此页面是自动翻译的，不保证翻译的准确性。请参阅 英文版 对于源文本。

Social Prescriptions and Micro-Learning to Improve Care for Cancer Patients and Their Support Persons (PRISMA)

2026年8月24日 更新者：Anne Herrmann、University of Regensburg

PRISMA - A Pilot Randomized Phase II Trial on Social Prescriptions and Micro- Learning to Improve Care for Cancer Patients and Their Support Persons

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.

研究概览

地位

招聘中

条件

干预/治疗

研究类型

介入性

注册 (估计的)

384

阶段

  • 不适用

联系人和位置

本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。

学习联系方式

  • 姓名：Anne Herrmann, Prof. Dr.
  • 电话号码：+49 941 944 5220
  • 邮箱：Anne.Herrmann@ur.de

研究联系人备份

学习地点

  • 德国
      • Bayreuth、德国
        • 主动，不招人
        • Faculty of Law, Business & Economics, Inst. for Healthcare Management & Health Sciences
      • Berlin、德国
        • 尚未招聘
        • Charité - University Medicine Berlin
        • 接触：
        • 首席研究员：
          • Susanne Rittig, Dr
      • Cologne、德国
    • Bavaria
      • Augsburg、Bavaria、德国
        • 尚未招聘
        • University Hospital Augsburg
        • 接触：
      • Erlangen、Bavaria、德国
        • 尚未招聘
        • University Hospital Erlangen
        • 接触：
      • Regensburg、Bavaria、德国、93053
        • 招聘中
        • University Hospital Regensburg
        • 接触：
        • 首席研究员：
          • Tobias Pukrop, Prof Dr
        • 首席研究员：
          • Daniel Heudobler, Prof Dr
        • 副研究员：
          • Daniel Wolff, Prof Dr
        • 副研究员：
          • Kathrin Reuthner
        • 副研究员：
          • Michael Koller, Prof Dr
        • 副研究员：
          • Florian Zeman
      • Regensburg、Bavaria、德国、93053
        • 主动，不招人
        • University Regensburg
      • Würzburg、Bavaria、德国
        • 尚未招聘
        • University Hospital Würzburg
        • 接触：
          • Hermann Einsele, Prof Dr
          • 电话号码：+49 931 201-40001
          • 邮箱：einsele_h@ukw.de
        • 首席研究员：
          • Imad Maatouk, Prof Dr

参与标准

研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 成人
  • 年长者

接受健康志愿者

是的

描述

Inclusion Criteria 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.

Exclusion Criteria:

Inability to

  • provide informed consent
  • independently complete interviews and/or questionnaires due to impaired speech, vigilance, or comprehension.

学习计划

本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。

研究是如何设计的？

设计细节

  • 主要用途：支持治疗
  • 分配：随机化
  • 介入模型：并行分配
  • 屏蔽：无（打开标签）

武器和干预

参与者组/臂
干预/治疗
无干预：控制
实验性的：干涉
其他：PRISMA-interventions
A multicomponent intervention including social prescriptions, web-based micro-learning modules, and stepwise care based on symptom monitoring.
其他名称：
  • Social prescription
  • Micro-learning
  • Monitoring (stepwise care)

研究衡量的是什么？

主要结果指标

结果测量
措施说明
大体时间
European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire - Functioning, 17 items (EORTC QLQ-F17)
大体时间：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.
From enrollment to the use of treatment at 4 weeks, 3 months, 6 months and 12 months

次要结果测量

结果测量
措施说明
大体时间
Cancer Behavior Inventory Brief Version (CBI-B-D-12)
大体时间：From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
Self-efficacy is measured as secondary outcome using the Cancer Behavior Inventory Brief Version (CBI-B-D-12), with total scores ranging from 12 to 108, where higher scores indicate greater self-efficacy.
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
大体时间：From enrollment to the use of treatment at 4 weeks and 3,6 and 12 months
Knowledge of health and care is measured as a secondary outcome using self-developed items. Items were developed based on a literature review, and were reviewed, refined, and pilot-tested with the PRISMA Patient Advisory Board.
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)
大体时间：From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months
Healthcare utilization will be assessed by patients' need for long-term care (care level), number of hospital admissions and length of hospital stays (both obtained from hospital records), and documentation of supportive care services (assessed using self-developed items based on standardized instruments).
From enrollment to the use of treatment at 4 weeks and 3, 6 and 12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

赞助

University of Regensburg

合作者

Charite University, Berlin, Germany
Wuerzburg University Hospital
University Hospital Erlangen
University Hospital Regensburg
Universitätsklinikum Köln
University Hospital Augsburg

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2026年4月21日

初级完成 (估计的)

2028年11月30日

研究完成 (估计的)

2028年11月30日

研究注册日期

首次提交

2026年8月19日

首先提交符合 QC 标准的

2026年8月24日

首次发布 (实际的)

2026年8月26日

研究记录更新

最后更新发布 (实际的)

2026年8月26日

上次提交的符合 QC 标准的更新

2026年8月24日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • Z-2026-2552-5 (其他赠款/资助编号：Nationales Centrum für Tumorerkrankungen (NCT))

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.

订阅