Article Text
PDF
Abstract
Objectives We examined the efficacy of case management (CM) interventions to encourage participation in colorectal cancer screening for patients with schizophrenia. This study aimed to clarify patients’ acceptability of the intervention and the helpful components of the intervention. Simultaneously, the study aimed to determine the acceptability, appropriateness and feasibility of the intervention from the perspective of psychiatric care providers.
Study design and setting This study was a secondary qualitative analysis of a mixed-method randomised controlled trial that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. The intervention comprised education and patient navigation for colorectal cancer screening. Interviews were conducted with patients who received the intervention and staff from two psychiatric hospitals in Japan who delivered the intervention.
Participants Of the 172 patients with schizophrenia who participated in the trial, 153 were included. In addition, three out of six providers were included.
Data collection and analysis Using a structured interview, the case manager asked participants about patient acceptability and the helpful components of the intervention. Content analysis was conducted for the responses obtained, and the number of responses was tabulated by two researchers. For the interviews with the providers, opinions obtained from verbatim transcripts were extracted and summarised.
Results Forty-three of the 56 patients perceived that the intervention was acceptable. For the intervention component, inperson counselling with an explanation of the screening process by psychiatric care providers was most frequently reported by the patients as helpful (48 of the 68 respondents). Psychiatric care providers evaluated the intervention as acceptable, appropriate and easy to understand and administer. However, providing the intervention to all patients simultaneously was considered difficult with the current human resources.
Conclusions This study showed that the CM intervention was perceived as acceptable by patients and acceptable and appropriate by psychiatric care providers.
Trial registration number UMIN000036017.
- schizophrenia & psychotic disorders
- qualitative research
- oncology
Data availability statement
Data are available upon reasonable request. The data sets in this study are not publicly available because of the terms of consent to which the participants agreed, but may be available from the corresponding author on reasonable request.
This is an open access article distributed in accordance with the Creative Commons Attribution Non Commercial (CC BY-NC 4.0) license, which permits others to distribute, remix, adapt, build upon this work non-commercially, and license their derivative works on different terms, provided the original work is properly cited, appropriate credit is given, any changes made indicated, and the use is non-commercial. See: http://creativecommons.org/licenses/by-nc/4.0/.
Statistics from Altmetric.com
Strengths and limitations of this study
This study was designed to incorporate a preplanned qualitative study into a randomised controlled trial.
Information related to the implementation of the intervention, as assessed by patients and psychiatric care providers, was organised according to theoretical frameworks.
Acceptability from the patients’ perspective may be overestimated because we only examined the opinions of patients who consented to the randomised controlled trial for cancer screening encouragement.
We did not investigate psychiatric hospitals of all sizes/regions, which limits the generalisability of the present results.
Background
Cancer is a leading cause of death among people with schizophrenia, and cancer mortality in those with schizophrenia is greater than in the general population.1 2 Delayed cancer detection is one factor that contributes to the high cancer mortality rates in this population.3 4 Therefore, there is a crucial need to encourage guideline-recommended screening in patients with schizophrenia.5
A previous study showed disparities in cancer screening among people with schizophrenia.6 7 Moreover, such disparities in cancer screening among people with a mental illness have persisted or become even wider.8 9 Therefore, we developed a case management (CM) approach to encourage participation in cancer screening, with a particular focus on colorectal cancer screening using a faecal occult blood test (FOBT), for patients with schizophrenia in psychiatric outpatient clinics.10 In psychiatric medical settings, CM, which includes planning and coordination of necessary services for community life, is commonly implemented. CM may also include advice on maintaining physical health and referral to appropriate specialists. The present intervention provided education and navigation regarding cancer screening as part of CM in daily clinical practice.
The efficacy of this intervention has been confirmed by a randomised controlled trial (RCT).11 For the next step, it is necessary to confirm the effectiveness of this intervention in routine clinical settings. However, to implement a new intervention in routine clinical practice, it is valuable to determine patients’ acceptability of the intervention and identify components of the intervention that patients perceive as helpful. This is because the intervention is complex and includes personal education and navigation for cancer screening. Furthermore, it is necessary to examine implementation outcomes, such as acceptability, appropriateness and feasibility,12 as perceived by psychiatric care providers.
During this trial, we conducted a preplanned qualitative study to determine the information needed to carry out future implementation research. In this qualitative study, we first aimed to evaluate patients’ acceptability of the intervention, identify helpful components of the intervention and explore the reasons for participation or non-participation in cancer screening. Second, we examined the acceptability, appropriateness and feasibility of the intervention as assessed by psychiatric care providers.
Methods
Study design and participants
This study was a secondary analysis of a mixed-method RCT that evaluated the efficacy of the CM approach to encourage participation in cancer screening for people with schizophrenia. In this RCT, we interviewed study participants and psychiatric care providers who administered the intervention. All participants provided written informed consent prior to enrolment. This study is registered in the University Hospital Medical Information (UMIN) Clinical Trials Registry (UMIN000036017). The protocol of the trial, details of the intervention and the main trial findings have been reported elsewhere.10 11 Therefore, the method of the trial is described briefly.
We recruited patients from two psychiatric outpatient clinics in Okayama City in Japan: the Okayama Psychiatric Medical Center (252 beds and approximately 250 outpatient visits per day) and Zikei Hospital (570 beds and approximately 160 outpatient visits per day). Eligible participants were aged ≥40 years in the 2019 fiscal year, had visited the recruitment sites as their primary psychiatric outpatient service and were outpatients diagnosed by their current primary psychiatrist with schizophrenia or schizoaffective disorder, according to the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition.13 Key exclusion criteria were patients with a history of colorectal cancer, those living in an institution where residents were supported in receiving cancer screening and patients judged to be at risk of symptom worsening by participating in the study.
Patients were randomly assigned to receive usual intervention, which included municipal public education (treatment as usual: TAU group), or an intervention to encourage participation in cancer screening using CM plus TAU (CM plus TAU group).
Cancer screening programme provided by the municipality
In Japan, the Ministry of Health, Labour and Welfare (MHLW) recommends population-based cancer screening for colorectal, gastric, lung, breast and cervical cancer. These screenings are provided by local governments with a low copayment. In this study, we recommended colorectal cancer screening using the FOBT for individuals aged 40 years and older. The cancer screening programme of Okayama City does not mail the FOBT kit in advance. Instead, individuals select a clinic offering cancer screening and make an appointment to visit the clinic to receive the kit. Although individuals with a low household income can receive free screening, eligible individuals must apply for a coupon in advance at the municipal office.
The Okayama municipal government distributes a leaflet and detailed brochure encouraging participation in the above cancer screening programme to all households in the city once a year.
CM intervention to encourage participation in cancer screening
A case manager (nurse or psychiatric social worker) provided three counselling sessions to the study participants allocated to the CM plus TAU group. The CM intervention aimed to educate and navigate patients around colorectal cancer screening.
The first session, which was conducted in person, comprised the following components: (1) education on the importance and content of colorectal cancer screening, using a pamphlet; (2) assistance in making decisions and an appointment for colorectal cancer screening; and (3) assistance in obtaining a coupon for free screening, if necessary. Other cancer screening was also briefly mentioned using the pamphlet. Education on cancer screening using the pamphlet did not take the approach whereby the seriousness or severity of cancer was emphasised.
After the first inperson session, a case manager provided at least two follow-up inperson or telephone counselling sessions to remind or support the patient’s participation in cancer screening. The follow-up session could be skipped if the subject was judged to be able to receive cancer screening without the follow-up sessions. This judgement was made by case managers according to their clinical assessment of the patient’s functioning.
This intervention was standardised in the form of a manual. Psychiatric nurses or social workers who had already worked at the study sites administered the intervention as case managers, according to the procedures described in the manual. The intervention was administered during patients’ outpatient visits. In Japan, the MHLW requires that primary care physicians encourage their patients to undergo cancer screening. The present intervention is consistent with the national policy for cancer screening.
Follow-up interview conducted after the end of the intervention period
After the end of the municipal cancer screening period, qualitative follow-up interviews were conducted with both case managers and study participants between January 2020 and March 2020.
Interviews with patients
In a structured interview, the case manager asked the CM plus TAU group participants about ‘patients’ acceptability of the intervention’, ‘helpful components of the intervention’ and ‘reasons for participation or non-participation in cancer screening’.
For patients’ acceptability of the intervention, patients were asked about ‘affective attitude’, which is one of the components of the theoretical framework of acceptability.14 This theoretical framework was developed according to the overview of systematic reviews focusing on patients’ acceptability of healthcare interventions.14 We selected the affective attitude that was considered most helpful in disseminating the intervention. Patients were asked: ‘how do you feel about this recommendation for cancer screening?’
For helpful components of the intervention, patients were asked to describe the components of the intervention that they perceived as helpful. The interviewer categorised patients’ open-ended responses into the following components of the intervention: assignment of a case manager, explanation of colorectal cancer screening, explanation of the coupon for free screening, planning a schedule for cancer screening and follow-up contact at a later date. Patients were asked: ‘what was helpful in this intervention?’
For reasons for participation or non-participation in cancer screening, patients were asked to describe their reasons for participation or non-participation with an open-ended question. The interviewers categorised patients’ responses into predetermined options, which were based on a Japanese public opinion survey on cancer control,15 and were classified into the following categories based on the health belief model: perceived susceptibility, perceived severity, perceived benefits, perceived barriers, cue to action and self-efficacy.16 Patients were asked: ‘what were your reasons for participating or not participating in colorectal cancer screening?’
The interviewer summarised the content immediately after the responses were obtained and the interviews with patients were not recorded.
Interviews with providers
A group interview was conducted with providers to assess the implementation outcomes of the intervention. Proctor et al17 proposed the implementation outcomes framework, which conceptualises the variables of interest in implementation evaluation. Among the implementation outcomes included in this framework, we investigated ‘acceptability’, ‘appropriateness’ and ‘feasibility’, which were all measurable factors in this study.
Acceptability is defined as the perception among providers that an intervention is agreeable, palatable or satisfactory.12 For ‘acceptability’, providers were asked: ‘what do you think about this intervention in terms of whether it is an agreeable, palatable, or satisfactory intervention?’
Appropriateness is defined as the perceived fit, relevance or compatibility of the intervention for providers.12 In this study, providers were asked: ‘did this intervention meet the objective of improving cancer screening uptake among people with schizophrenia?’ and ‘were the components of the intervention fit for purpose to make the intervention effective?’
Feasibility is defined as the extent to which an intervention can be successfully used or carried out within a given setting.12 In this study, providers were asked: ‘would this intervention be feasible to implement in a routine psychiatric outpatient setting?’
Two case managers who administered the intervention and a psychiatrist who was involved in the recruitment of the subjects participated in this study. One researcher (MFujiw, a psychiatrist with 14 years of clinical experience) acted as the interviewer and facilitated discussions on the ‘acceptability’, ‘appropriateness’ and ‘feasibility’ of the intervention.11 The interview was recorded and a verbatim transcript was produced.
Data analysis
For the analysis of patient responses, those whose self-reports of receiving colorectal cancer screening did not match the municipal records of the screening were excluded from the analysis to improve the validity of the results. For ‘patients’ acceptability of the intervention’, content analysis was performed on patients’ responses described by interviewers. The open-ended responses were coded following a discussion between two researchers (YYa, a psychiatrist with 6 years of clinical experience, and TE, a nurse with more than 10 years of clinical experience), and the number of responses was tabulated according to the codes created. For ‘helpful components of the intervention’, ‘reasons for participation in cancer screening’ and ‘reasons for non-participation in cancer screening’, the open-ended responses obtained from the interviews were categorised into predetermined options by the interviewers. Answers that did not fit into the predetermined options were coded by the same researchers, and the number of responses was tabulated according to the codes created. Responses to ‘patients’ acceptability of the intervention’ and ‘helpful components of the intervention’ were stratified according to whether patients had received cancer screening.
For the data obtained from the interviews with providers, the researcher extracted and summarised the opinions obtained from the verbatim transcripts and asked the interviewees to revise and confirm the summarised descriptions.
Patient and public involvement statement
Patients were not directly involved in the development of the research questions and interventions or in the design of the planned study. We obtained patients’ feedback regarding the intervention in this study. The results of the study will be published on our facilities’ and funder’s website.
Results
Patient enrolment and baseline characteristics
Between 3 June 2019 and 9 September 2019, 172 eligible participants were randomly assigned to either the CM plus TAU group (n=86) or the TAU group (n=86). Eighty participants in the CM plus TAU group (94.1%) and 83 participants in the TAU group (97.6%) took part in the follow-up interview. Of these, self-reports on whether they had received colorectal cancer screening were consistent with the results of the enquiry by Okayama City in 78 participants in the CM plus TAU group and 75 participants in the TAU group. There were inconsistencies between the self-reported results and the city’s records for two participants in the CM plus TAU group and eight participants in the TAU group. The background information of the included 153 participants is shown in table 1. Thirty-nine participants (50.0%) in the CM plus TAU group and one participant (10.0%) in the TAU group received cancer screening. Of these, seven participants in the CM plus TAU group and one in the TAU group required detailed examinations, such as colonoscopy, and all of these participants reported that they had undergone the prescribed detailed examination.
Patient characteristics
Patients’ acceptability and helpful components of the intervention
Table 2 shows the responses obtained from patients regarding their impressions of the intervention. Of the 78 patients in the CM plus TAU group, 56 responded, of whom 30 received colorectal cancer screening and 26 did not.
Patients’ acceptability of the intervention*
Of the 30 patients who underwent colorectal cancer screening, 29 reported that they were satisfied with the encouragement. Specifically, the following comments were made by the participants:
It was very good, please continue next year. —ID 111
I am glad that a polyp was found and treated quickly. —ID 136
Of the 26 patients who did not undergo cancer screening, 14 said they were satisfied with the encouragement. In addition, one patient voluntarily stated that they did not consider it uncomfortable to be encouraged. However, of the patients who did not undergo cancer screening, nine responded that they felt they did not need to undergo screening at the time. Specifically, the following comments were obtained:
It’s not necessary for me, so it doesn’t matter if you explain it to me. —ID 55
Table 3 shows the responses from patients regarding the components of the intervention which were considered helpful. Among the patients in the CM plus TAU group who underwent cancer screening, the most common response was ‘explanation of colorectal cancer screening’, which was deemed helpful by 31 (81.6%) patients. This was followed by ‘assignment of a case manager’ and ‘explanation of the coupon for free screening’, which were considered helpful by 19 (50.0%) and 17 (47.4%) patients, respectively.
Helpful components of the intervention*
Reasons for participation or non-participation in cancer screening
Table 4 shows the responses obtained from patients regarding their reasons for undergoing colorectal cancer screening. The most common response was ‘because it was encouraged in this study’, which was the response of 22 (56.4%) patients. The second most common reason was ‘because I want to prevent cancer/detect cancer early’, which was the response of 16 patients (41.0%). Seven patients (17.9%) answered ‘because I am afraid of cancer’.
Reasons for participation in cancer screening*
Supplemental material
Table 5 shows the responses of patients regarding the reasons for not receiving cancer screening. The most common reason for not receiving cancer screening was ‘because it was bothersome’, given by 13 (33.3%) patients. Other common reasons were ‘I will visit a hospital when necessary’ and ‘lack of knowledge about screening’, which were given by seven (17.9%) and five (12.8%) patients, respectively. For ‘lack of knowledge about cancer screening’, patients made the following comments:
I didn’t receive it because I have good bowel movements. —ID 67
I didn’t receive it because I had already had the screening before, and I thought I didn’t need to take it again. —ID 160
Reasons for non-participation in cancer screening*
Four patients (10.3%) provided the reason ‘failure to receive cancer screening’ and made the following comments:
I misunderstood the period during which the screening was conducted. —ID 75
I was going to see the doctor, but I forgot my coupon for free screening. —ID 4
Acceptability, appropriateness and feasibility of the intervention from the providers’ perspective
The group interviews were conducted with three of the six providers who were involved in the intervention. The providers’ backgrounds were a nurse with 20 years of clinical experience, a psychiatric social worker with 25 years of clinical experience and a psychiatrist with 11 years of clinical experience. The implementation outcomes of ‘acceptability’, ‘appropriateness’ and ‘feasibility’ as assessed by the providers are summarised in box 1.
Acceptability, appropriateness and feasibility of the intervention from the providers’ perspective
Acceptability
It is an acceptable intervention for psychiatric clinics to provide encouragement.
Appropriateness
Maintaining patients’ physical health is one of the roles of psychiatric clinics.
This intervention, which provides explanations and support tailored to each patient, is suited to the aim of enabling people with severe mental illness to have access to cancer screening.
It is worthwhile to encourage and explain cancer screening in person, rather than only providing materials to encourage screening.
It is important to explain to patients about the coupon for free screening. Some patients decided to receive screening after discovering it was available for free or at a low cost.
Most patients were able to make an appointment with the hospital to receive cancer screening by themselves; thus, this intervention was appropriate.
It is essential that the case manager and the patient choose which hospital to receive cancer screening together.
Few patients changed their intentions of receiving/not receiving cancer screening during the follow-up session. Therefore, follow-up sessions may not be necessary for all patients.
Feasibility
The intervention does not require time-consuming training sessions. Once explained, it is possible to administer the intervention in accordance with the procedures.
The intervention procedure could be conducted in routine clinical practice.
The intervention could be administered quickly for patients who have a family physician or a history of receiving cancer screening. As the number of those who have undergone cancer screening increases, the burden on case managers will reduce.
It is difficult to encourage all patients eligible for colorectal cancer screening simultaneously because of limited resources. The impact of the COVID-19 epidemic introduced further difficulties.
It is difficult to conduct follow-up sessions with the same staff member.
Regarding ‘acceptability’, the following comments were made:
There are many patients who think they should receive cancer screening but do not because they did not know much about cancer screening. It is an acceptable intervention for psychiatric clinics to provide encouragement that is tailored to the patient’s functional capabilities. —Psychiatric social worker, 25 years of clinical experience
Regarding ‘appropriateness’, the following comments were made:
Maintaining patients’ physical health is one of the roles of psychiatric clinics. —Psychiatrist, 11 years of clinical experience
It is worthwhile to encourage and explain screening in person. Many patients may not receive screening if they are only given materials to encourage screening. —Nurse, 20 years of clinical experience
It is important to explain about the coupon for free screening. Some patients decided to receive screening after realizing that it was available for free or at a low cost. —Nurse, 20 years of clinical experience
Many patients were able to go through the process on their own after receiving the explanation. It is an appropriate intervention. —Psychiatric social worker, 25 years of clinical experience
During the follow-up sessions, few patients changed their intentions of receiving/not receiving cancer screening or required additional support. Follow-up sessions may not be necessary for all patients. —Psychiatric social worker, 25 years of clinical experience
In terms of ‘feasibility’, the following comments were made:
This intervention will take some getting used to but will not require time-consuming training sessions. Once explained, it is possible to carry out the intervention in accordance with the procedures. —Psychiatric social worker, 25 years of clinical experience
This intervention could be administered quickly for patients who have a history of undergoing cancer screening. As the number of those who have undergone cancer screening increases, the burden on case managers will be reduced. —Psychiatric social worker, 25 years of clinical experience
It is difficult to encourage all eligible patients for colorectal cancer screening at once in terms of human resources. The impact of the COVID-19 epidemic made it even more difficult. —Nurse, 20 years of clinical experience
Discussion
In this study, the CM intervention was evaluated as acceptable by patients. Inperson counselling with an explanation of cancer screening by psychiatric care providers was the most common reason for receiving cancer screening. From the providers’ perspective, the intervention delivered in a psychiatric outpatient setting was perceived as ‘acceptable’ and ‘appropriate’. As was intended when the intervention was developed, the intervention was simple for providers to understand and administer. However, it was difficult to provide the intervention to all patients simultaneously, which presents a challenge to its implementation in routine clinical practice. The results of this study may help implement the CM intervention to encourage participation in colorectal cancer screening in clinical practice.
Patients’ acceptability and helpful components of the intervention
From the patients’ perspective, evaluations of the intervention were mostly positive, which suggested that there is patient demand for this intervention. In addition, few patients, including those who did not receive colorectal cancer screening, reported any discomfort or anxiety about receiving the intervention. This suggests that this intervention method is acceptable to most patients.
Regarding the components of the intervention that were considered helpful, most patients reported that the explanation of the colorectal cancer screening process was helpful. Patients with schizophrenia have barriers to accessing and understanding information about cancer screening and those related to practical issues.18–20 Moreover, many patients may not have been aware of the information distributed by the municipality (ie, the leaflet and brochure) or understood the procedure to receive colorectal cancer screening. The present findings suggest that providing direct and individualised explanations is effective in addressing these barriers.
Reasons for participation or non-participation in cancer screening
The largest proportion of patients stated that being encouraged in this study was the reason for receiving cancer screening. This suggests that the CM intervention acted as an effective cue to undergo cancer screening. This is consistent with a previous finding that physicians’ recommendation of screening is the strongest predictor of patients receiving cancer screening in those with psychiatric disorders.21 Furthermore, as other reasons for receiving screening, numerous patients highlighted the desire for prevention/early detection of cancer and the low cost of cancer screening. This suggests that the intervention was able to address the perceived benefits and barriers of patients with schizophrenia. Few patients responded that fear of cancer was the reason for undergoing colorectal cancer screening. This may be because the intervention did not emphasise the seriousness or severity of cancer. In addition, a significant number of patients answered that they underwent cancer screening because they had done so every year. Therefore, a simple intervention may be sufficient for such patients. It is essential to encourage patients to undergo consistent colorectal cancer screening every year.
In a public opinion survey of the general population in Japan, the most common reason for not receiving cancer screening is ‘lack of time’.16 However, few patients who participated in the present study cited lack of time or financial burden as reasons for not receiving cancer screening. In our study participants, the most common reason for not undergoing colorectal cancer screening was that it was bothersome, although the reasons why patients find cancer screening bothersome were not clarified in our survey. In addition, several patients could not fully appreciate the significance of screening or could not complete the procedure even after receiving the intervention. To overcome barriers to colorectal cancer screening in these patients, implementing system-level measures to enable the distribution of FOBT kits or conducting cancer screening at psychiatric hospitals may be effective.
Acceptability, appropriateness and feasibility of the intervention from the providers’ perspective
The providers who provided the intervention evaluated it as an ‘acceptable’ approach to encourage participation in cancer screening at the psychiatric outpatient clinic. Supporting the physical health of patients with mental illness was considered an important role of psychiatric outpatient clinics, and thus awareness of this issue should be raised within clinics when implementing the intervention.
It was also perceived as ‘appropriate’ to provide patients with tailored navigation on cancer screening procedures. The CM intervention was considered appropriate because many patients reported that they were able to complete the procedure themselves after receiving the individualised intervention. Patient navigation has been gaining interest as an approach to reducing disparities in cancer screening and diagnosis.22 This was an essential component of the CM intervention.
In this study, providers perceived that it was easy to understand the content of and administer the intervention. This suggests that it is likely to be ‘feasible’ for implementing in routine clinical practice. However, there are also challenges to the implementation of the intervention in a clinical setting in terms of resources. In particular, providers considered it would be difficult to deliver the intervention to all eligible patients simultaneously. There are currently insufficient outpatient staff to provide interventions to the large number of outpatients who visit each day. Thus, it may be necessary to adopt strategies according to the resources available at each facility, such as providing the intervention initially to patients within reach and eventually to all individuals.
Limitations
First, the intervention was provided in only two hospitals. In addition, only three staff members with long clinical experience participated in the interviews to evaluate the intervention. Because this study was not conducted across different regions, differently sized psychiatric hospitals or in staff with varied experience, the generalisability of the results may be limited. Second, we only examined the opinions of patients who had consented to participation in the RCT for cancer screening encouragement. This may lead to an overestimation of acceptability from the patients’ perspective due to volunteer bias.23 In addition, patients who did not participate in this study may have more severe psychiatric symptoms than those who did participate, and the feasibility of administering interventions to such patients remains unknown. Third, for the interviews with providers, only three of the six providers involved in the intervention participated. Therefore, the responses obtained in the present study may not be representative of the opinions of the providers at the two facilities. Fourth, regarding patient acceptability, we did not evaluate all seven components that comprise the theoretical framework.14
Conclusion
The most essential component of the CM intervention according to patients was the inperson counselling with an explanation of colorectal cancer screening by psychiatric care providers. From the psychiatric care providers’ perspective, the CM approach to encourage participation in colorectal cancer screening was considered acceptable and appropriate. Although offering the intervention to all patients eligible for cancer screening simultaneously may be difficult, the results indicated that the intervention is easy to understand and administer. Further research, including the development of educational methods for providers, is needed to implement this CM intervention in various psychiatric clinical settings.
Data availability statement
Data are available upon reasonable request. The data sets in this study are not publicly available because of the terms of consent to which the participants agreed, but may be available from the corresponding author on reasonable request.
Ethics statements
Patient consent for publication
Ethics approval
This study involves human participants and was approved by the Okayama University Graduate School of Medicine Dentistry and Pharmaceutical Sciences and the Okayama University Hospital Ethics Committee (approval number: RIN1904-003). Participants gave informed consent to participate in the study before taking part.
Acknowledgments
We thank all the staff of the outpatient service at the Okayama Psychiatric Medical Center and Zikei Hospital for their support in the study and all patients who participated in the study. We also thank Miyuki Kurosaki and Kumiko Seike for their support in data management, Shoko Yoshimoto and Sakura Hino for logistic assistance, and the staff of Okayama City Health Center (Hiroaki Matsuoka and his colleagues) who provided kind suggestions about the study and searched the database for cancer screening records. We thank Sarina Iwabuchi, PhD, from Edanz (https://jp.edanz.com/ac) for editing a draft of this manuscript.
References
Supplementary materials
Supplementary Data
This web only file has been produced by the BMJ Publishing Group from an electronic file supplied by the author(s) and has not been edited for content.
Footnotes
Contributors YYa, MFujiw, TS, MK, TMa, YYo, MFujim, HT, YU and MI developed the intervention procedures. YYa, MFujiw, TS, MK, RS, TMa, YYo, MFujim, HT, NN, TMi, SHi, KH, HO, YU, NY and MI participated in the design of the study. MK, RS, TMa, YYo and SHo conducted the investigation. SHi played a primary role in designing the statistical analysis. YYa, MFujiw and TE conducted the qualitative analysis. TMi played a primary role in designing the data management approach. YYa and MFujiw drafted the manuscript. MI acted as a guarantor for the manuscript. All authors revised the manuscript and approved the final version.
Funding This work was funded by the Research for Promotion of Cancer Control Programs from the MHLW (H30-Cancer Control-general-006 and 21EA1013) and was endorsed by the Japan Supportive, Palliative and Psychosocial Oncology Group (J-SUPPORT) as the J-SUPPORT 1901 study, funded by the National Cancer Center Research and Development Fund (30A-11). This work was also supported by the National Center Consortium in Implementation Science for Health Equity (N-EQUITY), which is funded by the Japan Health Research Promotion Bureau (JH) Research Fund (2019-(1)-4).
Competing interests YYa reports personal fees from Meiji and Sumitomo Dainippon outside the submitted work. MFujiw reports grants from the Japanese MHLW, received during the conduct of the study, and personal fees from Meiji outside the submitted work. TS reports grants from the MHLW, received during the conduct of the study. MK reports grants from the MHLW, received during the conduct of the study. RS reports personal fees from Kagakuhyoronsha, Medical Review, Otsuka, Igaku Shoin and CureApp outside the submitted work. YYo reports personal fees from Otsuka, Janssen and Meiji outside the submitted work. TMi reports grants from the MHLW, received during the conduct of the study. YU reports grants from the MHLW and grants and non-financial support from the Japan Health Research Promotion Bureau and the National Cancer Center Japan, received during the conduct of the study. NY reports grants from the MHLW, received during the conduct of the study; grants and personal fees from Daiichi Sankyo, Eisai and Takeda; and personal fees from Otsuka, MSD, UCB and Sumitomo Dainippon outside the submitted work. MI reports grants from the MHLW, received during the conduct of the study; personal fees from Technomics, Fuji Keizai, Novartis, Pfizer, MSD, Yoshitomiyakuhin, Meiji, Eisai, Otsuka, Sumitomo Dainippon, Mochida, Janssen, Takeda and Eli Lilly; and grants from Otsuka, Eisai, Daiichi Sankyo, Pfizer, Astellas, MSD, Takeda, Fujifilm, Shionogi and Mochida outside the submitted work. All other authors have nothing to disclose.
Patient and public involvement Patients and/or the public were not involved in the design, or conduct, or reporting, or dissemination plans of this research.
Provenance and peer review Not commissioned; externally peer reviewed.
Supplemental material This content has been supplied by the author(s). It has not been vetted by BMJ Publishing Group Limited (BMJ) and may not have been peer-reviewed. Any opinions or recommendations discussed are solely those of the author(s) and are not endorsed by BMJ. BMJ disclaims all liability and responsibility arising from any reliance placed on the content. Where the content includes any translated material, BMJ does not warrant the accuracy and reliability of the translations (including but not limited to local regulations, clinical guidelines, terminology, drug names and drug dosages), and is not responsible for any error and/or omissions arising from translation and adaptation or otherwise.