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NCT Number: NCT06553378

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

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.

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

Geriatric Oncology Supportive Clinic

Other

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.

Primary outcomes

  1. EuroQoL-5 Dimension (EQ5D-5L)

    Time frame: 1 month

    EuroQoL-5 Dimension (EQ5D-5L)

Study contacts

Contact information is provided by the study sponsor or research team.

Wen Yang Goh

CONTACT

[email protected]

91729436

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Collaborators

  • National Medical Research Council (NMRC), Singapore
  • National University of Singapore

Registry information

Acronym: GOS-Frail

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 14, 2024
Registry last updated
Aug 14, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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