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Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center (EORTC)

2026年5月30日 更新者：Sohag Oncology Center

Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center - A Cross-Sectional Study

This study investigates the use of the EORTC QLQ-C30 questionnaire to assess supportive care needs among cancer patients and align patient-identified needs with physician-assessed needs. The aim is to enhance care delivery and referral to supportive clinics, including pain management, physiotherapy, nutrition, and psychotherapy. Improved cancer care requires appropriate utilization of supportive clinics, particularly for patients with advanced or terminal disease.

The study evaluated a navigation process for patients requiring supportive care services based on responses to the EORTC Quality of Life questionnaire, conducted as part of the "Evidence-Based Patient Navigation" initiative. The questionnaire assessed multiple domains relevant to supportive care needs. Approval to use the EORTC QLQ-C30 questionnaire was obtained from the European Organisation for Research and Treatment of Cancer before study initiation.

The study process included both the EORTC Quality of Life questionnaire, representing patient-identified needs, and physician-assessed needs across four supportive clinics: pain management, physiotherapy, nutrition, and psychotherapy. Clinic navigation was determined by a threshold score ranging from 0 to 4. Patients requiring specialized support were defined as having a score greater than 2, whereas patients with scores of 2 or lower were classified as not requiring specialized supportive clinic referral. The data collection phase ran from January 1, 2024, to September 30, 2024, followed by data analysis. A consistency analysis was conducted to measure alignment between patient-identified needs and physician-assessed needs.

研究概览

地位

完全的

条件

详细说明

The study design is based on the growing recognition of the need for tailored supportive care services for cancer patients, particularly patients with advanced or terminal diagnoses. Supportive care services, such as pain management, physiotherapy, nutrition counseling, and psychotherapy, are essential for improving quality of life in this patient population.

The EORTC QLQ-C30 questionnaire was chosen as a validated tool to systematically identify patient-specific needs across multiple domains relevant to health and well-being. By integrating patient-reported outcomes with physician-assessed needs, the study addresses a critical gap in aligning healthcare provider interventions with patient-identified supportive care needs. The inclusion of a threshold score to guide navigation ensures objective, evidence-based decisions when directing patients to appropriate supportive services.

The intervention focuses on using a patient navigation system to bridge the gap between identified supportive care needs and utilization of specialized clinics. The rationale for this approach is based on evidence that tailored supportive care interventions can improve quality of life, symptom management, and patient satisfaction in cancer care. By combining patient-reported quality-of-life assessments with physician evaluations, the study ensures that referrals are based on a holistic understanding of patient needs.

The threshold score system provides a structured and standardized method to identify patients requiring specialized care, optimize resource allocation, and ensure timely access to critical supportive services. This structured approach has the potential to enhance care delivery for cancer patients, particularly patients in advanced or terminal stages.

研究类型

观察性的

注册 (实际的)

4423

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。

学习地点

  • 埃及
      • Sohag、埃及
        • Sohag Oncology Center

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

不

取样方法

非概率样本

研究人群

The study population comprises adult cancer patients, including terminal cases, who are actively receiving medical treatment or oncology follow-up care within a tertiary care setting. All participants are drawn directly from the outpatient clinics of the Sohag Oncology Center, a specialized facility equipped with dedicated supportive services such as pain management, physiotherapy, nutrition, and psychotherapy. This population represents individuals navigating complex healthcare barriers whose care pathways are being evaluated to align patient-reported quality-of-life needs with clinical physician assessments.

描述

Inclusion Criteria:

  1. Diagnosis: Adult patients (≥18 years) with a confirmed diagnosis of cancer, including terminal cases, requiring supportive care.
  2. Cognition: Patients capable of providing informed consent and completing the EORTC QLQ-C30 questionnaire.
  3. Treatment Status: Patients actively receiving treatment or follow-up care in the participating healthcare facility.
  4. Availability: Patients available for the study duration and willing to participate in both the questionnaire assessment and follow-up navigation processes.
  5. Language: Patients able to understand and respond to the EORTC QLQ-C30 questionnaire in the approved language version.

Exclusion Criteria:

  1. Cognitive Impairment: Patients unable to complete the EORTC QLQ-C30 questionnaire due to severe cognitive impairment or mental health conditions that hinder participation.
  2. Incomplete Consent: Patients who decline to provide informed consent or withdraw consent during the study.
  3. Non-Cancer Diagnoses: Patients without a confirmed cancer diagnosis or those receiving treatment for non-cancer-related conditions.
  4. Palliative Care Exclusivity: Patients already receiving comprehensive palliative care services that address the domains assessed in the study.
  5. Inaccessible for Follow-Up: Patients who are not reachable for follow-up during the study duration or have logistical barriers that prevent participation in the navigation process.

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

队列和干预

团体/队列
Adult Cancer Patients Requiring Supportive Care
This cross-sectional cohort consists of adult cancer patients (> 18 years old) receiving active treatment or follow-up care at the Sohag Oncology Center who are cognitively and linguistically capable of completing the EORTC QLQ-C30 questionnaire. The cohort includes patients across various stages of disease, specifically incorporating those with terminal diagnoses who require supportive interventions. Patients already receiving comprehensive, pre-established palliative care services are excluded.

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
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient
大体时间：Initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment

Patient-identified supportive care need will be assessed using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 and a study navigation score. The navigation score ranges from 0 to 4, with 1 point for each identified supportive clinic domain: pain management, physiotherapy, nutrition, and psychotherapy. Higher scores indicate greater supportive care need. Scores >2 indicate need for specialized supportive clinic referral; scores ≤2 indicate no referral need. Agreement between patient-identified and physician-assessed need classifications will be measured using Cohen's kappa coefficient, which ranges from -1 to +1. Higher kappa values indicate better agreement, with +1 indicating perfect agreement.

Unit of Measure: Cohen's kappa coefficient
Initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment
Accuracy of Patient-Identified Supportive Care Need Compared With Physician-Assessed Supportive Care Need
大体时间：At the initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment

Accuracy will be calculated as the percentage of participants for whom the patient-identified supportive care need classification matches the physician-assessed supportive care need classification. The four supportive clinic domains will be aggregated into one supportive-care navigation score, then dichotomized as greater than 2 versus 2 or lower before calculating accuracy.

Accuracy will be calculated as:

Accuracy = [(Number of matching classifications) / (Total number of assessed participants)] × 100

Possible values range from 0% to 100%, with higher percentages indicating greater alignment between patient-identified needs and physician-assessed needs.

Unit of Measure: Percentage of participants
At the initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment

次要结果测量

结果测量
措施说明
大体时间
Proportion of patients referred to supportive clinics
大体时间：January 1, 2025 - September 30, 2025

The proportion of participants referred to supportive clinics will be calculated as the number of participants referred to at least one supportive clinic divided by the total number of assessed participants, multiplied by 100. Supportive clinics include pain management, physiotherapy, nutrition, and psychotherapy. Referral will be based on the supportive-care navigation assessment and physician-directed follow-up plan. Higher percentages indicate that a greater proportion of assessed participants required referral to supportive care services.

Unit of Measure: Percentage of participants
January 1, 2025 - September 30, 2025

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

Sohag Oncology Center

调查人员

  • 首席研究员：Nesma Magdy Nesma, Pharmacist、Sohag Oncology Center

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

一般刊物

有用的网址

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)

2024年1月1日

初级完成 (实际的)

2024年9月30日

研究完成 (实际的)

2025年9月30日

研究注册日期

首次提交

2026年5月22日

首先提交符合 QC 标准的

2026年5月22日

首次发布 (实际的)

2026年5月29日

研究记录更新

最后更新发布 (实际的)

2026年6月2日

上次提交的符合 QC 标准的更新

2026年5月30日

最后验证

2026年5月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • Navigation-2024

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.

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