Feasibility of Frailty Assessment and Implementation of Protocol-led Geriatric Interventions in Women Over the Age of 70 With Epithelial Ovarian Cancer in the Oncology Clinic (FAIR-O)
试验速览
- 阶段
- 不适用
- 入组人数
- 120
- 主要终点
- Feasibility of completing the Functional Geriatric Assessment
研究概览
简要总结
Ovarian cancer is frequently diagnosed in older women, with over half of all new diagnoses being in women over 65 years. Current treatment options are based on the results of clinical trials that often do not include older, less fit patients in whom treatments may be less well tolerated. Further, in older patients the impact of complex medical and social issues is not known. The UK lags behind Europe and the United States in the development of research programs dedicated to improving outcomes for older patients. More research focus is urgently required to improve the assessment and management of older women with ovarian cancer to improve survival outcomes, quality of life and functional independence.
Current treatment decisions are made predominantly on age and fitness. However, it has been shown that undertaking a holistic, geriatric assessment of older patients can highlight important issues that would not necessarily be identified in a routine oncology appointment. In this study, we propose to ask oncology teams to undertake a geriatric assessment and specifically address issues that may arise as a result of this. The assessment comprises 8 simple non-invasive assessments that can be performed in the out-patient setting.
This approach could result in an important change in clinical practice leading to more holistic assessment of older cancer patients and better address their specific needs and manage their cancer treatment. The long-term goal is to show that pro-actively managing potential issues at the beginning of treatment allows patients to tolerate treatment and maintain their functional independence, leading to improved quality of life.
详细描述
FAIR-O is a single-arm, multi-center, phase II intervention trial of a geriatric assessment in older patients (≥ 70 years old) diagnosed with epithelial ovarian, fallopian tube or primary peritoneal cancer. Patients will be approached if they are being considered for systemic chemotherapy either as neoadjuvant / front-line chemotherapy in the first-line setting OR for chemotherapy at first relapse.
Two cohorts of patients will be recruited and run in parallel (no comparison will be performed between them):
- First-line cohort: patients with newly diagnosed advanced (stage III/IV) ovarian cancer who have received no prior treatment for ovarian cancer including surgery.
- First relapse cohort: ovarian cancer patients with first relapse
On consenting to the trial, a comprehensive medical and treatment history will be obtained including blood tests, tumour markers and a CT scan. The CT scan will be assessed for extent (volume) of muscle mass and compared to reference standards to identify patients with low muscle attenuation and sarcopenia (i.e. loss of muscle mass).
In addition, consented patients will be asked to undertake a comprehensive Geriatric Assessment which comprises a collection of 8 tests - all of which are non-invasive. These test comprise validated questionnaires and functional assessments including the G8 questionnaire, independent activities of daily living (IADL), activities of daily living (ADL), Charlson co-morbidity score, Hospital anxiety and depression scale (HADS), mini nutritional assessment (MNA), a timed up-and-go test and a mini cognitive assessment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Age at time of consideration for systemic chemotherapy of 70 years and above
- •Histological or cytological confirmation of epithelial ovarian cancer
- •Planning to commence systemic chemotherapy for either newly diagnosed epithelial ovarian cancer or first disease relapse
- •Life expectancy greater than 3 months
- •Able to give informed consent, complete questionnaires in english and comply with study procedures
排除标准
- •In the opinion of the investigator, patient is not fit for systemic chemotherapy or patient declines systemic chemotherapy
- •Patient does not have the capacity to consent for enrollment into the study or capacity to consent for systemic chemotherapy
结局指标
主要结局
Feasibility of completing the Functional Geriatric Assessment
时间窗: Obtained at Baseline (Date of Consent)
Proportion of patients in whom it was possible to complete the Functional Geriatric assessment within the Oncology Clinic setting, assessed at the point of the first oncology clinic visit.
次要结局
- Proportion of patients developing sarcopenia during chemotherapy treatment, amounting to an average of 6 months on chemotherapy treatment.(Baseline (Date of Consent) to date of last chemotherapy treatment, an average of 6 months.)
- Proportion of patients with deficits identified resulting in algorithm defined interventions(Obtained at Baseline (Date of Consent))
- Time on chemotherapy treatment(Start date of chemotherapy treatment to date of discontinuation of treatment, an average of 6 months.)
- Quality of Life Outcome score in Cancer Patients(Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.)
- Quality of Life Outcome score in Ovarian Cancer Patients(Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.)
- Sarcopenia and frailty(Assessed between baseline (date of Consent) mid-way though chemotherapy treatment to the date of delivery of last chemotherapy treatment, an average of 6 months.)
- Proportion of patients with grade 3/4 hematological and non-hematological toxicities(Baseline (date of Consent) to date of last chemotherapy treatment, an average of 6 months.)
- Quality of Life Outcome score in Elderly Cancer Patients(Start date of chemotherapy treatment, through treatment (average of 6 months) and at months 3, 6, 9, and 12 after date of last delivery of chemotherapy treatment.)