Clinical trial NCT06337487: Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Official title: Relevance of Health-related Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Oncology
Keywords: Supportive care
Lead sponsor: Centre Hospitalier Universitaire de Besancon
Sponsor class: OTHER
Collaborators: name: Direction Générale de l'Offre de Soins
First posted: 2024-03-29
Enrollment: 93
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Patients, nurses and health professionals and professionals assimilated to the health are recruited in 3 different groups but no comparison will be made between them. Recruitment of patients will be stopped once 79 analyzable patients will be enrolled.
Primary purpose: SUPPORTIVE_CARE

Brief summary: 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.

Detailed description: To put in place the conditions needed to move from a "care pathway" centred on the medical management of cancer to a "health pathway" that takes into account all the physical, psychological and social needs of patients and their families.

The incidence of cancer is increasing, due to longer life expectancy and improved diagnostic methods. The announcement of a cancer diagnosis and its treatment have a global and multidimensional impact on patients, so their care should not be limited to the direct symptoms of the disease and the management of the undesirable effects of treatment, but should focus on the person as a whole.

In France, oncological support care (SOS) was defined in the first cancer plan as "all the care and support required by patients throughout their illness, in conjunction with specific onco-haematological treatments, where available". The main aim of SOS is to ensure the best possible Quality of Life (QoL) for the patient. Whether or not they involve medication, they are used in conjunction with specific cancer treatments. It is recommended that SOS needs be identified at the outset of treatment.

The announcement process is a key stage in the care pathway, providing a multi-dimensional assessment of the patient's needs and the impact of the newly diagnosed cancer on his or her environment. There are four stages in this process: a medical stage (announcement and treatment proposal), a healthcare support stage (CSS), access to a team of SOS professionals, and a link-up stage with primary care. The CSS enables an in-depth assessment of the patient's SOS needs.

The use of patient-perceived health data (Patient Reported Outcome, PRO) could help with this assessment by measuring the patient's experience and quantifying the impact of the disease and treatment as experienced directly by the patient. PRO are defined as "any report on the patient's state of health that comes directly from the patient, without interpretation of the patient's response by a clinician or any other person".

QoL is considered to be part of PROs. QoL is a multidimensional and dynamic concept that reflects the patient's perception of the effect of the disease and its treatment on the physical, emotional, functional and social aspects of life in particular.

The oncology methodology and quality of life unit (UMQVC) at the Besançon university hospital centre (CHU) has developed a research project on routine electronic monitoring of the quality of life of patients undergoing cancer treatment: Routine Electronic Monitoring of Quality of Life (REMOQOL). The aim is to use the results of the QOL questionnaire as a complementary tool in the care of patients being monitored for cancer.

As part of this study, the use the PROs is proposed and, more specifically, the QoL assessment, to help identify SOS needs at the start of care. QoL assessment at the start of treatment provides a multidimensional representation of the patient's perceived state of health.

The hypothesis is that the use of the QLQ-C30 QoL questionnaire, with the aid of digital tools, could help with the initial assessment of the SOS needs of patients undergoing medical oncology treatment. This multidimensional assessment will provide a measurable and reproducible value for a measure that can only be assessed directly by the patient.

This initial assessment, during the CSS, could therefore serve as a reference and guide the patient towards specific care pathways, such as referring the patient to a supportive care day hospital, if the patient requires interdisciplinary care. This approach could allow patients to be at the centre of care and encourage their involvement in decision-making.

Ultimately, this questionnaire could be used to help assess patients' needs and monitor their progress at different points in the care process, and could be offered in institutions as well as at home.

Eligibility criteria: 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

Primary outcomes:
measure: Change between pre and post QoL Questionnaires
timeFrame: Day 1
measure: The nurse's assessement of the relevance of the information provided by each patients's QoL scores
timeFrame: Day1
Secondary outcomes:
Other outcomes:
Locations:
city: Besançon
country: France
facility: CHU de Besançon
city: Vesoul
country: France
facility: Groupement Hospitalier de Haute-Saône
Study officials:
affiliation: CHU de Besançon
name: Magalie Pagnot, Nurse
role: PRINCIPAL_INVESTIGATOR
References: