TY - JOUR

T1 - Cancer Loyalty Card Study (CLOCS)

T2 - protocol for an observational case-control study focusing on the patient interval in ovarian cancer diagnosis

AU - Brewer, Hannah R

AU - Hirst, Yasemin

AU - Sundar, Sudha

AU - Chadeau-Hyam, Marc

AU - Flanagan, James M

N1 - © Author(s) (or their employer(s)) 2020. Re-use permitted under CC BY. Published by BMJ.

PY - 2020/9/8

Y1 - 2020/9/8

N2 - 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.

AB - 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.

KW - Carcinoma, Ovarian Epithelial

KW - Case-Control Studies

KW - Female

KW - Humans

KW - Observational Studies as Topic

KW - Ovarian Neoplasms/diagnosis

KW - Retrospective Studies

KW - Risk Factors

U2 - 10.1136/bmjopen-2020-037459

DO - 10.1136/bmjopen-2020-037459

M3 - Journal article

C2 - 32900761

VL - 10

SP - e037459

JO - BMJ Open

JF - BMJ Open

SN - 2044-6055

IS - 9

ER -