Palliative CareMISTRALNCT07469761
MultidISciplinary Care paThway tailoRed on frAilty in Cancer Patients Referred to Outpatient paLliative Care
A study testing Structured Palliative Care and Classical Palliative Care in people with Palliative Care and Palliative Care, Health Services, run by Augusto Caraceni at 1 site in Italy.
Trial summary
The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Palliative Care, Palliative Care, Health Services, Patient Reported Outcome (PRO)
- What is being tested?
- Structured Palliative Care and Classical Palliative Care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteItaly
- Study dates
- 2 Nov 2025to 28 Feb 2027
- Phase
- Interventional
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
- diagnosis of advanced/metastatic cancer
- age > 18
- Eastern Cooperative Oncology Group (ECOG) performance status ≥2
- prognostic clinical prediction >1 month.
Who cannot join
- Serious medical or psychiatric illness that can interfere with informed consent and participation in this clinical study
- any condition that is unstable or could jeopardize the safety of the patient and their compliance in the study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Istituto Nazionale dei Tumori, Via Venezian n1
Milan, Lombardy, 20133
Giacomo Massa, Dr, +39 0223903279/3272, giacomo.massa@istitutotumori.mi.it
About this study
The goal of this clinical trial is to learn whether a structured, Patient-Reported Outcome Measures (PROMs)-tailored palliative care pathway improves clinical outcomes and care experience in adults with advanced cancer referred to outpatient palliative care.
Patients with advanced cancer often experience multiple symptoms and complex needs. Standard outpatient palliative care is usually guided by clinical judgment on patient-reported questionnaires. In this study, researchers aim to test whether a more structured approach, based on predefined cut-offs from PROMs, can improve symptom control, satisfaction with care, and use of healthcare resources. The main questions the study aims to answer are:
Read more
Does a structured, PROM-driven palliative care pathway reduce symptom burden and psychological distress compared with usual care? And through this, to improve patients' and caregivers' satisfaction with care or reduce emergency room visits, hospital admissions, healthcare costs, and aggressive treatments near the end of life?
Researchers will compare two groups:
Control group: Participants will receive standard outpatient palliative care. PROMs are collected as usual, but without predefined cut-offs or structured intervention checklists.
Experimental group: Participants will receive a structured palliative care pathway tailored to symptoms/needs identified at baseline using PROM cut-offs. Specific multidisciplinary interventions are activated according to identified needs.
- Conditions
- Palliative Care, Palliative Care, Health Services, Patient Reported Outcome (PRO), Patient Reported Outcome Measurements, Frailty, Cancer
- Being tested
- Structured Palliative Care, Classical Palliative Care
- Keywords
- Patient Reported Outcome Measurements (PROMs), Outpatient, Palliative Care, Advanced cancer, Frailty, Palliative Care intervention
- Medical subject headings
- Frailty, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Structured Palliative CareOther
Symptoms/needs domains are defined according to protocol-specified cut-offs, followed by the activation of a tailored intervention based on structured checklists targeting the reported symptoms/needs.
Classical Palliative CareOther
Multidisciplinary palliative care interventions are delivered according to usual clinical practice, without activation based on predefined cut-offs or structured algorithms.
| Study group | Role | What they receive |
|---|---|---|
| Structured interventions tailored to PROMs cut-off | Experimental | • Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off). Receives: Other: Structured Palliative Care |
| Classic Palliative Car interventions | Active comparator | • Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists) Receives: Other: Classical Palliative Care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in overall symptom burden assessed by the ESAS.
- Mean change in symptom burden from baseline to 1 month after initiation of palliative care, measured using the Edmonton Symptom Assessment System (ESAS) total score (range 0-90, higher scores indicating greater symptom burden). The analysis will compare the change in ESAS total score between the two randomized groups.
Measured: 1, 3 months
Change in psychological distress assessed by the Distress Thermometer (DT).
Mean change in psychological distress from baseline to 1 month after initiation of palliative care, measured using the Distress Thermometer (DT) (range 0-10, higher scores indicating greater distress). The analysis will compare the change in DT score between the two randomized groups.
Measured: 1, 3 Months
Secondary outcomes (4)
Patients' satisfaction with care
The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care measured by FAMCARE (Family Satisfaction with Advanced Cancer Care)-P13. This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-65, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).
Measured: 1, 3 months
Healthcare resource utilization
the differences between the experimental and control groups concerning the number of total visits, emergency room admissions, and urgent hospital admissions during the follow-up
Measured: 3, 6 months
Differeces in End of Life (EoL) care aggressiveness criteria
the differences between the experimental and control groups concerning the number of emergency room admissions, oncological therapy (radiotherapy, surgery, systemic), and hospitalizations occurring within 30 days of death (end of life, EoL).
Measured: 3, 6 months
Caregivers' satisfaction with care
The higher satisfaction with care after a structured intervention based on baseline PROMs. Endpoints: improvement in satisfaction with care, measured by FAMCARE (Family Satisfaction with Advanced Cancer Care). This self-administered questionnaire utilizes a 5-point Likert scale (from 1 = "very dissatisfied" to 5 = "very satisfied"), range 0-85, where the total score is directly proportional to satisfaction levels (higher scores indicate more satisfaction).
Measured: 1, 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2026
- Study start2 Nov 2025
- Primary completion30 Sep 2026 (estimated)
- Study completion28 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Palliative CareStudies 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study adopts a pragmatic design, leveraging resources already available within routine palliative care services, while implementing predefined algorithms in which symptom and need thresholds (cut-offs) trigger tailored multidisciplinary interventions. In particular: * Control group, which will undergo standard unstructured palliative care (based on PROMs as usual, but without cut-off or interventions' checklists) * Experimental group, which will follow a structured palliative care pathway (specific intervention defined in the protocol) based on the frailties identified at baseline PROMs (defined by cut-off).
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Augusto Caraceni
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Augusto Caraceni, Fondazione IRCCS Istituto Nazionale dei Tumori, Milano
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07469761
- Sponsor's protocol ID
- INT 101/25
- Acronym
- MISTRAL
- Status last verified
- Mar 2026
- First submitted
- 5 Mar 2026
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD underlying published results, together with the study protocol, statistical analysis plan, and data dictionary, will be shared in line with the FAIR principles and the "as open as possible, as closed as necessary" approach of Horizon Europe. Data management will follow a predefined Data Management Plan and comply with Regulation (EU) 2016/679 (GDPR) and GCP standards. Data will be available from 6 months after publication for at least 5 years through controlled access, subject to a scientifically sound proposal, steering committee approval, and a Data Access Agreement.