The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study (GOS-Frail)

August 13, 2024 updated by: Tan Tock Seng Hospital

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 and/or 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 and/or 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

154

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion criteria

  1. Age ≥ 65
  2. Diagnosis of solid organ cancer
  3. Plan for curative-intent chemotherapy and/or radiotherapy
  4. Clinical Frailty Scale (CFS) score ≥ 4,

Exclusion criteria: Evaluation by Geriatric or Palliative Medicine in the previous 6 months.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Usual Care
Usual care
Experimental: Geriatric Oncology Supportive Clinic
Seen at GOSC
Other: Geriatric Oncology Supportive Clinic
Subjects in the intervention arm will be seen within four weeks of recruitment. Clinical assessment involves a Comprehensive Geriatric Assessment (CGA) and Supportive Care Assessment conducted by a geriatric-oncologist. Both clinical assessments and targeted interventions are supported by a multi-disciplinary team comprising the geriatrician, geriatric trained nurse, physiotherapist, occupational therapist, speech therapist, pharmacist, dietician, and medical social worker. We will conduct an initial GOSC assessment, with a follow up review during oncology treatment. Subsequently, further GOSC clinic sessions duration of follow up will be determined by the subject's underlying disease, symptom burden and clinical course during treatment.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
EuroQoL-5 Dimension (EQ5D-5L)
Time Frame: 1 month
EuroQoL-5 Dimension (EQ5D-5L)
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tan Tock Seng Hospital

Collaborators

National Medical Research Council (NMRC), Singapore
National University Cancer Institute, Singapore

Investigators

  • Principal Investigator: Wen Yang Goh, Tan Tock Seng Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2024

Primary Completion (Estimated)

August 31, 2027

Study Completion (Estimated)

August 31, 2027

Study Registration Dates

First Submitted

August 12, 2024

First Submitted That Met QC Criteria

August 13, 2024

First Posted (Actual)

August 14, 2024

Study Record Updates

Last Update Posted (Actual)

August 14, 2024

Last Update Submitted That Met QC Criteria

August 13, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2024-3521

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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