Occupational Engagement in Alder Adults With Cancer - the Impact of Occupational Therapy (OCEAN-OT): a Multicenter Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 232
- 主要终点
- Quality of life (QLQ-C30 questionnaire)
研究概览
简要总结
The purpose of this randomized controlled superiority trial is to evaluate the impact of occupational therapy assessment and intervention on the quality of life of elderly cancer patients.
Patients will be randomized into 3 parallel, multicenter arms with patient-reported outcome and blinded evaluator.
- Experimental group A will combine the assessment of occupational problems (MCRO) and an occupational therapy intervention.
- Experimental group B will have only the MCRO assessment because the occupational problems assessment alone (without intervention) could improve quality of life and occupational performance outcomes, according to the Nielsen, 2019 study
- Group C will have the usual cancer management care combining specific treatments and supportive care.
详细描述
in order to limit the potential grading bias associated with the open-label design, the reassessment at 3 and 6 months will be performed by a different occupational therapist than the one who performed the initial assessment and occupational therapy intervention. For this reason, at least two occupational therapists per geographic area of the centers that include the patients will be included in the project.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 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
- •≥ 70 years;
- •Colorectal, breast, prostate or lung cancer;
- •Between 1 and 3 months after the start of cancer treatment depending on the type of treatment (Surgery and/or systemic treatment and/or radiotherapy);
- •For curative purposes;
- •Affiliated to a social security scheme;
- •Living at home;
- •Agreeing to participate in the research and having given a free, informed and signed consent
排除标准
- •person caring for a patient meeting the above criteria;
- •Living with the patient;
- •Agreeing to participate in the research and having given free, informed and signed consent
结局指标
主要结局
Quality of life (QLQ-C30 questionnaire)
时间窗: 3 months
Evolution of the EORTC QLQ-C30 role functioning score at 3 months
次要结局
未报告次要终点