Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center (EORTC)
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.
연구 개요
상태
상세 설명
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.
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
-
-
-
Sohag, 이집트
- Sohag Oncology Center
-
-
참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
샘플링 방법
연구 인구
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
|---|
|
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.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient
기간: 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
기간: 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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Proportion of patients referred to supportive clinics
기간: 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
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Nesma Magdy Nesma, Pharmacist, Sohag Oncology Center
간행물 및 유용한 링크
일반 간행물
- Wells KJ, Battaglia TA, Dudley DJ, Garcia R, Greene A, Calhoun E, Mandelblatt JS, Paskett ED, Raich PC; Patient Navigation Research Program. Patient navigation: state of the art or is it science? Cancer. 2008 Oct 15;113(8):1999-2010. doi: 10.1002/cncr.23815.
- Berry LL, Rock BL, Smith Houskamp B, Brueggeman J, Tucker L. Care coordination for patients with complex health profiles in inpatient and outpatient settings. Mayo Clin Proc. 2013 Feb;88(2):184-94. doi: 10.1016/j.mayocp.2012.10.016. Epub 2013 Jan 4.
- Forrest CB, Glade GB, Baker AE, Bocian A, von Schrader S, Starfield B. Coordination of specialty referrals and physician satisfaction with referral care. Arch Pediatr Adolesc Med. 2000 May;154(5):499-506. doi: 10.1001/archpedi.154.5.499.
- Freeman HP. The origin, evolution, and principles of patient navigation. Cancer Epidemiol Biomarkers Prev. 2012 Oct;21(10):1614-7. doi: 10.1158/1055-9965.EPI-12-0982. No abstract available.
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- Navigation-2024
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .