Development and Validation of a Patient Reported Experience Measure for Experimental Cancer Medicine

NCT05386602 | Completed DMC

• 1 other identifier: 18_CPCR_15
• Study Type: observational
• Target: 570
• Locations: 1 country
• Sites: 1

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.

Conditions

Cancer

Keywords

Patient Experience; Experimental Medicine; Patient Reported Experience Measure; PREM

Outcome Measures

Primary Outcomes (7)

• 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.

  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.

  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.

  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"

  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.

  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.

  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.

  1 week

Study Arms (3)

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• The Christie NHS Foundation Trust: lead

Study Sites (1)

The Christie NHS Foundation Trust

Manchester, Greater Manchester, M20 4BX, United Kingdom

Location

Related Links

• Results/Publication

MeSH Terms

Conditions

Neoplasms

Study Officials

• Sally Taylor, PhD

  The Christie NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 18, 2022
• First Posted: May 23, 2022
• Study Start: July 16, 2018
• Primary Completion: October 31, 2023
• Study Completion: November 20, 2023
• Last Updated: October 4, 2024

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)