- ICH GCP
- Registr klinických studií v USA
- Klinická studie NCT07615218
Enhancing Cancer Care: Patient Navigation Through EROTC Quality-of-Life Insights at Sohag Oncology Center - A Cross-Sectional Study (EROTC)
This study investigates the use of the EORTC QLQ-C30 questionnaire to assess and address the supportive care needs of cancer patients. It aims to align patient-identified needs with physician-assessed needs to enhance care delivery and referral to supportive clinics such as pain management, physiotherapy, nutrition, and psychotherapy.
To improve cancer patients' care, supportive clinics need to be utilised especially for terminal cases.
This study investigated the navigation process for patients needing supportive care services based on their responses to the EROTC Quality of Life (QoL) questionnaire, conducted as part of the "Evidence-Based Patient Navigation" initiative. The QoL questionnaire assessed patients across 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 (EORTC)"5 before study initiation.
Our process included both the EROTC-QoL questionnaire (patient-identified needs) and the physicians-assessed needs across four supportive clinics: pain management, physiotherapy, nutrition, and psychotherapy. Clinic navigation was determined by a threshold score (up to a maximum of 4), with patients needing specialized support scoring higher than 2 and those below 2 not needing such services. This initiative (data collection phase) ran from January 1, 2024, to September 31, 2024, and the analysis process was followed afterward. Additionally, we conducted a consistency analysis to measure the alignment between the two assessments.
Přehled studie
Postavení
Podmínky
Detailní popis
The study design is rooted in the growing recognition of the need for tailored, supportive care services for cancer patients, particularly those with terminal diagnoses. Supportive care services, such as pain management, physiotherapy, nutrition counseling, and psychotherapy, are essential for improving the quality of life (QoL) 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 their health and well-being. By integrating patient-reported outcomes with physician-assessed needs, this study addresses a critical gap in aligning healthcare provider interventions with the actual needs of cancer patients. The inclusion of a threshold score to guide navigation ensures objective, evidence-based decisions in directing patients to the appropriate supportive services.
The intervention focuses on utilizing a patient navigation system to bridge the gap between identified supportive care needs and the utilization of specialized clinics. The rationale for this approach lies in evidence that tailored supportive care interventions can improve quality of life, symptom management, and patient satisfaction in cancer care. By combining patient-reported QoL 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, standardized method to identify patients requiring specialized care, optimizing resource allocation and ensuring timely access to critical services. This structured approach has the potential to significantly enhance care delivery for cancer patients, particularly those in terminal stages.
Typ studie
Zápis (Aktuální)
Kontakty a umístění
Studijní místa
-
-
-
Sohag, Egypt
- Sohag Oncology Center
-
-
Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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.
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
|---|
|
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.
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Agreement between patient-identified needs and physician-assessed needs
Časové okno: January 1, 2025 - September 30, 2025
|
To evaluate the alignment between patient-identified needs and physician-assessed needs using the EORTC QLQ-C30 questionnaire and Cohen's kappa values, ensuring that patient needs are accurately identified and addressed for improved care delivery.
|
January 1, 2025 - September 30, 2025
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
Proportion of patients referred to supportive clinics
Časové okno: January 1, 2025 - September 30, 2025
|
To assess the improvement in patients' overall functioning and reduction in symptom burden using the EORTC QLQ-C30 summary score after the implementation of physician-directed, tailored follow-up plans.
|
January 1, 2025 - September 30, 2025
|
Spolupracovníci a vyšetřovatelé
Sponzor
Vyšetřovatelé
- Vrchní vyšetřovatel: Nesma Magdy Nesma, Pharmacist, Sohag Oncology Center
Publikace a užitečné odkazy
Obecné publikace
- 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.
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Aktuální)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
Další identifikační čísla studie
- Navigation-2024
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .