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Lynch syndrome, an inherited condition, increases bowel cancer risk. People with Lynch syndrome are recommended to have regular colonoscopies where a camera in a tube is used to look inside the bowel for cancer and for polyps (growths that sometimes can become cancerous). UK guidelines recommend that people with Lynch syndrome have colonoscopy check-up every 2 years after reaching a certain age; however, they face many challenges which make it difficult to have the recommended check-up.
Among a subset of people with Lynch syndrome in England, this study investigated the:
This study collected information from people in the 'Lynch syndrome research registry pilot' using a questionnaire. The Cancer Screening and Prevention Research Group (CSPRG) at Imperial College London set up the Lynch syndrome research registry pilot, which included adults with Lynch syndrome who had previously participated in the Cancer Prevention Programme 3 (CaPP3) trial.
The present study included people who took part in the Lynch syndrome research registry pilot, provided consent to be contacted about future research, and were aged ≥25 years. People who had undergone surgery to remove their rectum were excluded.
The investigators used the 'Views, experiences, and challenges of colonoscopy check-up questionnaire', together with a few pieces of additional information previously collected as part of the Lynch syndrome research registry pilot.
Participation involved completing the questionnaire only. The study was completed over approximately one year from administering the questionnaire in January 2024 to sharing results with participants in December 2024.
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| Measure | Description | Time Frame |
|---|---|---|
| Participant Non-adherence to 2-yearly Colonoscopy Check-up. | Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage. | Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion. |
| Measure | Description | Time Frame |
|---|---|---|
| The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants. | The 4 most important challenges to having colonoscopy check-up were identified using participants' responses in the questionnaire. The questionnaire asked participants to select up to 4 challenges they considered most important from a given list of 41 challenges. The 4 challenges most frequently selected by participants were considered the most important. The results show, for each challenge, the number and proportion of participants who selected it as one of their biggest challenges. As participants could select more than one challenge, the counts and percentages for individual challenges do not sum to the total number of participants and 100%, respectively. |
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Inclusion Criteria:
Exclusion Criteria:
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This study included people who were in the Lynch syndrome research registry pilot and who met the eligibility criteria for the present study.
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| Name | Affiliation | Role |
|---|---|---|
| Amanda J Cross, PhD | Imperial College London | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Cancer Screening and Prevention Research Group (CSPRG), Department of Surgery and Cancer, Queen Elizabeth The Queen Mother (QEQM) Building, St Mary's Hospital, Imperial College London | London | W2 1NY | United Kingdom |
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Of the 257 people in the registry pilot, seven were excluded at the initial participant eligibility assessment. The remaining 250 people were invited to take part in the present study, of whom 19 were subsequently excluded, either because the investigators were informed after invite that they met the exclusion criteria or because they did not respond to the questionnaire. This left 231 participants (92% of invitees). Participants were not assigned to any group or intervention.
Participants were recruited from the Lynch syndrome research registry pilot between 17 January 2024 and 4 April 2024.
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| ID | Title | Description |
|---|---|---|
| FG000 | All Study Participants | All participants with Lynch syndrome included in the present study |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | All Study Participants | All participants with Lynch syndrome included in the present study |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Participant Non-adherence to 2-yearly Colonoscopy Check-up. | Participant non-adherence to 2-yearly colonoscopy check-up was assessed using data from the national Hospital Episode Statistics (HES) database. Non-adherence was calculated based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies, depending on data availability, and the interval between participants' most recent check-up colonoscopy and questionnaire completion. Colonoscopy data recorded between December 1995 (when the earliest colonoscopy was recorded in the HES extract) and April 2024 (the final month in which participants completed the questionnaire) were used. Participant non-adherence was reported as a percentage. | The number here differs from the total number of participants because only those who had a past/current cancer recorded in national cancer registry data were included in the analysis of non-adherence with 2-yearly colonoscopy check-up; data on check-up colonoscopies from the HES database were available only for these participants. Additionally, participants had to have had at least 2 recorded check-up colonoscopies to be included in this analysis. | Posted | Count of Participants | Participants | Up to approximately 13 years (median 5 years), based on the interval(s) between participants' 2 or 3 most recent check-up colonoscopies and the interval between participants' most recent check-up colonoscopy and questionnaire completion. |
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All-Cause Mortality, Serious Adverse Events, and Other Adverse Events were not assessed for participants.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | All participants with Lynch syndrome included in the present study |
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Participants were receiving care at four of the best centres for Lynch syndrome in England. We were able to analyse information on check-up colonoscopies only for participants who had a past or current cancer. Data for this study were largely collected before colonoscopy check-up for people living with Lynch syndrome in England moved to the national Bowel Cancer Screening Programme.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr Emma Robbins | Imperial College London | +44 20 7594 3021 | 43021 | e.robbins@imperial.ac.uk |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Sep 7, 2023 | Mar 23, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003123 | Colorectal Neoplasms, Hereditary Nonpolyposis |
| ID | Term |
|---|---|
| D015179 | Colorectal Neoplasms |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
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| At time of questionnaire (1 day) |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Race/Ethnicity, Customized | Count of Participants | Participants |
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| Site | Participants were receiving care at one of 4 sites in England; we randomly assigned each of the sites a letter from A to D. | Count of Participants | Participants |
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| Secondary | The 4 Most Important Challenges to Having Colonoscopy Check-up for Participants. | The 4 most important challenges to having colonoscopy check-up were identified using participants' responses in the questionnaire. The questionnaire asked participants to select up to 4 challenges they considered most important from a given list of 41 challenges. The 4 challenges most frequently selected by participants were considered the most important. The results show, for each challenge, the number and proportion of participants who selected it as one of their biggest challenges. As participants could select more than one challenge, the counts and percentages for individual challenges do not sum to the total number of participants and 100%, respectively. | Posted | Count of Participants | Participants | At time of questionnaire (1 day) |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D009386 | Neoplastic Syndromes, Hereditary |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 'I feel anxious when I think about having a colonoscopy' |
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