IMPARTER:4
Research type
Research Study
Full title
IMproving PAtient undeRstanding of GEP TEst Results: Phase 4
IRAS ID
304561
Contact name
Antony Walsh
Contact email
Sponsor organisation
University of Sussex
Duration of Study in the UK
2 years, 0 months, 1 days
Research summary
Gene Expression Profiling (GEP) tests in breast cancer help determine whether or not adjuvant chemotherapy may help reduce a patient’s risk of recurrence. Two main tests are Oncotype DX and Prosigna. Many breast cancer teams provide patients with information leaflets about these tests but often they are not written as accessible to the general population.
To address this, we designed 2 short information films, and compared the ability of these to convey basic information about GEP testing, and recurrence risk results, with that achieved after reading an information leaflet. Results from this study (IMPARTER Phase 3), showed that providing information about Oncotype DX or Prosigna in film format, significantly improved the knowledge of 120 women aged 45-75 (without breast cancer) compared with that achieved after reading the information leaflets. Most participants preferred the films for reasons including clarity, graphics and reassuring tone. The leaflets proved difficult for most participants to understand, often due to the medical terminology used, irrelevant extra information and layout.
We now wish to explore breast cancer patients knowledge about GEP testing after receiving standard test information, or standard information plus a GEP patient information film, specific to either Oncotype DX or Prosigna.
We aim to do this by comparing the understanding of GEP testing between women with breast cancer (n=250) randomised to standard information or standard information plus film. We will also explore the impact of certain attitudes to uncertainty on decision making. The outcomes will show if the film and leaflet combination provides additional value to patients, over the standard information alone (usual practice/leaflet), in terms of knowledge and understanding about the test results for patients. Recruited patients will have already consented to GEP testing by their clinical team with their tumour sample sent for GEP analysis.
Summary of results
The IMPARTER:4 study (IMproving PAtient undeRstanding of GEP TEst Results: Phase 4) ran from April 2022 to January 2024.Study background and aims
Gene Expression Profiling (GEP) tests in breast cancer help determine whether the use of chemotherapy may help reduce a patient’s risk of recurrence. Two main tests which are used are Oncotype DX and Prosigna. Many breast cancer teams provide patients with information leaflets about these tests but they often contain complex and clinical language.We previously used these leaflets to design 2 short information films, one for each test. We then tested these in a study (IMPARTER:3), exploring their acceptability and ability to convey knowledge to women without breast cancer. Results from this showed that the films did help improve participant knowledge, compared with the leaflets alone.
In the IMPARTER:4 study, we wanted to continue assessing these films but in a real-world setting with women diagnosed with early breast cancer who had consented to having either the Oncotype or Prosigna test. We were interested to see if participant knowledge about these tests differed in people who received standard test information alone (leaflet and/or verbal explanation), or standard information plus the relevant film. Participants were randomised between these arms.
We also aimed to explore the impact of certain attitudes to uncertainty on decision making. We hoped that study outcomes would tell us whether having a combination of the film and standard information provided additional value to patients, above just having standard information alone.
Recruitment:
We recruited 251 women to take part from 18 different hospitals.Assessments and timepoints:
Participants were asked to complete baseline questionnaires about their general anxiety and anxiety specific to the testing process. They were also asked to complete a measure indicating how much tolerance they had for uncertainty. Participants were then randomised to receive either standard information alone or alongside the information film. A few days after randomisation, and before receiving their test results, participants took part in a telephone knowledge interview. They were asked questions to see how much they understood about the testing process and results. Once participants had received their test results, they were sent a final questionnaire link with repeat questions about their current anxiety and new questions about their treatment decision-making process.We also asked the clinicians who provided their test results to complete an intolerance of uncertainty measure and a questionnaire about the consultation itself, including the result and treatment decision.
Findings:
230 people completed all of their study assessments. Our results showed that watching the film improved knowledge about the testing process above standard information alone. Largely participants were happy with their treatment decision but baseline anxiety and intolerance of uncertainty had an impact on this. Those individuals who only received standard information were reported to ask more questions during their consultation and their appointments lasted longer than average.Practical implications
We have subsequently made the films freely available via YouTube (https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fyoutu.be%2F4PE4osrhW-8&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7Cdbc29d43cb984c0f455108dd3f82e058%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638736553526430392%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=a6NF57dzpGrGM6jw2QKIFBXeDcvrY5ISLwkMX04C6pw%3D&reserved=0 and https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fyoutu.be%252F3aPzzQARQM8&data=05%7C02%7Cbromley.rec%40hra.nhs.uk%7Cdbc29d43cb984c0f455108dd3f82e058%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638736553526464441%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=jBlBuAj8%2BLxmdRKeUTYeHqVcKSegatimyRmzj3F7WGk%3D&reserved=0)./NBTI/_-_6AQ/AQ/3bc0f524-c096-4957-b7d4-b0b5564981e4/1/olsVe2B7ip These have been shared with the recruiting hospital centres and have also been translated and made available in multiple languages.REC name
London - Bromley Research Ethics Committee
REC reference
21/PR/1576
Date of REC Opinion
21 Dec 2021
REC opinion
Further Information Favourable Opinion