Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06553378
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-08-12
Brief Title:
The GOS-Frail Geriatric Oncology Supportive Care for Frail Older Adults With Cancer Study
Sponsor:
None
Organization:
None
Study Overview
Official Title:
The GOS-Frail Geriatric Oncology Supportive Care for Frail Older Adults With Cancer Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
GOS-Frail
Brief Summary:
Background Cancer is more prevalent in older adults but most cancer treatment trials have mainly involved young and healthy subjects Among geriatric syndromes frailty is a significant risk factor for negative outcomes such as treatment delays discontinuation and treatment-related side effects as well as functional decline and poor survival Research has shown that geriatric assessment with appropriate intervention can improve these outcomes although the impact may be influenced by the inclusion of patients receiving palliative-intent treatment Supportive care focuses on symptom assessment and treatment to enhance treatment tolerance and quality of life To date there have been no studies examining the combined benefits of geriatric oncology and supportive care clinics We conducted a pilot study called Geriatric Oncology Supportive Clinic for Elderly GOSPEL which demonstrated an improved quality of life for older adults with curable cancer Based on these results we developed an enhanced care model
Aim The study GOS-Frail aims to assess the effect of an integrated Geriatric Oncology Supportive Clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy andor radiotherapy at 1 month
Methods The GOS-Frail study is a multi-centre open-label parallel-arm randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals 154 adults aged 65 and above diagnosed with solid organ cancer and planned for curative-intent chemotherapy andor radiotherapy and with a clinical frailty scale score of 4 and above will be recruited Subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material Quality of life questionnaires will be administered at baseline 2 weeks and 1 3 6 and 12 months from treatment initiation
Hypothesis
The GOS-Frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment
Aim The study GOS-Frail aims to assess the effect of an integrated Geriatric Oncology Supportive Clinic on the quality of life of older adults with cancer receiving curative-intent chemotherapy andor radiotherapy at 1 month
Methods The GOS-Frail study is a multi-centre open-label parallel-arm randomized controlled trial conducted in the specialist outpatient clinics of two university-affiliated tertiary care hospitals 154 adults aged 65 and above diagnosed with solid organ cancer and planned for curative-intent chemotherapy andor radiotherapy and with a clinical frailty scale score of 4 and above will be recruited Subjects will be randomized to either attend a geriatric oncology supportive clinic or receive frailty education material Quality of life questionnaires will be administered at baseline 2 weeks and 1 3 6 and 12 months from treatment initiation
Hypothesis
The GOS-Frail study investigates on the role of a synergistic geriatric oncology and supportive model of care in improving quality of life in older adults undergoing curative-intent cancer treatment
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None