4006 776 356
免费咨询 9:00-18:00
免费获得国外相关药品，最快 1 个工作日回馈药物信息
Cancer Loyalty Card Study (CLOCS)
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.
| Condition or disease | Intervention/treatment |
|---|---|
| Ovarian Neoplasms | Other: Risk Factor Questionnaire Other: Clinical Questionnaire |
Purpose and Design
The Cancer Loyalty Card Study (CLOCS) is addressing whether or not data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women who do not have ovarian cancer. The study aims to recruit at least 500 recently diagnosed ovarian cancer patients and at least 500 healthy women as controls and collate up to 7 years of prior purchase data.
Recruitment
Loyalty card holders will be invited to join the study by email and post from the high street retailers and can choose to sign up via the CLOCS website or via post by returning the consent form to the study team through the mail. There will also be a press release about the study inviting loyalty card holders to visit the CLOCS website for more information and join the study. Women, 18 years or older, who have a loyalty card at the participating high street retailers are eligible to join. Women with ovarian cancer and who own at least one of the participating high street retailer's loyalty cards will be recruited in a clinic by a member of their healthcare team where the study is open. Any woman considering joining the study can contact the research team using the contact details on the information sheet.
Consent
Ovarian cancer patients will be given the information sheet and consent form in the clinic by a member of their healthcare team. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever is convenient for them and return it to the CLOCS team in the free post envelope provided to them in the clinic.
Women without ovarian cancer will be presented with the information sheet and consent form in an email or letter in the mail from their high street retailer if they hold a loyalty card with them and return them to the CLOCS team in a free post envelope. They can also find the information sheet and consent form on the CLOCS website and consent online.
Methods
Consenting participants will complete a brief questionnaire about ovarian cancer risk factors, which will also be returned to the CLOCS team through the mail or on the website (healthy volunteers only). Participants with ovarian cancer will also have a clinical form for a member of their clinical team to complete in the clinic. This will be sent to the CLOCS team along with their consent and risk factor questionnaire in the free post envelope. Two ovarian cancer patients have reviewed all questionnaires and CLOCS documents and expressed their approval. Women without ovarian cancer from the general UK population have also reviewed the risk factor questionnaire and expressed their approval saying the questionnaire is 'easy to understand' and 'straightforward'.
If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification,they will provide either a contact email or phone number. There is no further action needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary)
| Study Type : | Observational |
| Estimated Enrollment : | 1000 participants |
| Observational Model: | Case-Control |
| Time Perspective: | Retrospective |
| Official Title: | Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study |
| Actual Study Start Date : | November 4, 2019 |
| Estimated Primary Completion Date : | July 2022 |
| Estimated Study Completion Date : | July 2022 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
Cases
Participants diagnosed with ovarian cancer
|
Other: Risk Factor Questionnaire
For cases, the study recruiter at the Trust will present this in the clinic. Controls will complete this online or at home when volunteering to participate. The participant questionnaire will be completed by the participant.
Other Name: Participant Questionnaire
Other: Clinical Questionnaire For cases, the study recruiter at the trust will complete this form together with the participant. Controls will not complete this form.
|
|
Controls
Participants without ovarian cancer
|
Other: Risk Factor Questionnaire
For cases, the study recruiter at the Trust will present this in the clinic. Controls will complete this online or at home when volunteering to participate. The participant questionnaire will be completed by the participant.
Other Name: Participant Questionnaire
|
- Purchase behaviours assessed by statistical model [ Time Frame: 3 years ]The primary outcome of the CLOCS will be to define the time by which the cases and controls are statistically significantly different in their purchase behaviors leading up to diagnosis.
- Alert about cancer symptoms assessed by purchase behaviour [ Time Frame: 3 years ]The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals
| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | Female |
| Gender Based Eligibility: | Yes |
| Gender Eligibility Description: | Ovarian cancer is a female only cancer. |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
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.
| Contact: James Flanagan, PhD | 0207 5942127 | j.flanagan@imperial.ac.uk | |
| Contact: Hannah Brewer, PhD | h.brewer@imperial.ac.uk |
| United Kingdom | |
| Imperial College Healthcare NHS Trust | Recruiting |
| London, United Kingdom | |
| Contact: Jonathan Krell | |
| Principal Investigator: | James Flanagan, PhD | Imperial College London |
| Tracking Information | |||||||||
|---|---|---|---|---|---|---|---|---|---|
| First Submitted Date | June 19, 2019 | ||||||||
| First Posted Date | June 21, 2019 | ||||||||
| Last Update Posted Date | February 10, 2021 | ||||||||
| Actual Study Start Date | November 4, 2019 | ||||||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures |
Purchase behaviours assessed by statistical model [ Time Frame: 3 years ] The primary outcome of the CLOCS will be to define the time by which the cases and controls are statistically significantly different in their purchase behaviors leading up to diagnosis.
|
||||||||
| Original Primary Outcome Measures | Same as current | ||||||||
| Change History | |||||||||
| Current Secondary Outcome Measures |
Alert about cancer symptoms assessed by purchase behaviour [ Time Frame: 3 years ] The secondary outcome of the CLOCS will be defining a purchase threshold as an "alert" about cancer symptoms in individuals
|
||||||||
| Original Secondary Outcome Measures | Same as current | ||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title | Cancer Loyalty Card Study | ||||||||
| Official Title | Cancer Loyalty Card Study: a Retrospective Observational Case-Control Study | ||||||||
| Brief 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. |
||||||||
| Detailed Description |
Purpose and Design The Cancer Loyalty Card Study (CLOCS) is addressing whether or not data already collected by high street retailers can detect significant changes in purchase behaviours of ovarian cancer patients prior to their diagnosis. The investigators aim to conduct a case-control study of ovarian cancer patients matched with women who do not have ovarian cancer. The study aims to recruit at least 500 recently diagnosed ovarian cancer patients and at least 500 healthy women as controls and collate up to 7 years of prior purchase data. Recruitment Loyalty card holders will be invited to join the study by email and post from the high street retailers and can choose to sign up via the CLOCS website or via post by returning the consent form to the study team through the mail. There will also be a press release about the study inviting loyalty card holders to visit the CLOCS website for more information and join the study. Women, 18 years or older, who have a loyalty card at the participating high street retailers are eligible to join. Women with ovarian cancer and who own at least one of the participating high street retailer's loyalty cards will be recruited in a clinic by a member of their healthcare team where the study is open. Any woman considering joining the study can contact the research team using the contact details on the information sheet. Consent Ovarian cancer patients will be given the information sheet and consent form in the clinic by a member of their healthcare team. They can take as much time as they need to read through the information sheet. If they choose to participate, they can complete the consent form whenever is convenient for them and return it to the CLOCS team in the free post envelope provided to them in the clinic. Women without ovarian cancer will be presented with the information sheet and consent form in an email or letter in the mail from their high street retailer if they hold a loyalty card with them and return them to the CLOCS team in a free post envelope. They can also find the information sheet and consent form on the CLOCS website and consent online. Methods Consenting participants will complete a brief questionnaire about ovarian cancer risk factors, which will also be returned to the CLOCS team through the mail or on the website (healthy volunteers only). Participants with ovarian cancer will also have a clinical form for a member of their clinical team to complete in the clinic. This will be sent to the CLOCS team along with their consent and risk factor questionnaire in the free post envelope. Two ovarian cancer patients have reviewed all questionnaires and CLOCS documents and expressed their approval. Women without ovarian cancer from the general UK population have also reviewed the risk factor questionnaire and expressed their approval saying the questionnaire is 'easy to understand' and 'straightforward'. If participants consent to be re-contacted by the CLOCS team for future studies or for loyalty card detail clarification,they will provide either a contact email or phone number. There is no further action needed from participants once they complete their consent form and questionnaire (and clarify loyalty card details if necessary) |
||||||||
| Study Type | Observational | ||||||||
| Study Design | Observational Model: Case-Control Time Perspective: Retrospective |
||||||||
| Target Follow-Up Duration | Not Provided | ||||||||
| Biospecimen | Not Provided | ||||||||
| Sampling Method | Non-Probability Sample | ||||||||
| Study Population | All participants will be females in the UK who are at least 18 years old and who own at least one of the participating high street retailer loyalty cards. Participants who have been diagnosed with ovarian cancer are considered cases. Participants who do not have ovarian cancer are considered controls. | ||||||||
| Condition | Ovarian Neoplasms | ||||||||
| Intervention |
|
||||||||
| Study Groups/Cohorts |
|
||||||||
| Publications * |
|
||||||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||||||
| Recruitment Information | |||||||||
| Recruitment Status | Recruiting | ||||||||
| Estimated Enrollment |
1000 | ||||||||
| Original Estimated Enrollment | Same as current | ||||||||
| Estimated Study Completion Date | July 2022 | ||||||||
| Estimated Primary Completion Date | July 2022 (Final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria |
Inclusion Criteria:
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:
|
||||||||
| Sex/Gender |
|
||||||||
| Ages | 18 Years and older (Adult, Older Adult) | ||||||||
| Accepts Healthy Volunteers | Yes | ||||||||
| Contacts |
|
||||||||
| Listed Location Countries | United Kingdom | ||||||||
| Removed Location Countries | |||||||||
| Administrative Information | |||||||||
| NCT Number | NCT03994653 | ||||||||
| Other Study ID Numbers | 19IC5156 | ||||||||
| Has Data Monitoring Committee | No | ||||||||
| U.S. FDA-regulated Product |
|
||||||||
| IPD Sharing Statement |
|
||||||||
| Responsible Party | Imperial College London | ||||||||
| Study Sponsor | Imperial College London | ||||||||
| Collaborators |
|
||||||||
| Investigators |
|
||||||||
| PRS Account | Imperial College London | ||||||||
| Verification Date | February 2021 | ||||||||
