- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning NCT07615218
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.
Studieöversikt
Status
Betingelser
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Kontakter och platser
Studieorter
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Sohag, Egypten
- Sohag Oncology Center
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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Testmetod
Studera befolkning
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
Kohorter och interventioner
Grupp / Kohort |
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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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient
Tidsram: Initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment
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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
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Accuracy of Patient-Identified Supportive Care Need Compared With Physician-Assessed Supportive Care Need
Tidsram: At the initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment
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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
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Proportion of patients referred to supportive clinics
Tidsram: January 1, 2025 - September 30, 2025
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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
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Samarbetspartners och utredare
Sponsor
Utredare
- Huvudutredare: Nesma Magdy Nesma, Pharmacist, Sohag Oncology Center
Publikationer och användbara länkar
Allmänna publikationer
- 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.
Användbara länkar
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Navigation-2024
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