A study comparing cancer patients randomly assigned to be offered either genetic testing ‘at home’ or in hospital

Plain English Summary

Background and study aims
Patients who are diagnosed with womb, bowel, or ovarian cancer that fulfill NHS genetic testing criteria are recommended to have genetic testing to see if their cancer was related to an inherited gene alteration. Identifying carriers of alterations allows novel personalised cancer treatments, prevention of second cancers, and testing of family members for cancer screening and prevention. Genetic testing requires pre-test counselling to ensure patients are informed about the impact of having a genetic test and managing the result. This ‘genetic counselling’ has traditionally been provided by genetics services. However, it is now routinely being offered by cancer-treating teams in an approach called “mainstreaming”. Currently, the demand for genetic counselling and testing is swiftly increasing and capacity constraints requires the development of new scalable cost and resource-efficient implementation models. This study will assess if pre-test counselling and genetic testing can be done using a direct-to-patient model. Participants will receive genetic testing information on a smartphone app or website that they can access at home along with counselling support through a study telephone helpline. Those who agree to testing can consent via the app and perform testing at home with a saliva genetic testing kit delivered and returned by post. In the study this direct-to-patient approach is directly compared to the standard mainstreaming approach.

Who can participate?
Patients aged 18 years and over diagnosed with bowel, womb, or ovarian cancer who are eligible for NHS genetic testing

What does the study involve?
This study compares and evaluates the uptake of genetic testing using both approaches. The researchers also assess patient satisfaction, quality-of-life, and psychological outcomes following testing, using standardized or customized questionnaires over 1 year of follow-up. Clinician opinions will be elicited. Some patients will also be interviewed to assess attitudes, experiences, and impact on emotional wellbeing. An economic analysis will be undertaken to assess the cost-effectiveness of this approach for the NHS.

What are the possible benefits and risks of participating?
Patients that take part in the study will be offered genetic testing. Everyone who is offered genetic testing is given information about the potential risks or benefits of genetic testing. This may have implications for patients’ cancer treatment, as they can be offered novel treatments which can improve outcomes. They can also opt for cancer prevention options to prevent other (second) cancers for themselves. Family members can also be tested and opt for screening or cancer prevention options.
Patients may be assigned to receive genetic testing information and genetic testing at home. They will not have to attend a hospital for this to take place. Taking part in this study will also help determine if this direct-to-patient approach of offering genetic testing is as acceptable for patients as standard genetic testing in clinics. Genetic testing is offered as part of standard NHS cancer care. Some people who receive positive genetic test results may feel frightened, sad or upset about their test result. A positive result may mean that patients find out that they have an increased risk of developing other cancers. This may be a result that they were not expecting.

Where is the study run from?
Wolfson Institute of Population Health, Queen Mary University of London (UK)

When is the study starting and how long is it expected to run for?
January 2022 to October 2028

Who is funding the study?
1. GlaxoSmithKline (UK)
2. Barts Charity (UK)
3. North East London Cancer Alliance (UK)
4. North Central London Cancer Alliance (UK)

Who is the main contact?
Prof. Ranjit Manchanda, bartsctu-detect-2@qmul.ac.uk

https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-two-different-ways-of-carrying-out-genetic-testing-for-people-with-cancer-detect

Study website

Contact information

Prof Ranjit Manchanda
Principal Investigator

Room 131, Centre for Prevention, Detection & Diagnosis
Wolfson Institute of Population Health
Charterhouse Square
London
EC1M 6BQ
United Kingdom

ORCID ID	0000-0003-3381-5057
Phone	+44 (0)7979884575
Email	r.manchanda@qmul.ac.uk

Study information

Eligibility

Locations

Countries of recruitment

• England
• Northern Ireland
• Scotland
• United Kingdom

Study participating centres

Sponsor information

Queen Mary University of London
University/education

Research Governance Operations Manager
Joint Research Management Office
Dept W, Research Services
69-89 Mile End Road
London
E1 4UJ
England
United Kingdom

Phone	+44 (0)20 7882 7275/6574
Email	research.governance@qmul.ac.uk
Website	http://www.qmul.ac.uk/
"ROR"	https://ror.org/026zzn846

Funders

Funder type

Industry

Results and Publications

Editorial Notes

03/10/2024: Cancer Research UK plain English summary link added to plain English summary field.
09/05/2024: The following changes were made to the trial record:
1. The exclusion criteria were changed.
2. The recruitment start date was changed from 01/12/2023 to 25/04/2024.
3. The study participating centres Somerset NHS Foundation Trust, South Tyneside and Sunderland NHS Foundation Trust, County Durham and Darlington NHS Foundation Trust, University Hospitals of Derby and Burton NHS Foundation Trust, Cardiff and Vale NHS Trust, University Hospitals of Leicester NHS Trust, North Bristol NHS Trust were added.
05/10/2023: The following changes have been made:
1. The recruitment end date has been changed from 30/09/2023 to 01/12/2023.
2. Queen's Hospital, Southampton General Hospital, City Hospital, Norfolk and Norwich University Hospital, Worthing Hospital, Poole General Hospital, Queen Alexandra Hospital, The Maidstone Hospital, Kent & Canterbury Hospital, Warneford Hospital, Manchester University NHS Foundation Trust, NHS Grampian, Belfast Health and Social Care Trust and NHS Lothian have been added to the study participating centres and Scotland and Northern Ireland added to the countries of recruitment.
04/09/2023: Ethics approval details added.
08/08/2023: Internal review.
26/07/2023: Study's existence confirmed by Barts Charity.