PRISMA - A Pilot Randomized Phase II Trial on Social Prescriptions and Micro- Learning to Improve Care for Cancer Patients and Their Support Persons
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 384
- 主要终点
- European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
研究概览
简要总结
Optimal patient-centered care is often not being delivered to cancer patients, especially to vulnerable populations like those living in underserved rural areas. This body of work will develop and pilot test a multicomponent intervention approach designed to improve the care and outcomes of cancer patients and their support persons (SPs) during and following their therapeutic journey. The intervention will involve the provision of social prescriptions and web-based micro-learning modules, as well as stepwise care based on ongoing monitoring of symptom burden and health. This project uses the strengths of innovative, individually tailored communication strategies and a comprehensive low-cost approach that are likely to support fair and equal patient access to optimal care beyond the funding period. By using a patient-driven approach in an interdisciplinary setting, it is anticipated that the intervention will improve the health outcomes of various patient populations, especially those living in rural areas. To achieve this, a methodologically robust mixed-methods approach and an effectiveness-implementation hybrid design will be employed to move effective strategies towards implementation into clinical practice. A number of standardized patient-reported outcome and experience measures will be used, including quality of life and knowledge of health and care. As a result of this research, an implementation toolbox will be developed that could be used by clinicians working in different healthcare settings and services, both nationally and internationally, to help provide highest quality cancer care.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •for patients:
- •aged at least 18 years
- •primary diagnosis of early-stage or advanced-stage lung cancer, colorectal cancer, hematological neoplasm or malignant melanoma within the past 12 months
- •expected survival of at least 18 months
- •sufficient German language proficiency to complete questionnaires and interviews
- •attendance at the medical oncology units of participating hospitals
- •provision of written informed consent
- •ECOG Performance Status 0-2
- •ability to name an eligible SP.
- •Inclusion criteria for Support Persons:
- •being nominated by the patient as someone who provides support, encouragement or assistance in coping with their cancer
- •aged at least 18 years
- •proficiency in German
- •provision of written informed consent.
排除标准
- •Inability to
- •provide informed consent
- •independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.
结局指标
主要结局
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
时间窗: From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months
Quality of life of patient and support person is obtained using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17). Scores range from 0 to 100, with higher scores indicating better functioning/quality of life.
次要结局
- Cancer Behavior Inventory Brief Version (CBI-B-D-12)(From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months)
- self-developed items on knowledge of health and care(From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months)
- Healthcare Utilization (Care Level, Hospital Admissions, Length of Stay, Supportive Care Services)(From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months)
研究者
Anne Herrmann
Prof. Dr.
University of Regensburg