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

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.

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.

Conditions

• Head and Neck Neoplasms

Interventions

PROCEDURE

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

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.

PROCEDURE

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

Sponsors & Collaborators

• European Organisation for Research and Treatment of Cancer - EORTC

  lead NETWORK

Principal Investigators

• Paolo Bossi, MD · Istituto Clinico Humanitas

• Kathy Taylor, MSc · Universitätsmedizin Mainz - Institut fuer Medizinische -Biometrie, Epidemiologie und informatik

• Luigi Lorini, MD · Istituto Clinico Humanitas

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-09-30

Primary Completion

2027-04-30

Completion

2028-12-31