Ignite Creation Date:
2024-05-06 @ 3:36 PM
Last Modification Date:
2024-10-26 @ 1:52 PM
Study NCT ID:
NCT04686851
Status:
RECRUITING
Last Update Posted:
2023-12-13
First Post:
2020-10-26
Brief Title:
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers
Sponsor:
Odense University Hospital
Organization:
Odense University Hospital
Study Overview
Official Title:
Predictive Value of Geriatric Oncology Screening and Geriatric Assessment in Older Patients With Solid Cancers PROGNOSIS-RCT
Status:
RECRUITING
Status Verified Date:
2023-12
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:
PROGNOSIS-RCT
Brief Summary:
A Randomized Clinical Trial examining the effects of Comprehensive Geriatric Assessment as an add on to oncologic treatment Participants included are cancer patients found eligible for oncologic treatment age 70 or more and screened frail with the Geriatric 8 screening tool
Detailed Description:
This study aims to examine the effects of Comprehensive Geriatric Assessment and interventions on prognosis in the older frail cancer patient in a Randomized Clinical Trial design
Patients screened frail with the Geriatric 8 screening tool aged 70 or more and found eligible for oncologic treatment will be included We plan to enrol a total of 322 cancer patients for 12 months Participants will be allocated randomly to either interventional or control group
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor nurse and physiotherapist If needed referral to a dietician or an occupational therapist for further evaluation will be made The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset G-CODE Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation
The randomized groups will be compared with respect to primary and secondary endpoints
Patients screened frail with the Geriatric 8 screening tool aged 70 or more and found eligible for oncologic treatment will be included We plan to enrol a total of 322 cancer patients for 12 months Participants will be allocated randomly to either interventional or control group
Participants in the interventional group will be offered a Comprehensive Geriatric Assessment and intervention at the start-up of cancer treatment The Comprehensive Geriatric Assessment will be an add on to standardized cancer treatment offered at the Oncologic Outpatient Clinic at Odense University Hospital
Comprehensive Geriatric Assessment will be performed by a team consisting of a doctor nurse and physiotherapist If needed referral to a dietician or an occupational therapist for further evaluation will be made The health issues are assessed using validated tests based on a Danish version of the Geriatric Core Dataset G-CODE Follow-up on Comprehensive Geriatric Assessment is scheduled for one month after initial evaluation
The randomized groups will be compared with respect to primary and secondary endpoints
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 20 17768 | OTHER | Region of Southern Denmark | None |
| R247-A14382 | OTHER_GRANT | None | None |