Efficacy of screening using annual fecal immunochemical test alone versus combined with one-time colonoscopy in reducing colorectal cancer mortality: the Akita Japan population-based colonoscopy screening trial (Akita pop-colon trial).

PURPOSE: Screening programs using fecal occult blood testing help reduce mortality from colorectal cancer (CRC). Colonoscopy and colonoscopy combined with fecal occult blood testing are considered alternatives with higher sensitivity than fecal tests; however, to our knowledge, randomized controlled trials (RCTs) providing such evidence have not been reported. Therefore, this study aimed to compare screening using the fecal immunochemical test (FIT) combined with colonoscopy and FIT alone to evaluate the efficacy of colonoscopy screening in reducing CRC mortality. METHODS: This multicenter, prospective, randomized, controlled study included average-risk individuals for CRC living in the study areas and aged 40-74 years. The exclusion criteria were history of CRC, hereditary non-polyposis CRC, familial adenomatous polyposis, inflammatory bowel diseases, history of cancer other than CRC within the past 5 years, and not expected to survive from comorbid illness. The intervention group underwent one-time colonoscopy and annual FIT, while the control group underwent annual FIT. The primary endpoint was mortality from CRC, while the secondary endpoints were cumulative incidence of invasive CRC, advanced CRC (invasion into the muscle layer or deeper), invasive cancer and screening sensitivities and specificities of invasive CRC, whole CRC, advanced neoplasia, and prevalence of adverse events. The intervention and control groups comprised 4876 and 4875 participants, respectively. CONCLUSION: This explanatory RCT evaluated the efficacy of colonoscopy screening by valid statistical inference based on randomization. Data on adverse events from this kind of screening are necessary when considering implementation of future screening programs. TRIAL REGISTRATION: UMIN Clinical Trials Registry, number UMIN000001980.

Correction to: Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.

An amendment to this paper has been published and can be accessed via the original article.

How long should we continue gastric cancer screening? From an epidemiological point of view.

BACKGROUND: In Japan, incidence of gastric cancer is expected to follow the current downward trend as the younger generation has lower incidence of Helicobacter pylori infection. In this study we aimed to estimate how long gastric cancer screening is deemed necessary in the future from epidemiologic perspectives. METHODS: Following the Japanese guidelines for gastric cancer screening 2014, recommendation of providing population-based gastric cancer screening is judged by balancing benefits and harms. Benefits and harms are estimated by number needed to screen (NNS) < 1000 and Number Needed to Recall (NNR) < 100. NNS is the number of people required to participate in a screening to prevent one death and NNR is the number of people required to undergo diagnostic examination to prevent one death. These index are estimated for 2020-2035 using future projections of gastric cancer mortality for the scenarios of relative risk (RR) of 0.5-0.9 for mortality reduction by the screening. RESULTS: The criteria of both NNS < 1000 and NNR < 100 are fulfilled for the following age groups: when RR is set as 0.6, men ≥ 55 and women ≥ 65; when RR is set as 0.7 and 0.8, men ≥ 65 and women ≥ 75; when RR is set as 0.9, men ≥ 75 only. CONCLUSIONS: In case of RR of 0.5 and 0.6, the gastric cancer screening are recommended for men ≥ 55 and women ≥ 65 until 2035, while it is not recommended for men and women in the 45-54 even in 2010 and 2015.

ROK study-C (Rainbow of KIBOU study-colorectum): a colorectal cancer survivor cohort study on food, nutrition, physical activity, psychosocial factors and its influences on colorectal cancer recurrence, survival and quality of life in Japan.

BACKGROUND: Many studies have shown that lifestyle factors such as diet, physical activity are related to the incidence of cancer. However, there are few studies on the association between lifestyle factors and cancer prognosis. To investigate the influence of lifestyle factors and psychosocial factors on prognosis, we started a prospective study of women with breast cancer, the Rainbow of KIBOU study-Breast (ROK Study-B) in 2007. As of February 2018, more than 6300 women have been enrolled, thus making this one of the world's largest cancer patient cohort studies. Based on the know-how obtained from this study, we started another new cohort study for colorectal cancer patient (ROK Study-C). METHODS: The ROK Study-C is a prospective observational study for colorectal cancer survivors at the National Cancer Center Hospital. Participants fill in several self-administrated questionnaires about lifestyle, psychosocial factors (including posttraumatic growth and benefit finding, support), and quality of life (QOL) 5 times in total: at diagnosis, 3 and 6 months, 1 and 5 years after surgery. CT-scans will be collected to assess body composition and obesity. We also use blood and cancer tissue from the Biobank. The primary endpoint is disease-free survival. The secondary endpoints are overall survival and health-related QOL. The planned sample size is 2000 and the follow-up period is 5 years after the last enrollment. DISCUSSION: Recruitment began in December 2015 and the study is still ongoing. The ROK Study-C will contribute to improvements in patient prognosis and yield important evidence for colorectal cancer survivorship.

Tailored message interventions versus typical messages for increasing participation in colorectal cancer screening among a non-adherent population: A randomized controlled trial.

BACKGROUND: The purpose of this study was to examine the effectiveness and cost-efficiency of a tailored message intervention compared with a non-tailored message intervention for increasing colorectal cancer (CRC) screening rates among a non-adherent population, in a community-based client reminder program. METHODS: After a baseline survey for psychological segmentation, 2140 eligible individuals were randomly assigned either to a group with a tailored matched-message condition (N = 356), a group with a non-tailored unmatched-message condition (N = 355), or to two control groups, one using a typical message with a professional design (N = 717) and one without a professional design (N = 712). The main outcome measure was attendance rates in a community-organized CRC screening program within five months of receiving a print reminder. RESULTS: There was a significant difference in fecal occult blood test (FOBT) attendance rates at follow-up assessments between the tailored matched-message condition (14.0 %) and the control (9.9 %; OR = 1.48, p = 0.026), while there was no significant difference between the unmatched-message condition (11.0 %) and the control (OR = 1.12, p = 0.558), and between the matched-message condition and the unmatched-message condition (OR = 1.32, p = 0.219). The cost of a one-person increase in FOBT screening was 3,740 JPY for the tailored matched-message condition, while it was 2,747 JPY for the control. CONCLUSIONS: A tailored-message intervention for segmented individuals designed to increase CRC screening rates in a community-based client reminder program was significantly effective compared to a usual reminder, but not more effective than an unmatched message in a randomized controlled trial, and was not sufficiently effective to highlight its value from a cost perspective. Therefore, the tailored intervention including target segmentation needs to be improved for future implementation in a CRC screening program for a non-adherent population. TRIAL REGISTRATION: UMIN Clinical Trials Registry UMIN000004384 . Date of Registration: March 2011.

Impact of modifiable lifestyle factors on outcomes after breast cancer diagnosis: the Setouchi Breast Cancer Cohort Study.

The primary purpose of this large cohort study is to investigate the effects on breast cancer outcomes of modifiable lifestyle factors after breast cancer diagnosis. These factors include physical activity, smoking, alcohol consumption, obesity and weight gain after diagnosis, alternative medicine and dietary factors. Women diagnosed with Stage 0 to III breast cancer are eligible for participation to this study. Lifestyle, use of alternative medicine, psychosocial factors, reproductive factors and health-related quality of life will be assessed using a questionnaire at the time of breast cancer diagnosis (baseline), and 1, 2, 3 and 5 years after diagnosis. Clinical information and breast cancer outcomes will be obtained from a breast cancer database. The primary endpoint will be disease-free survival. Secondary endpoints are overall survival, health-related quality of life, breast cancer-related symptoms and adverse events. Patient recruitment commenced in February 2013. Enrollment of 2000 breast cancer patients is planned during the 5-year recruitment period. The concept of the study is described in this article.

Perception and needs of reproductive specialists with regard to fertility preservation of young breast cancer patients.

BACKGROUND: Treatment-related infertility is one of the important quality-of-life issues in young breast cancer (YBC) patients. Although existing guidelines recommend supporting fertility preservation (FP) of YBC, the perceptions of reproductive specialists (RS) has not been evaluated. We investigated the perceptions and needs of RS with regard to FP of YBC patients. METHODS: A cross-sectional survey was sent to 423 certified RS registered to the Japan Society for Reproductive Medicine to self-evaluate their perceptions and needs regarding FP in YBC patients. RESULTS: Two hundred RS (47 %) responded to the survey. 99 % responded that RS should be engaged in FP of YBC patients. 88 % responded that they would like to treat YBC patients, while 46 % responded that cancer treatment is more important than childbirth, even when the patient is recurrence-free 5 years after primary treatment. Respondents affiliated to private clinics were more likely to accept both fertilized and unfertilized egg preservation than those affiliated with academic or general hospitals. 70 % responded that they were anxious about treating breast cancer patients: concerns regarding a greater or unknown risk of recurrence (66 %), insufficient knowledge about breast cancer (47 %), and lack of a patient's spouse/partner (24 %) were identified as major barriers in supporting FP for YBC patients. CONCLUSIONS: RS recognize the need for FP in YBC patients and are willing to participate in their care. Affiliation of RS was related to a positive attitude to egg preservation. Various concerns regarding FP among RS indicate the need for evidence that supports the safety of FP, inter-disciplinary communication, and practice guidelines.

Long-Term Physical Activity and Body Composition After Exercise and Educational Programs for Breast Cancer: A Randomized Controlled Trial From the Setouchi Breast Project-10.

BACKGROUND: It is unclear what interventions can sustain long-term higher physical activity (PA) to improve breast cancer outcomes. Thus, this study aimed to evaluate the long-term effects of interventions on PA after breast cancer treatment. METHODS: This was a prospective randomized controlled trial for patients with stage 0 to III breast cancer evaluating the efficacy of exercise and educational programs on long-term PA compared with usual care. The primary endpoint was proportion of patients with recreational PA (RPA) ≥5 metabolic equivalents (METs)/week at 1 year after registration. RESULTS: From March 16, 2016, to March 15, 2020, breast cancer patients were registered in the control (n = 120), education (n = 121), or exercise (n = 115) group. There were no significant differences in proportion of RPA ≥5 METs/week at 1 year between the exercise and control groups (54% and 53%, P = .492) and between the education and control groups (62% and 53%, P = .126). Significant difference in reductions from baseline at 1 year were noted on body weight (P = .0083), BMI (P = .0034), and body fat percentage (P = .0027) between education and control groups. Similarly, the exercise group showed significant difference in reduction in body fat percentage (P = .0038) compared to control group. CONCLUSION: Although there were no significant effects on RPA 1 year after exercise and educational programs for breast cancer survivors, both interventions reduced body composition. Future studies on PA should investigate appropriate interventions to improve overall survival.

Quantitative assessment of appearance changes and related distress in cancer patients.

OBJECTIVES: This study examined both the frequency of appearance-related symptoms and distress resulting from these symptoms in cancer patients receiving chemotherapy. METHODS: Self-report questionnaires were distributed to 753 outpatients receiving ≧ 4 weeks of treatment at an outpatient chemotherapy center. Valid responses were returned by 638 patients (response rate, 84.7%). Participants were questioned about 57 appearance-related symptoms (AS) and 23 non-appearance-related physical symptoms (non-AS); psychological well-being was assessed using a shortened version of the Derriford Appearance Scale 59. RESULTS: Questionnaire responses were obtained from 264 male and 374 female patients (mean age, 59.5 years; range, 18-85 years). Most respondents (80.3%) were concerned with changes in appearance resulting from treatment. By sex and disease type, women suffered more than men, and treatment for breast cancer created the greatest distress for women. CONCLUSION: Cancer patients are concerned about a variety of AS, and these may result in greater distress than non-AS. AS-related information and care are increasingly being sought in advance of treatment.

Prevalence of breast cancer risk factors in Japan.

OBJECTIVE: Breast cancer is the most common type of cancer in women worldwide. Although the incidence of breast cancer is still on an increasing trend, there are few studies concerning breast cancer risk factors in Japan. Therefore, we conducted an Internet survey investigating the prevalence of risk factors for breast cancer. METHODS: We conducted an Internet survey using opt-in panels in women aged from 20 to 70 years. The survey items consisted of potential and proven risk factors for breast cancer such as age at menarche, menopausal status, premenopausal use of oral contraceptives, postmenopausal use of hormones, parity, height, alcohol consumption and family history of breast cancer. RESULTS: Subjects comprised 2002 persons who were matched for sex, age and residential area with the National Census in 2005. Statistically significant trends were observed for most factors: age at menarche is becoming lower, age at first birth is higher, height is higher, the proportion of women who have given birth is smaller and the proportion of women who drink alcohol is larger. CONCLUSIONS: We showed a clear increase in the prevalence of risk factors for breast cancer. Based on the results, the incidence of breast cancer in Japan may be increasing for at least a few decades.

[Recruitment officers' attitude toward smoking habits of applicants].

OBJECTIVES: This study sought to determine the implications of smoking cessation/prevention policy in college students. METHODS: We conducted an internet survey to investigate the attitude of recruitment officers in a company concerning acceptance evaluation and smoking of applicants. RESULTS: Among 838 respondents, more than one-half had unfavorable impressions when they saw new employees or college students smoking. Among the respondents, 3.7% answered that their companies had already introduced the policy of considering smoking status during acceptance evaluation to be acceptance policies, and 14.3% answered that this introduction is under consideration. Among the remaining 687 respondents, 7.6% answered that it can be included in the acceptance policies in the future and 45.7% answered it will not be included in the policies but can be considered during acceptance evaluation itself. Regarding their personal impression, 30% have experienced the case in which smoking status might have affected acceptance and 48.7% answered that it might affect acceptance in the future. CONCLUSIONS: Our study clarified that smoking status affected acceptance evaluation by recruitment officers in not a little cases although smoking status is not included in formal acceptance policies. Considering that there are only a few countermeasures for smoking among college students, job hunting activities can be a good opportunity for smoking cessation/prevention among them in collaboration with companies, colleges, and policy makers.

Rainbow of KIBOU project: Effectiveness of invitation materials for improving cancer screening rate using social marketing and behavioral economics approaches.

Studies to date have shown that individual invitation (call) and re-invitation (recall) are effective in improving cancer screening rate. Also, by dividing subjects into segments and sending unique messages to each segment, the cancer screening rate is further improved. However, this approach is not realistic in the local governments due to limited resources, so we used social marketing and nudge techniques to develop cancer screening recommendation materials that do not need to send separately. This study therefore aimed to verify the effect of these materials in the real world. We compared the cancer screening rates in municipalities within Japan that used the invitation materials we developed (colorectal, breast, lung, cervical and stomach cancer), with those from the previous year. In addition, the usefulness of the materials in the real world was examined multilaterally using RE-AIM framework (Reach, Effectiveness, Adaption, Implementation, Maintenance). From 2015 to 2018, 4.3 million residents (Reach) from 787 municipalities (Adaption) were sent invitation materials for cancer screening. Of 167 municipalities that were compared, 141 (83%) showed an increase in screening rate when our materials were used. Overall, the screening rate improved by 2.6% or 1.44 fold (p < 0.001) (Effectiveness). However, the screening rate varied greatly depending on how screening is provided. Of the four years studied, 75 municipalities used the same materials for two or more years (Implementation). The material developed in this study improved the cancer screening rate in the real world, and it may be possible to further improve the screening rate if the number of opportunities for screening and its capacity is increased at the timing of sending materials. The materials can be found on the website (http://rokproject.jp/kenshin/) and free electronic files are available to municipalities wishing to use them.

How families in Japan view the disclosure of terminal illness: a study of iatrogenic HIV infection.

Physicians in Japan typically do not disclose diagnoses of terminal illnesses to patients, in deference to the wishes of family members. Nonetheless, some evidence indicates that relatives of patients with iatrogenic HIV infection would prefer patient disclosure. We collected survey data from 314 family members in 225 households of hemophiliac patients who died from illnesses related to iatrogenic HIV infection in order to examine current attitudes toward patient disclosure in Japan. Family members reported that the diagnosis of iatrogenic HIV infection was disclosed to the patient by the primary physician in 32.8% of cases, by the family in 8.3% of cases, and not disclosed in 26.4% of cases. The majority of families indicated that the timing of the physician's disclosure occurred too late. Multivariate analysis indicated that families wished that patients had been informed of the diagnosis, despite the stigma associated with HIV in Japan. Furthermore, many families blamed the physician for the infection and fatality in those cases in which the physician did not convey feelings of regret. These results have important clinical ramifications to the practice of disclosing terminal diagnoses in Japan.

Should we tell the truth? Why families in Japan chose to tell their loved ones they were victims of iatrogenic HIV infection.

Japanese families traditionally avoid disclosing diagnoses of terminal illnesses to patients, seeking to protect the patient from emotional pain and shock. Using awareness theory, in this study we aimed to investigate the attitudes toward disclosure among bereaved families of Japanese hemophiliacs with iatrogenic HIV/AIDS. Semistructured interviews were conducted with 34 bereaved family members. Qualitative content analysis centered around three main issues: (a) family attitudes toward physician nondisclosure of HIV diagnosis; (b) family attitudes regarding the consequences of nondisclosure; and (c) family attitudes regarding the impact of nondisclosure on patient-family relationships. Our findings suggest that families favored disclosure because they felt that knowledge of the iatrogenic HIV infection would benefit the patient.

Rainbow of KIBOU (ROK) study: a Breast Cancer Survivor Cohort in Japan.

BACKGROUND: Although there are a large number of epidemiological studies investigating the etiological role of lifestyle factors in breast cancer, there are few studies on the association between lifestyle factors and breast cancer prognosis. To investigate the influence of lifestyle factors such as diet and physical activity, use of complementary and alternative medicine, and psychosocial factors on prognosis, we designed a large-scale cohort study of female breast cancer patients in Japan. METHODS: The planned sample size is 7200. The cohort is being conducted in collaboration with several clinical trials, a cancer registry, and daily practice. Information on clinical factors, treatment, and follow-up will be obtained from the clinical trials and participating hospitals. A self-administered questionnaire is given to subjects before, immediately after, or 1 to 5 years after surgery. Blood and tissue samples are also collected. The primary endpoint is disease-free survival. The secondary endpoints are overall survival and health-related quality of life. The follow-up period will be at least 5 years after the last participant is enrolled. Recruitment began in November 2007. CURRENT STATUS: As of April 2017, there are 5852 patients enrolled in the study along with 1430 biological samples and the study is still ongoing. The number of subjects enrolled in the study is already the largest in the world. CONCLUSIONS: The ROK study will provide much important evidence for breast cancer survivorship.

Psychosocial problems of bereaved families of HIV-infected hemophiliacs in Japan.

This study sought to investigate the psychosocial difficulties faced by bereaved families of HIV-infected hemophiliacs in Japan, with the goal of clarifying appropriate ways to offer them support. Interviews were conducted with 46 family members from 36 families, and a written survey was mailed to 392 families. Valid responses from 225 families (307 family members) were analyzed (response rate 57.4%). We found that even at a mean 7-9 years after their family member's death, the bereaved continued to express deep feelings of sorrow and grief, and further, expressed strong feelings of resentment, anger, guilt and regret, anxiety over discrimination, and loneliness. Notably, 95% of the mothers endorsed feeling "sorry for giving birth to a hemophiliac child". Additionally, even after their family member's death, approximately 70% of the respondents continued to restrict their daily activities due to stigmatization or anxiety over discrimination. Finally, 59% of the respondents were found to have posttraumatic stress disorder-like symptoms according to the Impact of Event Scale-Revised, and 46% were found, according to General Health Questionnaire-12 (a measure of mental disorder) criteria, to suffer mental health problems. These results indicate that bereaved families of HIV-infected hemophiliacs in Japan have special characteristics and psychosocial needs, and still suffer significant psychosocial difficulties years after the bereavement.

Physicians' knowledge, attitude, and behavior regarding fertility issues for young breast cancer patients: a national survey for breast care specialists.

BACKGROUND: Fertility is one of the key aspects of quality of life for breast cancer patients of childbearing age. The objective of this study was to describe fertility-related practice for young breast cancer patients in Japan and to identify healthcare provider factors that contribute to physicians' behavior towards fertility preservation. METHODS: A cross-sectional survey was developed in order for Japanese breast cancer specialists (n = 843) to self-evaluate their knowledge, attitude, and behavior regarding fertility preservation. Survey items included questions regarding knowledge of and attitude toward fertility issues in cancer patients, fertility-related practice, potential barriers for the discussion of fertility with patients, and responding physicians' socio-demographic background. RESULTS: Four hundred and thirty-four (52%) breast oncologists responded to the survey. Female and younger oncologists (age less than 50 years) had significantly higher probability of referring patients to reproductive specialists. Physicians who had better knowledge score and positive attitudes toward fertility preservation were more likely to discuss potential fertility issues with cancer patients. This was significantly associated with consultation and referral to reproduction specialists when encountering fertility issues with cancer patients. Risk of recurrence, lack of collaborating reproductive specialists, and time constraints in the clinic were identified as major barriers to discussion of fertility preservation with breast cancer patients. CONCLUSION: Female and younger physicians as well as physicians working in a multidisciplinary environment had positive attitudes and behavior towards fertility preservation in breast cancer patients. The development of comprehensive and interdisciplinary programs for healthcare providers is necessary to meet the expectations and fertility needs of breast cancer patients.