Condition category
Cancer
Date applied
04/03/2015
Date assigned
28/04/2015
Last edited
28/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

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 will get information about ovarian cancer and its symptoms. Participants will 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, we will refer participants 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. We will provide full information about ovarian cancer at the end of the study and refer participants 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
02076791789
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

Condition

Intentions to take part in personalized risk-stratified 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 measures

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

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

http://www.ucl.ac.uk

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

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, we plan to disseminate research findings 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

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes