Condition category
Cancer
Date applied
05/01/2018
Date assigned
30/01/2018
Last edited
21/02/2018
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Previous research has shown that providing cancer risk information to people can improve their understanding of their risk of cancer, increase their intention to attend cancer screening, and increase their fruit and vegetable intake and physical activity. A risk calculator has been developed and tested based on modifiable behavioural risk factors, such as weight and smoking, which estimates the risk of an individual developing one of the five most common preventable cancers in the UK over a 10-year period. These cancers are lung, bowel, bladder, kidney and oesophageal cancer for men and breast, lung, bowel, endometrial and kidney cancer for women). Alongside 66 healthcare professionals who have taken part in focus groups and interviews, a web-based tool has been developed which allows people to enter details of their current lifestyle and then see their estimated risk of developing one of the cancers over the next 10 years, the effect changes in their lifestyle would make on that risk, and lifestyle advice. The aim of this study is to use that web-based tool to test whether people given their personalised cancer risk estimate in combination with lifestyle advice are more motivated to make changes in their behaviour than people given lifestyle advice alone. The study also compares different ways of presenting the risk information.

Who can participate?
Men and women aged 30-74 who do not have a past history of cancer

What does the study involve?
Participants answer a set of questions about their diet, lifestyle and beliefs about their risk of cancer. They are then randomly allocated to be presented with their personalised 10-year cancer risk and lifestyle advice, or go straight to the lifestyle advice without seeing their personalised risk. The cancer risk is presented in one of three formats. The first format is a bar chart, the second format is pictures of either 1000 or 100 faces depending on the individual's estimated risk, and the third format is a bar with a scale from below average to above average with arrows. Participants then answer a further set of questions about their thoughts about their risk of cancer and motivation to make lifestyle change. They are then asked if they agree to take part in a follow-up task 3 months later where they answer a similar set of questions to check how their lifestyle and ideas about cancer risk have changed with time. After completing that task, if they are one of the people who did not see their personalised risk in the first task, they are offered the opportunity to see it then.

What are the possible benefits and risks of participating?
The benefits are that participants receive a summary of their estimated risk of developing one of the five most common preventable cancers in the future and information about how they may be able to reduce that risk. Participation also provides an opportunity for people to contribute to and help influence cancer risk research. Being presented with the risk of developing cancer can be a sensitive or stressful issue. If participants become distressed by anything when completing the task they can exit it at any stage and there will be no consequences associated with doing so. Participants are also provided with details of how to access support if needed.

Where is the study run from?
University of Cambridge (UK)

When is the study starting and how long is it expected to run for?
November 2017 to August 2018

Who is funding the study?
1. Cancer Research UK
2. National Institute for Health Research (UK)

Who is the main contact?
Dr Juliet Usher-Smith
jau20@medschl.cam.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Juliet Usher-Smith

ORCID ID

http://orcid.org/0000-0002-8501-2531

Contact details

The Primary Care Unit
Department of Public Health and Primary Care
Box 113 Cambridge Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
+44 (0)1223 748 693
jau20@medschl.cam.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

1.0

Study information

Scientific title

A randomised controlled trial of an online risk information and lifestyle advice intervention for the most common preventable cancers

Acronym

I-CaPP online trial

Study hypothesis

To assess whether communicating a personalised cancer risk estimate based on modifiable lifestyle factors in combination with lifestyle advice motivates greater change in behaviour than lifestyle advice alone. Secondary objectives are to determine the effects of personalised cancer risk information on risk perception and psychological well-being and compare the impact of different formats of risk information.

Ethics approval

Psychology Research Ethics committee of the University of Cambridge, 12/12/2017, ref: PRE.2017.093

Study design

Parallel-group open randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Internet

Trial type

Prevention

Patient information sheet

Not available in web format, please use the contact details to request a patient information sheet

Condition

Lifestyle behaviours that influence risk of the five most common preventable cancers in the UK (lung, colorectal, bladder, kidney and oesophageal for men and breast, lung, colorectal, endometrial and kidney for women)

Intervention

Participants will first be asked to complete an online consent form. They will then answer a set of questions about their diet, lifestyle and beliefs about their risk of cancer. They will then be randomised 1:1:1:1 with stratification by risk relative to an individual with a recommended lifestyle and age (Added 21/02/2018: Participants are also stratified by sex):
1. A control group who receive cancer specific web-based lifestyle advice alone
2. One of three intervention groups who receive the same web-based lifestyle advice alongside their estimated 10 year risk of developing one of the five most common preventable cancers in one of three different formats:
2.1. The first format is a bar chart showing current estimated risk, new estimated risk after setting lifestyle targets, and risk if they followed a recommended lifestyle
2.2. The second is iconographs of either 1000 or 100 faces depending on the individuals estimated risk again for current estimated risk, new estimated risk after setting lifestyle targets and risk if they followed a recommended lifestyle
2.3. The third is a bar with a qualitative scale from below average to above average with arrows showing current estimated risk, new estimated risk after setting lifestyle targets and risk if they followed a recommended lifestyle

Participants will then answer a further set of questions about their thoughts about their risk of cancer and motivation to make lifestyle change. They will then be asked if they agree to take part in a follow up task 3 months later where they will answer a similar set of questions to check how your lifestyle and ideas about cancer risk have changed with time. After completing that task, if they were one of the people who did not see their personalised risk in the first task, they will be offered the opportunity to see it then.

Intervention type

Behavioural

Phase

Drug names

Primary outcome measures

Change in risk relative to an individual with a recommended lifestyle, measured via self-report of lifestyle at 3 months

Secondary outcome measures

Measured immediately after the intervention and again at 3 months, all measured via self-report:
1. Perceived risk of cancer
2. intention to change behaviour
3. Anxiety, measured using the six-item Spielberger State-Trait Anxiety inventory
4. Cancer-related worry, measured using the Lerman cancer worry scale
5. Awareness of cancer risk factors, measured using question 6 from the Cancer Awareness Measure

Overall trial start date

01/11/2017

Overall trial end date

01/08/2018

Reason abandoned

Eligibility

Participant inclusion criteria

1. 30-74 years of age
2. Resident in the UK
3. Registered with Prolific
4. Prolific approval rating ≥95%

Participant type

Healthy volunteer

Age group

Adult

Gender

Both

Target number of participants

1000

Participant exclusion criteria

Past history of cancer

Recruitment start date

01/03/2018

Recruitment end date

01/04/2018

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University of Cambridge
The Primary Care Unit Department of Public Health and Primary Care
Cambridge
CB2 0SR
United Kingdom

Sponsor information

Organisation

University of Cambridge

Sponsor details

School of Clinical Medicine
Box 111
Cambridge Biomedical Campus
Cambridge
CB2 0SP
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

Location

United Kingdom

Funder name

National Institute for Health Research

Alternative name(s)

NIHR

Funding Body Type

government organisation

Funding Body Subtype

Federal/National Government

Location

United Kingdom

Results and Publications

Publication and dissemination plan

Planned publication of the protocol in a peer-reviewed journal before completion of recruitment which will then be available online. Planned publication of the findings in high-impact peer reviewed journals approximately one year after the overall trial end date (01/08/2019).

IPD sharing statement
The anonymised patient level data will be stored in the University of Cambridge data repository (https://www.repository.cam.ac.uk). It will be open access and available to researchers approximately 2 years after the completion of the study (01/08/2020). The trialists have submitted an amendment to the ethics committee to obtain patient consent for this.

Intention to publish date

01/08/2019

Participant level data

Stored in repository

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

21/02/2018: The interventions have been updated.