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CancerGOSPELNCT04513977

Geriatric Oncology SuPportive Clinic for ELderly

A study testing Geriatric Oncology Supportive Clinic in people with Cancer and Frailty, run by Goh Wen Yang at 1 site in Singapore.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 65 years and older
Conditions the study is for
Cancer, Frailty
What is being tested?
Geriatric Oncology Supportive Clinic
Could I receive a placebo?
No, everyone receives an active treatment
How many people
200 participants
Where
1 siteSingapore
Study dates
19 Aug 2020to Sep 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 65 years and older
  • All sexes
  • No healthy volunteers
  • Older adult

Who may be able to join

  • 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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

Singapore1 site, 1 recruiting
  • Tan Tock Seng Hospital

    Singapore

    Wen Yang Goh

    Recruiting

Other trials in Singapore

About this study

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.

Read the 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.

Conditions
Cancer, Frailty
Being tested
Geriatric Oncology Supportive Clinic
Keywords
Geriatric Oncology, Frailty, Comprehensive Geriatric Assessment, Quality of life
Medical subject headings
Neoplasms, Frailty

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Geriatric Oncology Supportive ClinicOther

    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.

Study groups in NCT04513977
Study groupRoleWhat they receive
Usual careNo interventionFor older adults with cancer with G8 score 14 or less. Randomized to usual oncology care.
Geriatric Oncology Supportive ClinicExperimentalFor older adults with cancer with G8 score 14 or less. Randomized to attend Geriatric Oncology Supportive Clinic
Receives: Other: Geriatric Oncology Supportive Clinic

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. HRQOL questionnaire (EORTC QLQ-ELD14)

    Measured: 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Aug 2020
  2. Study start19 Aug 2020
  3. Primary completionSep 2024 (estimated)
  4. Study completionSep 2025 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
200 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04513977
Sponsor's protocol ID
DSRB: 2019/00639
Acronym
GOSPEL
Status last verified
Aug 2024
First submitted
12 Aug 2020
Last updated
12 Aug 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Goh WY, Tan HM, Teo HL, Vong EKY, Ho FCH, Lim MY, Hum AYM. Clinical Frailty Scale versus Geriatric-8 in predicting quality of life among older adults receiving curative cancer treatment. Support Care Cancer. 2025 Jun 6;33(7):550. doi: 10.1007/s00520-025-09616-1.

    PubMed 40478269
  • 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.

    PubMed 35843845

Questions about this trial

What is this clinical trial studying?

A study testing Geriatric Oncology Supportive Clinic in people with Cancer and Frailty, run by Goh Wen Yang at 1 site in Singapore.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Singapore. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Wen Yang Goh (91729436, wen_yang_goh@ttsh.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

HRQOL questionnaire (EORTC QLQ-ELD14) (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04513977, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2024.

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