The Effectiveness of Patient Coaching Within the Comprehensive Geriatric Assessment Process on Quality of Life in Older Patients With Cancer Receiving Systemic Therapy: a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 204
- 试验地点
- 2
- 主要终点
- Quality of Life (QoL): EORTC QLQ-C30
研究概览
简要总结
The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team.
详细描述
The G-oncoCOACH study aims to evaluate the effectiveness of the Comprehensive Geriatric Assessment (CGA) process coordinated by a geriatric team in combination with intensive patient coaching compared to the current standard of care, which is CGA coordinated by an oncology team. The Medical Research Council (MRC) Framework, developed to test complex interventions, is used to design this study. A multicenter randomized controlled trial will be conducted in two academic hospitals (UZ Brussel - UZ Leuven) with a follow-up at 3, 6 and 12 months after the start of systemic therapy. Patients will be recruited in both academic hospitals in the period between the cancer diagnosis and the start of the systemic therapy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
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
- •patients aged 70 years and older
- •diagnosis of cancer (solid tumors)
- •starting systemic therapy (chemotherapy, immunotherapy, targeted therapy or hormonal therapy)
- •curative intent (neo-adjuvant / adjuvant / concomitant / other)
- •palliative intent (first line / second line)
- •patients must be able to comply with the study procedures
- •physician-estimated life expectancy must be more than 6 months
排除标准
- •patients with antihormonal monotherapy
- •previous participation in geriatric intervention studies
- •patients included in clinical trials with non-registered anticancer drugs
结局指标
主要结局
Quality of Life (QoL): EORTC QLQ-C30
时间窗: QoL at 6 months since the start of the systemic therapy
QoL measured by the EORTC Qlq - C30. HRQOL evaluation was performed using the European Organization for Research and Treatment Quality of Life Questionnaire core 30 (EORTC QLQ-C30) Global Health Status Scale (GHS). The two general questions 29 and 30 are selected: "How would you rate your overall health during the past week?" and "How would you rate your overall quality of life during the past week?". Patients answer these two questions by means of seven-point Likert scales and the two scores are combined to define the GHS. The GHS score is linearly transformed to a 0-100 score to facilitate statistical interpretation. A higher HRQOL is reported by a higher GHS score.
次要结局
- Evolution in QoL: EORTC QLQ-C30(over 1 year follow up since the start of the systemic therapy)
- Measurement of patient satisfaction: questionnaire(over 1 year follow up since the start of the systemic therapy)
- Evolution of functional status (FS) measured by Activities of Daily Living (ADL)(over 1 year follow up since the start of the systemic therapy)
- Evolution of functional status (FS) measured by Instrumental Activities of Daily Living (IADL)(over 1 year follow up since the start of the systemic therapy)
- Rate of falls(at 3, 6 and 12 months since the start of systemic therapy)
- QoL: EORTC QLQ-C30(QoL at 3 and 12 months since the start of the systemic therapy)
- Measurement of systemic therapy-related adverse events(over 1 year follow up since the start of the systemic therapy)
- Measurement of geriatric recommendations(at 3, 6 and 12 months since the start of systemic therapy)
- Measurement of actions undertaken(at 3, 6 and 12 months since the start of systemic therapy)
- Overall Survival(over 2 year follow-up since the start of systemic therapy)
- Number of patients with premature interruption of systemic therapy(over 1 year follow up since the start of the systemic therapy)
研究者
prof. dr. Hans Wildiers
Principal Investigator
Universitaire Ziekenhuizen KU Leuven