Ignite Creation Date:
2024-05-06 @ 8:20 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06347185
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-04
First Post:
2024-01-25
Brief Title:
Simultaneous Care in Recurrent andor Metastatic Head and Neck Cancer the SupCare Study
Sponsor:
European Organisation for Research and Treatment of Cancer - EORTC
Organization:
European Organisation for Research and Treatment of Cancer - EORTC
Study Overview
Official Title:
Simultaneous Care in Recurrent andor Metastatic Head and Neck Cancer the SupCare Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SupCare
Brief 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 11 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-HN and the patients 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-HN and patient priority questionnaires 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
The study randomizes patients in a 11 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-HN and the patients 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-HN and patient priority questionnaires 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None