Trial Title:
Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
NCT ID:
NCT06337487
Condition:
Oncology
Conditions: Official terms:
Neoplasms
Conditions: Keywords:
Supportive care
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Non-Randomized
Intervention model:
Parallel Assignment
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
Masking:
None (Open Label)
Intervention:
Intervention type:
Other
Intervention name:
QoL questionnaires
Description:
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."
Arm group label:
Patients
Intervention type:
Other
Intervention name:
Qualitative Interview (for one part of nurses only)
Description:
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.
Arm group label:
Nurses
Intervention type:
Other
Intervention name:
ORIC questionnaire
Description:
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.
Arm group label:
Health professionals and professionals assimilated to the health
Arm group label:
Nurses
Intervention type:
Other
Intervention name:
Professionals satisfaction survey
Description:
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.
Arm group label:
Nurses
Intervention type:
Other
Intervention name:
Patients satisfaction survey
Description:
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
Arm group label:
Patients
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.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CHU de Besançon
Address:
City:
Besançon
Zip:
25000
Country:
France
Contact:
Last name:
Magalie Pagnot, Nurse
Email:
m1courgey@chu-besancon.fr
Facility:
Name:
Groupement Hospitalier de Haute-Saône
Address:
City:
Vesoul
Country:
France
Contact:
Last name:
Cathy Pothier, Nurse
Start date:
March 2024
Completion date:
August 2025
Lead sponsor:
Agency:
Centre Hospitalier Universitaire de Besancon
Agency class:
Other
Collaborator:
Agency:
Direction Générale de l'Offre de Soins
Agency class:
Other
Source:
Centre Hospitalier Universitaire de Besancon
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06337487