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Cancer Loyalty Card Study

NCT03994653CompletedOBSERVATIONAL

Summary

Approximately 7,400 new cases of ovarian cancer are diagnosed each year in the United Kingdom (UK), 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. The Cancer Loyalty Card Study (CLOCS) proposes to use loyalty card data from two participating high street retailers to investigate purchase behaviour as an opportunity for cancer symptom surveillance. The investigators 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. 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.

Key Facts

Lead Sponsor

Imperial College London

Enrollment

963

Start Date

2019-11-04

Completion Date

2022-01-31

Study Type

OBSERVATIONAL

Official Title

Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study

Interventions

Risk Factor QuestionnaireClinical Questionnaire

Conditions

Ovarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

Inclusion Criteria:

* 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.

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.

Exclusion Criteria:

* Women under the age of 18 years and, since this is a study about ovarian cancer,men will not be eligible to join this study. Women who do not own loyalty cards with the participating high street retailers are not eligible to join this study.

Outcome Measures

Primary Outcomes

Purchase Behaviours (Purchase of Items)

The primary outcome of the CLOCS will be to define the time by which the cases and controls are statistically significantly (p=0.05) different in their purchase behaviours leading up to ovarian cancer diagnosis. A higher purchase amount of relevant items (pain and indigestion medications) in cases compared to controls associated with cancer.

Time frame: 24 months

Secondary Outcomes

Alert About Cancer Symptoms Assessed by Purchase Behaviour

The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals

Time frame: 3 years

Locations

Imperial College Healthcare NHS Trust, London, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

Linked Papers

2023-06-14

Cancer Loyalty Card Study (CLOCS): feasibility outcomes for an observational case–control study focusing on the patient interval in ovarian cancer

ObjectivesOvarian cancer symptoms are often non-specific and can be normalised before patients seek medical help. The Cancer Loyalty Card Study investigated self-management behaviours of patients with ovarian cancer prior to their diagnosis using loyalty card data collected by two UK-based high street retailers. Here, we discuss the feasibility outcomes for this novel research.DesignObservational case–control study.SettingControl participants were invited to the study using social media and other sources from the general public. Once consented, control participants were required to submit proof of identification (ID) for their loyalty card data to be shared. Cases were identified using unique National Health Service (NHS) numbers (a proxy for ID) and were recruited through 12 NHS tertiary care clinics.ParticipantsWomen in the UK, 18 years or older, with at least one of the participating high street retailers’ loyalty cards. Those with an ovarian cancer diagnosis within 2 years of recruitment were considered cases, and those without an ovarian cancer diagnosis were considered controls.Primary outcome measuresRecruitment rates, demographics of participants and identification of any barriers to recruitment.ResultsIn total, 182 cases and 427 controls were recruited with significant differences by age, number of people in participants’ households and the geographical region in the UK. However, only 37% (n=160/427) of control participants provided sufficient ID details and 81% (n=130/160) matched retailers’ records. The majority of the participants provided complete responses to the 24-Item Ovarian Risk Questionnaire.ConclusionsOur findings show that recruitment to a study aiming to understand self-care behaviours using loyalty card data is challenging but feasible. The general public were willing to share their data for health research. Barriers in data sharing mechanisms need to be addressed to maximise participant retention.Trial registration numberISRCTN14897082, CPMS 43323,NCT03994653.

2023-01-26

Association Between Purchase of Over-the-Counter Medications and Ovarian Cancer Diagnosis in the Cancer Loyalty Card Study (CLOCS): Observational Case-Control Study

Background Over-the-counter (OTC) medications are frequently used to self-care for nonspecific ovarian cancer symptoms prior to diagnosis. Monitoring such purchases may provide an opportunity for earlier diagnosis. Objective The aim of the Cancer Loyalty Card Study (CLOCS) was to investigate purchases of OTC pain and indigestion medications prior to ovarian cancer diagnosis in women with and without ovarian cancer in the United Kingdom using loyalty card data. Methods An observational case-control study was performed comparing purchases of OTC pain and indigestion medications prior to diagnosis in women with (n=153) and without (n=120) ovarian cancer using loyalty card data from two UK-based high street retailers. Monthly purchases of pain and indigestion medications for cases and controls were compared using the Fisher exact test, conditional logistic regression, and receiver operating characteristic (ROC) curve analysis. Results Pain and indigestion medication purchases were increased among cases 8 months before diagnosis, with maximum discrimination between cases and controls 8 months before diagnosis (Fisher exact odds ratio [OR] 2.9, 95% CI 2.1-4.1). An increase in indigestion medication purchases was detected up to 9 months before diagnosis (adjusted conditional logistic regression OR 1.38, 95% CI 1.04-1.83). The ROC analysis for indigestion medication purchases showed a maximum area under the curve (AUC) at 13 months before diagnosis (AUC=0.65, 95% CI 0.57-0.73), which further improved when stratified to late-stage ovarian cancer (AUC=0.68, 95% CI 0.59-0.78). Conclusions There is a difference in purchases of pain and indigestion medications among women with and without ovarian cancer up to 8 months before diagnosis. Facilitating earlier presentation among those who self-care for symptoms using this novel data source could improve ovarian cancer patients’ options for treatment and improve survival. Trial Registration ClinicalTrials.gov NCT03994653; https://clinicaltrials.gov/ct2/show/NCT03994653

2020-09-08

Cancer Loyalty Card Study (CLOCS): protocol for an observational case–control study focusing on the patient interval in ovarian cancer diagnosis

Introduction Ovarian cancer is the eighth most common cancer in women worldwide, and about 1 in 5 women with ovarian cancer do not receive treatment, because they are too unwell by the time they are diagnosed. Symptoms of ovarian cancer are non-specific or can be associated with other common conditions, and women experiencing these symptoms have been shown to self-manage them using over-the-counter medication. Results from a recent proof-of-concept study suggest there may be an increase in the purchases of painkillers and indigestion medication 10–12 months before ovarian cancer diagnosis. We propose a case–control study, as part of a larger project called the Cancer Loyalty Card Study (CLOCS), to investigate whether a significant change in medication purchases could be an indication for early signs of ovarian cancer, using data already collected through store loyalty cards. Methods and analysis Using a retrospective case–control design, we aim to recruit 500 women diagnosed with ovarian cancer (cases) and 500 women without ovarian cancer (controls) in the UK who hold a loyalty card with at least one participating high street retailer. We will use pre-existing loyalty card data to compare past purchase patterns of cases with those of controls. In order to assess ovarian cancer risk in participants and their purchase patterns, we will collect information from participants on ovarian cancer risk factors and clinical data including symptoms experienced before diagnosis from recruited women with ovarian cancer. Ethics and dissemination CLOCS was reviewed and approved by the North West-Greater Manchester South Research Ethics Committee (19/NW/0427). Study outcomes will be disseminated through academic publications, the study website, social media and a report to the research sites that support the study once results are published. Trial registration number ISRCTN 14897082, CPMS 43323, NCT03994653 .

Linked Investigators

Eric Johnson

Hannah R Brewer

James M. Flanagan

Dr James Flanagan, completed his PhD in 2002 at the Queensland Institute of Medical Research in Brisbane, Australia, and has pursued postdoctoral work in Cancer Genetics, Epigenetics and Cancer Epigenetics. Working in the Division of Cancer Epigenetics Unit, his current work is aimed at investigating germline epigenetic alterations as a mechanism for carcinogenesis funded by Breast Cancer Campaign and Cancer Research UK.He was awarded the British Association of Cancer Research Translational Researcher Award in 2011.

Marc Chadeau-Hyam

Professor Chadeau-Hyam holds a chair in Computational Epidemiology and Biostatistics at the School of Public Health, Imperial College, and an honorary position at Utrecht University. He obtained a PhD From Paris University, and while his background was in disease modelling, he has gained expertise over the last 14 years in devising, applying and adapting computationally efficient methods to analyse and integrate multiple OMICs data. He has been involved in numerous large-scale projects as lead statistician, responsible for the analysis and integration of OMICs data. As an active member of the European exposome initiative, he has expertise in the development and application of statistical methods to screen and integrate OMICs profiles and explore the stressor- triggered molecular mechanisms involved in the determination of individual risk profiles. Alongside this applied work, he has focused on the development of dynamic disease models including OMIC variable selection methods to study the dynamics of cancer natural history. Professor Chadeau-Hyam is the director of the MSc in Health Data Analytics at ICL, and leads a series of two Exposome short courses. His team currently includes >15 members with a unique diversity of profiles, including medical, biological, and statistical backgrounds, all collaborating for the in-depth analysis of large-scale data from mega-sized and/or deeply phenotypes cohort studies.

Sudha Sundar

Yasemin Hirst

https://www.lancashire.ac.uk/academics/yasemin-hirst