Clinical trial NCT05386602: Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine
Official title: Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine (PREM-ECM)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cancer
Keywords: Patient Experience
Experimental Medicine
Patient Reported Experience Measure
PREM
Lead sponsor: The Christie NHS Foundation Trust
Sponsor class: OTHER
First posted: 2022-05-23
Enrollment: 570
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients and carers of patients who are recruited into a phase 1-2 experimental cancer medicine clinical trial. Patients and carers will be identified by their treating clinician/physician or another healthcare professional at the hospital recruitment site.

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.

Eligibility criteria: Patient Inclusion Criteria:

* Recruited into a phase 1-2 experimental cancer medicine clinical trial
* Ability to understand and communicate in the English language
* Able to provide written informed consent

Patient Exclusion Criteria:

* Patients who are not able to complete informed consent or the study questionnaires

Carer Inclusion Criteria:

* Ability to understand and communicate in the English language
* Able to provide written informed consent
* Nominated by the patient as their primary caregiver/most able to describe relevant experience

Carer Exclusion Criteria:

* Carers who are not able to complete informed consent or the study questionnaires

Primary outcomes:
measure: Patients reported care experience
timeFrame: 1 week
measure: Patient quality of life
timeFrame: 1 week
measure: Patient anxiety and depression
timeFrame: 1 week
measure: Carer quality of life
timeFrame: 1 week
measure: Carer health-related quality of life
timeFrame: 1 week
measure: Carer reported care experience
timeFrame: 1 week
measure: Carer anxiety and depression
timeFrame: 1 week
Secondary outcomes:
Other outcomes:
Locations:
city: Manchester
country: United Kingdom
facility: The Christie NHS Foundation Trust
state: Greater Manchester
Study officials:
affiliation: The Christie NHS Foundation Trust
name: Sally Taylor, PhD
role: PRINCIPAL_INVESTIGATOR
References: