Clinical and Cost-effectiveness of a Comprehensive Geriatric Assessment and Management for Canadian Elders With Cancer: the 5C Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 351
- 试验地点
- 4
- 主要终点
- Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
研究概览
简要总结
A multicentre two-group parallel single-blind (outcome assessor) randomized controlled trial (RCT). A cost effectiveness study alongside a clinical trial using a payer and societal perspective to study the cost-effectiveness of geriatric assessment and management compared to usual care will be conducted.
Participants allocated to the control group will receive usual oncology care. Participants allocated to the intervention group will receive a comprehensive geriatric assessment and management in addition to their usual oncology care. The intervention will take 6 months to be completed. Total study follow-up will be 12 months for each participant.
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
- Single (Outcomes Assessor)
盲法说明
The outcome assessor and statistician will be blinded to group allocation
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+ with any solid tumor (excluding pancreatic) or lymphoma/myeloma referred for first/second line adjuvant/curative or palliative chemotherapy (cannot have received more than 1 cycle),
- •Able to speak English/French,
- •Have a physician-estimated life expectancy >6 months,
- •Have an ECOG Performance Score 0-2 (indicating participants are ambulatory and able to complete all self-care activities),
- •Able to give informed consent.
排除标准
- •Receiving palliative care services upon recruitment
- •Already participating in another psychosocial/educational intervention study (new treatment study is allowed if the participants would like to participate in 2 studies)
结局指标
主要结局
Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
时间窗: 12 months
Quality of Life questionnaire (QLQ) C30 Questionnaire Global quality of Life scale
次要结局
- Functional status(12 months)
- Satisfaction with care provided(6 months)
- Overall survival(12 months)
- Cost-effectiveness(12 months)
- Unplanned health care use(6 months)
- Satisfaction with intervention(12 months)
- Cancer treatment plan modification(3 months)
- The number of geriatric issues successfully addressed for participants in intervention group(6 months)
- Treatment toxicity(6 months)
- Intervention fidelity by treatment centre(12 months)
研究者
Martine Puts
Assistant Professor
University of Toronto