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

T

Tan Tock Seng Hospital

Status

Not yet enrolling

Conditions

Supportive Care
Quality of Life
Geriatric Oncology

Treatments

Other: Geriatric Oncology Supportive Clinic

Study type

Interventional

Funder types

Other

Identifiers

NCT06553378
2024-3521

Details and patient eligibility

About

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.

Enrollment

154 estimated patients

Sex

All

Ages

21+ years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Single Blind

154 participants in 2 patient groups

Usual Care
No Intervention group
Description:
Usual care
Geriatric Oncology Supportive Clinic
Experimental group
Description:
Seen at GOSC
Treatment:
Other: Geriatric Oncology Supportive Clinic

Trial contacts and locations

1

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Central trial contact

Wen Yang Goh

Data sourced from clinicaltrials.gov

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