Abstract
Cancer affects older adults with varying levels of frailty, but cancer treatment is
extrapolated from clinical trials involving predominantly young and robust subjects.
Recent geriatric oncology randomised controlled trials (RCT) report that geriatric
assessment leading to frailty-guided intervention reduces treatment-related toxicity
whilst maintaining survival and improving quality of life (QoL). However, these positive
results have not have been consistently reported in the literature. We postulate that
the impact of geriatric interventions has been underestimated in these studies with
the inclusion of subjects receiving palliative-intent chemotherapy in whom dose reduction
is common. Integrating supportive care with current geriatric oncology models may
improve the QoL of older adults undergoing treatment. However, no studies as yet have
examined such integrated geriatric and supportive models of care.
The Geriatric Oncology SuPportive clinic for Elderly (GOSPEL) study is a single-centre,
open-label, analyst-blinded RCT evaluating the impact of comprehensive geriatric and
supportive care on QoL of older adults with cancer undergoing curative treatment.
Older adults aged above 65, with a Geriatric-8 score ≤ 14, with plans for high dose
radiotherapy and/or curative chemotherapy will be recruited. The primary QoL outcome
is measured using the European Organisation for Research and Treatment of Cancer (EORTC)
QLQ-ELD14 mobility scale at 12 weeks. Secondary outcomes include overall and disease-free
survival, treatment-related adverse events, and hospital admissions. We pre-powered
this study to recruit 200 subjects based on the minimally clinically important difference
for EORTC QLQ-ELD14 to achieve 80% statistical power (alpha 0.05), assuming 25% attrition.
Outcomes will be analysed using intention-to-treat.
Intervention consists of multi-domain comprehensive geriatric and supportive care
assessments from a multidisciplinary team targeting unmet needs. These include functional
decline, falls, incontinence, cognitive impairment, multi-morbidity, polypharmacy,
and symptom relief, as well as social and psycho-spiritual concerns. Standard care
entails routine oncological management with referral to geriatrics based on the discretion
of the primary oncologist. Recruitment has been ongoing since August 2020. Results
from the GOSPEL study will increase understanding of the impact of integrated geriatric
and supportive care programs in older adults with cancer receiving curative treatment.
Trial registration: This study is registered under ClinicalTrials.gov (ID NCT04513977).
Keywords
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Article info
Publication history
Published online: July 15, 2022
Accepted:
July 7,
2022
Received in revised form:
June 29,
2022
Received:
May 20,
2022
Identification
Copyright
© 2022 Elsevier Ltd. All rights reserved.
