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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.

調査の概要

状態

完了

条件

詳細な説明

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.

研究の種類

観察的

入学 (実際)

4423

連絡先と場所

このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。

研究場所

エジプト
- - Sohag、エジプト
    - Sohag Oncology Center

参加基準

研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。

適格基準

就学可能な年齢

大人
高齢者

健康ボランティアの受け入れ

いいえ

サンプリング方法

非確率サンプル

調査対象母集団

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.

説明

Inclusion Criteria:

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

Exclusion Criteria:

Cognitive Impairment: Patients unable to complete the EORTC QLQ-C30 questionnaire due to severe cognitive impairment or mental health conditions that hinder participation.
Incomplete Consent: Patients who decline to provide informed consent or withdraw consent during the study.
Non-Cancer Diagnoses: Patients without a confirmed cancer diagnosis or those receiving treatment for non-cancer-related conditions.
Palliative Care Exclusivity: Patients already receiving comprehensive palliative care services that address the domains assessed in the study.
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.

研究計画

このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。

研究はどのように設計されていますか？

デザインの詳細

グループ/コホートの数

コホートと介入

グループ/コホート
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.

グループ/コホート

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.

この研究は何を測定していますか？

主要な結果の測定

結果測定	メジャーの説明	時間枠
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient 時間枠：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 時間枠：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

二次結果の測定

結果測定	メジャーの説明	時間枠
Proportion of patients referred to supportive clinics 時間枠：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

協力者と研究者

ここでは、この調査に関係する人々や組織を見つけることができます。

スポンサー

Sohag Oncology Center

捜査官

主任研究者：Nesma Magdy Nesma, Pharmacist、Sohag Oncology Center

出版物と役立つリンク

研究に関する情報を入力する責任者は、自発的にこれらの出版物を提供します。これらは、研究に関連するあらゆるものに関するものである可能性があります。

一般刊行物

便利なリンク

EORTC (European Organisation for Research and Treatment of Cancer)

研究記録日

これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。

主要日程の研究

研究開始 (実際)

2024年1月1日

一次修了 (実際)

2024年9月30日

研究の完了 (実際)

2025年9月30日

試験登録日

最初に提出

2026年5月22日

QC基準を満たした最初の提出物