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

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

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06553378
Acronym
GOS-Frail
Enrollment
154
Registered
2024-08-14
Start date
2024-09-01
Completion date
2027-08-31
Last updated
2024-08-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Geriatric Oncology, Quality of Life, Supportive Care

Keywords

Geriatric Oncology, Supportive Care, Quality of Life

Brief 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.

Interventions

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

National University of Singapore
CollaboratorOTHER
National Medical Research Council (NMRC), Singapore
CollaboratorOTHER_GOV
Tan Tock Seng Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Outcomes Assessor)

Intervention model description

Randomized Controlled Trial

Eligibility

Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
EuroQoL-5 Dimension (EQ5D-5L)1 monthEuroQoL-5 Dimension (EQ5D-5L)

Countries

Singapore

Contacts

Primary ContactWen Yang Goh
wen_yang_goh@ttsh.com.sg91729436

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026