Cancer CareEORTCNCT07615218
Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center
An observational study of Cancer Care and Patient Navigation, run by Sohag Oncology Center at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Cancer Care, Patient Navigation, EORTC
- How many people
- 4,423 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2024to 30 Sep 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the detailed description
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.
- 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
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
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
Measured: January 1, 2025 - September 30, 2025
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2026
- Study start1 Jan 2024
- Primary completion30 Sep 2024
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Cancer CareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 4,423 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag Oncology Center
- Sponsor type
- Other government
- Responsible party
- Sponsor
- Investigators
- Nesma Magdy Nesma, Pharmacist, Principal investigator, Sohag Oncology Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07615218
- Sponsor's protocol ID
- Navigation-2024
- Acronym
- EORTC
- Status last verified
- May 2026
- First submitted
- 22 May 2026
- Last updated
- 2 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 18780320Berry 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.
PubMed 23290738Forrest 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.
PubMed 10807303Freeman 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.
PubMed 23045534
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Enhancing Cancer Care: Patient Navigation Through EORTC Quality-of-Life Insights at Sohag Oncology Center - A Cross-Sectional Study
- ClinicalTrials.gov ID
- NCT07615218
- Acronym / sponsor ID
- EORTC / Navigation-2024
- 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
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 4,423 participants (actual)
- Lead sponsor
- Sohag Oncology CenterOther government
- Study start
- 1 Jan 2024 (actual)
- Primary completion
- 30 Sep 2024 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 29 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient
Time frame: 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
Accuracy of Patient-Identified Supportive Care Need Compared With Physician-Assessed Supportive Care Need
Time frame: 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
1 secondary outcome
Proportion of patients referred to supportive clinics
Time frame: January 1, 2025 - September 30, 2025
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2026.
- Background: PubMed 18780320Wells 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.
- Background: PubMed 23290738Berry 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.
- Background: PubMed 10807303Forrest 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.
- Background: PubMed 23045534Freeman 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.
- EORTC (European Organisation for Research and Treatment of Cancer)Link provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nesma Magdy Nesma, Pharmacist principal investigator
Sohag Oncology Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer Care and Patient Navigation, run by Sohag Oncology Center at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement Between Patient-Identified Supportive Care Need and Physician-Assessed Supportive Care Need Measured by Cohen's Kappa Coefficient (time frame: Initial needs assessment and physician assessment, within approximately 1-2 weeks of enrollment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07615218, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2026.