Cancer Loyalty Card Study (CLOCS): aiming to reduce delays in cancer diagnosis using everyday data
| ISRCTN | ISRCTN14897082 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN14897082 |
| IRAS number | 262776 |
| ClinicalTrials.gov number | NCT03994653 |
| Secondary identifying numbers | CPMS 43323 |
- Submission date
- 16/09/2019
- Registration date
- 29/10/2019
- Last edited
- 19/12/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Cancer
Plain English Summary
https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/a-study-looking-at-how-women-manage-symptoms-that-might-be-ovarian-cancer-cancer-loyalty-card-study
Background and study aims
The Cancer Loyalty Card Study (CLOCS) is addressing whether data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The researchers aim to conduct a study of ovarian cancer patients matched with women who do not have ovarian cancer and collate up to 7 years of prior purchase data.
Who can participate?
Ovarian cancer patients aged 18 and older with loyalty cards at a participating high street retailer and women aged 18 and older who have not been diagnosed with ovarian cancer
What does the study involve?
Consenting participants provide their loyalty card details and complete a brief questionnaire about ovarian cancer risk factors, which is also returned to the CLOCS team through the mail or on the secure website (healthy volunteers only). Participants with ovarian cancer also have a clinical form for a member of their clinical team to complete in the clinic. This is sent to the CLOCS team along with their consent and risk factor questionnaire in a freepost envelope. If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification, they provide either a contact email or phone number. There is no further action needed from participants once they complete and return their consent form and questionnaire (and clarify loyalty card details if necessary).
What are the possible benefits and risks of participating?
There are no clear risks in taking part in this study. However, it may be emotional or distressing to think about cancer and the first time a patient noticed some changes in their body. The researchers intended to design the survey questions in the most sensible and sensitive way to ensure that there are no negative effects of this study on patients’ well-being. To their knowledge, this study is a unique project which could have important public health benefits for women. If the study is successful, this could be instrumental in raising cancer symptom awareness in commercial settings.
Where is the study run from?
Imperial College London (UK)
When is the study starting and how long is it expected to run for?
February 2019 to July 2022
Who is funding the study?
Cancer Research UK
Who is the main contact?
Dr James Flanagan, j.flanagan@imperial.ac.uk
Contact information
Scientific
Imperial College London
Division of Cancer, Department of Surgery and Cancer
Hammersmith Campus
Du Cane Road (Artillery Lane)
London
W12 0HS
United Kingdom
| Phone | +44 (0)207 5942127 |
|---|---|
| j.flanagan@imperial.ac.uk |
Scientific
Imperial College London
4th Floor, Institute of Reproductive and Developmental Biology (IRDB)
London
W12 0HS
United Kingdom
| Phone | +44 (0)7503468620 |
|---|---|
| h.brewer@imperial.ac.uk |
Study information
| Study design | Observational; Design type: Case-controlled study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Case-control study |
| Study setting(s) | Community, Retail/food outlet |
| Study type | Other |
| Participant information sheet | Not available in web format, please use the contact details to request a patient information sheet |
| Scientific title | Cancer Loyalty Card Study (CLOCS) |
| Study acronym | CLOCS |
| Study hypothesis | Approximately 7,400 new cases of ovarian cancer are diagnosed each year in the United Kingdom, and with over 4,000 women dying from the disease each year it is a particularly lethal form of cancer. The symptoms for ovarian cancer are not well known and vague, and most women are diagnosed at a late stage when the cancer has already spread around the abdominal cavity with poor prognosis. Novel methods are needed to improve earlier detection and thereby improve survival from this disease. In the Cancer Loyalty Card Study (CLOCS) the researchers propose to use loyalty card data from two participating high street retailers to investigate purchase behaviour as an opportunity for cancer symptom surveillance. They aim to conduct a case-control study of ovarian cancer patients matched with women without ovarian cancer and to explore public preferences for how to communicate potential outcomes of the commercial and health data linkages back to individuals. |
| Ethics approval(s) | Approved 11/09/2019, North West - Greater Manchester South Research Ethics Committee (3rd Floor, Barlow House 4 Minshull Street Manchester M1 3DZ, UK; Tel: +44 (0)207 104 8010; Email: nrescommittee.northwest-gmsouth@nhs.net), REC ref: 19/NW/0427 |
| Condition | Ovarian cancer |
| Intervention | Eligible participants will be women in the UK who own at least one loyalty card with the participating high street retailers. Of these women, those who have been diagnosed with ovarian cancer are eligible to participate in the study as cases, while women who have not been diagnosed with ovarian cancer are eligible to participate as controls. Upon choosing to participate, all participants will be asked to complete a short questionnaire about well-established ovarian cancer risk factors and common symptoms either in the clinic (cases) or online/from a packet in the mail (controls). This information will be used in risk assessment for ovarian cancer of participants, which will be used at the analysis stage. Once participant questionnaires and consent forms are returned to the CLOCS research team, only the researchers will have access to participants’ past purchase information already collected by high street retailers through the use of loyalty cards. |
| Intervention type | Other |
| Primary outcome measure | The time by which the cases and controls are statistically significantly different in their purchase behaviours leading up to diagnosis on a population level. Method: Data will be collected using questionnaire to establish ovarian cancer risk factors and clinical information; high street retailer loyalty cards data will be collected to establish an individual’s purchases and purchase behaviours. Timepoints: Participants will be recruited at baseline, and data collected at one timepoint (date of recruitment), and all data available up until that timepoint will be analysed. |
| Secondary outcome measures | The purchase threshold defined as an “alert” about cancer symptoms in individuals and the predictive utility of purchasing behaviours in the early detection of ovarian cancer. Exploratory analyses will include longitudinal analyses, frequency of purchases and unbiased analysis of other purchase categories. Method: Data will be collected using questionnaire to establish ovarian cancer risk factors and clinical information; high street retailer loyalty cards data will be collected to establish an individual’s purchases and purchase behaviours; Timepoints: Participants will be recruited at baseline, and data collected at one timepoint (date of recruitment), and all data available up until that timepoint will be analysed. |
| Overall study start date | 01/02/2019 |
| Overall study end date | 31/07/2022 |
Eligibility
| Participant type(s) | Mixed |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | Planned Sample Size: 1000; UK Sample Size: 1000 |
| Total final enrolment | 624 |
| Participant inclusion criteria | 1. Women, at least 18 years old, recently diagnosed with ovarian cancer (preferably recruited just after diagnosis and during treatment period, but are still eligible if diagnosed up to 2 years prior, at the latest) who hold at least one participating high street retailer loyalty card are eligible to join the CLOCS as cases 2. Women, at least 18 years old, who have not been diagnosed with ovarian cancer and hold at least one participating high street retailer loyalty card are eligible to join the CLOCS as controls |
| Participant exclusion criteria | 1. Women under the age of 18 years 2. Men |
| Recruitment start date | 01/11/2019 |
| Recruitment end date | 28/07/2022 |
Locations
Countries of recruitment
- England
- Scotland
- United Kingdom
- Wales
Study participating centres
Du Cane Road (Artillery Lane)
London
W12 0HS
United Kingdom
Praed Street
London
W2 1NY
United Kingdom
Dudley Road
Birmingham
B18 7QH
United Kingdom
London
NW1 2PG
United Kingdom
Hollyhurst Road
Darlington
DL3 6HX
United Kingdom
Moat Road
Walsall
WS2 9PS
United Kingdom
Canada Avenue
Redhill
RH1 5RH
United Kingdom
Skipton Road
Steeton
Keighley
BD20 6TD
United Kingdom
Seaway Parade Industrial Estate
Baglan
Port Talbot
SA12 7BR
United Kingdom
Gateshead
NE9 6SX
United Kingdom
Colney
Norwich
NR4 7UY
United Kingdom
Beckett Street
Leeds
LS9 7TF
United Kingdom
2-4 Waterloo Place
Edinburgh
EH1 3EG
United Kingdom
Haslingden Road
Blackburn
BB2 3HH
United Kingdom
Bristol
BS1 3NU
United Kingdom
Guildford
GU2 7XX
United Kingdom
London
SW3 6JJ
United Kingdom
Charnwood Court
Heol Billingsley
Cardiff
CF15 7QZ
United Kingdom
Heath Park
Cardiff
CF14 4XW
United Kingdom
Marton Road
Middlesbrough
TS4 3BW
United Kingdom
Watford General Hospital
Vicarage Road
Watford
WD18 0HB
United Kingdom
Withington
Manchester
M20 4BX
United Kingdom
Oxford Road
Manchester
M13 9WL
United Kingdom
Gartnavel Royal Hospital
1055 Great Western Road
Glasgow
G12 0XH
United Kingdom
Sponsor information
University/education
c/o Becky Ward
215, 2nd Floor, Norfolk Place
St Mary's Campus
London
W2 1PG
England
United Kingdom
| Phone | +44 (0)20 7594 9459 |
|---|---|
| becky.ward@imperial.ac.uk | |
"ROR" |
https://ror.org/041kmwe10 |
Funders
Funder type
Charity
Private sector organisation / Other non-profit organizations
- Alternative name(s)
- CR_UK, Cancer Research UK - London, CRUK
- Location
- United Kingdom
Results and Publications
| Intention to publish date | 30/06/2023 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | 1. Peer reviewed scientific journals 2. Conference presentation 3. Publication on website |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available due to fact that the raw data contains participant identifiable data and only the anonymised risk factor questionnaire data will be made available to collaborators upon reasonable request. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Protocol article | protocol | 08/09/2020 | 10/09/2020 | Yes | No |
| Results article | 26/01/2023 | 27/01/2023 | Yes | No | |
| Results article | 14/06/2023 | 15/06/2023 | Yes | No | |
| HRA research summary | 28/06/2023 | No | No | ||
| Plain English results | 10/04/2024 | No | Yes |
Editorial Notes
19/12/2024: The following changes were made to the trial record:
1. The overall end date was changed from 31/12/2024 to 31/07/2022.
2. The intention to publish date
3. The total final enrolment was changed from 273 to 624.
10/04/2024: Cancer Research UK plain English results link added.
15/06/2023: Publication reference added.
27/01/2023: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added from the reference.
3. The study setting has been updated from 'Other'.
28/07/2022: The recruitment end date was changed from 31/10/2021 to 28/07/2022.
23/02/2022: The overall trial end date has been changed from 31/01/2022 to 31/12/2024 and the plain English summary updated accordingly.
16/02/2022: The following changes have been made:
1. The trial website has been added.
2. The overall trial end date has been changed from 30/06/2022 to 31/01/2022 and the plain English summary updated accordingly.
10/09/2020: Publication reference added.
04/09/2020: Cancer Research UK lay summary link added to plain English summary field.
15/11/2019: Internal review.
16/09/2019: Trial's existence confirmed by the NIHR.
