Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
NCT ID: NCT06337487
Last Updated: 2024-03-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
93 participants
INTERVENTIONAL
2024-03-31
2025-08-31
Brief Summary
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* 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
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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.
Conditions
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Keywords
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Study Design
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NON_RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Patients
Quality of life and satisfaction assessment
QoL questionnaires
The EORTC QLQ-C30 questionnaire is a specific cancer questionnaire. A score is calculated per dimension reflecting the patient's level for the corresponding QoL scale (dimension). These scores are calculated according to the EORTC recommendations.
Research work was recently developed by Giesinger et al. within the EORTC QoL group, with the aim of providing thresholds of clinical importance for the different dimensions of the QLQ-C30.
An item was added to complete the QLQ-C30. It comes from the EORTC bank library item based on the INCa organizational framework. This item was chosen because it addressed a theme not addressed in the QLQ-C30, sexual health. After consultation with a multidisciplinary team, the threshold was determined for this additional item. "Has your illness or treatment had a negative effect on your sex life? ", the threshold is reached when the answer is "enough" or "a lot."
Patients satisfaction survey
A patient satisfaction questionnaire was drawn up for the study. It includes items taken from :
* the EORTC's PATSAT33 satisfaction questionnaire, and in particular items relating to the quality of information provided by nurses and the time spent
* the EORTC COMU26 communication evaluation questionnaire, and in particular the items on being comfortable asking questions, professional responses to difficult difficult subjects, explanation of treatment objectives, etc.
* the questionnaire developed jointly by the UMQVC team and the psychology laboratory of the psychology laboratory at the University of Franche Comté as part of the REMOQOL-Poumon study and assessing in particular
* understanding of the purpose of using the QoL questionnaire
* ease of completion and use of the tablet
* satisfaction with the questionnaire and the tablet
* intention to use in the future
Nurses
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.
Qualitative Interview (for one part of nurses only)
At the end of the study, semi-directed qualitative interviews will be conducted with the nurses carrying out the TAS with the aim of understanding the obstacles and facilitators of the routine implementation of the QoL assessment to early identify the SOS needs of patients treated in medical oncology. The semi-structured interviews will be accompanied by an interview grid composed of main questions and follow-up questions. The main questions help introduce the theme. The follow-up questions make it possible to clarify the participants' comments without interrupting the fluidity of the exchanges. The themes discussed between the researcher and the participant during the interview will be as follows: Personal information and overall professional experiences, Knowledge of the study and experience of training with tools (questionnaire and software), Perception of tools (questionnaire and software) and their implementation, Definition and perception of key concepts.
ORIC questionnaire
Organisational readiness is a factor known to influence the predisposition of individuals to change within an organisation. Based on Weiner's organisational theory, Organizational Readiness for Implementing Change (ORIC) is a questionnaire that has been developed and validated, particularly in French, to measure the organisation's state of in the field of healthcare. It comprises ten items which measure two concepts: commitment to change and effectiveness of change.
Professionals satisfaction survey
A satisfaction questionnaire will be offered to all professionals involved once the last patient has been included. This questionnaire has previously been developed by the UMQVC team to assess investigator satisfaction for other studies and adapted to the context of SOS-Deteqt.
This questionnaire evaluates in particular :
* the quality of training
* ease of use of the CHES
* the relevance of using the CHES and the PROs
* the relevance of maintaining the PRO evaluation approach in current clinical practice.
Health professionals and professionals assimilated to the health
ORIC questionnaire
ORIC questionnaire
Organisational readiness is a factor known to influence the predisposition of individuals to change within an organisation. Based on Weiner's organisational theory, Organizational Readiness for Implementing Change (ORIC) is a questionnaire that has been developed and validated, particularly in French, to measure the organisation's state of in the field of healthcare. It comprises ten items which measure two concepts: commitment to change and effectiveness of change.
Interventions
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QoL questionnaires
The EORTC QLQ-C30 questionnaire is a specific cancer questionnaire. A score is calculated per dimension reflecting the patient's level for the corresponding QoL scale (dimension). These scores are calculated according to the EORTC recommendations.
Research work was recently developed by Giesinger et al. within the EORTC QoL group, with the aim of providing thresholds of clinical importance for the different dimensions of the QLQ-C30.
An item was added to complete the QLQ-C30. It comes from the EORTC bank library item based on the INCa organizational framework. This item was chosen because it addressed a theme not addressed in the QLQ-C30, sexual health. After consultation with a multidisciplinary team, the threshold was determined for this additional item. "Has your illness or treatment had a negative effect on your sex life? ", the threshold is reached when the answer is "enough" or "a lot."
Qualitative Interview (for one part of nurses only)
At the end of the study, semi-directed qualitative interviews will be conducted with the nurses carrying out the TAS with the aim of understanding the obstacles and facilitators of the routine implementation of the QoL assessment to early identify the SOS needs of patients treated in medical oncology. The semi-structured interviews will be accompanied by an interview grid composed of main questions and follow-up questions. The main questions help introduce the theme. The follow-up questions make it possible to clarify the participants' comments without interrupting the fluidity of the exchanges. The themes discussed between the researcher and the participant during the interview will be as follows: Personal information and overall professional experiences, Knowledge of the study and experience of training with tools (questionnaire and software), Perception of tools (questionnaire and software) and their implementation, Definition and perception of key concepts.
ORIC questionnaire
Organisational readiness is a factor known to influence the predisposition of individuals to change within an organisation. Based on Weiner's organisational theory, Organizational Readiness for Implementing Change (ORIC) is a questionnaire that has been developed and validated, particularly in French, to measure the organisation's state of in the field of healthcare. It comprises ten items which measure two concepts: commitment to change and effectiveness of change.
Professionals satisfaction survey
A satisfaction questionnaire will be offered to all professionals involved once the last patient has been included. This questionnaire has previously been developed by the UMQVC team to assess investigator satisfaction for other studies and adapted to the context of SOS-Deteqt.
This questionnaire evaluates in particular :
* the quality of training
* ease of use of the CHES
* the relevance of using the CHES and the PROs
* the relevance of maintaining the PRO evaluation approach in current clinical practice.
Patients satisfaction survey
A patient satisfaction questionnaire was drawn up for the study. It includes items taken from :
* the EORTC's PATSAT33 satisfaction questionnaire, and in particular items relating to the quality of information provided by nurses and the time spent
* the EORTC COMU26 communication evaluation questionnaire, and in particular the items on being comfortable asking questions, professional responses to difficult difficult subjects, explanation of treatment objectives, etc.
* the questionnaire developed jointly by the UMQVC team and the psychology laboratory of the psychology laboratory at the University of Franche Comté as part of the REMOQOL-Poumon study and assessing in particular
* understanding of the purpose of using the QoL questionnaire
* ease of completion and use of the tablet
* satisfaction with the questionnaire and the tablet
* intention to use in the future
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Direction Générale de l'Offre de Soins
OTHER_GOV
Centre Hospitalier Universitaire de Besancon
OTHER
Responsible Party
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Principal Investigators
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Magalie Pagnot, Nurse
Role: PRINCIPAL_INVESTIGATOR
CHU de Besançon
Locations
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CHU de Besançon
Besançon, , France
Groupement Hospitalier de Haute-Saône
Vesoul, , France
Countries
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Central Contacts
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Facility Contacts
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Magalie Pagnot, Nurse
Role: primary
Cathy Pothier, Nurse
Role: primary
Other Identifiers
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2022/716
Identifier Type: -
Identifier Source: org_study_id