About this trial
Cancer is one of the leading causes of mortality worldwide and is responsible for an estimated 9.6 million deaths yearly. Cancer-related deaths can be reduced if patients are diagnosed and treated early. Delay in cancer diagnosis can occur at any point along the diagnostic spectrum, from the first observation of symptoms to the start of treatment. Diagnosing cancer when it is still at an early stage, before it has spread, gives surgery, radiotherapy and other treatments the best chance of working.
Therefore, early diagnosis is the most important way to improve cancer outcomes.Most of the cancers usually presents with vague and non-alarming symptoms. Most individuals are diagnosed late when the cancer has already spread, and the prognosis is poor. There are over 200 different types of cancer that can cause many different signs and symptoms. Sometimes symptoms affect specific body areas, such as abdomen or skin. But signs can also be more general, and include weight loss, tiredness (fatigue) or unexplained pain. The type of symptoms varies from person to person.
The major reasons for not presenting to the GP with symptoms such as these are "not wanting to waste the GP's time" and normalisation of these symptoms.
The persistence of a symptom, social influence and awareness encourage help-seeking behaviours in primary care. However, few believe their symptom(s) might be a sign of cancer. Consequently, people might choose to self-manage their symptoms by using over-the-counter medication, and to seek advice from other sources, (pharmacists, family, internet), rather than a primary care physician.
RATIONALE FOR CURRENT STUDY
An early cancer diagnosis is essential for receiving treatment as early as possible to have the best chance for successful treatment. Early diagnosis of cancer can be challenging. Sometimes, the cancer symptoms resemble common illnesses and could resolve with the use of over-the-counter medications and other remedies until they become persistent or debilitating. The present study focuses on ten cancer forms: colon, oesophageal, stomach, liver, bladder, uterine, vulval, ovarian, endometrial and pancreatic. Patients diagnosed with the cancers mentioned above often report experiencing vague symptoms (such as abdominal or back pain, indigestion, feeling full etc). They often use over-the-counter medication to manage their symptoms before seeing a doctor.
Information about how often and what products participants purchase (e.g. pain killers, digestive products and natural remedies) to care for these symptoms could help identify these cancers a few crucial weeks or months earlier and encourage people to seek help sooner from their doctors.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Individuals aged >18 years of age
Individuals must be residing in the United Kingdom at the time of giving informed consent
Individuals must be registered with an NHS GP Practice
Individuals must meet the criteria of ONE of the groups. For example, to be eligible for Group 1 (Cases), individuals must have been diagnosed with one of the following cancer types in the last 24 months: Bladder, colorectal (bowel), endometrial, liver, oesophageal, ovarian, pancreatic, stomach (gastric), uterine, or vulval; whereas for Group 2 (Controls), individuals must not have received a cancer diagnosis of any type in the last 6 years (except where the diagnosis was of non-melanoma skin cancer).
Disqualifiers
Individuals under the age of 18 years
Non-UK residents, at the time of giving informed consent
Individuals without an eligible loyalty card, or who have no one in their household who has an eligible loyalty card
Individuals who are not the primary registered cardholder in their household and where the primary registered loyalty card holder is not willing to join the study, and/or where the primary registered cardholder does not make purchases for or on behalf of the individual
Trial population
Adults aged ≥18 years old, who own at least one participating high street retailer loyalty cad in their household. Among these individuals, those who have been diagnosed with any form of cancer as mentioned above (can join the CLOCS-2 as cases, and those who have no prior cancer diagnosis from the list of cancers mentioned above are eligible to join as controls.
Trial design
Case-control
Retrospective
Treatments tested in this trial
Cases & Controls
Other interventionParticipants will complete a brief online questionnaire at REDCap about their health, clinical history and lifestyle choices. The participant will only need to provide a photo ID and utility bill for ID verification, if the retailer cannot match participant details. After recruitment the participants purchase history in the past 6 years will be requested from the retailers.
Treatment groups
Trial outcomes
Primary outcomes
Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model
The primary outcome of the CLOCS-2 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 a cancer diagnosis on a population level.
Secondary outcomes
Alert about Cancer symptoms assessed by purchase behaviour
Defining a purchase threshold as an 'alert' about cancer symptoms in individuals and determining the predictive utility of purchasing behaviours in the early detection of these cancer forms.
Development of risk profiles for each cancer type
Risk profiles for each main cancer type created from the participants self-reported health data; adjusted for in the analyses
Development of predictive model to assess utility of purchasing behaviours
A predictive model to assess the utility of identified purchasing behaviours in early cancer detection, tested for efficacy of its predictive utility of purchasing behaviours in the early detection of these cancer forms
Sponsors and contacts
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Imperial College London
Lead sponsor
University of Birmingham
Collaborator
University of Nottingham
Collaborator
University of Central Lancashire
Collaborator
Cancer Research UK
Collaborator
Imperial College Healthcare NHS Trust
Collaborator