protocolSection identificationModule nctId: NCT06347185, orgStudyIdInfo id: EORTC-2236-HNCG-QLG, briefTitle: Simultaneous Care in Recurrent and/or Metastatic Head and Neck Cancer: the SupCare Study, acronym: SupCare, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2027-04, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-04-04, lastUpdatePostDateStruct date: 2024-04-04, sponsorCollaboratorsModule leadSponsor name: European Organisation for Research and Treatment of Cancer - EORTC, class: NETWORK, descriptionModule briefSummary: 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., conditionsModule conditions: Head and Neck Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 160, type: ESTIMATED, armsInterventionsModule interventions name: Early palliative care, integrated with the standard oncologic care (proactive approach), interventions name: Palliative care requested as needed, integrated with the standard oncologic care (reactive approach), outcomesModule primaryOutcomes measure: Change from baseline in emotional functioning and pain scores according to Item List (IL) 250 questionnaire at 15 weeks., secondaryOutcomes measure: Change from baseline in emotional functioning and pain scores according to Item List 250 (IL250) questionnaire at 6 weeks, 24 weeks and 52 weeks., secondaryOutcomes measure: 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, secondaryOutcomes measure: Number of unplanned visits to emergency room or specialist visits, secondaryOutcomes measure: Hospitalization due to treatment toxicities or tumour signs/symptoms, as evaluated by number of admissions and duration, secondaryOutcomes measure: Identification of the rate of patients starting a new systemic treatment in the last three months of life, secondaryOutcomes measure: Rate of patients receiving systemic treatment in the last month of life, secondaryOutcomes measure: Rate of patients with a tracheostomy performed in the last 3 months of life, secondaryOutcomes measure: Rate of patients with gastrostomy performed in the last 3 months of life, secondaryOutcomes measure: Caregiver/family members' satisfaction (FAMcare questionnaire) at 15 weeks, secondaryOutcomes measure: Overall Survival (OS), secondaryOutcomes measure: Prediction error of survival (defined as the difference between actual survival (AS) of patients and clinician prediction of survival (CPS)), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False