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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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Early palliative care, integrated with the standard oncologic care (proactive approach) | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | at 15 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paolo Bossi, MD | Istituto Clinico Humanitas | Principal Investigator |
| Kathy Taylor, MSc | Universitätsmedizin Mainz - Institut fuer Medizinische -Biometrie, Epidemiologie und informatik | Principal Investigator |
| Luigi Lorini, MD | Istituto Clinico Humanitas | Principal Investigator |
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|
| Palliative care requested as needed, integrated with the standard oncologic care (reactive approach) | Procedure | 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. |
|
| 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 | 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 | 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 | 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. | 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 | 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. | 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. | 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. | at 15 weeks |
| Overall Survival (OS) | Overall Survival | 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 | until 1 year from last patient enrolled |
| ID | Term |
|---|---|
| D006258 | Head and Neck Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D006301 | Health Services Needs and Demand |
| ID | Term |
|---|---|
| D006302 | Health Services Research |
| D006285 | Health Planning |
| D004472 | Health Care Economics and Organizations |
| D003695 | Delivery of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
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