Plain English Summary
Background and study aims
Despite progress in early detection and treatment for many cancers, ovarian cancer (OC) remains a leading cause of cancer death in women. The absence of a distinct ‘pre-cancerous’ stage combined with non-specific symptoms such as bloating and back pain makes timely detection challenging. A novel research programme (PROMISE, jointly funded by CRUK and The Eve Appeal) is currently under way to test whether a ‘personalized’ approach to ovarian cancer screening (which includes assessment of genetic risk markers alongside biomarkers and epidemiological data) could improve current risk prediction approaches; making population-based screening for ovarian cancer feasible. One important aspect of the research is to discover how to best convey the potential benefits and risks of the programme to women to help them make an informed decision about participating in the PROMISE programme.
Who can participate?
All women aged 18-74 who are able to give informed consent and who have not been diagnosed with ovarian cancer
What does the study involve?
The study is run over the Internet. Participants are randomly allocated into one of two groups and are asked to visit one of two versions of the website informing about PROMISE. Here, they find information about ovarian cancer, genetic testing and PROMISE. Participants are instructed to browse the website at their leisure, and to make a hypothetical decision whether or not they'd like to take part in PROMISE. Participants are asked questions about ovarian cancer and genetic testing before and after visiting the website. They are also asked about their thoughts and feelings about taking part in PROMISE after they visited the website.
What are the possible benefits and risks of participating?
Participants get information about ovarian cancer and its symptoms. Participants also learn about potential benefits and harms of ovarian cancer screening. This may be helpful in current and future related health decision making. In addition, participants are referred to trusted sources to find out further information should they wish to do so (e.g. CRUK; The Eve Appeal, Ovacome). Thinking about cancer may be upsetting for some people. Full information is provided about ovarian cancer at the end of the study and participants are referred to trusted sources to find out further information should they wish to do so (e.g. CRUK; Eve Appeal, Ovacome).
Where is the study run from?
The Health Behaviour Research Centre, University College London, London (UK)
When is the study starting and how long is it expected to run for?
April 2015 to September 2016
Who is funding the study?
The study is jointly funded by Cancer Research UK and The Eve Appeal
Who is the main contact?
Dr Susanne Meisel
susanne.meisel@ucl.ac.uk
Trial website
Contact information
Type
Scientific
Primary contact
Dr Susanne Meisel
ORCID ID
http://orcid.org/0000-0002-5080-3050
Contact details
Health Behaviour Research Centre
University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
+44 (0)2076791789
susanne.meisel@ucl.ac.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N/A
Study information
Scientific title
The impact of brief vs. extended information about personalized, risk-stratified ovarian cancer screening based on genetic risk assessment on intentions to participate in risk-stratified ovarian cancer screening: study protocol for a randomised controlled trial
Acronym
Study hypothesis
This study will test the impact of information format (brief vs. extended) on hypothetical uptake of risk-stratified OC screening based on genetic risk, genetic literacy and knowledge about OC, and decision satisfaction in a web-based randomized controlled trial.
Ethics approval
Not provided at time of registration
Study design
Web-based single-centre open individually randomized controlled trial, 1:1 group allocation
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Internet
Trial type
Screening
Patient information sheet
Not available in web format, please use the contact details to request a patient information sheet
Condition
Ovarian cancer screening
Intervention
We will create two versions of a website outlining information about OC risk, genetic testing and the risk-stratification programme (PROMISE) for the purpose of this study. With the exception of content length, all components of the website (layout, overarching themes, and decision aid) will be standardised.
1. Intervention group (‘brief’ information)
Following baseline measurements, participants randomized to access the ‘brief’ version of the website will be invited to browse the website at their leisure. They can access each component of the website in the order they prefer. At any point, they can choose to access the decision aid which aims to help them to make a hypothetical decision about participation in PROMISE in line with their personal values.
2. Control group (‘extended’ information)
The extended version of the website is based on information given to patients attending clinical genetics services; resembling a ‘usual care’ arm of the trial. Following baseline measurements, participants randomized to the ‘extended’ version of the website will will also be invited to browse the website at their leisure. Identical to the intervention group, they can also access each component of the website in the order they prefer, and they can choose to access the decision aid at any point.
Intervention type
Behavioural
Phase
Drug names
Primary outcome measure
Intention to participate in personalized-risk stratified OC screening, measured 1-2 weeks after the intervention
Secondary outcome measures
1. Changes in knowledge about ovarian cancer and genetic literacy
2. Decision satisfaction
Measured 1-2 weeks after the intervention.
Overall trial start date
01/04/2015
Overall trial end date
30/09/2016
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women
2. Aged 18-74
3. Able to give informed consent
4. No personal history of ovarian cancer
Participant type
Healthy volunteer
Age group
Adult
Gender
Female
Target number of participants
600
Participant exclusion criteria
1. Women not able to give informed consent
2. Personal history of ovarian cancer
Recruitment start date
01/05/2015
Recruitment end date
30/08/2016
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Health Behaviour Research Centre, University College London
1-19 Torrington Place
London
WC1E 6BT
United Kingdom
Sponsor information
Organisation
University College London
Sponsor details
Gower Street
London
WC1E 6BT
United Kingdom
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Cancer Research UK
Alternative name(s)
CRUK
Funding Body Type
private sector organisation
Funding Body Subtype
Other non-profit organizations
Location
United Kingdom
Funder name
The Eve Appeal (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Findings from the current study will form the basis for the PROMISE feasibility study website. Results from this study will be published in peer-reviewed scientific journals and at conferences. In addition, research findings will be disseminated via social media (Twitter), the HBRC blog and news outlets. These should be accessible for participants.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)
Publication list
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29145813