across 7 domains. These include: Seeking and Understanding Medical Information, Emotion Regulation, Coping with Treatment Related Side Effects, Accepting Cancer/ Maintaining a Positive Attitude, Seeking Social Support, and Using Spiritual Coping. The instrument utilizes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident".
Measured: Enrollment, Months 1,2,3,4,5,6
Subjective Assessment of Patient Experience in Managing CAR T Specific Care
As there are no currently validated instruments specific to CAR T-cell therapy, a 5-item assessment of patients' experience in monitoring, managing, and reporting treatment related toxicities will be created specifically for use in this study and will mirror the response scale in the CBI-B. This includes a 9-point response scale ranging from 1 "Not at all confident" to 9 "Confident". The following items will be included: 1) Understand the treatment toxicities I may experience while receiving CAR T-cell therapy; 2) Identify the signs and symptoms of these toxicities; 3) Communicate symptoms to provider; 4) Manage symptoms according to provider's instructions; 5) Explain treatment to a healthcare provider
Measured: Enrollment, Months 1,2,3,4,5,6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start25 Jan 2022
- Primary completion13 Sep 2022
- Study completion13 Sep 2022
Why it stopped: Sponsor requested early termination
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (14)Papers the sponsor has linked to this study.
- Other trials for Lymphoma, Large B-Cell, DiffuseStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pack Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Novartis, Ohio State University Comprehensive Cancer Center
- Responsible party
- Sponsor
- Investigators
- Gretchen McNally, PhD, Principal investigator, The Ohio State University Comprehensive Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05199961
- Sponsor's protocol ID
- 2021C0141
- Status last verified
- May 2023
- First submitted
- 6 Jan 2022
- Last updated
- 12 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Buitrago J, Adkins S, Hawkins M, Iyamu K, Oort T. Adult Survivorship: Considerations Following CAR T-Cell Therapy. Clin J Oncol Nurs. 2019 Apr 1;23(2):42-48. doi: 10.1188/19.CJON.S1.42-48.
PubMed 30880816Chakraborty R, Sidana S, Shah GL, Scordo M, Hamilton BK, Majhail NS. Patient-Reported Outcomes with Chimeric Antigen Receptor T Cell Therapy: Challenges and Opportunities. Biol Blood Marrow Transplant. 2019 May;25(5):e155-e162. doi: 10.1016/j.bbmt.2018.11.025. Epub 2018 Nov 28.
PubMed 30500439Beaupierre A, Lundberg R, Marrero L, Jain M, Wang T, Alencar MC. Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-Cell Therapy in Multiple Care Settings. Clin J Oncol Nurs. 2019 Apr 1;23(2):27-34. doi: 10.1188/19.CJON.S1.27-34.
PubMed 30880815Ventura F, Ohlen J, Koinberg I. An integrative review of supportive e-health programs in cancer care. Eur J Oncol Nurs. 2013 Aug;17(4):498-507. doi: 10.1016/j.ejon.2012.10.007. Epub 2012 Nov 15.
PubMed 23158437Madore S, Kilbourn K, Valverde P, Borrayo E, Raich P. Feasibility of a psychosocial and patient navigation intervention to improve access to treatment among underserved breast cancer patients. Support Care Cancer. 2014 Aug;22(8):2085-93. doi: 10.1007/s00520-014-2176-5. Epub 2014 Mar 18.
PubMed 24639035Jansen F, van Uden-Kraan CF, van Zwieten V, Witte BI, Verdonck-de Leeuw IM. Cancer survivors' perceived need for supportive care and their attitude towards self-management and eHealth. Support Care Cancer. 2015 Jun;23(6):1679-88. doi: 10.1007/s00520-014-2514-7. Epub 2014 Nov 26.
PubMed 25424520Green AC, Hayman LL, Cooley ME. Multiple health behavior change in adults with or at risk for cancer: a systematic review. Am J Health Behav. 2015 May;39(3):380-94. doi: 10.5993/AJHB.39.3.11.
PubMed 25741683Girault A, Ferrua M, Lalloue B, Sicotte C, Fourcade A, Yatim F, Hebert G, Di Palma M, Minvielle E. Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients. Eur J Cancer. 2015 Mar;51(4):551-557. doi: 10.1016/j.ejca.2014.12.001. Epub 2015 Feb 4.
PubMed 25661828Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
PubMed 1593914Maziarz RT, Waller EK, Jaeger U, Fleury I, McGuirk J, Holte H, Jaglowski S, Schuster SJ, Bishop MR, Westin JR, Mielke S, Teshima T, Bachanova V, Foley SR, Borchmann P, Salles GA, Zhang J, Tiwari R, Pacaud LB, Ma Q, Tam CS. Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Feb 25;4(4):629-637. doi: 10.1182/bloodadvances.2019001026.
PubMed 32074277Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
PubMed 28472964Hlubocky FJ, Webster K, Beaumont J, Cashy J, Paul D, Abernethy A, Syrjala KL, Von Roenn J, Cella D. A preliminary study of a health related quality of life assessment of priority symptoms in advanced lymphoma: the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy - Lymphoma Symptom Index. Leuk Lymphoma. 2013 Sep;54(9):1942-6. doi: 10.3109/10428194.2012.762977. Epub 2013 Feb 7.
PubMed 23320888Heitzmann CA, Merluzzi TV, Jean-Pierre P, Roscoe JA, Kirsh KL, Passik SD. Assessing self-efficacy for coping with cancer: development and psychometric analysis of the brief version of the Cancer Behavior Inventory (CBI-B). Psychooncology. 2011 Mar;20(3):302-12. doi: 10.1002/pon.1735.
PubMed 20878830Harris PA, Taylor R, Thielke R, Payne J, Gonzalez N, Conde JG. Research electronic data capture (REDCap)--a metadata-driven methodology and workflow process for providing translational research informatics support. J Biomed Inform. 2009 Apr;42(2):377-81. doi: 10.1016/j.jbi.2008.08.010. Epub 2008 Sep 30.
PubMed 18929686
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life of Adults With Diffuse Large B-cell Lymphoma Treated With Tisagenlecleucel
- ClinicalTrials.gov ID
- NCT05199961
- Acronym / sponsor ID
- 2021C0141
- Conditions
- Lymphoma, Large B-Cell, Diffuse
- Keywords
- Quality of Life, Digital Health Coaching, adult, Receptors, Chimeric Antigen
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Sponsor requested early termination
- Enrolment
- 4 participants (actual)
- Lead sponsor
- Pack HealthIndustry (pharma, biotech, devices)
- Collaborators
- Novartis, Ohio State University Comprehensive Cancer Center
- Study start
- 25 Jan 2022 (actual)
- Primary completion
- 13 Sep 2022 (actual)
- Study completion
- 13 Sep 2022 (actual)
- First posted
- 20 Jan 2022 (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 aim of this non-interventional multi-center study is to evaluate quality of life (QOL) and other patient reported outcomes (PROs) among adults with diffuse large b-cell lymphoma (DLBCL) following Chimeric Antigen Receptor (CAR) T-cell therapy with tisagenlecleucel (Kymriah). Up to 100 individuals will be enrolled prior to tisagenlecleucel infusion in either the inpatient or ambulatory setting and followed for 6 months post-enrollment to evaluate changes in QOL from baseline to post-treatment, as measured by the Functional Assessment of Cancer Treatment- lymphoma (FACT-Lym). Secondary outcomes will assess patient self-efficacy in assessing for and managing treatment-related toxicities including cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS) and communicating these and other concerns across care settings. To support patients and facilitate the collection of key PROs, a digital health coaching solution provided by Pack Health will be provided to each participant over the 6-month study enrollment. The digital coaching program provides an evidence-based curriculum focused on monitoring and managing CAR T-cell associated toxicities, enhancing overall wellness post-treatment, and navigating within and between referring and treating facilities. The participating site(s) will collect longitudinal PRO data focused on QOL across physiologic and psychosocial domains that coaching personnel will access and review with participants.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- A single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of which will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center.
| Arm | Type | Receives |
|---|---|---|
| Single Arm Cohort Receiving Digital Health Coaching | Experimental | Behavioral: Digital Health CoachingA single cohort of up to 100 individuals receiving chimeric antigen receptor T cell therapy will be enrolled in the study, all of whom will be enrolled in a 6-month digital health coaching program. Individuals will be enrolled at The Ohio State University Comprehensive Cancer Center. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adults aged 18 and older
- Able to read, speak and consent in English
- Diagnosis of diffuse large b-cell lymphoma
- Confirmed treatment with tisagenlecleucel (Kymriah)
- Internet access via smartphone, tablet, a computer, or another device with the capacity to receive calls, texts, or e-mails, as well as the electronic study assessments.
Key exclusion criteria (2 listed)
- Individuals who are terminally ill, defined as individuals identified by their physician as likely having 6 months or less to live, or those individuals transitioned to comfort measures only (meaning only supportive care measures without curative focused treatment)
- Individuals for whom there is documentation of inability to provide consent in the medical record
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 |
|---|---|---|
| Digital Health CoachingThe digital health coaching program consists of weekly calls and delivery of evidence-based content across health and wellness domains (e.g. nutrition, exercise, physical, emotional and financial health) up to 4 times weekly via text, email or mobile application. The program is 6-months in duration and designed for engagement following CAR T cell infusion. | Behavioural | Single Arm Cohort Receiving Digital Health Coaching |
Primary outcome
Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym)
Time frame: Change across Enrollment, Months 1,2,3,4,5,6
The FACT-lym is a 42-item assessment that measures self-reported quality of life across 4 domains: physical, functional, emotional and social and includes 15 additional items validated specifically for individuals with lymphoma. The instrument can be scored as a whole as well as within the individual domains.
3 secondary outcomes
SF-36
Time frame: Enrollment, Months 3,6
Cancer Behavior Inventory- Brief (CBI-B)
Time frame: Enrollment, Months 1,2,3,4,5,6
Subjective Assessment of Patient Experience in Managing CAR T Specific Care
Time frame: Enrollment, Months 1,2,3,4,5,6
Results and safety
The study was stopped early (reason given: Sponsor requested early termination). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2023.
- Background: PubMed 30880816Buitrago J, Adkins S, Hawkins M, Iyamu K, Oort T. Adult Survivorship: Considerations Following CAR T-Cell Therapy. Clin J Oncol Nurs. 2019 Apr 1;23(2):42-48. doi: 10.1188/19.CJON.S1.42-48.
- Background: PubMed 30500439Chakraborty R, Sidana S, Shah GL, Scordo M, Hamilton BK, Majhail NS. Patient-Reported Outcomes with Chimeric Antigen Receptor T Cell Therapy: Challenges and Opportunities. Biol Blood Marrow Transplant. 2019 May;25(5):e155-e162. doi: 10.1016/j.bbmt.2018.11.025. Epub 2018 Nov 28.
- Background: PubMed 30880815Beaupierre A, Lundberg R, Marrero L, Jain M, Wang T, Alencar MC. Management Across Settings: An Ambulatory and Community Perspective for Patients Undergoing CAR T-Cell Therapy in Multiple Care Settings. Clin J Oncol Nurs. 2019 Apr 1;23(2):27-34. doi: 10.1188/19.CJON.S1.27-34.
- Background: PubMed 23158437Ventura F, Ohlen J, Koinberg I. An integrative review of supportive e-health programs in cancer care. Eur J Oncol Nurs. 2013 Aug;17(4):498-507. doi: 10.1016/j.ejon.2012.10.007. Epub 2012 Nov 15.
- Background: PubMed 24639035Madore S, Kilbourn K, Valverde P, Borrayo E, Raich P. Feasibility of a psychosocial and patient navigation intervention to improve access to treatment among underserved breast cancer patients. Support Care Cancer. 2014 Aug;22(8):2085-93. doi: 10.1007/s00520-014-2176-5. Epub 2014 Mar 18.
- Background: PubMed 25424520Jansen F, van Uden-Kraan CF, van Zwieten V, Witte BI, Verdonck-de Leeuw IM. Cancer survivors' perceived need for supportive care and their attitude towards self-management and eHealth. Support Care Cancer. 2015 Jun;23(6):1679-88. doi: 10.1007/s00520-014-2514-7. Epub 2014 Nov 26.
- Background: PubMed 25741683Green AC, Hayman LL, Cooley ME. Multiple health behavior change in adults with or at risk for cancer: a systematic review. Am J Health Behav. 2015 May;39(3):380-94. doi: 10.5993/AJHB.39.3.11.
- Background: PubMed 25661828Girault A, Ferrua M, Lalloue B, Sicotte C, Fourcade A, Yatim F, Hebert G, Di Palma M, Minvielle E. Internet-based technologies to improve cancer care coordination: current use and attitudes among cancer patients. Eur J Cancer. 2015 Mar;51(4):551-557. doi: 10.1016/j.ejca.2014.12.001. Epub 2015 Feb 4.
- Background: PubMed 1593914Ware JE Jr, Sherbourne CD. The MOS 36-item short-form health survey (SF-36). I. Conceptual framework and item selection. Med Care. 1992 Jun;30(6):473-83.
- Background: PubMed 32074277Maziarz RT, Waller EK, Jaeger U, Fleury I, McGuirk J, Holte H, Jaglowski S, Schuster SJ, Bishop MR, Westin JR, Mielke S, Teshima T, Bachanova V, Foley SR, Borchmann P, Salles GA, Zhang J, Tiwari R, Pacaud LB, Ma Q, Tam CS. Patient-reported long-term quality of life after tisagenlecleucel in relapsed/refractory diffuse large B-cell lymphoma. Blood Adv. 2020 Feb 25;4(4):629-637. doi: 10.1182/bloodadvances.2019001026.
- Background: PubMed 28472964Bunevicius A. Reliability and validity of the SF-36 Health Survey Questionnaire in patients with brain tumors: a cross-sectional study. Health Qual Life Outcomes. 2017 May 4;15(1):92. doi: 10.1186/s12955-017-0665-1.
- Background: PubMed 23320888Hlubocky FJ, Webster K, Beaumont J, Cashy J, Paul D, Abernethy A, Syrjala KL, Von Roenn J, Cella D. A preliminary study of a health related quality of life assessment of priority symptoms in advanced lymphoma: the National Comprehensive Cancer Network-Functional Assessment of Cancer Therapy - Lymphoma Symptom Index. Leuk Lymphoma. 2013 Sep;54(9):1942-6. doi: 10.3109/10428194.2012.762977. Epub 2013 Feb 7.
- 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.
Gretchen McNally, PhD principal investigator
The Ohio State University Comprehensive Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Digital Health Coaching in people with Lymphoma, Large B-Cell, Diffuse, run by Pack Health 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 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: stopped early, as of the sponsor's last update on 12 May 2023. 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 was stopped early (reason given: Sponsor requested early termination). Results are not available in the source record.
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?
Functional Assessment of Cancer Therapy- Lymphoma (FACT-Lym) (time frame: Change across Enrollment, Months 1,2,3,4,5,6). 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 NCT05199961, which also lists 14 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 12 May 2023.