We hypothesized that a nursing navigator intervention with needs assessment, distress evaluation, and emotional support from diagnosis to follow-up would improve self-efficacy compared with standard care in colorectal cancer. Patients with a physician-verified suspicion of colorectal cancer following colonoscopy were assessed for eligibility. Those who fulfilled inclusion criteria and consented were randomized to either intervention (nurse navigation) or standard care during the following cancer treatment trajectory. Five special educated nurse navigators delivered the intervention. Self-efficacy was assessed using the short form of the Cancer Behavior Inventory questionnaire (CBI-B) at baseline before randomization and at treatment completion or within 1 year at the latest. The group difference between CBI-B changes from baseline to follow-up was assessed in a population-averaged linear regression model employing generalized estimating equations. Of 271 included participants, 222 were completed cases (115 in standard care, 107 in intervention). Based on 4888 observations, self-efficacy under standard care increased by a 2.06 score (CI −0.84; 4.97) and by 6.98 (CI 3.99; 9.97) under intervention. Estimated effect size was 4.92 (CI 0.75; 9.08), which was statistically significant (p = 0.021). Tailored nurse navigation across the course of colorectal cancer treatment significantly increased patients’ self-efficacy.

This study evaluates the usability of outpatient video consultations (VCs) at a major Danish university hospital and examines variations by patient demographics. We conducted a cross-sectional analysis using a Danish translation of the Telehealth Usability Questionnaire (TUQ) among patients invited for VCs across 13 departments at Odense University Hospital (June–December 2023). All scheduled VC patients were automatically sent a questionnaire, including the TUQ and sociodemographic queries. The TUQ assesses overall usability and five domains: usefulness, ease of use, effectiveness, reliability, and satisfaction. Usability scores were analyzed using linear regression models. Of 5262 invited patients, 2424 (46

Background/Objectives: The successful integration of video consultations in routine hospital care requires further research. This study explores how healthcare professionals experienced and engaged with a pilot training program in video consultations (VCs), focusing on patient-centred communication and technical skills. Methods: A qualitative study was conducted at a gynaecological outpatient clinic in a Danish university hospital. In October 2022, healthcare professionals (n = 8) piloted a training program in VCs with patients suffering from gynaecological disorders, followed by semi-structured interviews. Our data analysis was inductive and inspired by thematic analysis, as proposed by Braun and Clarke. Results: Our analysis resulted in an overall theme, namely feasible, with context-dependent considerations, and followed by four other themes:, namely that (1) pre in situ training presents benefits and challenges, (2) consultation via video can be an advantage to consultations via phone or in-clinic, (3) individual planning and organising is a must, and (4) video consultation calls for new competencies. Conclusions: Our study indicates that a training program focusing on patient-centred communication, technical skills and in situ training with peer feedback is relevant when implementing VCs. Visual contact was an advantage of VC versus phone; however, patient triage was identified as essential when planning VCs. Overall, VCs are feasible in a gynaecological outpatient setting when their implementation is supported by an in situ training program and with ongoing technical support available.

Background Colonoscopy is among the standard tests for colorectal cancer (CRC) screening. However, uptake varies, and alternatives such as colon capsule endoscopy (CCE) are available. The uptake and detection rate of clinically significant neoplasia with CCE, compared with colonoscopy, remain unclear in this setting. Objective The primary objective of this study was to compare the detection rates of advanced neoplasia between CCE and colonoscopy, using a pathway in which the study group could choose between the two procedures, while the control group was offered only colonoscopy. Design A randomised, intention-to-treat trial was conducted among Danish CRC screening participants who tested positive with a faecal immunochemical test (FIT). The trial compared the detection rate of advanced neoplasia (primary outcome) and the uptake rate of both approaches between the two arms. Results A total of 473 684 invitations were sent to 396 676 individuals, with 62.6% returning the test. Among them, 11 075 tests were positive (4.5%), with no significant differences between the two study groups. Among FIT-positive cases, the uptake for colonoscopy was 91.1% in the control arm and 91.7% in the study arm, where participants had a choice of methods. In the study arm, 45.8% preferred CCE, 11.4% preferred colonoscopy and 42.8% had no preference and underwent colonoscopy. Ultimately, 69.9% of patients who initially opted for CCE were later referred for colonoscopy. The rate of advanced neoplasia detection was similar between the groups: 0.67% in the study arm versus 0.64% in the control arm. Conclusion Offering CCE as an alternative to colonoscopy did not significantly alter the detection rate of advanced neoplasia, nor did it increase uptake in a screening programme with high adherence to colonoscopy following a positive FIT test. Instead, it led to a very high rate of secondary colonoscopies. Therefore, CCE cannot be recommended in this setting. Trial registration number NCT04049357 (ClinicalTrials.gov)

OBJECTIVES:Significant sociodemographic inequalities in participation in colorectal cancer (CRC) screening programmes across the globe are evident. We aimed to investigate the effect of introducing colon capsule endoscopy (CCE) as a filter test in faecal immunochemical test (FIT)-based CRC screening on overall FIT participation and social inequalities in FIT participation. STUDY DESIGN:We conducted a randomised controlled trial, randomising 368,452 individuals. METHODS:Both groups received an invitation to submit a FIT sample, which elicited a follow-up investigation if ≥ 20 μg haemoglobin/g faeces was detected. The control group followed the standard screening pathway and was referred for follow-up colonoscopy. The intervention group were free to choose between colonoscopy and colon capsule endoscopy. RESULTS:The overall FIT participation proportion was significantly lower in the intervention group (63.4 %), compared to the control group (64.9 %). All sociodemographic subgroups in the intervention group had lower participation proportions than their control group counterpart, with an average of 1.4 (range 0.3-2.7) percentage points lower participation. The odds of non-participation, divided by sociodemographic characteristics, were not significantly different between interventions and controls for any subgroup, except for those aged 55-59 in which the odds ratios for non-participation was 1.59 (1.54-1.65) in the control group and 1.48 (1.43-1.53) in the intervention group, comparing them to those aged above 70. CONCLUSIONS:Introducing a free choice between colon capsule endoscopy and colonoscopy if FIT positive did not increase FIT participation in CRC screening. Further, it did not affect the pattern of social inequalities in FIT uptake.

Background: Social inequalities in colorectal cancer screening participation are evident. Barriers to screening participation include discomfort from diagnostic modalities. We aimed to describe the discomfort experienced from colonoscopy and colon capsule endoscopy (CCE) and investigate the discrepancy between expected and experienced discomfort stratified by socioeconomic status. Methods: A randomised controlled trial was conducted offering half of the colorectal cancer screening invitees the choice between CCE and colonoscopy after a positive faecal immunochemical test. This paper includes those who elected to undergo CCE. A positive CCE elicited referral for a therapeutic colonoscopy. Participants reported their discomfort from CCE and from any following colonoscopies in electronically distributed questionnaires. Discomfort was measured using visual analogue scales and compared between socioeconomic subgroups determined by educational level and income. Results: The experienced discomfort from CCE and colonoscopy differed significantly between educational levels but not income levels. The bowel preparation contributed the most to the experienced discomfort in both CCE and colonoscopy. The discrepancy between expected and experienced discomfort from colonoscopy increased with increasing educational and income levels. A similar trend was seen in CCE between educational levels but not income levels. Conclusions: None of the results indicated a higher discomfort in lower socioeconomic subgroups. Regardless of the investigation modality, the bowel preparation was the main contributor to experienced discomfort. The discrepancy between expected and experienced discomfort did not seem to be larger in lower socioeconomic subgroups, indicating that this is not a major barrier causing inequalities in screening uptake. This is the first study investigating individual discomfort discrepancy in both CCE and colonoscopy, while being able to stratify by socioeconomic status.

Individual income and educational level are associated with participation rates in colorectal cancer screening. We aimed to investigate the expected discomfort from the endoscopic diagnostic modalities of colonoscopy and colon capsule endoscopy in different socioeconomic groups as a potential barrier for participation. In a randomized clinical trial within the Danish colorectal cancer screening program, we distributed questionnaires to 2031 individuals between August 2020 and December 2022 to investigate the expected procedural and overall discomfort from investigations using visual analogue scales. Socioeconomic status was determined by household income and educational level. Multivariate continuous ordinal regressions were performed to estimate the odds of higher expected discomfort. The expected procedural and overall discomfort from both modalities were significantly higher with increasing educational levels and income, except for procedural discomfort from colon capsule endoscopy between income quartiles. The odds ratios for higher expected discomfort increased significantly with increasing educational level, whereas the differences between income groups were less substantial. Bowel preparation contributed most to expected discomfort in colon capsule endoscopy, whereas in colonoscopy, the procedure itself was the largest contributor. Individuals with prior experiences of colonoscopy reported significantly lower expected overall but not procedural discomfort from colonoscopy. The threshold for acceptable discomfort between subgroups is unknown, but the expected discomfort in colon capsule endoscopy and colonoscopy was higher in higher socioeconomic subgroups, suggesting that expected discomfort is not a significant contributor to the inequalities in screening uptake.

Objective To estimate the risk of interval colorectal cancer (CRC) in faecal immunochemical test (FIT) negative screening participants according to socioeconomic status. Design In this register-based study, first round FIT negative (<20 µg hb/g faeces) screening participants (biennial FIT, citizens aged 50–74) were followed to estimate interval CRC risk. Multivariate Cox proportional hazard regression models estimated HRs based on socioeconomic status defined by educational level and income. Models were adjusted for age, sex and FIT concentration. Results We identified 829 (0.7‰) interval CRC in 1 160 902 individuals. Interval CRC was more common in lower socioeconomic strata with 0.7‰ for medium-long higher education compared with 1.0‰ for elementary school and 0.4‰ in the highest income quartile compared with 1.2‰ in the lowest. These differences did not translate into significant differences in HR in the multivariate analysis, as they were explained by FIT concentration and age. HR for interval CRC was 7.09 (95% CI) for FIT concentrations 11.9–19.8 µg hb/g faeces, and 3.37 (95% CI) for FIT between 7.2 and 11.8 compared with those <7.2. The HR rose with increasing age ranging from 2.06 (95% CI 1.45 to 2.93) to 7.60 (95% CI 5.63 to 10.25) compared with those under 55 years. Conclusion Interval CRC risk increased with decreasing income, heavily influenced by lower income individuals more often being older and having increased FIT concentrations. Individualising screening interval based on age and FIT result, may decrease interval CRC rates, reduce the social gradient and thereby increase the screening efficiency.

Purpose: To investigate whether the prokinetic prucalopride increases the completion rate of colon capsule endoscopy (CCE). Secondary outcomes included demographic distribution, polyp detection rate (PDR), distribution of Leighton-Rex grade, and adverse events. Patients and Methods: In a nested cohort within the CareForColon2015 trial, a subgroup of 406 individuals underwent CCE in 2021. The first half (control) received the standard bowel preparation and the second half (prucalopride) was supplemented with 2 mg of prucalopride. Transit times and bowel preparations were analyzed and completion rates calculated as those having timely transit and acceptable bowel cleanliness. Major adverse events were recorded continuously and minor adverse events were quantified from questionnaires. Results: The group demographics were homogenous. The prevalence ratio for complete CCE was 1.32 (CI 95% 1.15; 1.53) in the prucalopride group compared to the control group. Completion rate was 74.9% in the prucalopride group and 56.7% in the control group. The proportions of acceptable bowel preparation and complete transits were higher in the prucalopride group. The mean CCE transit time was 2 hours and 8 minutes faster in the prucalopride group. The PDR was higher in the intervention group with 55.7% compared to 36.0% in the control group for polyps greater than 9 mm, whereas the groups' PDRs were similar for small and diminutive polyps. In all, 589 polyps (mean 2.9) were found in the prucalopride group compared to 522 polyps (mean 2.6) in the control group. Conclusion: Prucalopride led to an increase in CCE completion rates. The proportions of complete transits and acceptable bowel preparations were higher in the prucalopride group. The PDR was higher in the prucalopride group compared to the control group. No major adverse events were identified. Nausea, diarrhea, headache and fatigue were more commonly reported in the prucalopride group.

Purpose: To investigate whether the prokinetic prucalopride increases the completion rate of colon capsule endoscopy (CCE). Secondary outcomes included demographic distribution, polyp detection rate (PDR), distribution of Leighton–Rex grade, and adverse events. Patients and Methods: In a nested cohort within the CareForColon2015 trial, a subgroup of 406 individuals underwent CCE in 2021. The first half (control) received the standard bowel preparation and the second half (prucalopride) was supplemented with 2 mg of prucalopride. Transit times and bowel preparations were analyzed and completion rates calculated as those having timely transit and acceptable bowel cleanliness. Major adverse events were recorded continuously and minor adverse events were quantified from questionnaires. Results: The group demographics were homogenous. The prevalence ratio for complete CCE was 1.32 (CI 95% 1.15; 1.53) in the prucalopride group compared to the control group. Completion rate was 74.9% in the prucalopride group and 56.7% in the control group. The proportions of acceptable bowel preparation and complete transits were higher in the prucalopride group. The mean CCE transit time was 2 hours and 8 minutes faster in the prucalopride group. The PDR was higher in the intervention group with 55.7% compared to 36.0% in the control group for polyps greater than 9 mm, whereas the groups’ PDRs were similar for small and diminutive polyps. In all, 589 polyps (mean 2.9) were found in the prucalopride group compared to 522 polyps (mean 2.6) in the control group. Conclusion: Prucalopride led to an increase in CCE completion rates. The proportions of complete transits and acceptable bowel preparations were higher in the prucalopride group. The PDR was higher in the prucalopride group compared to the control group. No major adverse events were identified. Nausea, diarrhea, headache and fatigue were more commonly reported in the prucalopride group.

Aims To compare participation rates for fecal immunochemical test (FIT) prior to offering colon capsule endoscopy (CCE) or colonoscopy with controls offered only colonoscopy as follow-up to positive FIT, and to analyze the choice of screening method in the intervention group within the large randomized clinical trial CareForColon2015[ 1 ].

Based on literature search and discussions among clinician-scientists, ideas of effect types were specified and outcomes selected, notably self-efficacy. Bandura’s theory of self-efficacy states: your judgement of own ability to meet challenges increase, if you or a known another has overcome similar situations, if you have relevant knowledge, and/or significant others trust your abilities(1). Discussions with lay-persons allowed us to transform the theory to actions, and pilot-audit it.

Background and study aims The Danish CareForColon2015 trial, launched in 2020 as part of the Danish Colorectal Cancer Screening program, is the largest randomized controlled trial to date on colon capsule endoscopy (CCE). This paper presents the interim analysis with the objective of ensuring the safety of patients in the intervention group and evaluating the clinical performance of the trial's predefined clinical parameters. Patients and methods We evaluated the initial 234 CCEs according to quality, safety, and completion. The participation rates and preference distribution of all individuals invited were analyzed and sample size calculations were adjusted. Results Fecal immunochemical test and diagnostic participation rates were 62.1% and 91.1%, respectively. The completion rate for CCEs was 67.9% and the rate of conclusive investigations was 80.3%. The polyp detection rate (PDR) was high (73.5%), only two (0.85%) technical failures in 234 videos were observed, and six suspected cancers were identified (2.6%). No major adverse events were recorded. The required number of invitations had been underestimated due to inaccurate assumptions in sample size calculations. Conclusions The trial was efficient and safe in terms of CCE quality and time to diagnostic investigation. Participation rates and PDRs were high. The proportion of suspected cancers was lower than expected and will be followed. The completion rate for CCEs was acceptable but lower than expected and the CCE procedure was reviewed for potential improvements and Resolor was added to the regime. The number of invitations for the intervention group of the trial has been adjusted from 62,107 to 185,153.

Main Objective: Continuously support and coordination of psychosocial care to patients, added to usual care in whole cancer trajectories will better support patient self-efficacy, than will usual care. Participants: Patients in the diagnostic period of colorectal cancer. Methods: In a randomized controlled trial, 280 Danish patients will be assigned to one of two groups. 1) Usual care: Patient-centered and performed by nurses and secretaries, who can answer department specific questions. They work in separate relevant hospital units. 2) Usual care plus intervention: An additional offer of one or two nurse navigators to follow patients throughout the whole cancer trajectory. Nurse navigators offers a family-centered approach targeting patient selfefficacy by assessment of distress and unmet needs, and intelligent integration of psychosocial care activities from hospitals, primary care, spiritual and social care, not-for-profit organizations, and families. Data is collected with questionnaires. The primary outcome measure is change in patients’ self-efficacy for cancer. Secondary outcomes are unmet needs, continuity of care, health related quality of life and nurse navigation time spent. The adjustment of the intervention after pilot test is reported. Conclusion: The study will be performed in primarily low and middle-income areas in Denmark, and as the intervention is complex, the underlying evidence based theories will serve for good guesses of causal processes. If positive results, we will be able to further advise the clinic in their efforts to reach a goal of optimal support in cancer trajectories.

Introduction The use of capsule endoscopy has become an approved method in small bowel diagnostics, but the same level of integration is not seen in large bowel diagnostics. We will use colon capsule endoscopy (CCE) as a filter test in colorectal cancer (CRC) screening between the faecal immunochemical test (FIT) and colonoscopy. We aim to investigate the clinical performance, population acceptability, and economic implications of the procedure in a large-scale clinical trial. Methods and analysis We will randomly allocate 124 214 Danish citizens eligible for participation in the national CRC screening programme within the Region of Southern Denmark to either an intervention group or a control group. Prior to submitting a FIT, citizens randomised to the intervention group will be informed about their opportunity to undergo CCE, instead of colonoscopy, if the FIT is positive. Suspected cancers; >3 adenomas <10 mm in size, 1 adenoma >10 mm in size or >4 adenomas regardless of size, detected during CCE will generate an invitation to colonoscopy as per regular screening guidelines, whereas citizens with suspected low risk polyps will re-enter the biennial screening programme. Citizens with no CCE findings will be excluded from screening for 8 years. In the control group, citizens will follow standard screening procedures. Ethics and dissemination All participants must consent prior to capsule ingestion. All collected data will be handled and stored in accordance with current data protection legislation. Approvals from the regional ethics committee (ref. S-20190100) and the Danish data protection agency have been obtained (ref. 19/29858). Trial registration details The study has been registered with ClinicalTrials.gov under: NCT04049357.

Background: The standard investigation in colorectal cancer screening (optical colonoscopy [OC]) has a less invasive alternative with the colon capsule endoscopy (CCE). The experiences of screening individuals are needed to support a decision aid (DA) and to provide a patient view in future health technology assessments (HTA). We aimed to explore the experiences of CCE at home and OC in an outpatient clinic by screening participants who experienced both investigations on the same bowel preparation. Methods: In a mixed methods study, Danish screening individuals with a positive immunological fecal occult blood test (FIT) were consecutively included and underwent both CCE and OC in the same bowel preparation. They answered questionnaires about discomfort during CCE, delivered at home, and during a following OC in the outpatient clinic. Data were calculated in percentages and Wilcoxon signed rank test was used for comparisons. Among the 253 included patients, 10 participants were selected for a semi-structured interview about their experiences of the two examinations. The analysis and interpretation of the transcribed data were inspired by Ricoeur. Results: Questionnaire data were received from 239 participants and revealed significant less discomfort during the CCE than the OC. Interview data included explained discomfort elements in two categories: 'The examination' and 'The setting'. Compared to OC, the CCE was experienced with less pain, embarrassment and invasiveness, but presented challenges and disadvantages as well, i.e., a large camera capsule to swallow, a longer waiting time for test results after CCE and an additional OC, if pathologies were found. The home setting for CCE delivery made the participants feel less like they were ill or patients less restricted and that they received more personal care, but could induce technical challenges. Conclusion: In screening individuals, CCE at home was associated with significantly less discomfort compared to OC at a hospital, and multiple reasons for this was identified.