Assessing the Evolution and Determinants of Quality of Life in Elderly Cancer Patients and Their Caregivers: a Prospective Multicenter Observational Cohort Study.
试验速览
- 阶段
- 不适用
- 入组人数
- 300
- 试验地点
- 3
- 主要终点
- Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires
研究概览
简要总结
Patients face multiple stresses and challenges in the aftermath of cancer diagnosis. Despite needs perceived by elderly patients might differ from those of younger patients, there is a paucity of published data assessing the specific evolution and relevant determinants of health-related quality of life (HRQoL) in older patients with cancer. Such determinants may include cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features, but also practical organization of care -frequency, geographical distance, supporting measures -, or psychosocial and material support - social network, housing conditions and contextual neighborhood features. Comparatively to dementia or cancer in younger patients, little is known in the oncogeriatric field of the impact on caregivers' perceived burden and HRQol of the support they provide to patients. Further, the potential interactions between patients' and caregivers' HRQoL remain largely unknown, while caregivers are often themselves old with chronic diseases and/or daily living activities' limitations.
The DEQOLAGE study is a prospective observational cohort study that aims to describe the HRQoL of patients aged over 70 years with a colorectal or prostatic cancer during the first year following the diagnosis of the disease as well as the HRQoL and burden in their main caregivers. This study will allow a comprehensive assessment of multiple determinants of HRQoL operating at different levels, including individual (cancer type/location/stage, treatment type/intensity, comorbidities, nutritional status or socioeconomic features), contextual (social network, housing conditions and contextual neighborhood features) and organizational factors (frequency, geographical distance, supporting measures). We also hypothesize that complex interactions may operate between patient's and caregiver's HRQoL and perceived burden. Quality of life measurement will be based on two recent scales specifically designed for the elderly to confirm their psychometric properties and in-field feasibility.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 70 Years 至 —（Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Aged 70 or more
- •With a new histologically confirmed diagnosis of colorectal or prostate cancer
- •With a Comprehensive Geriatric Assessment (CGA) performed before the initiation of cancer treatment
- •Having expressed their oral non-opposition to participate in the study
- •Affiliated to a health insurance scheme
排除标准
- •Expected survival inferior to 6 months, based on the clinical appreciation from the physician in charge of the enrollment
- •Cancer recurrence in patients previously treated
- •Physical, cognitive or linguistic incapacity to complete questionnaires
- •Caregivers Inclusion criteria
- •Aged 18 or more
- •Nonprofessionally, partially or fully helping the patient in daily activities and accompanying the patient to visits; familial ties with the patient are not required (spouse, child, friend or neighbor)
- •In contact with the patient more than once a week
- •Defined by the patient during the inclusion visit as the main caregiver
- •Exclusion criteria
- •Physical, cognitive or linguistic incapacity to complete questionnaires
结局指标
主要结局
Changes in HRQoL of patients and their caregivers as assessed by the generic WHOQOL-BREF questionnaires
时间窗: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC-QLQ C30 questionnaire
时间窗: At baseline, 3, 6, and 12 months
Changes in burden of patients' caregivers as assessed by the Zarit burden inventory questionnaire
时间窗: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients and their caregivers if aged >70 years as assessed by the WHOQOL-OLD questionnaire
时间窗: At baseline, 3, 6, and 12 months
Changes in HRQoL of patients as assessed by the specific EORTC QLQ-ELD14 questionnaire
时间窗: At baseline, 3, 6, and 12 months
次要结局
- Prognostic value of baseline HRQoL measurements on overall survival(At baseline, 3, 6, and 12 months)
- Prognostic value of baseline HRQoL measurements on cancer progression-free survival(At baseline, 3, 6, and 12 months)
- Psychometric properties of the HRQoL questionnaire WHOQOL-OLD (validity, reliability, sensitivity to change, feasibility)(At baseline, 3, 6, and 12 months)
- Psychometric properties of the HRQoL questionnaire EORTC QLQ-ELD14 (validity, reliability, sensitivity to change, feasibility)(At baseline, 3, 6, and 12 months)
- Prognostic value of baseline HRQoL measurements on patient's functional decline, defined as any decrease in the ADL scale(At baseline, 3, 6, and 12 months)