Clinical trial NCT06553378: The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study
Official title: The GOS-Frail (Geriatric Oncology Supportive Care for Frail Older Adults With Cancer) Study
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Geriatric Oncology
Supportive Care
Quality of Life
Keywords: Geriatric Oncology
Supportive Care
Quality of Life
Lead sponsor: Tan Tock Seng Hospital
Sponsor class: OTHER
Collaborators: name: National University of Singapore
name: National Medical Research Council (NMRC), Singapore
First posted: 2024-08-14
Enrollment: 154
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial
Primary purpose: SUPPORTIVE_CARE

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.


Eligibility 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.

Primary outcomes:
measure: EuroQoL-5 Dimension (EQ5D-5L)
timeFrame: 1 month
Secondary outcomes:
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
Study officials:
affiliation: Tan Tock Seng Hospital
name: Wen Yang Goh
role: PRINCIPAL_INVESTIGATOR
References: