miR-371a-3p Predicting Viable Tumor in Patients Undergoing Retroperitoneal Lymph Node Dissection for Metastatic Testicular Cancer: The SWENOTECA-MIR Study.

PURPOSE: The SWENOTECA-MIR prospective multicenter study aims to assess the clinical value of miR-371a-3p as a novel marker in metastatic germ cell tumor patients undergoing retroperitoneal lymph node dissection (RPLND), to predict the presence of viable residual tumor. MATERIALS AND METHODS: A total of 114 patients (86 nonseminomas, 28 seminomas) who underwent surgery for presumed metastatic disease pre chemotherapy (primary RPLND) and post chemotherapy RPLND were included. The expression of miR-371a-3p was evaluated using reverse transcription-digital droplet polymerase chain reaction before and after RPLND. Pre- and postoperative miR-371a-3p levels were statistically compared, and optimism-corrected performance calculations compared with conventional serum tumor markers. Associations were evaluated by logistic regression. Patients who underwent primary RPLND were categorized into seminoma and nonseminoma groups. RESULTS: Among the seminoma patients (n = 24) undergoing primary RPLND, all had normal conventional markers. Six patients received adjuvant treatment before surgery. miR-371a-3p exhibited a sensitivity of 74%, specificity of 100%, positive predictive value of 100%, and negative predictive value of 21% for viable tumor. The levels of miR-371a-3p significantly decreased after surgery. In the nonseminoma group (n = 18) treated with primary RPLND, 22% had elevated conventional markers and 3 had received prior adjuvant treatment. miR-371a-3p showed a sensitivity of 34%, specificity of 88%, positive predictive value of 67%, and negative predictive value of 62% for the primary nonseminoma patients. No association was observed between stage or prior adjuvant treatment and the outcome of the miR test. In the postchemotherapy group (n = 72), the miR-371a-3p sensitivity was 9%, reducing to 0 when excluding patients with seminoma (n = 4). Teratomas and benign histology were essentially negative. CONCLUSIONS: Our study highlights miR-371a-3p as a fairly sensitive and highly specific marker for prechemotherapy seminomas, outperforming conventional markers. However, in prechemotherapy nonseminomas as well as in postchemotherapy patients, we observed low sensitivity and no significant differences in miR-371a-3p levels before and after surgery, suggesting limited utility for miR-371a-3p in this context.

Outcomes after robot-assisted radical cystectomy with orthotopic neobladder in women.

PURPOSE: To investigate functional, oncological and complication outcomes in women undergoing robot-assisted cystectomy (RARC) with intracorporeal orthotopic neobladder. METHODS: From a multi-institutional database, we identified females with bladder cancer treated with RARC and intracorporeal orthotopic neobladder. We evaluated the continence rate, short-term oncological outcomes, and complication rates. Analyses were repeated and stratified by the status of preserving gynecological organs. RESULTS: The study involved 146 patients with the median age 60 years (IQR, 51-66 years). Pelvic organ-preserving procedure (POP) was performed in 77 patients (53%). Overall daytime and nighttime continence rates were 54% and 53%, respectively. For POP, the continence rate was 58% for both daytime and nighttime continence. In the non-POP cohort, the continence rate was 50% for daytime and 49% for nighttime continence. Both groups had balanced positive surgical margin rates (5,3% for POP and 4,7% for non-POP). In the whole cohort, high-grade (Clavien-Dindo ≥3) early and late complication rate was 7,5% and 7,5%, respectively. CONCLUSIONS: Robot-assisted radical cystectomy with intracorporeal orthotopic neobladder in females demonstrate excellent functional and complication outcomes. Pelvic organ-preserving cystectomy enhances urinary continence rates without adversely affecting surgical margins. Orthotopic neobladder in selected women with bladder cancer, along with pelvic organ-preserving cystectomy may be used for improved functional outcomes without compromising oncological results.

Sexual health and wellbeing among female pelvic cancer survivors following individualized interventions in a nurse-led clinic.

PURPOSE: Treatment-induced sexual and intestinal dysfunctions coexist among women after pelvic radiotherapy. We aimed to explore if sexual health and wellbeing may be improved after radiotherapy following nurse-led interventions and if an association exists between improved intestinal health and sexual health. METHODS: A population-based cohort of women treated with pelvic radiotherapy underwent interventions at a nurse-led clinic at Sahlgrenska University Hospital, Sweden, from 2011 to 2017. Self-reported questionnaires were used, pre- and post-intervention, to compare self-reported changes in sexual health and wellbeing. A regression model was performed to explore the association between intestinal and wellbeing variables. RESULTS: Among the 260 female pelvic cancer survivors included in the study, more women reported increased than decreased satisfaction with overall sexual health post-intervention (26.0% vs. 15.3%, p = 0.035). They also reported significantly reduced superficial genital pain (25.8% vs. 13.1%, p ≤ 0.025), reduced deep genital pain (23.1% vs. 8.0%, p ≤ 0.001), increased QoL (42.7% vs. 22.4%, p < 0.001), and reduced levels of depression (43.1% vs. 28.0%, p = 0.003) or anxiety (45.9% vs. 24.4%, p < 0.001) post-intervention. We found a significant association between reduced urgency to defecate and improved satisfaction with overall sexual health (RR 3.12, CI 1.27-7.68, p = 0.004) and between reduced urgency to defecate with fecal leakage and reduced anxious mode (RR 1.56, CI 1.04-2.33, p = 0.021). CONCLUSION: Sexual health and wellbeing can be improved by interventions provided in a nurse-led clinic focusing on physical treatment-induced late effects. Further research to optimize treatment strategies in female pelvic cancer survivors is needed.

Sexual health and wellbeing after pelvic radiotherapy among women with and without a reported history of sexual abuse: important issues in cancer survivorship care.

AIMS: Sexual abuse is a women's health concern globally. Although experience of sexual abuse and cancer may constitute risk factors for sexual dysfunction and low wellbeing, the effects of sexual abuse have received little attention in oncology care. This study aims to explore sexual health and wellbeing in women after pelvic radiotherapy and to determine the relationship between sexual abuse and sexual dysfunction, and decreased wellbeing. METHODS: Using a study-specific questionnaire, data were collected during 2011-2017 from women with gynaecological, anal, or rectal cancer treated with curative pelvic radiotherapy in a population-based cohort and a referred patient group. Subgroup analyses of data from women with a reported history of sexual abuse were conducted, comparing socio-demographics, diagnosis, aspects of sexual health and wellbeing. RESULTS: In the total sample of 570 women, 11% reported a history of sexual abuse and among these women the most common diagnosis was cervical cancer. More women with than without a history of sexual abuse reported feeling depressed (19.4% vs. 9%, p = 0.007) or anxious (22.6% vs. 11.8%, p = 0.007) and suffering genital pain during sexual activity (52% vs. 25.1%, p = 0.011, RR 2.07, CI 1.24-3.16). In the total study cohort, genital pain during sexual activity was associated with vaginal shortness (68.5% vs. 31.4% p ≤ 0.001) and inelasticity (66.6% vs. 33.3%, p ≤ 0.001). CONCLUSIONS: Our findings suggest that a history of both sexual abuse and pelvic radiotherapy in women are associated with increased psychological distress and sexual impairment, challenging healthcare professionals to take action to prevent retraumatisation and provide appropriate interventions and support.

Acute and long-term grief reactions and experiences in parentally cancer-bereaved teenagers.

BACKGROUND: Previous research shows that many cancer-bereaved youths report unresolved grief several years after the death of a parent. Grief work hypothesis suggests that, in order to heal, the bereaved needs to process the pain of grief in some way. This study explored acute grief experiences and reactions in the first 6 months post-loss among cancer-bereaved teenagers. We further explored long-term grief resolution and potential predictors of having had "an okay way to grieve" in the first months post-loss. METHODS: We used a population-based nationwide, study-specific survey to investigate acute and long-term grief experiences in 622 (73% response rate) bereaved young adults (age > 18) who, 6-9 years earlier, at ages 13-16 years, had lost a parent to cancer. Associations were assessed using bivariable and multivariable logistic regression. RESULTS: Fifty-seven per cent of the participants reported that they did not have a way to grieve that felt okay during the first 6 months after the death of their parent. This was associated with increased risk for long-term unresolved grief (odds ratio (OR): 4.32, 95% confidence interval (CI): 2.99-6.28). An association with long-term unresolved grief was also found for those who reported to have been numbing and postponing (42%, OR: 1.73, 95% CI: 1.22-2.47), overwhelmed by grief (24%, OR: 2.02, 95% CI: 1.35-3.04) and discouraged from grieving (15%, OR: 2.68, 95% CI: 1.62-4.56) or to have concealed their grief to protect the other parent (24%, OR: 1.83, 95% CI: 1.23-2.73). Predictors of having had an okay way to grieve included being male, having had good family cohesion, and having talked about what was important with the dying parent. CONCLUSION: More than half of the cancer-bereaved teenagers did not find a way to grieve that felt okay during the first 6 months after the death of their parent and the acute grief experiences and reaction were associated with their grief resolution long-term, i.e. 6-9 years post-loss. Facilitating a last conversation with their dying parent, good family cohesion, and providing teenagers with knowledge about common grief experiences may help to prevent long-term unresolved grief.

A Fiber-Rich Diet and Radiation-Induced Injury in the Murine Intestinal Mucosa.

Dietary fiber is considered a strong intestinal protector, but we do not know whether dietary fiber protects against the long-lasting mucosal damage caused by ionizing radiation. To evaluate whether a fiber-rich diet can ameliorate the long-lasting pathophysiological hallmarks of the irradiated mucosa, C57BL/6J mice on a fiber-rich bioprocessed oat bran diet or a fiber-free diet received 32 Gray in four fractions to the distal colorectum using a linear accelerator and continued on the diets for one, six or 18 weeks. We quantified degenerating crypts, crypt fission, cell proliferation, crypt survival, macrophage density and bacterial infiltration. Crypt loss through crypt degeneration only occurred in the irradiated mice. Initially, it was most frequent in the fiber-deprived group but declined to levels similar to the fiber-consuming group by 18 weeks. The fiber-consuming group had a fast response to irradiation, with crypt fission for growth or healing peaking already at one week post-irradiation, while crypt fission in the fiber-deprived group peaked at six weeks. A fiber-rich diet allowed for a more intense crypt cell proliferation, but the recovery of crypts was eventually lost by 18 weeks. Bacterial infiltration was a late phenomenon, evident in the fiber-deprived animals and intensified manyfold after irradiation. Bacterial infiltration also coincided with a specific pro-inflammatory serum cytokine profile. In contrast, mice on a fiber-rich diet were completely protected from irradiation-induced bacterial infiltration and exhibited a similar serum cytokine profile as sham-irradiated mice on a fiber-rich diet. Our findings provide ample evidence that dietary fiber consumption modifies the onset, timing and intensity of radiation-induced pathophysiological processes in the intestinal mucosa. However, we need more knowledge, not least from clinical studies, before this finding can be introduced to a new and refined clinical practice.

A decrease in cesarean sections and labor inductions among Swedish women by awareness of fetal movements with the Mindfetalness method.

BACKGROUND: Maternal perception of decreased fetal movements is commonly used to assess fetal well-being. However, there are different opinions on whether healthcare professionals should encourage maternal observation of fetal movements, as researchers claim that raising awareness increases unnecessary interventions, without improving perinatal health. We aimed to investigate whether cesarean sections and labor induction increase by raising women's awareness of fetal movements through Mindfetalness. Further, we aimed to study perinatal health after implementing Mindfetalness in maternity care. METHODS: In a cluster randomized controlled trial, 67 maternity clinics were allocated to Mindfetalness or routine care. In the Mindfetalness group, midwives distributed a leaflet telling the women to focus on the character, strength and frequency of the fetal movements without counting each movement. The instruction was to do so for 15 min daily when the fetus was awake, from gestational week 28 until birth. In this sub-group analysis, we targeted women born in Sweden giving birth from 32 weeks' gestation. We applied the intention-to-treat principle. RESULTS: The Mindfetalness group included 13,029 women and the Routine-care group 13,456 women. Women randomized to Mindfetalness had less cesarean sections (18.4% vs. 20.0%, RR 0.92, CI 0.87-0.97) and labor inductions (19.2% vs. 20.3%, RR 0.95, CI 0.90-0.99) compared to the women in the Routine-care group. Less babies were born small for gestational age (8.5% vs. 9.3%, RR 0.91, CI 0.85-0.99) in the Mindfetalness group. Women in the Mindfetalness group contacted healthcare due to decreased fetal movements to a higher extent than women in the Routine care group (7.8% vs. 4.3%, RR 1.79, CI 1.62-1.97). The differences remain after adjustment for potential confounders. CONCLUSIONS: Raising awareness about fetal movements through Mindfetalness decreased the rate of cesarean sections, labor inductions and small-for-gestational age babies. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02865759 ). Registered 12 August 2016, www.clinicaltrials.gov .

Dose-response relationships of the sigmoid for urgency syndrome after gynecological radiotherapy.

PURPOSE: To find out what organs and doses are most relevant for 'radiation-induced urgency syndrome' in order to derive the corresponding dose-response relationships as an aid for avoiding the syndrome in the future. MATERIAL AND METHODS: From a larger group of gynecological cancer survivors followed-up 2-14 years, we identified 98 whom had undergone external beam radiation therapy but not brachytherapy and not having a stoma. Of those survivors, 24 developed urgency syndrome. Based on the loading factor from a factor analysis, and symptom frequency, 15 symptoms were weighted together to a score interpreted as the intensity of radiation-induced urgency symptom. On reactivated dose plans, we contoured the small intestine, sigmoid colon and the rectum (separate from the anal-sphincter region) and we exported the dose-volume histograms for each survivor. Dose-response relationships from respective risk organ and urgency syndrome were estimated by fitting the data to the Probit, RS, LKB and gEUD models. RESULTS: The rectum and sigmoid colon have steep dose-response relationships for urgency syndrome for Probit, RS and LKB. The dose-response parameters for the rectum were D50: 51.3, 51.4, and 51.3 Gy, γ50 = 1.19 for all models, s was 7.0e-09 for RS and n was 9.9 × 107 for LKB. For Sigmoid colon, D50 were 51.6, 51.6, and 51.5 Gy, γ50 were 1.20, 1.25, and 1.27, s was 2.8 for RS and n was 0.079 for LKB. CONCLUSIONS: Primarily the dose to sigmoid colon as well as the rectum is related to urgency syndrome among gynecological cancer survivors. Separate delineation of the rectum and sigmoid colon in order to incorporate the dose-response results may aid in reduction of the incidence of the urgency syndrome.

Late radiation-induced bowel syndromes, tobacco smoking, age at treatment and time since treatment - gynecological cancer survivors.

BACKGROUND: It is unknown whether smoking; age at time of radiotherapy or time since radiotherapy influence the intensity of late radiation-induced bowel syndromes. MATERIAL AND METHODS: We have previously identified 28 symptoms decreasing bowel health among 623 gynecological-cancer survivors (three to twelve years after radiotherapy) and 344 matched population-based controls. The 28 symptoms were grouped into five separate late bowel syndromes through factor analysis. Here, we related possible predictors of bowel health to syndrome intensity, by combining factor analysis weights and symptom frequency on a person-incidence scale. RESULTS: A strong (p < .001) association between smoking and radiation-induced urgency syndrome was found with a syndrome intensity (normalized factor score) of 0.4 (never smoker), 1.2 (former smoker) and 2.5 (current smoker). Excessive gas discharge was also related to smoking (p = .001). Younger age at treatment resulted in a higher intensity, except for the leakage syndrome. For the urgency syndrome, intensity decreased with time since treatment. CONCLUSIONS: Smoking aggravates the radiation-induced urgency syndrome and excessive gas discharge syndrome. Smoking cessation may promote bowel health among gynecological-cancer survivors. Furthermore, by understanding the mechanism for the decline in urgency-syndrome intensity over time, we may identify new strategies for prevention and alleviation.

Intra-abdominal Surgery and Intestinal Syndromes After Pelvic Radiation Therapy.

Purpose: To determine the effects of intra-abdominal surgery on the intensities of 5 radiation-induced intestinal syndromes in survivors of pelvic cancer. Methods and Materials: The analysis included 623 women born in 1927 or later who had survived cancer. They all had received external radiation therapy toward the pelvic area to treat gynecologic cancers. Information from 344 women who did not undergo irradiation, matched for age and residency, was also included. Main outcome measures after the surgical procedures were the intensity scores for 5 radiation-induced intestinal syndromes: urgency-tenesmus syndrome, fecal-leakage syndrome, excessive mucus discharge, excessive gas discharge, and blood discharge. The scores were based on symptom frequencies obtained from patient-reported outcomes and on factor loadings obtained from a previously reported factor analysis. Follow-up was 2 to 15 years after radiation therapy. Results: Among survivors of cancer, intra-abdominal surgery increased the intensity of the urgency-tenesmus syndrome, the fecal-leakage syndrome, excessive gas discharge, and blood discharge but had a negligible effect on mucus discharge. Intra-abdominal surgery had an especially negative effect on the urgency-tenesmus syndrome. Although the combination of appendectomy with 1 or more other intra-abdominal surgeries resulted in the highest score for all syndromes, appendectomy alone had weak to no effect. In women who did not undergo irradiation, a similar pattern was seen, albeit with much lower scores. Conclusions: We found intra-abdominal surgery to be a risk factor among survivors of gynecologic cancer, increasing the intensity score of 4 out of 5 radiation-induced intestinal syndromes. During radiation therapy, it may be worthwhile to pay extra attention to the dose of unwanted ionizing radiation to the intestines if the patient previously has undergone intra-abdominal surgery.

Effects on Serum Hormone Concentrations after a Dietary Phytoestrogen Intervention in Patients with Prostate Cancer: A Randomized Controlled Trial.

Phytoestrogens have been suggested to have an anti-proliferative role in prostate cancer, potentially by acting through estrogen receptor beta (ERß) and modulating several hormones. We primarily aimed to investigate the effect of a phytoestrogen intervention on hormone concentrations in blood depending on the ERß genotype. Patients with low and intermediate-risk prostate cancer, scheduled for radical prostatectomy, were randomized to an intervention group provided with soybeans and flaxseeds (∼200 mg phytoestrogens/d) added to their diet until their surgery, or a control group that was not provided with any food items. Both groups received official dietary recommendations. Blood samples were collected at baseline and endpoint and blood concentrations of different hormones and phytoestrogens were analyzed. The phytoestrogen-rich diet did not affect serum concentrations of testosterone, insulin-like growth factor 1, or sex hormone-binding globulin (SHBG). However, we found a trend of decreased risk of increased serum concentration of estradiol in the intervention group compared to the control group but only in a specific genotype of ERß (p = 0.058). In conclusion, a high daily intake of phytoestrogen-rich foods has no major effect on hormone concentrations but may lower the concentration of estradiol in patients with prostate cancer with a specific genetic upset of ERß.

Low-grade intestinal inflammation two decades after pelvic radiotherapy.

BACKGROUND: Radiotherapy is effective in the treatment of cancer but also causes damage to non-cancerous tissue. Pelvic radiotherapy may produce chronic and debilitating bowel symptoms, yet the underlying pathophysiology is still undefined. Most notably, although pelvic radiotherapy causes an acute intestinal inflammation there is no consensus on whether the late-phase pathophysiology contains an inflammatory component or not. To address this knowledge gap, we examined the potential presence of a chronic inflammation in mucosal biopsies from irradiated pelvic cancer survivors. METHODS: We biopsied 24 cancer survivors two to 20 years after pelvic radiotherapy, and four non-irradiated controls. Using tandem mass tag (TMT) mass spectrometry and mRNA sequencing (mRNA-seq), we charted proteomic and transcriptomic profiles of the mucosal tissue previously exposed to a high or a low/no dose of radiation. Changes in the immune cell populations were determined with flow cytometry. The integrity of the protective mucus layers were determined by permeability analysis and 16S rRNA bacterial detection. FINDINGS: 942 proteins were differentially expressed in mucosa previously exposed to a high radiation dose compared to a low radiation dose. The data suggested a chronic low-grade inflammation with neutrophil activity, which was confirmed by mRNA-seq and flow cytometry and further supported by findings of a weakened mucus barrier with bacterial infiltration. INTERPRETATION: Our results challenge the idea that pelvic radiotherapy causes an acute intestinal inflammation that either heals or turns fibrotic without progression to chronic inflammation. This provides a rationale for exploring novel strategies to mitigate chronic bowel symptoms in pelvic cancer survivors. FUNDING: This study was supported by the King Gustav V Jubilee Clinic Cancer Foundation (CB), The Adlerbertska Research Foundation (CB), The Swedish Cancer Society (GS), The Swedish State under the ALF agreement (GS and CB), Mary von Sydow's foundation (MA and VP).

Effect of digital-enabled multidisciplinary therapy conferences on efficiency and quality of the decision making in prostate cancer care.

OBJECTIVES: To investigate the impact on efficiency and quality of preprostatectomy multidisciplinary therapy conferences (MDT) at Karolinska University Hospital related to the use of a digital solution compared with standard of care. Further, to explore whether gains in MDT efficiency and quality impact oncological or functional patient outcomes. METHODS: We conducted a prospective, observational study of preoperative prostate cancer MDT at Karolinska between February 2017 and March 2021, including 1329 patients. We compared efficiency and quality of the standard MDT and the MDT using the digital solution IntelliSpace Precision Medicine Multidisciplinary Team Orchestrator (ISPM) based on the previously used MDT-MODe approach. Clinical and patient-reported functional outcomes were derived from the medical records and the Swedish National Prostate Cancer Register. RESULTS: While ISPM was used during the MDT meeting, the time spent per patient was reduced by 24% (p<0.001) and most of the MDT-MODe items were scored significantly higher. There was a reduction in pelvic lymph-node dissection procedures in the ISPM cohort (p=0.001) and an increased proportion of unilateral nerve-sparing procedures (p=0.005), while all other outcome-related measures were not significantly different between the two patient groups. DISCUSSION AND CONCLUSION: To increase the value of the MDT, all data relevant for treatment decision need to be purposefully presented and compiled, which also enables secondary use of the data.The use of a digital solution during preoperative MDTs for prostate cancer decision making at Karolinska University Hospital improved the efficiency and quality of this multidisciplinary team meeting without impacting patient outcomes.

Country of birth, educational level and other predictors of seeking care due to decreased fetal movements: an observational study in Sweden using data from a cluster-randomised controlled trial.

OBJECTIVES: To identify predictors of seeking care for decreased fetal movements and assess whether care-seeking behaviour is influenced by Mindfetalness. DESIGN: Observational study with data from a cluster-randomised controlled trial. SETTING: 67 maternity clinics and 6 obstetrical clinics in Sweden. PARTICIPANTS: All pregnant women with a singleton pregnancy who contacted the obstetrical clinic due to decreased fetal movements from 32 weeks' gestation of 39 865 women. METHODS: Data were collected from a cluster-randomised controlled trial where maternity clinics were randomised to Mindfetalness or routine care. Mindfetalness is a self-assessment method for women to use daily to become familiar with the unborn baby's fetal movement pattern. OUTCOME MEASURES: Predictors for contacting healthcare due to decreased fetal movements. RESULTS: Overall, 5.2% (n=2059) of women contacted healthcare due to decreased fetal movements, among which 1287 women (62.5%) were registered at a maternity clinic randomised to Mindfetalness and 772 women (37.5%) were randomised to routine care. Predictors for contacting healthcare due to decreased fetal movements were age, country of birth, educational level, parity, prolonged pregnancy and previous psychiatric care (p<0.001). The main differences were seen among women born in Africa as compared with Swedish-born women (2% vs 6%, relative risk (RR) 0.34, 95% CI 0.25 to 0.44) and among women with low educational level compared with women with university-level education (2% vs 5.4%, RR 0.36, 95% CI 0.19 to 0.62). Introducing Mindfetalness in maternity care increased the number of women seeking care due to decreased fetal movements overall. CONCLUSION: Women with country of birth outside Sweden and low educational level sought care for decreased fetal movements to a lesser extent compared with women born in Sweden and those with university degrees. Future research could explore whether pregnancy outcomes can be improved by motivating women in these groups to contact healthcare if they feel a decreased strength or frequency of fetal movements. TRIAL REGISTRATION NUMBER: NCT02865759.

Epidural use among women with spontaneous onset of labour - an observational study using data from a cluster-randomised controlled trial.

OBJECTIVE: To investigate whether the proportion of pregnant women who use epidural analgesia during birth differed between women registered at a maternity clinic randomised to Mindfetalness or to routine care. DESIGN: An observational study including women born in Sweden with singleton pregnancies, with spontaneous onset of labour from 32 weeks' gestation. Data used from a cluster-randomised controlled trial applying the intention-to-treat principle in 67 maternity clinics where women were randomised to Mindfetalness or to routine care. ClinicalTrials.gov (NCT02865759). INTERVENTIONS: Midwives were instructed to distribute a leaflet about Mindfetalness to pregnant women at 25 weeks' gestation. Mindfetalness is a self-assessment method for the woman to use to become familiar with the unborn baby's fetal movement pattern. When practising the method in third trimester, the women are instructed to daily lie down on their side, when the baby is awake, and focus on the movements' intensity, character and frequency (but not to count each movement). FINDINGS: Of the 18 501 women with spontaneous onset of labour, 47 percent used epidural during birth. Epidural was used to a lower extent among women registered at a maternity clinic randomised to Mindfetalness than women in the routine-care group (46.2% versus 47.8%, RR 0.97, CI 0.94-1.00, p= 0.04). Epidural was more common among primiparous women, women younger than 35 years, those with educational levels below university, with BMI ≥25 and with a history of receiving psychiatric care or psychological treatment for mental illness. CONCLUSIONS AND IMPLICATIONS FOR PRACTICE: Pregnant women who were informed about a self-assessment method, with the aim of becoming familiar with the unborn baby's fetal movement pattern, used epidural to a lower extent than women who were not informed about the method. Future studies are needed to investigate and understand the association between Mindfetalness and the reduced usage of epidural during birth.

Dose-response relationships of intestinal organs and excessive mucus discharge after gynaecological radiotherapy.

BACKGROUND: The study aims to determine possible dose-volume response relationships between the rectum, sigmoid colon and small intestine and the 'excessive mucus discharge' syndrome after pelvic radiotherapy for gynaecological cancer. METHODS AND MATERIALS: From a larger cohort, 98 gynaecological cancer survivors were included in this study. These survivors, who were followed for 2 to 14 years, received external beam radiation therapy but not brachytherapy and not did not have stoma. Thirteen of the 98 developed excessive mucus discharge syndrome. Three self-assessed symptoms were weighted together to produce a score interpreted as 'excessive mucus discharge' syndrome based on the factor loadings from factor analysis. The dose-volume histograms (DVHs) for rectum, sigmoid colon, small intestine for each survivor were exported from the treatment planning systems. The dose-volume response relationships for excessive mucus discharge and each organ at risk were estimated by fitting the data to the Probit, RS, LKB and gEUD models. RESULTS: The small intestine was found to have steep dose-response curves, having estimated dose-response parameters: γ50: 1.28, 1.23, 1.32, D50: 61.6, 63.1, 60.2 for Probit, RS and LKB respectively. The sigmoid colon (AUC: 0.68) and the small intestine (AUC: 0.65) had the highest AUC values. For the small intestine, the DVHs for survivors with and without excessive mucus discharge were well separated for low to intermediate doses; this was not true for the sigmoid colon. Based on all results, we interpret the results for the small intestine to reflect a relevant link. CONCLUSION: An association was found between the mean dose to the small intestine and the occurrence of 'excessive mucus discharge'. When trying to reduce and even eliminate the incidence of 'excessive mucus discharge', it would be useful and important to separately delineate the small intestine and implement the dose-response estimations reported in the study.

Development and Validation of a Mobile Phone Application Developed for Measuring Dietary Fiber Intake.

We have developed a mobile phone application for measuring the intake of dietary fiber and validated the ability of the application to accurately capture this intake against measurements registered by a dietary record. We also investigated what food groups contributed most to the total, soluble, and insoluble dietary fiber intake. Twenty-six randomly selected Swedish women aged 35-85 years were included and randomized to either start to register dietary intake in the application or by a dietary record, during three consecutive days. After a washout period of at least two weeks, the participants used the other method. We found that the difference in measured mean fiber intake between the dietary record and the application was two grams independent of the total intake per day. A statistically significant correlation between fiber intake as measured by the two methods was found (rho = 0.65, p < 0.001). Vegetables and roots were the predominantly contributing foods to total and soluble fiber intake. Bread and crackers contributed most to insoluble fiber intake. In conclusion, the application may be considered as a useful and easy-to-use method to measure dietary fiber intake.

Cohort profile: an observational longitudinal data collection of health aspects in a cohort of female cancer survivors with a history of pelvic radiotherapy-a population-based cohort in the western region of Sweden.

PURPOSE: The study 'Health among women after pelvic radiotherapy' was conducted in response to the need for more advanced and longitudinal data concerning long-term radiotherapy-induced late effects and chronic states among female cancer survivors. The objective of this paper is to detail the cohort profile and the study procedure in order to provide a sound basis for future analyses of the study cohort. PARTICIPANTS: Since 2011, and still currently ongoing, participants have been recruited from a population-based study cohort including all female patients with cancer, over 18 years of age, treated with pelvic radiotherapy with curative intent at Sahlgrenska University Hospital in Gothenburg, in the western region of Sweden, which covers 1.7 million of the Swedish population. The dataset presented here consists of baseline data provided by 605 female cancer survivors and 3-month follow-up data from 260 individuals with gynaecological, rectal or anal cancer, collected over a 6-year period. FINDINGS TO DATE: Data have been collected from 2011 onwards. To date, three studies have been published using the dataset reporting long-term radiation-induced intestinal syndromes and late adverse effects affecting sexuality, the urinary tract, the lymphatic system and physical activity. These projects include the evaluation of interventions developed by and provided in a nurse-led clinic. FUTURE PLANS: This large prospective cohort offers the possibility to study health outcomes in female pelvic cancer survivors undergoing a rehabilitation intervention in a nurse-led clinic, and to study associations between demographics, clinical aspects and long-term late effects. Analysis focusing on the effect of the interventions on sexual health aspects, preinterventions and postinterventions, is currently ongoing. The cohort will be expanded to comprise the entire data collection from 2011 to 2020, including baseline data and data from 3-month and 1-year follow-ups after interventions. The data will be used to study conditions and treatment-induced late effects preintervention and postintervention.

A Preparatory Study for a Randomized Controlled Trial of Dietary Fiber Intake During Adult Pelvic Radiotherapy.

Background: Patients undergoing pelvic radiotherapy are often advised to omit fiber-rich foods from their diet to reduce the adverse effects of treatment. Scientific evidence supporting this recommendation is lacking, and recent studies on animals and humans have suggested that there is a beneficial effect of dietary fiber for the alleviation of symptoms. Randomized controlled studies on dietary fiber intake during pelvic radiotherapy of sufficient size and duration are needed. As preparation for such a large-scale study, we evaluated the feasibility, compliance, participation rate, and logistics and report our findings here in this preparatory study. Methods: In this preparatory study of a fiber intervention trial, Swedish gynecological cancer patients scheduled for radiotherapy were recruited between January 2019 and August 2020. During the intervention, the participants filled out questionnaires and used an application. They also consumed a fiber supplement at first in powder form, later in capsules. Blood- and fecal samples were collected. The study is registered in clinicaltrials.gov (https://clinicaltrials.gov/ct2/show/NCT04534075?cond=fidura&draw=2&rank=1). Results: Among 136 approached patients, 57 started the study and the participation rate for primary outcomes was 63% (third blood sample) and 65% (third questionnaire). Barely half of the participants provided fecal samples. Providing concise and relevant information to the patients at the right time was crucial in getting them to participate and stay in the study. The most common reasons for declining participation or dropping out were the expected burden of radiotherapy or acute side effects. Tailoring the ambition level to each patient concerning the collection of data beyond the primary endpoints was an important strategy to keep the dropout rate at an acceptable level. Using capsules rather than psyllium in powder form made it much easier to document intake and to create a control group. During the course of the preparatory study, we improved the logistics and for the last 12 participants included, the participation rate was 100% for the earliest primary outcome. Conclusion: A variety of adjustments in this preparatory study resulted in an improved participation rate, which allowed us to set a final protocol and proceed with the main study.