Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncolog… (NCT07615218) | Clinical Trial Compass
CompletedNot Applicable
Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center
Egypt4,423 participantsStarted 2024-01-01
Plain-language 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.
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient
Timeframe: Initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment
2
Accuracy of Patient-Identified Supportive Care Need Compared With Physician-Assessed Supportive Care Need
Timeframe: At the initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment
. 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.