Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06582498
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
None
First Post:
2024-08-29
Brief Title:
Short Questionnaire to Assess Individual Needs in Cancer Survivors in a Clinical Setting
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Life S-Can a Novel Clinical Tool to Effectively Assess Individual Needs in Cancer Survivorship Care and Improve Quality of Life in Cancer Survivors
Status:
ENROLLING_BY_INVITATION
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LIFE S-CAN
Brief Summary:
The rate of cancer survivorship is increasing posing the need to create high quality survivorship care plans Traditionally follow-up of cancer survivors has focused on detection of cancer recurrence or new cancers but often it does not fully address behavioural and psychosocial elements which could improve quality of life QoL and potentially decrease recurrence risk There is a current lack of short validated screeners to assess diet lifestyle and other behaviours that might influence QoL and prognosis in cancer survivors The hypothesis of this project is that the creation of a screener with the capacity to rapidly validly and effectively assess nutritional factors lifestyle sleep quality and psychosocial distress in cancer survivors could be useful to identify individuals who may need further care and support The aim is to create a valid and rapid tool Life S-Can to evaluate a total of seven domains body composition physical activity diet alcohol intake smoking sleeping behaviour and psychosocial distress in cancer survivors for its use in a clinical setting to improve survivorship care and QoL The project is divided into three phases and will be carried out in one year at the University Hospital Son Espases HUSE Palma Spain The objective of Phase I is to design the screener which will be administered to a small convenience sample to determine comprehension clarity and usefulness In Phase II Life S-Can will be validated in cancer survivors n100 at HUSE and a pilot intervention will be carried out with the objective to test the feasibility of a larger intervention to effectively implement Life S-Can in clinical settings to improve QoL in cancer survivors For this patients will be recruited by the Oncology Department and will be invited to attend the Clinical Trials Unit for an exhaustive assessment A research dietitian will administer Life S-Can and will then collect data using validated questionnaires and objective measurements to compare to the data obtained with the Life S-Can screener Participants will then be randomly allocated to either the Low Intensity Intervention Group LIIG or Active Intervention Group AIG LIIG patients will receive standard care and advice given to cancer survivors and AIG patients will receive personalised feedback by means of individual and group sessions in order to improve their body composition physical activity diet alcohol intake and psychosocial elements based on their answers by trained professionals Patients of both groups will also answer both Life S-Can and validated questionnaires at baseline and after three months Outcome measurements will be indicators of feasibility completion of questionnaires acceptability by patients health professionals behavioural changes diet physical activity psychosocial distress and QoL Finally Phase III consists of a qualitative study conducted in cancer patients and health professionals to obtain data to design an implementation study Cancer survivors care should be multifactorial however often due to time constraints and clinical burden health professionals might not assess certain aspects relevant for cancer survivors QoL such as nutritional status diet physical and mental health adequately Life S-Can will enable clinicians health practitioners charities and other stakeholders work with cancer survivors early-on and refer them to adequate health and mental care teams and resources
Detailed Description:
The aim of this project is to develop a valid and rapid screening tool Life S-Can with the capacity to evaluate a total of seven domains body composition physical activity diet alcohol intake smoking sleeping behaviour and psychosocial distress in cancer survivors for its use in a clinical setting to improve survivorship care and QoL The project is divided into four specific aims SA and will be carried out in one year at the University Hospital Son Espases HUSE Palma Spain
SA1 Develop a short screener Life S-Can to evaluate body composition physical activity diet alcohol intake smoking habits sleeping behaviour and psychosocial distress in cancer survivors
SA2 Determine relative and construct validity of individual domains and total score of the Life S-Can in cancer survivors using data obtained from validated and objective measurements
SA3 Carry out a pilot intervention study in cancer survivors to determine the feasibility acceptability and efficacy of Life S-Can
SA4 Carry out a qualitative study in cancer survivors and health professionals to design an implementation study
The project herein presented proposes three phases tool development Phase I validation of the tool Phase II - validation and pilot intervention study and qualitative Phase III
PHASE I Phase I refers to SA1
Recruit an expert panel Together with the Principal Investigator five key personnel have been listed in this project all of whom carry out research at the Health Research Institute of the Balearic Islands IdISBa Spain together with other duties university professor medical doctor Key personnel not contemplated as researchers in this project include international experts in nutrition and cancer and will be consulted throughout the project Cancer survivors will also be contacted at this stage through the hospital to involve them in the design stage
Elements of the intervention at discussion A series of meetings semi-structured interviews and panel groups will be planned with expert panel members and non-scientific actors to define the best intervention Elements to be defined during this stage are scoring of the individual domains of Life S-Can herein studied and traffic-light system good intermediate and non-adherence which will direct the intervention and health professionals to be visited monitoring of patients pipeline feedback appointment system Clinical Trials Unit and data collection
PHASE II
Phase II consists of two objectives a validation study SA2 and a pilot intervention study SA3 The validation study will consist of three visits to the researchhospital facility The first visit will be at the Clinical Trials Unit will take approximately 1 h and will be divided into three parts 1 Administration of Life S-Can 2 Administration of validated questionnaires and 3 Obtain objective measurements of the patient The second visit will also be at the Clinical Trials Unit and will take approximately 10-15 minutes Participants will be asked to return the accelerometer and complete the Life S-Can questionnaire again reproducibility At this visit patients will be randomly allocated to the Low Intensity Intervention Group LIIG or Active Intervention Group AIG The third and final visit will also be at the Clinical Trials Unit and will take approximately 30 minutes The participant will be asked to answer the Life S-Can again together with other questionnaires QLQ-C30 and anthropometric measurements to measure changes in QoL
The pilot intervention study SA3 will be designed using a multi-disciplinary approach whereby knowledge and expertise in oncology nutrition epidemiology psychology and psychometry validation and implementation will be called upon In addition the views and experiences of cancer patients and patient organizations are essential in designing an effective intervention hence non-scientific authors will be contacted and included in this phase
This intervention phase is divided into three stages intervention design patient recruitment and group allocation and intervention Participation in this study will entail visits to the Clinical Trials Unit at IdISBa located within the Hospital Universitari Son Espases When possible visits will be coordinated with other routine appointments at the hospital in order to reduce as much as possible the burden on the participant Dietary physical activity and psychologic interventions will be carried out by in-house researchers trained oncological dietitian and external health professionals
Participants allocated to the LIIG will receive routine advice offered by their oncological care team and a set of standard recommendations offered by the World Cancer Research Fund the American Institute for Cancer Research and the American Cancer Society Participants in the AIG will also receive this and will also be offered the chance to visit an oncological dietitian a physical activity health professional and a psychologist one individual session and one group session
At the final visit Life S-Can and QLQ-C30 questionnaires will be administered again in order to determine any changes or impact on lifestyle and quality of life Information regarding feasibility and acceptability of the intervention will be collected from participants
PHASE III The aim of the qualitative study is to design an implementation study
SA1 Develop a short screener Life S-Can to evaluate body composition physical activity diet alcohol intake smoking habits sleeping behaviour and psychosocial distress in cancer survivors
SA2 Determine relative and construct validity of individual domains and total score of the Life S-Can in cancer survivors using data obtained from validated and objective measurements
SA3 Carry out a pilot intervention study in cancer survivors to determine the feasibility acceptability and efficacy of Life S-Can
SA4 Carry out a qualitative study in cancer survivors and health professionals to design an implementation study
The project herein presented proposes three phases tool development Phase I validation of the tool Phase II - validation and pilot intervention study and qualitative Phase III
PHASE I Phase I refers to SA1
Recruit an expert panel Together with the Principal Investigator five key personnel have been listed in this project all of whom carry out research at the Health Research Institute of the Balearic Islands IdISBa Spain together with other duties university professor medical doctor Key personnel not contemplated as researchers in this project include international experts in nutrition and cancer and will be consulted throughout the project Cancer survivors will also be contacted at this stage through the hospital to involve them in the design stage
Elements of the intervention at discussion A series of meetings semi-structured interviews and panel groups will be planned with expert panel members and non-scientific actors to define the best intervention Elements to be defined during this stage are scoring of the individual domains of Life S-Can herein studied and traffic-light system good intermediate and non-adherence which will direct the intervention and health professionals to be visited monitoring of patients pipeline feedback appointment system Clinical Trials Unit and data collection
PHASE II
Phase II consists of two objectives a validation study SA2 and a pilot intervention study SA3 The validation study will consist of three visits to the researchhospital facility The first visit will be at the Clinical Trials Unit will take approximately 1 h and will be divided into three parts 1 Administration of Life S-Can 2 Administration of validated questionnaires and 3 Obtain objective measurements of the patient The second visit will also be at the Clinical Trials Unit and will take approximately 10-15 minutes Participants will be asked to return the accelerometer and complete the Life S-Can questionnaire again reproducibility At this visit patients will be randomly allocated to the Low Intensity Intervention Group LIIG or Active Intervention Group AIG The third and final visit will also be at the Clinical Trials Unit and will take approximately 30 minutes The participant will be asked to answer the Life S-Can again together with other questionnaires QLQ-C30 and anthropometric measurements to measure changes in QoL
The pilot intervention study SA3 will be designed using a multi-disciplinary approach whereby knowledge and expertise in oncology nutrition epidemiology psychology and psychometry validation and implementation will be called upon In addition the views and experiences of cancer patients and patient organizations are essential in designing an effective intervention hence non-scientific authors will be contacted and included in this phase
This intervention phase is divided into three stages intervention design patient recruitment and group allocation and intervention Participation in this study will entail visits to the Clinical Trials Unit at IdISBa located within the Hospital Universitari Son Espases When possible visits will be coordinated with other routine appointments at the hospital in order to reduce as much as possible the burden on the participant Dietary physical activity and psychologic interventions will be carried out by in-house researchers trained oncological dietitian and external health professionals
Participants allocated to the LIIG will receive routine advice offered by their oncological care team and a set of standard recommendations offered by the World Cancer Research Fund the American Institute for Cancer Research and the American Cancer Society Participants in the AIG will also receive this and will also be offered the chance to visit an oncological dietitian a physical activity health professional and a psychologist one individual session and one group session
At the final visit Life S-Can and QLQ-C30 questionnaires will be administered again in order to determine any changes or impact on lifestyle and quality of life Information regarding feasibility and acceptability of the intervention will be collected from participants
PHASE III The aim of the qualitative study is to design an implementation study
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None