Clinical trial · Interventional
Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Relevance of Health-related Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this study is to evaluate the value of the nurse's use of the Quality of Life (QoL) scores of the European Organisation for Research and Treatment of Cancer \[EORTC\] Quality of Life Questionnaire \[QLQ\] C30 as an aid in identifying the needs for supportive oncological care at the start of care, in patients followed up for locally advanced or metastatic cancer starting systemic antineoplastic treatment. The main questions it aims to answer are as follows: * Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained * The nurse's assessment of the relevance of the information provided by the QOL scores. During the Care Support Stage (CSS), the nurse will assess the patient's situation during the interview and will fill in directly on an electronic form the Oncological Support Care proposed to the patient, making up the Personalised Pre-QoL Oncological Support Care Plan (PPSOS pre-QoL). The nurse will then give the patient the tablet to fill in the QoL questionnaire. She will then look at the results of the QoL questionnaire and the alerts in the event of deterioration, and will reassess the PPSOS using a new computerised PPSOS post-QoL form. The nurse will assess the relevance of the information provided by the QoL scores concerning the urgency of care, the need to go into certain subjects in greater depth, the identification of problems not addressed before or the discussion of sensitive subjects not addressed before. The nurse will give the patient the tablet to fill in a satisfaction questionnaire. In an attempt to control the biases inherent in an assessment carried out by a single healthcare professional, the clinical records of the patients included will be presented to a group of professionals who will also propose a PPSOS, known as Experts. The group will be made up of a nurse, a medical oncologist and at least two healthcare professionals and professionals in a similar field (dietician, psychologist, APA teacher, social worker, etc.). This group will analyse all the patient files included in the two study centres at dedicated meetings. In order to characterise patient care following the CSS, the oncological support care performed, unscheduled hospitalisations, emergency room visits and calls to the on-call medical team will be collected for the two months following the CSS.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Oncology | — | UNRESOLVED | — |
Interventions
Interventions (5)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| ORIC questionnaire | Other | — | UNRESOLVED |
| Patients satisfaction survey | Other | — | UNRESOLVED |
| Professionals satisfaction survey | Other | — | UNRESOLVED |
| QoL questionnaires | Other | — | UNRESOLVED |
| Qualitative Interview (for one part of nurses only) | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- Patients
- description
- Quality of life and satisfaction assessment
- interventionNames
- Other: QoL questionnaires
- Other: Patients satisfaction survey
- type
- OTHER
- label
- Nurses
- description
- Assess the value of nurses using the Quality of Life (QoL) scores from the EORTC QLQ-C30 questionnaire to help identify SOS needs at the start of care.
- interventionNames
- Other: Qualitative Interview (for one part of nurses only)
- Other: ORIC questionnaire
- Other: Professionals satisfaction survey
- type
- OTHER
- label
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
CRITERIA FOR PATIENTS: Inclusion Criteria: * Patient with locally advanced or metastatic cancer * Patient due to start antineoplastic systemic treatment (immunotherapy, chemotherapy, targeted therapy, etc.) in 1st line, * Patient able to understand French and fill in questionnaires (no major cognitive impairment), * Male and female, at least 18 years of age, * Signature of informed consent to participate, indicating that subject has understood procedures required by the study and that he/she agrees to participate in the study study and to abide by the requirements and restrictions inherent to this study, * Affiliation with a French social security scheme or beneficiary of such a scheme. Exclusion Criteria: * Cognitive disorders compromising the comprehension of information or the or completion of QoL questionnaires, * Patients who were unable to benefit from SBT prior to initiation of their systemic antineoplastic systemic treatment and having already received more than 2 1st-line injections, * Legal incapacity or limited legal capacity, * Subject unlikely to cooperate with study and/or poor cooperation anticipated by investigator, * Subject without health insurance, * Pregnant woman. CRITERIA FOR PROFESSIONALS: For the evaluation of satisfaction and the ORIC questionnaire: all health professionals and professionals assimilated to the health field use the QoL results For the qualitative analysis: the nurses carrying out the TAS and participating in the study
References
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