Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients

NCT06337487 | Not Yet Recruiting DMC

• 1 other identifier: 2022/716
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 2

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.

Conditions

Oncology

Keywords

Supportive care

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (3)

Patients

EXPERIMENTAL

Quality of life and satisfaction assessment

Other: QoL questionnaires; Other: Patients satisfaction survey

Nurses

OTHER

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.

Other: Qualitative Interview (for one part of nurses only); Other: ORIC questionnaire; Other: Professionals satisfaction survey

Health professionals and professionals assimilated to the health

OTHER

ORIC questionnaire

Other: ORIC questionnaire

Interventions

QoL questionnaires OTHER

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

Qualitative Interview (for one part of nurses only) OTHER

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.

Nurses

ORIC questionnaire OTHER

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.

Health professionals and professionals assimilated to the health; Nurses

Professionals satisfaction survey OTHER

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.

Nurses

Patients satisfaction survey OTHER

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

Patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Hospitalier Universitaire de Besancon: lead
• Direction Générale de l'Offre de Soins: collaborator

Study Sites (2)

CHU de Besançon

Besançon, 25000, France

Location

Groupement Hospitalier de Haute-Saône

Vesoul, France

Location

MeSH Terms

Conditions

Neoplasms

Study Officials

• Magalie Pagnot, Nurse

  CHU de Besançon

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Magalie Pagnot, Nurse

CONTACT

0381479999; m1courgey@chu-besancon.fr

Joelle Fritzsch

CONTACT

0370632165; jfritzsch@chu-besancon.fr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 15, 2024
• First Posted: March 29, 2024
• Study Start: March 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: August 1, 2025
• Last Updated: March 29, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (2)