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Clinical Trial NCT06337487 (SOS-DETEQT) for Oncology is not yet recruiting. See the Trial Radar Card View and AI discovery tools for all the details. Or ask anything here. | ||
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Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients (SOS-DETEQT) 93 Dietary
Clinical Trial NCT06337487 (SOS-DETEQT) is an interventional study for Oncology and is currently not yet recruiting. Enrollment is planned to begin on 1 March 2024 and continue until the study accrues 93 participants. Led by Centre Hospitalier Universitaire de Besancon, this study is expected to complete by 1 August 2025. The latest data from ClinicalTrials.gov was last updated on 29 March 2024.
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. T...Show More
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 mul...
Show MoreOfficial Title
Relevance of Health-related Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Conditions
OncologyOther Study IDs
- SOS-DETEQT
- 2022/716
NCT ID Number
Start Date (Actual)
2024-03
Last Update Posted
2024-03-29
Completion Date (Estimated)
2025-08
Enrollment (Estimated)
93
Study Type
Interventional
PHASE
N/A
Status
Not yet recruiting
Keywords
Supportive care
Primary Purpose
Supportive Care
Design Allocation
Non-Randomized
Interventional Model
Parallel
Masking
None (Open Label)
Arms / Interventions
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalPatients 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 dimensio...Show More 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...Show More |
OtherNurses 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 ques...Show More 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:...Show More 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 ...Show More |
OtherHealth 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:...Show More |
Primary Outcome Measures
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Change between pre and post QoL Questionnaires | EORTC QLG Core Questionnaire (EORTC QLQ-C30) + additional item = 31 items submitted to patients.
Each item of QLQ-C30 is rated from 1 (= not at all) to 4 (= very much). The change between the personalized plan for supportive oncology care completed before the QLQ assessment and the personalized plan for oncology care completed with the graphical results of the QLQ assessment.
The change is defined by at least one different SOS proposal, regardless of the direction of the difference (addition or removal of an SOS proposal). The pre-QoV PPSOS is drawn up by the nurse after interviewing the patient, without consulting the QoV results. The post-QoV PPSOS is drawn up by the nurse immediately after interviewing the patient, and after reviewing the QoV results via the CHES software. | Day 1 |
The nurse's assessement of the relevance of the information provided by each patients's QoL scores | The nurse's assessment of the relevance of the information provided by each patient's QoL scores, in terms of the urgency of care, the need for further investigation of certain topics, the identification of issues not previously addressed, or the discussion of sensitive topics not previously addressed. Information will be considered relevant for a patient if at least one of these reasons is mentioned.
A QoL assessment will be considered as soon as there is a change in the PPSOS and/or relevant information provided by QoL scores. | Day1 |
Participation Assistant
Eligibility Criteria
Eligible Ages
Adult, Older Adult
Minimum Age
18 Years
Eligible Sexes
All
- 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.
- 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
Centre Hospitalier Universitaire de BesanconDirection Générale de l'Offre de SoinsStudy Central Contact
Contact: Magalie Pagnot, Nurse, 0381479999, [email protected]
Contact: Joelle Fritzsch, 0370632165, [email protected]
2 Study Locations in 1 Countries
CHU de Besançon, Besançon, 25000, France
Magalie Pagnot, Nurse, Contact, [email protected]
Groupement Hospitalier de Haute-Saône, Vesoul, France
Cathy Pothier, Nurse, Contact