Acta Oncol. 2019;58(sup1):S71-S76. doi: 10.1080/0284186X.2019.1581372.

Screening individuals’ experiences of colonoscopy and colon capsule endoscopy; a mixed methods study

Marianne K. Thygesena,b, Gunnar Baatrupa,b, Christina Petersena, Niels Qvista,b, Rasmus Kroijera,b and Morten Kobaek-Larsenb

aSurgery Department A, Odense University Hospital, Odense, Denmark; bFaculty of Health Sciences, Clinical Institute, University of Southern Denmark, Odense, Denmark.

 

Abstract

Background: The standard investigation in colorectal cancer screening (optical colonoscopy [OC]) might have a less invasive alternative in the colon capsule endoscopy (CCE). The experiences from 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 in 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 the experiences from 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 during 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 ill or less restricted and that they received more personal care, but the setting 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.

PMID: 30821625

 

 

Supplement:

Deding U.a,b, Baatrup, G. a,b and Thygesen, M.K. a,b

a. Department of Clinical Research, University of Southern Denmark, Odense, Denmark

b. Department of Surgery, Odense University Hospital, Odense, Denmark.

 

Colorectal screening interventions are widely implemented internationally as a prevention strategy against colorectal cancer. In Denmark, colorectal cancer screening consists of a fecal immunochemical test (FIT), followed by optical colonoscopy if FIT the value exceeds 100 ng/mL buffer. Generally, screening populations do not have symptoms of colorectal cancer and screening has resulted in high numbers of negative procedures performed in individuals, with a positive FIT. Endoscopy will not reveal abnormalities in approximately four out of ten individuals. The procedure is often experienced as distressing, painful and humiliating (1), and hol­ding risks of adverse events (2, 3).

Colon capsule endoscopy (CCE) is an alternative procedure to examine the colon. Although it is only a diagnostic tool, which cannot perform biopsies or therapeutic actions, it may be of benefit in screening populations as a filter test. The capsules find more polyps than OC, especially in the right side of the colon (4), and the procedure holds very low risk of major complications. Moreover, it presents low level of discomfort, i.e. in a sample of 253 individuals undergoing both investigation types, only 1 (0.4%) individual reported a high level of discomfort when using the capsule, whereas 70 (27.2%)  felt high degree of discomfort from colonoscopy (fig. 1) (5).

 

 

Fig 1: Distribution of discomfort levels in individuals undergoing colon capsule endoscopy followed by optical colonoscopy, n=253.

 

Amongst these participants, ten individuals were selected at random and were interviewed with semi structured interview technique about their experiences with the two examinations. Results from these interviews revealed several differences and both advantages and disadvantages to the procedures. Advantages to colonoscopy were the therapeutic options and the immediate result of the investigation. Disadvantages included the pain level, embarrassment and invasiveness. Advantages to colon camera endoscopy included the minor pain level, the reduced feeling of invasiveness and no embarrassment. Disadvantages included worrying while waiting for test result in up to three days after capsule excretion, longer investigation time and additional colonoscopy if therapeutic measures were needed. The setting of the two investigation types were also perceived differently by participants. Disadvantages of the hospital colonoscopy setting were experiences of being ill, minor experiences of personal care, and more restriction (e.g. no private restroom, difficulties with transportation, and time away from other duties). Disadvantages of the examination at home with the camera capsule were, before instruction in the technique, a short period of minor apprehension of incompetency, due to thought of being left alone with the equipment. Advantages of the home capsule setting were lesser experience of being ill and less restriction (e.g. with a private restroom, no transportation, and can continue duties at home.). No advantages of the hospital setting were mentioned in the interviews.

 

Large scale investigation

It is still unknown, which examinations of colon and rectum are preferred by the screening population, and why they make their choices. In order to confirm and explore the above mentioned results further, large scale studies are needed. In the autumn of 2019 we will launch the randomized controlled trial CareForColon2015. The study is registered at ClinicalTrials.gov (Identifier. NCT04049357). It is the largest RCT regarding camera capsules internationally to this date. In the regional colorectal cancer screening program in Denmark, 124.214 individuals will be randomly allocated into a control group and receive normal screening offer, or into an intervention group, where they will get a choice of examination with camera capsule or colonoscopy, if FIT test is positive. The setting for those examined with the camera capsule will differ from previous investigations. Those who accept this type of examination will receive a bowel preparation kit in order to complete the preparation at home. Moreover, they will be able to stay at home, when the colon and rectum is examined, but in this new trial, participants will go to one of four capsule hand-out locations and first leave from there, when the capsule has left the stomach. Further, only in case of significant findings, the patient will undergo a following colonoscopy.

 

Screening individuals’ expectations, experience and preferences

We will ask participants in CareForColon2015 to fill in three questionnaires in a longitudinal fashion following their screening trajectory. Here we take the opportunity to explore in deeper details, patient preferences and experiences in a screening setting, and we will collect data on demographics, baseline characteristics, health behavior, bowel preparation adherence, expectation and later experience of the examinations, experienced major and minor complications and adverse events. This could be events such as bloating, abdominal pain and discomfort, but also events such as absence from work or social gatherings.  We expect to get data from so many, that we will be able to examine what contribute to peoples’ choice of examination type and what characterize those cases, where experienced discomfort actually mirrored the expected discomfort and vice versa. Moreover, we will estimate the total costs of the two examinations, including costs for screening individuals, the hospitals, and the society in general.

 

Implications

If findings from the previous study are confirmed in the large scale RCT, it may hold numerous implications. It will then be possible to offer people a screening of the colon and rectum with low level of discomfort, and few adverse events and complications. By investigating specific population profiles’ expectations, experiences and preferences, we will be able to give generalizable characteristics of those, who will benefit the most from a specific examination method. Such results, plus the results from our mixed-method study of former screening individuals will be useful information for clinicians and screening individuals, if a choice between more methods should be realized. If the camera capsule still performs well, it might then be a candidate to become a more general offer in the colorectal cancer screening context. In the current screening program, social inequalities exist in both FIT participation (6) and participation in further examination following positive FIT (7), i.e. those with low socioeconomic status do not participate as frequent in screening for colorectal cancer, as does those with higher socioeconomic status. If colonoscopy or its following complications or adverse events is identified as a barrier in low socioeconomic status subgroups, the offer of a personal choice between more examination types including camera capsule, might increase screening uptake. This, in turn, might very well, for some years, increase the prevalence of curable early stage colorectal cancers. In this way a higher screening uptake in the non-participant group might decrease social inequalities in colorectal cancer screening. We expect the CareForColon2015 study to include patients in 1 – 2 years.

 

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