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

NCT06553378 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 154

Last updated 2024-08-14

No results posted yet for this study

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 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.

Conditions

  • Geriatric Oncology
  • Supportive Care
  • Quality of Life

Interventions

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.

Sponsors & Collaborators

  • National University of Singapore

    collaborator OTHER

  • National Medical Research Council (NMRC), Singapore

    collaborator OTHER_GOV

  • Tan Tock Seng Hospital

    lead OTHER

Principal Investigators

  • Wen Yang Goh · Tan Tock Seng Hospital

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
21 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-09-01
Primary Completion
2027-08-31
Completion
2027-08-31

Countries

  • Singapore

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06553378 on ClinicalTrials.gov