Head and Neck NeoplasmsSupCareNCT06347185
Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study
A study testing Early palliative care, integrated with the standard oncologic care (proactive approach) and Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) in people with Head and Neck Neoplasms, run by European Organisation for Research and Treatment of Cancer - EORTC.
Trial summary
This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Neoplasms
- What is being tested?
- Early palliative care, integrated with the standard oncologic care (proactive approach) and Palliative care requested as needed, integrated with the standard oncologic care (reactive approach)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Sep 2024to Dec 2028
- 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
- Patients over 18 years of age
- Histological diagnosis of HNC of epithelial origin. Any sub-site of head and neck is eligible except endocrine tumours such as thyroid and parathyroid cancer
- First diagnosis of recurrent disease and/or distant metastasis; with recurrent disease not amenable to salvage surgery or re-irradiation
- Patient candidate to any first line systemic treatment
- Life expectancy more than 3 months
- PS Eastern Cooperative Oncology Group (ECOG) ≤2
Show all 10Show fewer
- Adequate cognitive and reading abilities.
- Availability of baseline scores for Emotional Functioning and Pain
- Patient agrees to complete questionnaires at week 6, 15, 24 and 52 after systemic treatment start
- Before patient 's enrolment, written informed consent must be given according to International Council for Harmonisation (ICH)/Good Clinical Practice (GCP), and national/local regulations.
Who cannot join
- Patients requiring a palliative care consultation right from the beginning of treatment
- Cutaneous primary cancer
- Any psychological, familial, sociological or geographical condition potentially hampering compliance with the study protocol and follow-up schedule; those conditions should be assessed and discussed with the patient before the enrolment in the study
About this study
This is a late phase II, prospective, multicenter randomized study, to assess the value of early palliative care integrated with the standard oncologic care in patients with Recurrent Metastatic (RM) Head and Neck Cancer (HNC) proposed to first line palliative systemic treatment.
The study randomizes patients in a 1:1 fashion to standard oncologic care, in which the palliative care is requested as needed (reactive approach) or to early palliative care integrated with the standard oncologic care (proactive approach).
Read more
Standard of Care: the oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.
Integrated approach: Besides the Oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results.
Stratification Factors
- Institution
- Performance Status (PS) (0 vs 1-2)
- Presence of any caregiver at home
- Type of treatment (Immunotherapy alone vs any other combination)
Study duration: the total study duration is estimated at 36 months, with a total accrual time estimated to be 24 months from first patient in (FPI) and with an additional follow-up period of 12 months.
End of study occurs when all patients have completed their end of study visit and the study is mature for all analyses defined in the protocol and the database has been cleaned and frozen for these analyses.
- Conditions
- Head and Neck Neoplasms
- Being tested
- Early palliative care, integrated with the standard oncologic care (proactive approach), Palliative care requested as needed, integrated with the standard oncologic care (reactive approach)
- Keywords
- Quality of life
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Early palliative care, integrated with the standard oncologic care (proactive approach)Procedure or surgery
Besides the Oncology visit, patient will have the palliative care expert visit and follow up (proactive approach). The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and patient priority questionnaire's results.
Palliative care requested as needed, integrated with the standard oncologic care (reactive approach)Procedure or surgery
The oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise (reactive approach). The oncologist will base the choices also upon the results of the PCI-H\&N and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient.
| Study group | Role | What they receive |
|---|---|---|
| Standard of Care | Active comparator | The oncologist will be the main referral of the patient, deciding the therapeutic approach, the assessments requested, in terms of type of exams and timing and the need of possible further support from other expertise. The oncologist will base the choices also upon the results of the Liverpool Head and Neck Patient Concern Inventory (PCI-H\&N) and the patient's preferences. At the end of the first oncological visit, the physician will be asked to predict the survival of the patient. Receives: Procedure: Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) |
| Integrated Care | Experimental | Besides the oncology visit, patient will have the palliative care expert visit and follow up. The oncologist will define the therapeutic approach and the assessments requested, in terms of type of exams and timing. The palliative care clinician and the oncologist will judge the burden of symptoms and together they will propose the suggested interventions to relief the symptoms, with a particular attention to a validated instrument (the PCI-H\&N) and patient priority questionnaire's results. Receives: Procedure: Early palliative care, integrated with the standard oncologic care (proactive approach) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks.
To assess the added value of early palliative care integrated with the standard oncologic care as measured by the difference in mean change from baseline to 15 weeks between arms in patient reported emotional functioning and pain.
Minimum = -100; Maximum = +100; higher means better outcome
Measured: at 15 weeks
Secondary outcomes (11)
Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks.
Evaluate the added value of early palliative care integrated with the standard oncologic care as measured by the difference in mean change from baseline at alternative timepoints between arms in patient reported emotional functioning and pain.
Minimum = -100; Maximum = +100; higher means better outcome
Measured: at 6 weeks, 24 weeks and 52 weeks
Change from baseline in the selected Health Related Quality of Life (HRQoL) scales from the Item List 250 (IL250) questionnaire at 6 weeks, 15 weeks, 24 weeks and 52 weeks
Evaluate the change from baseline in supportive patient-reported symptom and functional outcomes at 6 weeks, 15 weeks, 24 weeks and 52 weeks.
Minimum = -100; Maximum = +100; higher means better outcome
Measured: at 6 weeks, 15 weeks, 24 weeks and 52 weeks
Number of unplanned visits to emergency room or specialist visits
Evaluate the frequency of the unplanned access to emergency room or specialist visits
Measured: up to 52 weeks
Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration
Frequency of hospitalization due to adverse effects of treatment or due to tumour symptoms/signs
Measured: up to 52 weeks
Identification of the rate of patients starting a new systemic treatment in the last three months of life
Frequency of oncological treatments in last three months of life.
Measured: until 1 year from last patient enrolled
Rate of patients receiving systemic treatment in the last month of life
Identification of the rate of patients receiving systemic treatment in the last month of life
Measured: until 1 year from last patient enrolled
Rate of patients with a tracheostomy performed in the last 3 months of life
Identification of the rate of patients with tracheostomy performed in the last 3 months of life.
Measured: until 1 year from last patient enrolled
Rate of patients with gastrostomy performed in the last 3 months of life
Identification of the rate of patients with gastrostomy performed in the last 3 months of life.
Measured: until 1 year from last patient enrolled
Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks
Assessment of the caregiver/family members' satisfaction. Minimum = -99; Maximum = +99; higher means better outcome.
Measured: at 15 weeks
Overall Survival (OS)
Overall Survival
Measured: until 1 year from last patient enrolled
Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS))
Accuracy of physician prediction of survival
Measured: until 1 year from last patient enrolled
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Apr 2024
- Study startSep 2024 (estimated)
- Primary completionApr 2027 (estimated)
- Study completionDec 2028 (estimated)
Why it stopped: The necessary funding for this study was not secured
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck NeoplasmsStudies of the same condition, open and under way.
- More trials run by European Organisation for Research and Treatment of Cancer - EORTCThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Sponsor type
- Research network
- Responsible party
- Sponsor
- Investigators
- Paolo Bossi, MD, Principal investigator, Istituto Clinico HumanitasKathy Taylor, MSc, Principal investigator, Universitätsmedizin Mainz - Institut fuer Medizinische -Biometrie, Epidemiologie und informatikLuigi Lorini, MD, Principal investigator, Istituto Clinico Humanitas
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06347185
- Sponsor's protocol ID
- EORTC-2236-HNCG-QLG
- Acronym
- SupCare
- Status last verified
- Jul 2025
- First submitted
- 25 Jan 2024
- Last updated
- 17 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No