Ignite Creation Date:
2025-12-25 @ 3:47 AM
Ignite Modification Date:
2025-12-26 @ 2:34 AM
Study NCT ID:
NCT05386602
Status:
COMPLETED
Last Update Posted:
2024-10-04
First Post:
2022-05-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine
Sponsor:
The Christie NHS Foundation Trust
Organization:
Study Overview
Official Title:
Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine (PREM-ECM)
Status:
COMPLETED
Status Verified Date:
2023-08
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:
PREM-ECM
Brief Summary:
This is a four stage, non-interventional study to develop and pilot test a Patient Reported Experience Measure (PREM) in experimental cancer medicine trials.
Detailed Description:
PREM-ECM will be conducted in four stages
Stage I - Item generation Two focus groups with four-eight participants each and approximately 20 interviews will be conducted with experimental cancer medicine trial participants to capture their experiences of participating in clinical trials and the care they have received during screening and trial participation. The investigators will also conduct up to ten interviews with informal carers (either as dual carer-patient or carer only interviews). Potential items for PREM-ECM inclusion will be extracted from these interviews (depending on carer data extraction their views will be incorporated into the patient item list or a separate 'carer experience' item list. Participants in Stage I will be asked to consent to possible cognitive interviews later in stage II. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage II - Cognitive interviewing Following the creation of a draft item list, approximately five-seven participants from Stage I and three-five study naïve patients will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage III - Item reduction and refinement for two PREM-ECMs A draft PREM-ECM (less than six weeks) and the EORTC PATSATC33 and HAD questionnaires will be administered to approximately 180 participants recruited into an experimental cancer medicine trial at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the draft of the PREM-ECM (less than six weeks) approximately one week later at time point 2 (T2) - this is to test for individual item test retest reliability. A draft of the PREM-ECM (over six weeks) and the EORTC PATSATC33 and HAD questionnaires will be administered to approximately 180 participants recruited into an experimental cancer medicine trial at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the PREM-ECM during approximately one week later at time point 2 (T2) - this is to test for individual item test retest reliability.
A draft PREM-ECM-carers, the Adult Carer Quality of Life Questionnaire (AC-QOL), the EQ5D-5L, and the Hospital Anxiety and Depression Scale (HADS) questionnaire will be administered to approximately 150 carers of patients recruited into an experimental cancer medicine trial (baseline/time point 1 (T1)). Approximately 50 carers will be asked to repeat the draft of the PREM-ECM - carers approximately one week later at time point 2 (T2) - this is to test for retest reliability.
Stage IV - Pilot testing of the PREM-ECM Both the PREM-ECM will be pilot tested with approximately 20 patients per questionnaire at The Christie site to assess its feasibility for routine collection of patient experience data.
Stage I - Item generation Two focus groups with four-eight participants each and approximately 20 interviews will be conducted with experimental cancer medicine trial participants to capture their experiences of participating in clinical trials and the care they have received during screening and trial participation. The investigators will also conduct up to ten interviews with informal carers (either as dual carer-patient or carer only interviews). Potential items for PREM-ECM inclusion will be extracted from these interviews (depending on carer data extraction their views will be incorporated into the patient item list or a separate 'carer experience' item list. Participants in Stage I will be asked to consent to possible cognitive interviews later in stage II. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage II - Cognitive interviewing Following the creation of a draft item list, approximately five-seven participants from Stage I and three-five study naïve patients will undergo cognitive interviews to ensure that all items are clear and easily understood. Interviews will be audio recorded using a Dictaphone which encrypts files in real time.
Stage III - Item reduction and refinement for two PREM-ECMs A draft PREM-ECM (less than six weeks) and the EORTC PATSATC33 and HAD questionnaires will be administered to approximately 180 participants recruited into an experimental cancer medicine trial at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the draft of the PREM-ECM (less than six weeks) approximately one week later at time point 2 (T2) - this is to test for individual item test retest reliability. A draft of the PREM-ECM (over six weeks) and the EORTC PATSATC33 and HAD questionnaires will be administered to approximately 180 participants recruited into an experimental cancer medicine trial at entry to the PREM study (baseline/time point 1 (T1)). Approximately 50 patients will be asked to repeat the PREM-ECM during approximately one week later at time point 2 (T2) - this is to test for individual item test retest reliability.
A draft PREM-ECM-carers, the Adult Carer Quality of Life Questionnaire (AC-QOL), the EQ5D-5L, and the Hospital Anxiety and Depression Scale (HADS) questionnaire will be administered to approximately 150 carers of patients recruited into an experimental cancer medicine trial (baseline/time point 1 (T1)). Approximately 50 carers will be asked to repeat the draft of the PREM-ECM - carers approximately one week later at time point 2 (T2) - this is to test for retest reliability.
Stage IV - Pilot testing of the PREM-ECM Both the PREM-ECM will be pilot tested with approximately 20 patients per questionnaire at The Christie site to assess its feasibility for routine collection of patient experience data.
Study Oversight
Has Oversight DMC:
True
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?: