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

NCT07615218 | Completed

• 1 other identifier: Navigation-2024
• Study Type: observational
• Target: 4,423
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Cancer Care; Patient Navigation; EORTC; Survey; Oncology

Keywords

Patient Navigation; Quality of Life (QoL); EORTC QLQ-C30; Cancer Care / Oncology; Supportive Care; Supportive Clinics; Cross-Sectional Study; Referral Rates and Adherence; Enhancing Cancer Care

Outcome Measures

Primary Outcomes (2)

• Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient

  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

  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

Secondary Outcomes (1)

• Proportion of patients referred to supportive clinics

  January 1, 2025 - September 30, 2025

Study Arms (1)

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.

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sohag Oncology Center: lead

Study Sites (1)

Sohag Oncology Center

Sohag, Egypt

Location

Related Publications (4)

• 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.

  PMID: 18780320 BACKGROUND

• 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.

  PMID: 23290738 BACKGROUND

• 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.

  PMID: 10807303 BACKGROUND

• 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.

  PMID: 23045534 BACKGROUND

Related Links

• EORTC (European Organisation for Research and Treatment of Cancer)

MeSH Terms

Conditions

Neoplasms

Study Officials

• Nesma Magdy Nesma, Pharmacist

  Sohag Oncology Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2026
• First Posted: May 29, 2026
• Study Start: January 1, 2024
• Primary Completion: September 30, 2024
• Study Completion: September 30, 2025
• Last Updated: June 2, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)