Symptoms and General Pathology

All Conditions

Neoplasms

Behaviors and Mental Disorders

Recurrence

Head and Neck Neoplasms

Quality of Life

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.

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.

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.

Early palliative care, integrated with the standard oncologic care (proactive approach)

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.

Palliative care requested as needed, integrated with the standard oncologic care (reactive approach)

EORTC HQ

Paolo Bossi, MD

Kathy Taylor, MSc

Luigi Lorini, MD

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).

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.

Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study

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

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

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

Evaluate the frequency of the unplanned access to emergency room or specialist visits

Frequency of hospitalization due to adverse effects of treatment or due to tumour symptoms/signs

Frequency of oncological treatments in last three months of life.

Identification of the rate of patients receiving systemic treatment in the last month of life

Identification of the rate of patients with tracheostomy performed in the last 3 months of life.

Identification of the rate of patients with gastrostomy performed in the last 3 months of life.

Assessment of the caregiver/family members' satisfaction. Minimum = -99; Maximum = +99; higher means better outcome.

Accuracy of physician prediction of survival

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study	NCT06347185	Head and Neck N...	Early palliativ... Palliative care...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC
Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study	NCT06347185	Head and Neck N...	Early palliativ... Palliative care...	18 Years -	European Organisation for Research and Treatment of Cancer - EORTC

Spots Global Cancer Trial Database for early palliative care, integrated with the standard oncologic care (proactive approach)