A randomised controlled trial of the effect of providing online risk information and lifestyle advice for the most common preventable cancers
| ISRCTN | ISRCTN17450583 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN17450583 |
| Secondary identifying numbers | 1.0 |
- Submission date
- 05/01/2018
- Registration date
- 30/01/2018
- Last edited
- 28/02/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English summary of protocol
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 October 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
Contact information
Scientific
The Primary Care Unit
Department of Public Health and Primary Care
Box 113 Cambridge Biomedical Campus
Cambridge
CB2 0SR
United Kingdom
 ORCID ID |
0000-0002-8501-2531 |
|---|---|
| Phone | +44 (0)1223 748 693 |
| jau20@medschl.cam.ac.uk |
Study information
| Study design | Parallel-group open randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Internet/virtual |
| Study type | Prevention |
| Participant information sheet | ISRCTN17450583_PIS_ModelConsentForm.pdf |
| Scientific title | A randomised controlled trial of an online risk information and lifestyle advice intervention for the most common preventable cancers |
| Study acronym | I-CaPP online trial |
| Study objectives | 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(s) | Psychology Research Ethics committee of the University of Cambridge, 12/12/2017, ref: PRE.2017.093 |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/11/2017 |
| Completion date | 31/10/2018 |
Eligibility
| Participant type(s) | Healthy volunteer |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 1000 |
| Total final enrolment | 1018 |
| Key inclusion criteria | 1. 30-74 years of age 2. Resident in the UK 3. Registered with Prolific 4. Prolific approval rating ≥95% |
| Key exclusion criteria | Past history of cancer |
| Date of first enrolment | 01/03/2018 |
| Date of final enrolment | 01/04/2018 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Public Health and Primary Care
Cambridge
CB2 0SR
United Kingdom
Sponsor information
University/education
School of Clinical Medicine
Box 111, Cambridge Biomedical Campus
Cambridge
CB2 0SP
England
United Kingdom
"ROR" |
https://ror.org/013meh722 |
|---|
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Government organisation / National government
- Alternative name(s)
- National Institute for Health Research, NIHR Research, NIHRresearch, NIHR - National Institute for Health Research, NIHR (The National Institute for Health and Care Research), NIHR
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 01/02/2020 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Stored in repository |
| 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. |
| IPD sharing plan | 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. The trialists have submitted an amendment to the ethics committee to obtain patient consent for this. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/09/2020 | 05/08/2020 | Yes | No |
| Protocol article | 26/06/2018 | 10/08/2022 | Yes | No | |
| Participant information sheet | 28/02/2024 | No | Yes |
Additional files
Editorial Notes
28/02/2024: Patient information sheet and model consent form added.
10/08/2022: Publication reference added.
05/08/2020: Publication reference added.
08/10/2019: The following changes were made to the trial record:
1. The total final enrolment number was added.
2. The intention to publish date was changed from 01/08/2019 to 01/02/2020.
13/07/2018: The overall trial end date was changed from 01/08/2018 to 31/10/2018.
21/02/2018: The interventions have been updated.
