- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07376694
Improving Uptake of Bowel Cancer Screening Among South Asian Adults in Bradford
Bowel cancer is the second most common cause of cancer related deaths in England. Bowel cancer screening can reduce bowel cancer deaths by detecting bowel cancer early. Previous research has shown that screening can lower a person's risk of dying from bowel cancer by over 25%. In England, the NHS offers free bowel cancer screening for adults aged 60 - 74 years who are registered with a GP every two years, but screening uptake remains poor among those in deprived areas and amongst minority ethnic groups. In socioeconomically deprived areas like Bradford, where there is a high proportion of South Asian residents, bowel cancer screening uptake is low compared to other parts of England. The investigators previous research has shown that people of South Asian ethnicity are limited by many factors beyond language barriers and thus require culturally tailored approaches to facilitate uptake.
For this study, the investigators will aim to answer the question: 'Does a culturally tailored enhanced screening kit, comprising an instruction letter and booklet, and a bio-degradable poo catcher increase bowel cancer screening uptake among South Asians living in Bradford?'. Over a 6-month period, individuals registered in 17 GP practices in Bradford and due to receive their NHS bowel cancer screening invitation will be assigned to two groups: standard kit (usual screening kit only) and enhanced kit (culturally tailored instruction letter and biodegradable poo catcher). Uptake of bowel cancer screening among South Asian participants in each group will be assessed 13 weeks after the identification of the final participant. The findings of this study will provide valuable information for policy makers about how to address population specific barriers to bowel cancer screening using culturally tailored approaches in the UK.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Bowel cancer is the fourth most common cancer and the second leading cause of cancer deaths in England. Screening can improve survival by detecting cancer earlier, when cancer is easier to treat. However, participation in screening is sub-optimal, and there are ethnic and regional inequalities in uptake. Indeed, in 2022, uptake of bowel cancer screening in Yorkshire and Humber was 72.2% overall, but only 67.8% in Bradford, where there is a high proportion of South Asian residents (uptake of bowel cancer screening in England has been shown to be 50% lower among South adults, compared with White British adults).
Universal approaches attempting to increase the uptake of bowel cancer screening, such as text-message reminders, have been shown to be effective, but tend to be inaccessible to those whose first language is not English and, thus, may widen health inequalities. In addition, recent research indicates that a plethora of culturally specific barriers, over and above language barriers, prohibit participation in bowel cancer screening by South Asian individuals. Thus, culturally tailored approaches, which address population-specific barriers, are needed to ensure equitable access to, and uptake of, screening.
The investigators have spent the past two years working with South Asian communities to understand their barriers to participation, and have identified the following barriers to completing the test: 1) lack of knowledge about bowel cancer and screening (knowledge); 2) lack of language, literacy and physical ability (skills) to carry out the home test; 3) confidence to carry it out correctly (belief about capabilities); 4) appropriate space and time to carry out the test (environmental context and resources); 5) putting off undertaking the test (memory attention and decision processes); 6) risk perception and fear of cancer (emotions).
Mapping previous findings onto the Theoretical Domains Framework (in red) and, subsequently, the Behaviour Change Technique Taxonomy (BCTT), research suggests that interventions which include 'education/information', 'persuasion', 'modelling' and 'enablement' functions (as defined by the BCTT) could address the barriers and increase the completion rate of the home-based bowel cancer screening test (among South Asian adults).
To address the identified barriers, and implement the above functions (in blue) the investigators propose a multifaceted intervention, comprising: 1) an easy to use and hygienic biodegradable poo catcher compared with the standard faecal immunochemical test kit (enablement) [see Appendix A]; 2) an instruction letter and booklet, with additional information on bowel cancer and screening, provided in English and multiple South Asian languages (enablement and education/information); 3) links to YouTube videos on how to use the biodegradable poo catcher (modelling and persuasion) [see Appendix A].
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Yorkshire
-
Gateshead, Yorkshire, United Kingdom
- Northeast Bowel cancer Screening Hub
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Patients registered with one of 17 participating GP practices in Bradford
- Patients invited for bowel cancer screening during the implementation period
Exclusion Criteria:
- Individuals who are self-referrals
- Type 2 objectors
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Screening
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Enhanced screening kit
Culturally tailored enhanced screening kit, comprising an instruction letter and booklet, and a bio-degradable poo catcher
|
Home Fecal Occult Blood Test kit
Other Names:
|
|
Active Comparator: Usual kit
Screening kit only
|
Home Fecal Occult Blood Test kit
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Return of bowel screening kit for testing
Time Frame: 13 weeks (screening episode)
|
% of individuals who return their bowel screening kit for foecal immunochemical testing measured using data recorded in their clinical records
|
13 weeks (screening episode)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Bowel cancer screening test result
Time Frame: 13 weeks (screening episode)
|
% of individuals who screen positive for the bowel cancer screening test measured using Foecal Immunochemical Test (FIT) result recorded n clinical records
|
13 weeks (screening episode)
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Practicality of implementation of the enhanced kit
Time Frame: 13 weeks (screening episode)
|
Practicality of implementation of the enhanced kit by screening hub staff measured using qualitative interviews
|
13 weeks (screening episode)
|
|
Costs
Time Frame: 13 weeks (screening episode)
|
Costs of implementation of the enhanced kit and its distribution measured using qualitative interviews
|
13 weeks (screening episode)
|
|
Acceptability of implementation of enhanced kit
Time Frame: 13 weeks (screening episode)
|
Acceptability to bowelc cancer screening hub staff of implementation of the enhanced kit measured using qualitative interviews
|
13 weeks (screening episode)
|
Collaborators and Investigators
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- RS213-332905
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Bowel Cancer Screening
-
Morehouse School of MedicineRecruitingColorectal Cancer Screening | Bowel Cleansing for ColonoscopyUnited States
-
Nanfang Hospital, Southern Medical UniversityRecruitingBowel Preparation Solutions | Colonoscopy | Colorectal Cancer ScreeningChina
-
Joseph SpataroHappy Colon FoodsCompletedAssessment of Safety, Quality, and Acceptance of a Bowel Preparation Using a Food Kit With LaxativesBowel Preparation for Colonoscopy | Colon Cancer Screening | Bowel Preparation, Efficacy, Tolerability, SafetyUnited States
-
Sheffield Teaching Hospitals NHS Foundation TrustCompletedAnalgesia | Colonoscopy | Bowel Cancer Screening | EntonoxUnited Kingdom
-
Pamukkale UniversityThe Scientific and Technological Research Council of TurkeyActive, not recruitingCancer Screening | Men's Health ScreeningTurkey (Türkiye)
-
Harvard School of Public Health (HSPH)National Cancer Institute (NCI); Massachusetts League of Community Health Centers and other collaboratorsNot yet recruitingTobacco Cessation | Cervical Cancer Screening | Breast Cancer Screening | Colon Cancer Screening
-
Lanxi Hospital of Traditional Chinese MedicineZhejiang Cancer Hospital; Zhejiang Chinese Medical UniversityWithdrawn
-
Beth Israel Deaconess Medical CenterNational Cancer Institute (NCI)Completed
-
Johns Hopkins UniversityState of MarylandCompleted
-
University of South DakotaNot yet recruitingCervical Cancer ScreeningUnited States
Clinical Trials on Bowel cancer screening kit
-
University of SydneyNational Health and Medical Research Council, AustraliaUnknownColorectal NeoplasmsAustralia
-
Jubaan Ltd.RecruitingColorectal Adenoma | Colorectal Cancer (CRC) | Colorectal Cancer (CRC) ScreeningUnited States
-
Chinese University of Hong KongEnrolling by invitationNeuro-Degenerative DiseaseHong Kong
-
Massachusetts General HospitalUniversity of California, Los Angeles; Stand Up To Cancer; Great Plains Tribal...CompletedColorectal CancerUnited States
-
Braintree LaboratoriesCompletedEndoscopy | Colonoscopy | Bowel PreparationUnited States
-
Braintree LaboratoriesCompletedColonoscopyUnited States
-
University of UtahNational Cancer Institute (NCI); AmeriSpeak - NORCCompleted
-
University of Medicine and Dentistry of New JerseyCenters for Medicare and Medicaid ServicesCompleted
-
University of ArkansasWithdrawnPancreatic Neoplasms | Colorectal Neoplasms, Hereditary Nonpolyposis | BRCA1 Gene Mutation | BRCA2 Gene Mutation | Hereditary Pancreatitis | Ataxia Telangiectasia | Peutz-Jegher's Syndrome | Familial Atypical Mole-Malignant Melanoma SyndromeUnited States
-
Washington University School of MedicineNational Institute on Minority Health and Health Disparities (NIMHD)CompletedOncology | Breast Cancer Screening | Mammography | Preventative MedicineUnited States