Heart FailureTIER-HF-PCNCT06244953
Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
A study testing TIER-HF-PC in people with Heart Failure, run by National Cancer Centre, Singapore at 4 sites in Singapore.
Trial summary
There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. Read more about this study
- Who is it for?
- Ages 21 to 99 years
- Conditions the study is for
- Heart Failure
- What is being tested?
- TIER-HF-PC
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 240 participants
- Where
- 4 sitesSingapore
- Study dates
- 14 Aug 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 21 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients:
- 21 years or older and
- able to communicate in English/Chinese/Malay and
- be of stage C or D heart failure, as defined by American College of Cardiology/American Heart Association (ACC/AHA) classification system and
- have functional limitation of New York Heart Association (NYHA) functional status of at least 2 or more and
- be deemed by their cardiologist's clinical judgement to have an expected prognosis of at least 6 months survival, and
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- have had a heart failure related hospitalization event (e.g. symptomatic decompensated heart failure) within 6 months prior to recruitment and
- have a phone that allows telecommunication.
- Caregivers must meet all the following inclusion criteria to be eligible for the study :
- direct, unpaid, family caregiver of the patient;
- self-reported by the patient to be the main person to be either:
- responsible for up to 4 hours a day of caregiving tasks
- and/or decision maker/spokesperson with the medical team
- Caregiver may or may not live in the same residence as the patient.
- Caregivers must be 21 years and above.
- Able to communicate in English/Chinese/Malay.
Who cannot join
- Patients:
- have cognitive impairment (e.g., dementia)
- have severe, untreated, active mental illness (e.g., major depressive disorder)
- have ventricular assist device implant.
- have non-reversible hearing or visual loss or
- are active drug abuser or
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- already known to a palliative care service.
- Caregivers who meet any of the exclusion criteria at baseline will be ineligible for the study:
- have cognitive impairment (e.g., dementia) or
- have severe, untreated, active mental illness (e.g., major depressive disorder)
- have non-reversible hearing or visual loss.
- are active drug abuser or
- are a domestic helper for the patient
Trial locations and contacts
4 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Singapore4 sites, 4 recruiting
- Recruiting
National Heart Centre Singapore
Singapore, 169609
Dr David KL Sim, MBBS, MMed, MRCP(UK), +6567048895, david.sim@singhealth.com.sg
- Recruiting
Sengkang General Hospital
Singapore, 544886
Dr Lionel KY See, MD, MRCP (UK), MMed (Int Med), lionel.see.k.y@singhealth.com.sg
- Recruiting
Khoo Teck Puat Hospital
Singapore, 768828
Dr Laurence LC Tan, MBBS, MMed, FAMS, tan.laurence.lc@ktph.com.sg
- Recruiting
National Cancer Centre, Singapore
Singapore
Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS, +6563065838, shirlyn.neo.h.s@singhealth.com.sg
About this study
There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. In the short term, this study will assess if TIER-HF-PC is beneficial for patients and caregivers.
Read the detailed description
Timely Interventions to Enable and Reach patients with Heart Failure, and their caregivers with Palliative Care, or TIER-HF-PC, is a novel model of palliative care, designed to address gaps of palliative care delivery for patients with advanced heart failure, and their caregivers.
TIER-HF-PC is a service, led by a health coach, with support by a palliative care physician. This health coach will actively screen and monitor patients for problems, and then match the type and intensity of palliative care treatments to the severity of problems reported. The health coach will also facilitate processes for patients to initiate contact with health care providers should problems arise. This decreases the overall burden on palliative care services, enabling a scalable and more cost-effective model of care for a larger number of patients. The service will also utilize a proactive approach to care, increasing self-care skills and understanding of disease and treatment options. Earlier palliative care support will enable problems to be managed actively before they escalate into crises.
Overall aim: To test the effectiveness and implementation of the interacting components of TIER-HF-PC.
Specific aim 1a: To evaluate the impact of TIER-HF-PC on patients. The primary outcome is patient quality-of-life at 24 weeks, measured on the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes include patient anxiety, depression, coping, spirituality, healthcare utilization, survival, and cost-effectiveness of TIER-HF-PC.
Specific aim 1b: To evaluate the impact of TIER-HF-PC on caregivers. Outcomes evaluated include caregiver quality-of-life.
- Hypothesis 1: The researchers hypothesize that TIER-HF-PC will be superior to usual care, in improving patient and caregiver quality-of-life.
Specific aim 2: To evaluate the implementation outcomes of TIER-HF-PC.
- Hypothesis 2: The researchers hypothesize that participants will be satisfied with the TIER-HF-PC service, though modifications might be needed for fine-tuning of the appropriateness and timeliness of care provision in TIER-HF-PC. They will evaluate these implementation outcomes through a validated service evaluation survey and semi-structured interviews. Fidelity to study protocols will be assessed through audits of case notes and study processes.
- Conditions
- Heart Failure
- Being tested
- TIER-HF-PC, Usual Care
- Keywords
- Palliative care, Patients, Caregivers, Distress thermometer (DT), Integrated Palliative Care Outcome Scale (IPOS), TIER-HF-PC
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TIER-HF-PCOther
The patient will be assigned to one of the three levels of care which is determined by the results given by Distress Thermometer (DT) and the Integrated Palliative Care Outcome Scale (IPOS).
Usual CareOther
Patient continues on clinical care by his/her cardiologist. If the cardiologist picks up their symptoms or other concerns, he/or can be referred to a specialist palliative care physician by the cardiologist.
| Study group | Role | What they receive |
|---|---|---|
| Regular screening with needs-guided palliative care treatments | Experimental | The patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns. Receives: Other: TIER-HF-PC |
| Usual Care | Other | Patient is referred by cardiologist to palliative care. Receives: Other: Usual Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient quality of life (QOL) per the KCCQ-12 Questionnaire
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used: It is a 12-item QOL scale, composed of physical function, symptoms, QOL, social interference and summary score will be used. The KCCQ-12 has similar validity to the 23-item version and is shorter with less respondent burden. The KCCQ-12 can be self-reported by patients or read to patients over the phone by a research coordinator. The total summary score can range from 0 to 100, with higher scores representing better health status. A clinically meaningful change is defined as a change of at least 5 points on the KCCQ. The KCCQ-12 will be measured for all participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. The frequency of our proposed KCCQ tracking is referenced from trials which used KCCQ to track longitudinal changes in QOL.
Measured: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire
The non cardiac specific health-related quality of life (EUROQOL EQ-5D-5L) questionnaire will also be used: This is a global assessment of the patient's quality-of-life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, that can also be administered over the phone. The results from the 5 dimensions can be combined into a 5-digit number that describes the patient's health state utility. The EQ-5D-5L has been validated in the Singapore cardiac population.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Caregiver Quality of Life (QOL)
The Singapore Caregiver Quality of Life Scale-15 (SCQOLS-15) will be used: This is a 15-item scale with 5 domains measuring QOL of life caregivers in domains: physical well-being, mental well-being, experience and meaning, impact on daily life, and financial well-being will be used. This will be measured for all caregiver participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. A difference of between 3-5 points in QOL scores could serve as a benchmark to evaluate if the difference between intervention and usual-care group is meaningful.
Measured: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
Secondary outcomes (8)
Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)
The client satisfaction questionnaire (CSQ-4) will be used. The total score of the CSQ per participant will be computed. Analysis will be conducted on the patient and caregiver scores separately. The percentage of participants in TIER-HF-PC who have at least a CSQ score of 12 and above will also be calculated.
Measured: At Week 25.
Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews
Regarding the analysis of semi-structured interviews, a qualitative coding team who is experienced in qualitative analysis will be formed. Interviews will be open coded line by line. Code categories will be developed and iteratively adjusted through discussions. The code categories will be subsequently mapped back to the main domains of the RE-AIM and PRISM framework to identify key multi-level contextual factors influencing the TIER-HF-PC outcomes as well as to assess the adoption, implementation, and impact of TIER-HF-PC. Hence, the analysis will involve both inductive and deductive approaches.
Measured: From Week 25 onwards, up to Week 48.
Patient anxiety and depression
The Hospital Anxiety and Depression Scale (HADS) will be used. This is a 14-item scale with a score range of 0 to 42. It is composed of two subscales- anxiety and depression- with a cut-off point of 11 for each subscale, that determines anxiety and depression of clinical significance.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Patient and Caregiver Spirituality
The Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being 12 Item Scale (Facit-SP-12)/Functional Assessment of Chronic Illness Therapy-Spiritual Well-Being Non-Illness (FACIT-Sp Non-Illness) will be used. This is a 12-item survey that measures the spiritual well-being of patients and caregivers. The total of Facit-SP-12/ FACIT-Sp Non-Illness ranges from 0 to 48 with higher scores representing increased spirituality.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Patient and Caregiver Coping
Brief Coping with Problems Experienced (Brief-COPE) scale will be used. It is a 28-item scale measuring the ways people cope with stressful events. It has been used in the heart failure population, where the coping style was shown to correlate with the level of physical functioning.
Measured: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Assessment of impact of TIER-HF-PC on healthcare utilization
The differences in community hospice usage, number and length of hospital admissions, number of emergency visits, number, and length of intensive care visits between TIER-HF-PC participants and those in usual care will be assessed using generalized linear models, with binomial model for community hospice usage and Poisson model with robust standard effort for other healthcare utilization outcomes.
Measured: Week 1 to Week 24.
Healthcare cost analysis
The total cost of inpatient bills and outpatient bills including emergency visit bills for TIER-HF-PC participants and usual care participants from week 1 to week 24 will be summed up and the cost differences between both groups will be quantified by generalized linear model with Gamma model and robust standard error. The net cost of the TIER-HF-PC model will be calculated based upon the cost of care provision in TIER-HF-PC minus the cost savings from reduction of health care utilization. We will also calculate incremental cost-effectiveness ratios (ICERs) to measure the average net cost per quality-adjusted-life-year (QALY) gained for TIER-HF-PC versus usual care participants. The QALY will be calculated by the product of quality-of-life (EQ-5d-5L) and survival.
Measured: Up to 24 weeks.
Survival analysis
The differences in survival between TIER-HF-PC and usual care will be analyzed using a Cox model regression, censoring at week 48 or death, whichever occurs earlier.
Measured: Up to 48 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2024
- Study start14 Aug 2024
- Primary completion31 Oct 2026 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 240 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Cancer Centre, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National Heart Centre Singapore, Khoo Teck Puat Hospital, Sengkang General Hospital
- Responsible party
- Sponsor
- Investigators
- Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS, Principal investigator, National Cancer Centre, Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06244953
- Sponsor's protocol ID
- TIER-HF-PC
- Acronym
- TIER-HF-PC
- Status last verified
- Jul 2026
- First submitted
- 17 Jan 2024
- Last updated
- 16 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Neo SH, Yu K, Lee CF, Cheung YB. Interventions to enable and reach patients with heart failure and their caregivers, with palliative care (TIER-HF-PC): a study protocol of a two-armed parallel group, open label randomised controlled trial that evaluates the effectiveness of a tiered model of palliative care in tertiary cardiac institutes in Singapore. BMJ Open. 2025 Mar 27;15(3):e100581. doi: 10.1136/bmjopen-2025-100581.
PubMed 40147986
Study at a glance
From the registry record, last updated by the sponsor on 16 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Timely Interventions to Enable and Reach Patients With Heart Failure, and Their Caregivers With Palliative Care
- ClinicalTrials.gov ID
- NCT06244953
- Acronym / sponsor ID
- TIER-HF-PC / TIER-HF-PC
- Conditions
- Heart Failure
- Keywords
- Palliative care, Patients, Caregivers, Distress thermometer (DT), Integrated Palliative Care Outcome Scale (IPOS), TIER-HF-PC
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 240 participants (estimated)
- Lead sponsor
- National Cancer Centre, SingaporeUniversity, hospital or other
- Collaborators
- National Heart Centre Singapore, Khoo Teck Puat Hospital, Sengkang General Hospital
- Study start
- 14 Aug 2024 (actual)
- Primary completion
- 31 Oct 2026 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 6 Feb 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.
There is evidence for the effectiveness and feasibility of the individual components of TIER-HF-PC, however there is a need to test how these individual components interact to allow the researchers to deliver TIER-HF-PC as a model of care in its totality. In the short term, this study will assess if TIER-HF-PC is beneficial for patients and caregivers.
Detailed description
Timely Interventions to Enable and Reach patients with Heart Failure, and their caregivers with Palliative Care, or TIER-HF-PC, is a novel model of palliative care, designed to address gaps of palliative care delivery for patients with advanced heart failure, and their caregivers.
TIER-HF-PC is a service, led by a health coach, with support by a palliative care physician. This health coach will actively screen and monitor patients for problems, and then match the type and intensity of palliative care treatments to the severity of problems reported. The health coach will also facilitate processes for patients to initiate contact with health care providers should problems arise. This decreases the overall burden on palliative care services, enabling a scalable and more cost-effective model of care for a larger number of patients. The service will also utilize a proactive approach to care, increasing self-care skills and understanding of disease and treatment options. Earlier palliative care support will enable problems to be managed actively before they escalate into crises.
Overall aim: To test the effectiveness and implementation of the interacting components of TIER-HF-PC.
Specific aim 1a: To evaluate the impact of TIER-HF-PC on patients. The primary outcome is patient quality-of-life at 24 weeks, measured on the Kansas City Cardiomyopathy Questionnaire. Secondary outcomes include patient anxiety, depression, coping, spirituality, healthcare utilization, survival, and cost-effectiveness of TIER-HF-PC.
Specific aim 1b: To evaluate the impact of TIER-HF-PC on caregivers. Outcomes evaluated include caregiver quality-of-life.
- Hypothesis 1: The researchers hypothesize that TIER-HF-PC will be superior to usual care, in improving patient and caregiver quality-of-life.
Specific aim 2: To evaluate the implementation outcomes of TIER-HF-PC.
- Hypothesis 2: The researchers hypothesize that participants will be satisfied with the TIER-HF-PC service, though modifications might be needed for fine-tuning of the appropriateness and timeliness of care provision in TIER-HF-PC. They will evaluate these implementation outcomes through a validated service evaluation survey and semi-structured interviews. Fidelity to study protocols will be assessed through audits of case notes and study processes.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Regular screening with needs-guided palliative care treatments | Experimental | Other: TIER-HF-PCThe patient continues to receive clinical care from the cardiologist, as well as palliative care treatments that are based upon his/her reported distress and concerns. |
| Usual Care | Other | Other: Usual CarePatient is referred by cardiologist to palliative care. |
Who may qualify
- Ages
- 21 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (16 listed)
- Patients:
- Caregivers must meet all the following inclusion criteria to be eligible for the study :
Key exclusion criteria (13 listed)
- Patients:
- Caregivers who meet any of the exclusion criteria at baseline will be ineligible for the study:
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 |
|---|---|---|
| TIER-HF-PCThe patient will be assigned to one of the three levels of care which is determined by the results given by Distress Thermometer (DT) and the Integrated Palliative Care Outcome Scale (IPOS). | Other | Regular screening with needs-guided palliative care treatments |
| Usual CarePatient continues on clinical care by his/her cardiologist. If the cardiologist picks up their symptoms or other concerns, he/or can be referred to a specialist palliative care physician by the cardiologist. | Other | Usual Care |
Primary outcome
Patient quality of life (QOL) per the KCCQ-12 Questionnaire
Time frame: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The Kansas City Cardiomyopathy Questionnaire (KCCQ-12) will be used: It is a 12-item QOL scale, composed of physical function, symptoms, QOL, social interference and summary score will be used. The KCCQ-12 has similar validity to the 23-item version and is shorter with less respondent burden. The KCCQ-12 can be self-reported by patients or read to patients over the phone by a research coordinator. The total summary score can range from 0 to 100, with higher scores representing better health status. A clinically meaningful change is defined as a change of at least 5 points on the KCCQ. The KCCQ-12 will be measured for all participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. The frequency of our proposed KCCQ tracking is referenced from trials which used KCCQ to track longitudinal changes in QOL.
Patient quality of life (QOL) per the EUROQOL EQ-5D-5L Questionnaire
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
The non cardiac specific health-related quality of life (EUROQOL EQ-5D-5L) questionnaire will also be used: This is a global assessment of the patient's quality-of-life in 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression, that can also be administered over the phone. The results from the 5 dimensions can be combined into a 5-digit number that describes the patient's health state utility. The EQ-5D-5L has been validated in the Singapore cardiac population.
Caregiver Quality of Life (QOL)
Time frame: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.
The Singapore Caregiver Quality of Life Scale-15 (SCQOLS-15) will be used: This is a 15-item scale with 5 domains measuring QOL of life caregivers in domains: physical well-being, mental well-being, experience and meaning, impact on daily life, and financial well-being will be used. This will be measured for all caregiver participants (TIER-HF-PC and usual care), and tracked every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier. A difference of between 3-5 points in QOL scores could serve as a benchmark to evaluate if the difference between intervention and usual-care group is meaningful.
8 secondary outcomes
Acceptability of TIER-HF-PC from patient and caregiver participants - through completion of the client satisfaction questionnaire (CSQ-4)
Time frame: At Week 25.
Acceptability of TIER-HF-PC from patient and caregiver participants - through semi-structured interviews
Time frame: From Week 25 onwards, up to Week 48.
Patient anxiety and depression
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Patient and Caregiver Spirituality
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Patient and Caregiver Coping
Time frame: Baseline, 8 weeks, 16 weeks, and 24 weeks.
Assessment of impact of TIER-HF-PC on healthcare utilization
Time frame: Week 1 to Week 24.
Healthcare cost analysis
Time frame: Up to 24 weeks.
Survival analysis
Time frame: Up to 48 weeks.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jul 2026.
- Derived from this study: PubMed 40147986Neo SH, Yu K, Lee CF, Cheung YB. Interventions to enable and reach patients with heart failure and their caregivers, with palliative care (TIER-HF-PC): a study protocol of a two-armed parallel group, open label randomised controlled trial that evaluates the effectiveness of a tiered model of palliative care in tertiary cardiac institutes in Singapore. BMJ Open. 2025 Mar 27;15(3):e100581. doi: 10.1136/bmjopen-2025-100581.
- Individual participant dataSharing planned: Undecided
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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.
Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS principal investigator
National Cancer Centre, Singapore
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TIER-HF-PC in people with Heart Failure, run by National Cancer Centre, Singapore at 4 sites in Singapore.
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 16 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 16 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Singapore. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Shirlyn Neo, MBBS, MRCP (UK), MMed, FAMS (+65 63065838, shirlyn.neo.h.s@singhealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient quality of life (QOL) per the KCCQ-12 Questionnaire (time frame: Every 8 weeks from baseline, till the point of patient death, or till week 48, whichever is earlier.). 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 NCT06244953, which also lists 1 linked publication.
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 16 Jul 2026.