Ignite Creation Date:
2024-05-06 @ 3:05 PM
Last Modification Date:
2024-10-26 @ 1:42 PM
Study NCT ID:
NCT04513977
Status:
RECRUITING
Last Update Posted:
2022-05-02
First Post:
2020-08-12
Brief Title:
Geriatric Oncology SuPportive Clinic for ELderly
Sponsor:
Goh Wen Yang
Organization:
Tan Tock Seng Hospital
Study Overview
Official Title:
Geriatric Oncology SuPportive Clinic for ELderly
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
RECRUITING
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:
GOSPEL
Brief Summary:
This is a randomized controlled trial comparing the impact of Geriatric-Oncology-Supportive Clinic GOSC on quality of life in older adult with newly diagnosed cancer undergoing cancer related treatment
Detailed Description:
i Recognition of unique need of older adults cancer patients Cancer is a disease largely affecting the older adults with incidence of malignancies after age of 65 years 11 folds higher than younger adults Despite this our understanding of cancer treatment effects in older adults is poor because they are largely unrepresented in such trials Efforts to extrapolate cancer treatment effects from younger adults to the older adults have been difficult because of their heterogeneous health status which lead to a recognition of the need for Comprehensive Geriatric Assessment CGA to detect vulnerability and formulate individualized care plan This awareness has been echoed in multiple international guidelines including the American Society of Clinical Oncology ASCO European Organization for Research and Treatment of Cancer EORTC European Society of Medical Oncology ESMO National Comprehensive Cancer Network NCCN and has led to the founding of International Society of Geriatric Oncology SIOG in 2000
ii Geriatric-Oncology In Geriatric Medicine CGA is the cornerstone in caring for the older adults and is defined as multidisciplinary diagnostic and treatment process that identifies medical psychosocial and functional capabilities of older adults to develop a coordinated plan to maximize overall health with aging The diagnostic outcomes and treatment targets of CGA are traditionally represented as geriatric giants including instability incontinence immobility and intellectual impairment with recent inclusion of modern geriatric giants represented by frailty and sarcopenia CGA has been shown to improve function health status quality of life and healthcare utilization outcomes in diverse clinical settings It is important to understand that the key to improve patient outcomes based on CGA relies not only on the assessment butalso the intervention that follows The CGA by a geriatrician however is labor-intensive time consuming and limited by the number of geriatricians available Hence in a busy oncology clinic there are 3 recommended approaches for assessment of older adults Firstly in a form of risk assessment tool such as Cancer and Aging Research Group CARG or Chemotherapy Risk Assessment Scale for High-Age Patients CRASH that predicts likelihood of toxicity from chemotherapy Secondly a screening test such as Geriatric-8 G8 with an aggregate that serves to identify vulnerable older adults who may benefit from a subsequent CGA Thirdly a geriatric assessment GA which takes into account the different domains of CGA to identify vulnerable older adults who may benefit from a subsequent CGA The above 3 pathways also form the current models of care for geriatric-oncology G8 has been recommended by ASCO and EORTC as a screening test of choice 14 as vulnerable and 14 as fit with good sensitivity specificity positive predictive value and negative predictive value for vulnerability against CGA assessment outcomes as the gold standard G8 has been extensively studied in older adults with cancer undergoing radiochemotherapy
iii Special consideration to older adults with early and locally advanced cancer Current published trials and ongoing trials focused on older adults who are undergoing oncological treatment regardless on cancer stage However generally early and locally advanced cancer patients and advanced cancer groups should not be regarded to be homogenous Firstly the intention for treatment may be vastly different with most of the advanced cancer group being treated with palliative intent Henceforth the treatment intensity frequency and likelihood for further treatment escalation is higher in early and locally advanced cancer Secondly the prognosis between the 2 groups in view of disease burden and treatment intent will be vastly different Thirdly recently studies of early palliative care has shown significant improvement in quality of life and mood in patients with advanced cancer but there had been no studies looking at early and locally advanced cancer group Henceforth older adults with early and locally advanced cancer is a unique group facing higher potential of complication from treatment with worsened quality of life for a prolonged period of life without any useful service option
iv Special consideration to early palliative care in older adults with newly diagnosed cancer In older adults frequently their focus is for maintenance of quality of life and less so for prolonging life In Geriatric-Oncology this aim is fulfilled by 1 detecting vulnerability 2 intervention to maintain fitness and quality of life 3 providing advice to oncologist for optimized management However we propose for a 4th dimension of care for older adults with cancer which entails symptom control from principles of palliative care It is crucial to know that poorly controlled symptoms is associated with poorer quality of life This is even more important for older adults who are not undergoing treatment Henceforth to look into maintenance of quality of life there had been recent calls for integration of palliative care with geriatric oncology
v Identified evidence gap Despite multiple studies looking at the efficacy of Geriatric-Oncology there had been a paucity in research on its impact on quality of life This is especially so specifically for older adults with early and locally advanced cancer who may suffer for a prolonged time with poor quality of life Research is also lacking on the effect of palliative care in early and locally advanced cancer Henceforth the impetus to seek for the benefit of a new service that integrates principles of Geriatric-Oncology with palliative care
ii Geriatric-Oncology In Geriatric Medicine CGA is the cornerstone in caring for the older adults and is defined as multidisciplinary diagnostic and treatment process that identifies medical psychosocial and functional capabilities of older adults to develop a coordinated plan to maximize overall health with aging The diagnostic outcomes and treatment targets of CGA are traditionally represented as geriatric giants including instability incontinence immobility and intellectual impairment with recent inclusion of modern geriatric giants represented by frailty and sarcopenia CGA has been shown to improve function health status quality of life and healthcare utilization outcomes in diverse clinical settings It is important to understand that the key to improve patient outcomes based on CGA relies not only on the assessment butalso the intervention that follows The CGA by a geriatrician however is labor-intensive time consuming and limited by the number of geriatricians available Hence in a busy oncology clinic there are 3 recommended approaches for assessment of older adults Firstly in a form of risk assessment tool such as Cancer and Aging Research Group CARG or Chemotherapy Risk Assessment Scale for High-Age Patients CRASH that predicts likelihood of toxicity from chemotherapy Secondly a screening test such as Geriatric-8 G8 with an aggregate that serves to identify vulnerable older adults who may benefit from a subsequent CGA Thirdly a geriatric assessment GA which takes into account the different domains of CGA to identify vulnerable older adults who may benefit from a subsequent CGA The above 3 pathways also form the current models of care for geriatric-oncology G8 has been recommended by ASCO and EORTC as a screening test of choice 14 as vulnerable and 14 as fit with good sensitivity specificity positive predictive value and negative predictive value for vulnerability against CGA assessment outcomes as the gold standard G8 has been extensively studied in older adults with cancer undergoing radiochemotherapy
iii Special consideration to older adults with early and locally advanced cancer Current published trials and ongoing trials focused on older adults who are undergoing oncological treatment regardless on cancer stage However generally early and locally advanced cancer patients and advanced cancer groups should not be regarded to be homogenous Firstly the intention for treatment may be vastly different with most of the advanced cancer group being treated with palliative intent Henceforth the treatment intensity frequency and likelihood for further treatment escalation is higher in early and locally advanced cancer Secondly the prognosis between the 2 groups in view of disease burden and treatment intent will be vastly different Thirdly recently studies of early palliative care has shown significant improvement in quality of life and mood in patients with advanced cancer but there had been no studies looking at early and locally advanced cancer group Henceforth older adults with early and locally advanced cancer is a unique group facing higher potential of complication from treatment with worsened quality of life for a prolonged period of life without any useful service option
iv Special consideration to early palliative care in older adults with newly diagnosed cancer In older adults frequently their focus is for maintenance of quality of life and less so for prolonging life In Geriatric-Oncology this aim is fulfilled by 1 detecting vulnerability 2 intervention to maintain fitness and quality of life 3 providing advice to oncologist for optimized management However we propose for a 4th dimension of care for older adults with cancer which entails symptom control from principles of palliative care It is crucial to know that poorly controlled symptoms is associated with poorer quality of life This is even more important for older adults who are not undergoing treatment Henceforth to look into maintenance of quality of life there had been recent calls for integration of palliative care with geriatric oncology
v Identified evidence gap Despite multiple studies looking at the efficacy of Geriatric-Oncology there had been a paucity in research on its impact on quality of life This is especially so specifically for older adults with early and locally advanced cancer who may suffer for a prolonged time with poor quality of life Research is also lacking on the effect of palliative care in early and locally advanced cancer Henceforth the impetus to seek for the benefit of a new service that integrates principles of Geriatric-Oncology with palliative care
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