CancerPREM-ECMNCT05386602
Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine
An observational study of Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- Type of treatment
- Injection or infusion
- How many people
- 570 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 16 Jul 2018to 20 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
The Christie NHS Foundation Trust
Manchester, Greater Manchester, M20 4BX
About this study
Official title: Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine (PREM-ECM)
This is a four stage, non-interventional study to develop and pilot test a Patient Reported Experience Measure (PREM) in experimental cancer medicine trials.
Read the 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.
- Conditions
- Cancer
- Keywords
- Patient Experience, Experimental Medicine, Patient Reported Experience Measure, PREM
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Prior trial patients | In stage III, patients who have been on an experimental cancer medicine trial for less than six weeks will complete a draft PREM-ECM (less than six weeks), the EORTC PATSATC33 and HAD questionnaires 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). In stage IV, the PREM-ECM will be administered alone. | |
| On trial patients | In stage III, patients who have been on an experimental cancer medicine trial for more than six weeks will complete a draft PREM-ECM (more than six weeks), the EORTC PATSATC33 and HAD questionnaires 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 (more than six weeks) approximately one week later at time point 2 (T2). In stage IV, the PREM-ECM will be administered alone. | |
| Carers of patients | In stage III, carers of patients recruited on an experimental cancer medicine trial will be asked to complete 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) at entry to the PREM study (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). In Stage IV, the PREM-ECM-carer will be administered alone. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients reported care experience
Collected by a Patient Reported Experience Measure in Experimental Cancer Medicine (PREM-ECM) questionnaire. A five point Likert scale is used to specify their levels of agreement with a statement, from low (1) to high (5). Higher scores are interpreted as better patient experience.
Measured: 1 week
Patient quality of life
European Organisation Research and Treatment of Cancer (EORTC) Satisfaction with cancer care core questionnaire (PATSATC33). incorporates seven multi-item scales to assess doctors' technical skills, information exchange and affective behaviour, nurses/radiotherapy technicians' information/responsiveness and affective behaviour, and services and care organisation in terms of coordination and interaction with health care providers. In addition, five single items assess family/close persons' care involvement, access, environment, and overall perceived care quality. All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care / perceived care quality.
Measured: 1 week
Patient anxiety and depression
Hospital Anxiety and Depression Scale (HADS). It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (>) 9 = anxiety; HADS (depression): 0-8 = no depression; >9 = depression.
Measured: 1 week
Carer quality of life
Adult Carer Quality of Life Questionnaire (AC-QOL). It is made up of eight different areas (care giving, caring preference, patient care stress, financial issues, personal development, valuing, caregiving ability and caregiver satisfaction). In scale evaluation, 0-40 points indicate "low quality of life", 41-80 points "average quality of life" and 81-120 points indicate "high quality of life"
Measured: 1 week
Carer health-related quality of life
EQ-5D-5L. Consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.
Measured: 1 week
Carer reported care experience
Collected by a Patient Reported Experience Measure in Experimental Cancer Medicine- Carers (PREM-Carers) questionnaire. A five point Likert scale is used to specify their levels of agreement with a statement, from low (1) to high (5). Higher scores are interpreted as better carer experience.
Measured: 1 week
Carer anxiety and depression
Hospital Anxiety and Depression Scale (HADS). It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (>) 9 = anxiety; HADS (depression): 0-8 = no depression; >9 = depression.
Measured: 1 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 May 2022
- Study start16 Jul 2018
- Primary completion31 Oct 2023
- Study completion20 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 570 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Christie NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sally Taylor, PhD, Principal investigator, The Christie NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05386602
- Sponsor's protocol ID
- 18_CPCR_15
- Acronym
- PREM-ECM
- Status last verified
- Aug 2023
- First submitted
- 18 May 2022
- Last updated
- 4 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine (PREM-ECM)
- ClinicalTrials.gov ID
- NCT05386602
- Acronym / sponsor ID
- PREM-ECM / 18_CPCR_15
- Conditions
- Cancer
- Keywords
- Patient Experience, Experimental Medicine, Patient Reported Experience Measure, PREM
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 570 participants (actual)
- Lead sponsor
- The Christie NHS Foundation TrustUniversity, hospital or other
- Study start
- 16 Jul 2018 (actual)
- Primary completion
- 31 Oct 2023 (actual)
- Study completion
- 20 Nov 2023 (actual)
- First posted
- 23 May 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Prior trial patients | – | –In stage III, patients who have been on an experimental cancer medicine trial for less than six weeks will complete a draft PREM-ECM (less than six weeks), the EORTC PATSATC33 and HAD questionnaires 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). In stage IV, the PREM-ECM will be administered alone. |
| On trial patients | – | –In stage III, patients who have been on an experimental cancer medicine trial for more than six weeks will complete a draft PREM-ECM (more than six weeks), the EORTC PATSATC33 and HAD questionnaires 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 (more than six weeks) approximately one week later at time point 2 (T2). In stage IV, the PREM-ECM will be administered alone. |
| Carers of patients | – | –In stage III, carers of patients recruited on an experimental cancer medicine trial will be asked to complete 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) at entry to the PREM study (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). In Stage IV, the PREM-ECM-carer will be administered alone. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Patients reported care experience
Time frame: 1 week
Collected by a Patient Reported Experience Measure in Experimental Cancer Medicine (PREM-ECM) questionnaire. A five point Likert scale is used to specify their levels of agreement with a statement, from low (1) to high (5). Higher scores are interpreted as better patient experience.
Patient quality of life
Time frame: 1 week
European Organisation Research and Treatment of Cancer (EORTC) Satisfaction with cancer care core questionnaire (PATSATC33). incorporates seven multi-item scales to assess doctors' technical skills, information exchange and affective behaviour, nurses/radiotherapy technicians' information/responsiveness and affective behaviour, and services and care organisation in terms of coordination and interaction with health care providers. In addition, five single items assess family/close persons' care involvement, access, environment, and overall perceived care quality. All of the scales and single-item measures range in score from 0 to 100. A high score represents a high level of satisfaction with care / perceived care quality.
Patient anxiety and depression
Time frame: 1 week
Hospital Anxiety and Depression Scale (HADS). It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (>) 9 = anxiety; HADS (depression): 0-8 = no depression; >9 = depression.
Carer quality of life
Time frame: 1 week
Adult Carer Quality of Life Questionnaire (AC-QOL). It is made up of eight different areas (care giving, caring preference, patient care stress, financial issues, personal development, valuing, caregiving ability and caregiver satisfaction). In scale evaluation, 0-40 points indicate "low quality of life", 41-80 points "average quality of life" and 81-120 points indicate "high quality of life"
Carer health-related quality of life
Time frame: 1 week
EQ-5D-5L. Consists of two components: a health state profile and a visual analog scale (VAS). EQ-5D health state profile comprises five dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has five levels: 1=no problems, 2=slight problems, 3=moderate problems, 4=severe problems, and 5=extreme problems. The 5D-5L systems are converted into a single index utility score between 0 to 1, where a higher score indicates a better health state. The VAS records the participant's health on a 0-100 mm VAS scale, with 0 indicating "the worst health you can imagine" and 100 indicating "the best health you can imagine". Higher scores of EQ VAS indicate better health.
Carer reported care experience
Time frame: 1 week
Collected by a Patient Reported Experience Measure in Experimental Cancer Medicine- Carers (PREM-Carers) questionnaire. A five point Likert scale is used to specify their levels of agreement with a statement, from low (1) to high (5). Higher scores are interpreted as better carer experience.
Carer anxiety and depression
Time frame: 1 week
Hospital Anxiety and Depression Scale (HADS). It comprises 14 items, seven to assess anxiety (HADS-A), namely items 1, 3, 5, 7, 9, 11, and 13; and seven to assess depression (HADS-D), namely items 2, 4, 6, 8, 10, 12, and 14. Each item receives a score from 0 to 3 on a Likert Scale. The total score for each HADS-A and HADS-D scale is obtained by adding the individual scores for each item, with the maximum score 21. The presence or absence of depression and anxiety was defined, for each respective scale, based on the following cutoff values: HADS (anxiety): 0-8 equal to (=) no anxiety; greater than (>) 9 = anxiety; HADS (depression): 0-8 = no depression; >9 = depression.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2024.
- Results/PublicationLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sally Taylor, PhD principal investigator
The Christie NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by The Christie NHS Foundation Trust at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patients reported care experience (time frame: 1 week). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Oct 2024.