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

NCT06553378 | Not Yet Recruiting

• 1 other identifier: 2024-3521
• Study Type: interventional
• Target: 154
• Locations: 1 country
• Sites: 1

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.

Conditions

Geriatric Oncology; Supportive Care; Quality of Life

Keywords

Geriatric Oncology; Supportive Care; Quality of Life

Outcome Measures

Primary Outcomes (1)

• EuroQoL-5 Dimension (EQ5D-5L)

  EuroQoL-5 Dimension (EQ5D-5L)

  1 month

Study Arms (2)

Usual Care

NO INTERVENTION

Usual care

Geriatric Oncology Supportive Clinic

EXPERIMENTAL

Seen at GOSC

Other: Geriatric Oncology Supportive Clinic

Interventions

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.

Geriatric Oncology Supportive Clinic

Eligibility Criteria

• Age: 21 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead
• National University of Singapore: collaborator
• National Medical Research Council (NMRC), Singapore: collaborator

Study Sites (1)

Tan Tock Seng Hospital

Singapore, Singapore

Location

Study Officials

• Wen Yang Goh

  Tan Tock Seng Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Wen Yang Goh

CONTACT

91729436; wen_yang_goh@ttsh.com.sg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Randomized Controlled Trial

Study Record Dates

• First Submitted: August 12, 2024
• First Posted: August 14, 2024
• Study Start: September 1, 2024
• Primary Completion (Estimated): August 31, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: August 14, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

SG (1)