Adherence, MedicationNCT06696521
An Analysis of Medication Adherence Using Televideo and Telephonic Monitoring and Utilization of an Education Protocol
A study testing Intervention A- Telephone and Intervention B- Televideo in people with Adherence, Medication and Cancer, run by Abramson Cancer Center at Penn Medicine at 1 site in United States.
Trial summary
The objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Adherence, Medication, Cancer
- What is being tested?
- Intervention A- Telephone and Intervention B- Televideo
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 76 participants
- Where
- 1 siteUnited States
- Study dates
- 9 Feb 2021to 11 Feb 2025
- 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 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Has a diagnosis of cancer
- Receives cancer care at Abramson Cancer Center at Penn Presbyterian Medical Center
- Physically and cognitively able to provide informed consent
- Is 18 years or older
- Is starting an oral cancer agent
- Has access to the UPENN televideo platform
- Lives in Pennsylvania
Who cannot join
- Does not desire to participate in the study
- Cannot consent for himself/herself
- Does not have access to the UPENN televideo platform
- Does not live in Pennsylvania
- Chemoradiation patients
Trial locations and contacts
1 site in 1 country.
United States1 site
Abramson Cancer Center at PPMC
Philadelphia, Pennsylvania, 19104
About this study
Official title: A Prospective Analysis of Medication Adherence Comparing Televideo and Telephonic Modes of Longitudinal Monitoring and Utilization of a Standardized Educational Protocol
The objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Researchers aim to evaluate whether the modality of education and monitoring impact adherence.
Read the detailed description
The study will consist of eight total interactions. We will allow for a 72 hour window for each encounter to allow for patient flexibility and scheduling. The first encounter will include medication education using the standardized tool. The remaining seven interactions will include toxicity and adherence assessment through patient interviews, the OCAS, pill counts, and pharmacy fill data. All interactions will be completed via telephonic outreach or televideo platform by either CRNP, PA-C or PharmD. The patient will be approached when an OCA is prescribed to be given a copy of the OncoLink® patient education material and consent form for review. Patients will be randomized 1:1 to either televideo or telephonic interactions using a block size of 4. All study staff will be blinded to block size. Once a patient is randomized, s/he will be scheduled for the series of follow up encounters via the assigned modality. The first telemedicine interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second encounter will occur approximately 2 weeks after the patient starts the medication to assess for adherence and toxicity. The third through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS) (Bagcivan and Akbayrak 2015) will be completed per standard of care in addition to patient interview to assess adherence and toxicity. Fill history will be obtained prior to each interaction to verify medication possession ratio and proportion of days covered.
Each patient in the study will participate for a duration of up to 4 months. All of the research will take place at the Abramson Cancer Center at Penn Presbyterian Medical Center.
- Conditions
- Adherence, Medication, Cancer
- Being tested
- Intervention A- Telephone, Intervention B- Televideo
- Medical subject headings
- Medication Adherence, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention A- TelephoneBehavioural
For intervention A: Once a patient is randomized to telephone (Intervention A), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months.
Intervention B- TelevideoBehavioural
For intervention B: Once a patient is randomized to televideo (Intervention B), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months.
| Study group | Role | What they receive |
|---|---|---|
| Telephonic and telemedicine evaluation | Other | Patients will be randomized to telephonic or telemedicine evaluation during participation in the study Receives: Behavioral: Intervention A- Telephone; Behavioral: Intervention B- Televideo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)?
The MPR and PDC will be calculated along with pill count and OCAS with each interaction through study completion and then evaluated for the individual patient and as an aggregate for all participants.
Measured: Through study completion, approximately 4 months
Will modality of outreach impact adherence based on medication pill counts?
This will be measured with patient providing pill count at time of each interaction. MPR and PDC will also be calculated with each interaction to determine patient's compliance evaluating medication fill/refill information.
Measured: Through study completion, approximately 4 months
Will modality of outreach impact adherence based on Oral Chemotherapy Adherence Scale (OCAS)?
The OCAS will be completed with each interaction and scored using the grading criteria of the scale authors. The OCAS scale contains 19 questions that are graded from 1-5 based on answer for a total score. A score of 84 and higher is classified as good adherence and a score of 83 and lower is classified as bad adherence. The highest score is 95 and the lowest score is 19. This calculation will be made with each interaction through the study completion. The scores will be analyzed for each patient and as an aggregate and compared between the groups
Measured: Through study completion, approximately 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Nov 2024
- Study start9 Feb 2021
- Primary completion11 Feb 2025
- Study completion11 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Adherence, MedicationStudies of the same condition, open and under way.
- More trials run by Abramson Cancer Center at Penn MedicineThe 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients randomized to telephonic or televideo participation once enrolled in the study.
- Masking
- None (open label)
- Enrolment
- 76 participants (actual)
Sponsor and investigators
- Lead sponsor
- Abramson Cancer Center at Penn Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elizabeth Prechtel Dunphy, DNP, RN, ANP-BC, AOCN, Abramson Cancer Center at Penn Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06696521
- Sponsor's protocol ID
- UPCC24220
- Status last verified
- Nov 2024
- First submitted
- 18 Sep 2024
- Last updated
- 11 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.
PubMed 22486599Voils CI, Venne VL, Weidenbacher H, Sperber N, Datta S. Comparison of Telephone and Televideo Modes for Delivery of Genetic Counseling: a Randomized Trial. J Genet Couns. 2018 Apr;27(2):339-348. doi: 10.1007/s10897-017-0189-1. Epub 2017 Dec 15.
PubMed 29243007Tipton JM. Overview of the challenges related to oral agents for cancer and their impact on adherence. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):37-40. doi: 10.1188/15.S1.CJON.37-40.
PubMed 26030391Spoelstra SL, Rittenberg CN. Assessment and measurement of medication adherence: oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):47-52. doi: 10.1188/15.S1.CJON.47-52.
PubMed 26030393Spoelstra SL, Given CW. Assessment and measurement of adherence to oral antineoplastic agents. Semin Oncol Nurs. 2011 May;27(2):116-32. doi: 10.1016/j.soncn.2011.02.004.
PubMed 21514481Sirintrapun SJ, Lopez AM. Telemedicine in Cancer Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:540-545. doi: 10.1200/EDBK_200141.
PubMed 30231354Burhenn PS, Smudde J. Using tools and technology to promote education and adherence to oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):53-9. doi: 10.1188/15.S1.CJON.53-59.
PubMed 26030395Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
PubMed 31912902McCabe CC, Barbee MS, Watson ML, Billmeyer A, Lee CE, Rupji M, Chen Z, Haumschild R, El-Rayes B. Comparison of rates of adherence to oral chemotherapy medications filled through an internal health-system specialty pharmacy vs external specialty pharmacies. Am J Health Syst Pharm. 2020 Jul 7;77(14):1118-1127. doi: 10.1093/ajhp/zxaa135.
PubMed 32537656Jacobs JM, Ream ME, Pensak N, Nisotel LE, Fishbein JN, MacDonald JJ, Buzaglo J, Lennes IT, Safren SA, Pirl WF, Temel JS, Greer JA. Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life. J Natl Compr Canc Netw. 2019 Mar 1;17(3):221-228. doi: 10.6004/jnccn.2018.7098.
PubMed 30865917Bertsch NS, Bindler RJ, Wilson PL, Kim AP, Ward B. Medication Therapy Management for Patients Receiving Oral Chemotherapy Agents at a Community Oncology Center: A Pilot Study. Hosp Pharm. 2016 Oct;51(9):721-729. doi: 10.1310/hpj5109-721.
PubMed 27803501Bagcivan G, Akbayrak N. Development and Psychometric Testing of the Turkish-Version Oral Chemotherapy Adherence Scale. J Nurs Res. 2015 Dec;23(4):243-51. doi: 10.1097/JNR.0000000000000101.
PubMed 26562455
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Analysis of Medication Adherence Comparing Televideo and Telephonic Modes of Longitudinal Monitoring and Utilization of a Standardized Educational Protocol
- ClinicalTrials.gov ID
- NCT06696521
- Acronym / sponsor ID
- UPCC24220
- Conditions
- Adherence, Medication, Cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (actual)
- Lead sponsor
- Abramson Cancer Center at Penn MedicineUniversity, hospital or other
- Study start
- 9 Feb 2021 (actual)
- Primary completion
- 11 Feb 2025 (actual)
- Study completion
- 11 Feb 2025 (actual)
- First posted
- 20 Nov 2024 (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 objective of this study is to evaluate adherence to oral oncologic medication regimens utilizing a standardized education tool to explain the dosing, side effects and purpose of oral chemotherapy via televideo or telephonic interactions. Researchers aim to evaluate whether the modality of education and monitoring impact adherence.
Detailed description
The study will consist of eight total interactions. We will allow for a 72 hour window for each encounter to allow for patient flexibility and scheduling. The first encounter will include medication education using the standardized tool. The remaining seven interactions will include toxicity and adherence assessment through patient interviews, the OCAS, pill counts, and pharmacy fill data. All interactions will be completed via telephonic outreach or televideo platform by either CRNP, PA-C or PharmD. The patient will be approached when an OCA is prescribed to be given a copy of the OncoLink® patient education material and consent form for review. Patients will be randomized 1:1 to either televideo or telephonic interactions using a block size of 4. All study staff will be blinded to block size. Once a patient is randomized, s/he will be scheduled for the series of follow up encounters via the assigned modality. The first telemedicine interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second encounter will occur approximately 2 weeks after the patient starts the medication to assess for adherence and toxicity. The third through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS) (Bagcivan and Akbayrak 2015) will be completed per standard of care in addition to patient interview to assess adherence and toxicity. Fill history will be obtained prior to each interaction to verify medication possession ratio and proportion of days covered.
Each patient in the study will participate for a duration of up to 4 months. All of the research will take place at the Abramson Cancer Center at Penn Presbyterian Medical Center.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients randomized to telephonic or televideo participation once enrolled in the study.
| Arm | Type | Receives |
|---|---|---|
| Telephonic and telemedicine evaluation | Other | Behavioral: Intervention A- Telephone, Behavioral: Intervention B- TelevideoPatients will be randomized to telephonic or telemedicine evaluation during participation in the study |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Has a diagnosis of cancer
- Receives cancer care at Abramson Cancer Center at Penn Presbyterian Medical Center
- Physically and cognitively able to provide informed consent
- Is 18 years or older
- Is starting an oral cancer agent
Key exclusion criteria (5 listed)
- Does not desire to participate in the study
- Cannot consent for himself/herself
- Does not have access to the UPENN televideo platform
- Does not live in Pennsylvania
- Chemoradiation patients
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intervention A- TelephoneFor intervention A: Once a patient is randomized to telephone (Intervention A), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months. | Behavioural | Telephonic and telemedicine evaluation |
| Intervention B- TelevideoFor intervention B: Once a patient is randomized to televideo (Intervention B), s/he will be scheduled for the series of follow up encounters via the assigned modality. The first interaction will occur within 72 hours of the patient receiving their prescribed OCA(s) at which time the standardized educational information regarding the agent(s), dosing of the medication and potential medication side effects will be reviewed with the patient and/or caregiver. The second through eighth encounters will take place every 2 weeks thereafter through the study timeframe up to four months to assess for adherence and toxicity. At each visit, an adherence assessment including pill count, and Oral Chemotherapy Adherence Scale (OCAS), fill history will be obtained prior to each interaction to verify medication possession ratio (MPR) and proportion of days covered (PDC). Each patient in the study will participate for a duration of up to 4 months. | Behavioural | Telephonic and telemedicine evaluation |
Primary outcome
Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)?
Time frame: Through study completion, approximately 4 months
The MPR and PDC will be calculated along with pill count and OCAS with each interaction through study completion and then evaluated for the individual patient and as an aggregate for all participants.
Will modality of outreach impact adherence based on medication pill counts?
Time frame: Through study completion, approximately 4 months
This will be measured with patient providing pill count at time of each interaction. MPR and PDC will also be calculated with each interaction to determine patient's compliance evaluating medication fill/refill information.
Will modality of outreach impact adherence based on Oral Chemotherapy Adherence Scale (OCAS)?
Time frame: Through study completion, approximately 4 months
The OCAS will be completed with each interaction and scored using the grading criteria of the scale authors. The OCAS scale contains 19 questions that are graded from 1-5 based on answer for a total score. A score of 84 and higher is classified as good adherence and a score of 83 and lower is classified as bad adherence. The highest score is 95 and the lowest score is 19. This calculation will be made with each interaction through the study completion. The scores will be analyzed for each patient and as an aggregate and compared between the groups
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 11 Mar 2025.
- Background: PubMed 22486599Vrijens B, De Geest S, Hughes DA, Przemyslaw K, Demonceau J, Ruppar T, Dobbels F, Fargher E, Morrison V, Lewek P, Matyjaszczyk M, Mshelia C, Clyne W, Aronson JK, Urquhart J; ABC Project Team. A new taxonomy for describing and defining adherence to medications. Br J Clin Pharmacol. 2012 May;73(5):691-705. doi: 10.1111/j.1365-2125.2012.04167.x.
- Background: PubMed 29243007Voils CI, Venne VL, Weidenbacher H, Sperber N, Datta S. Comparison of Telephone and Televideo Modes for Delivery of Genetic Counseling: a Randomized Trial. J Genet Couns. 2018 Apr;27(2):339-348. doi: 10.1007/s10897-017-0189-1. Epub 2017 Dec 15.
- Background: PubMed 26030391Tipton JM. Overview of the challenges related to oral agents for cancer and their impact on adherence. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):37-40. doi: 10.1188/15.S1.CJON.37-40.
- Background: PubMed 26030393Spoelstra SL, Rittenberg CN. Assessment and measurement of medication adherence: oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):47-52. doi: 10.1188/15.S1.CJON.47-52.
- Background: PubMed 21514481Spoelstra SL, Given CW. Assessment and measurement of adherence to oral antineoplastic agents. Semin Oncol Nurs. 2011 May;27(2):116-32. doi: 10.1016/j.soncn.2011.02.004.
- Background: PubMed 30231354Sirintrapun SJ, Lopez AM. Telemedicine in Cancer Care. Am Soc Clin Oncol Educ Book. 2018 May 23;38:540-545. doi: 10.1200/EDBK_200141.
- Background: PubMed 26030395Burhenn PS, Smudde J. Using tools and technology to promote education and adherence to oral agents for cancer. Clin J Oncol Nurs. 2015 Jun;19(3 Suppl):53-9. doi: 10.1188/15.S1.CJON.53-59.
- Background: PubMed 31912902Siegel RL, Miller KD, Jemal A. Cancer statistics, 2020. CA Cancer J Clin. 2020 Jan;70(1):7-30. doi: 10.3322/caac.21590. Epub 2020 Jan 8.
- Background: PubMed 32537656McCabe CC, Barbee MS, Watson ML, Billmeyer A, Lee CE, Rupji M, Chen Z, Haumschild R, El-Rayes B. Comparison of rates of adherence to oral chemotherapy medications filled through an internal health-system specialty pharmacy vs external specialty pharmacies. Am J Health Syst Pharm. 2020 Jul 7;77(14):1118-1127. doi: 10.1093/ajhp/zxaa135.
- Background: PubMed 30865917Jacobs JM, Ream ME, Pensak N, Nisotel LE, Fishbein JN, MacDonald JJ, Buzaglo J, Lennes IT, Safren SA, Pirl WF, Temel JS, Greer JA. Patient Experiences With Oral Chemotherapy: Adherence, Symptoms, and Quality of Life. J Natl Compr Canc Netw. 2019 Mar 1;17(3):221-228. doi: 10.6004/jnccn.2018.7098.
- Background: PubMed 27803501Bertsch NS, Bindler RJ, Wilson PL, Kim AP, Ward B. Medication Therapy Management for Patients Receiving Oral Chemotherapy Agents at a Community Oncology Center: A Pilot Study. Hosp Pharm. 2016 Oct;51(9):721-729. doi: 10.1310/hpj5109-721.
- Background: PubMed 26562455Bagcivan G, Akbayrak N. Development and Psychometric Testing of the Turkish-Version Oral Chemotherapy Adherence Scale. J Nurs Res. 2015 Dec;23(4):243-51. doi: 10.1097/JNR.0000000000000101.
- 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.
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 Intervention A- Telephone and Intervention B- Televideo in people with Adherence, Medication and Cancer, run by Abramson Cancer Center at Penn Medicine 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 7 inclusion and 5 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 11 Mar 2025. 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?
Will modality of outreach impact adherence based on medication possession ratio (MPR) or proportion of days covered (PDC)? (time frame: Through study completion, approximately 4 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06696521, which also lists 12 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 11 Mar 2025.