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Geriatric Oncology SuPportive Clinic for ELderly (GOSPEL)

Primary Purpose

Cancer, Frailty

Status
Recruiting
Phase
Not Applicable
Locations
Singapore
Study Type
Interventional
Intervention
Geriatric Oncology Supportive Clinic
Sponsored by
Goh Wen Yang
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Cancer focused on measuring Geriatric Oncology, Frailty, Comprehensive Geriatric Assessment, Quality of life

Eligibility Criteria

65 Years - undefined (Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 65 and above
  • Newly diagnosed early or locally advanced cancer
  • Planned for treatment

    • high dose radiotherapy (both curative and palliative) and / or
    • curative chemotherapy

Exclusion Criteria:

  • Seen in Geriatric or Palliative Medicine Clinic in prior 6 months

Sites / Locations

  • Tan Tock Seng HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care

Geriatric Oncology Supportive Clinic

Arm Description

For older adults with cancer with G8 score 14 or less. Randomized to usual oncology care.

For older adults with cancer with G8 score 14 or less. Randomized to attend Geriatric Oncology Supportive Clinic

Outcomes

Primary Outcome Measures

HRQOL questionnaire (EORTC QLQ-ELD14)

Secondary Outcome Measures

Full Information

First Posted
August 12, 2020
Last Updated
April 26, 2022
Sponsor
Goh Wen Yang
Collaborators
The Palliative Care Centre for Excellence in Research and Education (PalC), Lee Kong Chian School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT04513977
Brief Title
Geriatric Oncology SuPportive Clinic for ELderly
Acronym
GOSPEL
Official Title
Geriatric Oncology SuPportive Clinic for ELderly
Study Type
Interventional

2. Study Status

Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 19, 2020 (Actual)
Primary Completion Date
January 2023 (Anticipated)
Study Completion Date
January 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Goh Wen Yang
Collaborators
The Palliative Care Centre for Excellence in Research and Education (PalC), Lee Kong Chian School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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 radio(chemo)therapy. (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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cancer, Frailty
Keywords
Geriatric Oncology, Frailty, Comprehensive Geriatric Assessment, Quality of life

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Usual care
Arm Type
No Intervention
Arm Description
For older adults with cancer with G8 score 14 or less. Randomized to usual oncology care.
Arm Title
Geriatric Oncology Supportive Clinic
Arm Type
Experimental
Arm Description
For older adults with cancer with G8 score 14 or less. Randomized to attend Geriatric Oncology Supportive Clinic
Intervention Type
Other
Intervention Name(s)
Geriatric Oncology Supportive Clinic
Intervention Description
Patients will undergo Comprehensive Geriatric Assessment with subsequent tailored intervention based on deficits identified. Comprehensive palliative assessment for any symptom burden and symptommatic treatment will be done as well.
Primary Outcome Measure Information:
Title
HRQOL questionnaire (EORTC QLQ-ELD14)
Time Frame
3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 65 and above Newly diagnosed early or locally advanced cancer Planned for treatment high dose radiotherapy (both curative and palliative) and / or curative chemotherapy Exclusion Criteria: Seen in Geriatric or Palliative Medicine Clinic in prior 6 months
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Wen Yang Goh
Phone
91729436
Email
wen_yang_goh@ttsh.com.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wen Yang Goh
Organizational Affiliation
TTSH
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tan Tock Seng Hospital
City
Singapore
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Wen Yang Goh

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
35843845
Citation
Goh WY, Neo HY, Teo HL, Koh MYH, Griva K, Lim MY, Ho FCH, Hum AYM. Protocol for a randomised controlled trial on impact of comprehensive geriatric and supportive assessment versus standard care in older adults with cancer undergoing curative treatment: The Geriatric Oncology SuPportive clinic for ELderly (GOSPEL) study. J Geriatr Oncol. 2023 Jan;14(1):101342. doi: 10.1016/j.jgo.2022.07.002. Epub 2022 Jul 15.
Results Reference
derived

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Geriatric Oncology SuPportive Clinic for ELderly

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