دورية أكاديمية
Protocol for a randomised controlled trial on impact of comprehensive geriatric and supportive assessment versus standard care in older adults with cancer undergoing curative treatment: The Geriatric Oncology SuPportive clinic for ELderly (GOSPEL) study.
| العنوان: | Protocol for a randomised controlled trial on impact of comprehensive geriatric and supportive assessment versus standard care in older adults with cancer undergoing curative treatment: The Geriatric Oncology SuPportive clinic for ELderly (GOSPEL) study. |
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| المؤلفون: | Goh WY; Department of Palliative Medicine, Tan Tock Seng Hospital, Singapore; Department of Geriatric Medicine, Institute of Geriatrics and Active Ageing, Tan Tock Seng Hospital, Singapore; Palliative Care Centre for Excellence in Research and Education, Singapore. Electronic address: Wen_Yang_Goh@ttsh.com.sg., Neo HY; Department of Palliative Medicine, Tan Tock Seng Hospital, Singapore; Department of Geriatric Medicine, Institute of Geriatrics and Active Ageing, Tan Tock Seng Hospital, Singapore; Palliative Care Centre for Excellence in Research and Education, Singapore., Teo HL; Department of Medical Oncology, Tan Tock Seng Hospital, Singapore., Koh MYH; Department of Palliative Medicine, Tan Tock Seng Hospital, Singapore; Department of Geriatric Medicine, Institute of Geriatrics and Active Ageing, Tan Tock Seng Hospital, Singapore; Palliative Care Centre for Excellence in Research and Education, Singapore., Griva K; Health Psychology and Behavioural Medicine, Lee Kong Chian School of Medicine, Nanyang Technological University, Singapore., Lim MY; Department of Otolaryngology, Tan Tock Seng Hospital, Singapore., Ho FCH; Department of Radiation Oncology, National University Cancer Institute, Singapore., Hum AYM; Department of Palliative Medicine, Tan Tock Seng Hospital, Singapore; Department of Geriatric Medicine, Institute of Geriatrics and Active Ageing, Tan Tock Seng Hospital, Singapore; Palliative Care Centre for Excellence in Research and Education, Singapore. |
| المصدر: | Journal of geriatric oncology [J Geriatr Oncol] 2023 Jan; Vol. 14 (1), pp. 101342. Date of Electronic Publication: 2022 Jul 15. |
| نوع المنشور: | Clinical Trial Protocol; Journal Article; Research Support, Non-U.S. Gov't |
| اللغة: | English |
| بيانات الدورية: | Publisher: Elsevier Country of Publication: Netherlands NLM ID: 101534770 Publication Model: Print-Electronic Cited Medium: Internet ISSN: 1879-4076 (Electronic) Linking ISSN: 18794068 NLM ISO Abbreviation: J Geriatr Oncol Subsets: MEDLINE |
| أسماء مطبوعة: | Original Publication: Amsterdam : Elsevier |
| مواضيع طبية MeSH: | Frailty* , Neoplasms*/therapy , Geriatrics*, Aged ; Humans ; Medical Oncology ; Geriatric Assessment/methods ; Quality of Life ; Randomized Controlled Trials as Topic |
| مستخلص: | 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). Competing Interests: Declaration of Competing Interest The authors have no competing interests to declare. (Copyright © 2022 Elsevier Ltd. All rights reserved.) |
| فهرسة مساهمة: | Keywords: Chemotherapy; Comprehensive geriatric assessment; Curative-intent; Frailty; Geriatric oncology; Radiotherapy; Supportive care |
| سلسلة جزيئية: | ClinicalTrials.gov NCT04513977 |
| تواريخ الأحداث: | Date Created: 20220717 Date Completed: 20230228 Latest Revision: 20230307 |
| رمز التحديث: | 20231215 |
| DOI: | 10.1016/j.jgo.2022.07.002 |
| PMID: | 35843845 |
| قاعدة البيانات: | MEDLINE |
Full Text via ClinicalKey 
Full Text Finder | تدمد: | 1879-4076 |
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| DOI: | 10.1016/j.jgo.2022.07.002 |