Cancer Loyalty Card Study 2: a Retrospective Observational Case-Control Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 2,900
- 试验地点
- 1
- 主要终点
- Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model
研究概览
简要总结
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.
详细描述
Purpose and Design
The Cancer Loyalty Card Study-2 (CLOCS-2) addresses whether or not data already collected by high street retailers can detect significant changes in cancer patients' purchase behaviours before their diagnosis. The aim is to conduct a case-control study of cancer patients matched with participants without these cancer types. 1450 recently diagnosed cancer patients and 1450 participants as controls will be recruited and up to six years of prior purchase data will be collated.
Recruitment
Participants, 18 years or older, with any of the aforementioned cancer forms and having at least one of the participating high street retailer's loyalty cards from Tesco or Boots in their household, will be recruited through the GP invites, NHS cancer clinics and Be Part of Research.
All participants registering in the study and not holding the primary ownership of the loyalty cards from Tesco or Boots must register in the study along with the primary owner of the loyalty card from the same household. All the collected data will be safeguarded in a secure enclave with limited access to the CLOCS-2 team.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Retrospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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).
- •Individuals must be a primary registered cardholder* of one of the loyalty cards listed below, and consent to share their loyalty card data with the study team
- •Tesco Clubcard
- •Boots Advantage Card
- •Provision of written informed consent
- •Willing and able to comply with all required study activities
- •The primary registered card holder, i.e., the person who is named on the loyalty card account, must also enrol into the study, if someone other than the registered primary card holder from the same household, wants to take part in the study.
排除标准
- •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
- •Exclusion Criteria (CASES):
- •Individuals will not be able to join as a case if:
- •they have been diagnosed with an eligible cancer type more than 24 months ago (except where the diagnosis was non-melanoma skin cancer).
- •they have received an ineligible cancer diagnosis within the last 6 years except where the diagnosis was non-melanoma skin cancer).
- •Exclusion Criteria (Controls):
- •Individuals will not be able to join as a control (Group 2) if:
- •o they have received any cancer diagnosis in the last six years (except where the diagnosis was non-melanoma skin cancer).
结局指标
主要结局
Purchase behaviours (purchase of pain relief medications) assessed by Statistical Model
时间窗: 3 years
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.
次要结局
- Alert about Cancer symptoms assessed by purchase behaviour(3 years)
- Development of risk profiles for each cancer type(3 years)
- Development of predictive model to assess utility of purchasing behaviours(3 years)