Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337487
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-15
Brief Title:
Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Sponsor:
Centre Hospitalier Universitaire de Besancon
Organization:
Centre Hospitalier Universitaire de Besancon
Study Overview
Official Title:
Relevance of Health-related Quality of Life Assessment for Early Identification of Supportive Care Needs in Oncology Patients
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
SOS-DETEQT
Brief Summary:
The aim of this study is to evaluate the value of the nurses 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 nurses assessment of the relevance of the information provided by the QOL scores
During the Care Support Stage CSS the nurse will assess the patients 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
Comparison of the personalised oncology support care plans proposed by the nurse before and after the QoL results were obtained
The nurses assessment of the relevance of the information provided by the QOL scores
During the Care Support Stage CSS the nurse will assess the patients 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 patients 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 patients SOS needs
The use of patient-perceived health data Patient Reported Outcome PRO could help with this assessment by measuring the patients experience and quantifying the impact of the disease and treatment as experienced directly by the patient PRO are defined as any report on the patients state of health that comes directly from the patient without interpretation of the patients 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 patients 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 patients 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
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 patients 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 patients SOS needs
The use of patient-perceived health data Patient Reported Outcome PRO could help with this assessment by measuring the patients experience and quantifying the impact of the disease and treatment as experienced directly by the patient PRO are defined as any report on the patients state of health that comes directly from the patient without interpretation of the patients 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 patients 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 patients 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None