Effect of reduced follow-up care on patient satisfaction with care among patients with endometrial cancer: The ENSURE randomized controlled trial.

BACKGROUND: Evidence on the optimal follow-up schedule after endometrial cancer is lacking. The study aim was to compare satisfaction with care between women who received reduced follow-up care and women who received usual guideline-directed follow-up care for three years after surgery. METHODS: The ENSURE (ENdometrial cancer SURvivors' follow-up carE) trial was a non-inferiority randomized controlled multicenter trial in 42 hospitals in the Netherlands. The intervention arm received reduced follow-up care (4 visits/3 years), while the control group received usual follow-up care (8-11 visits/3 years). Primary outcome was overall satisfaction with care, PSQIII score, over three years follow-up, with a non-inferiority margin of 6. Mixed linear regression, intention-to-treat and per-protocol analyses (presented below) were used. RESULTS: Among 316 women included, overall satisfaction with care was not lower in the reduced follow-up (mean 82; SD = 15) compared with the usual follow-up group (mean 80; SD = 15) group (B = 1.80(-2.09;5.68)). At 6, 12 and 36 months, more women (93/94/90%) in the reduced follow-up group were satisfied with their follow-up schedule than in the usual follow-up group (79/79/82%; p < 0.001; p < 0.001; p = 0.050). CONCLUSIONS AND RELEVANCE: Women with low-risk, early-stage endometrial cancer who received reduced follow-up care were no less satisfied with their care than women receiving usual follow-up care. Compared with usual follow-up, women in the reduced follow-up group had fewer clinical visits and, at the same time, more often reported being satisfied with their follow-up schedule. Findings suggest that reduced follow-up care may be the new standard, but should be tailored to meet additional needs where indicated.

Functional estrogen receptor signal transduction pathway activity and antihormonal therapy response in low-grade ovarian carcinoma.

BACKGROUND: Advanced low-grade ovarian carcinoma (LGOC) is difficult to treat. In several studies, high estrogen receptor (ER) protein expression was observed in patients with LGOC, which suggests that antihormonal therapy (AHT) is a treatment option. However, only a subgroup of patients respond to AHT, and this response cannot be adequately predicted by currently used immunohistochemistry (IHC). A possible explanation is that IHC only takes the ligand, but not the activity, of the whole signal transduction pathway (STP) into account. Therefore, in this study, the authors assessed whether functional STP activity can be an alternative tool to predict response to AHT in LGOC. METHODS: Tumor tissue samples were obtained from patients with primary or recurrent LGOC who subsequently received AHT. Histoscores of ER and progesterone receptor (PR) were determined. In addition, STP activity of the ER STP and of six other STPs known to play a role in ovarian cancer was assessed and compared with the STP activity of healthy postmenopausal fallopian tube epithelium. RESULTS: Patients who had normal ER STP activity had a progression-free survival (PFS) of 16.1 months. This was significantly shorter in patients who had low and very high ER STP activity, with a median PFS of 6.0 and 2.1 months, respectively (p < .001). Unlike ER histoscores, PR histoscores were strongly correlated to the ER STP activity and thus to PFS. CONCLUSIONS: Aberrant low and very high functional ER STP activity and low PR histoscores in patients with LGOC indicate decreased response to AHT. ER IHC is not representative of functional ER STP activity and is not related to PFS.

A web-based decision aid for shared decision making in pelvic organ prolapse: the SHADE-POP trial.

INTRODUCTION AND HYPOTHESIS: Among women worldwide, pelvic organ prolapse (POP) is a common problem. There are three different treatment options for POP: pelvic floor muscle therapy, pessary treatment and prolapse surgery. As none of the three treatment options is clearly superior, shared decision making (SDM) is very important. A decision aid (DA) is known to facilitate patient participation and SDM. We hypothesise that the use of a web-based DA for POP increases patients' satisfaction with information and care and reduces decisional conflict. METHODS: This two-arm, multicentre, cluster randomised controlled trial was performed in women with POP in five different Dutch hospitals. The control group received usual care (UC) and the intervention group received the DA in addition to UC. Primary outcome measures were satisfaction with treatment decision making and satisfaction with information. Analyses were performed using independent sample t tests, Chi-squared tests, and multilevel linear regression analyses. RESULTS: Between the DA group (n=40) and the UC group (n=56) no differences were found concerning patients' satisfaction with information, with scores of 45.63 and 46.14 out of 50 respectively (p=0.67). Also, no differences were found concerning the perceived role in decision making, as patients scored 46.83 in the DA group and 46.41 in the UC group, out of a maximum of 54 (n=0.81). CONCLUSIONS: No differences were found concerning patients' satisfaction with information and treatment decision making between the DA and UC. However, both groups scored high on the questionnaires, which suggests that the decision process is already of high quality.

Patient characteristics and factors contributing to recurrence of bacterial vaginosis presented in primary care.

BACKGROUND: Bacterial vaginosis (BV) is a common problem in primary care. BV symptoms often have a negative impact on patients' quality of life and may predispose to gynaecological problems. Some patients experience recurring episodes of BV. This study's objective is to identify possible factors that may be associated with BV recurrence and describe the characteristics of these patients and interventions performed by general practitioners. METHODS: In this retrospective cohort study, we used data from a primary care registration network in the Netherlands in the period 2015-2020. We analysed differences between patients with recurrent BV and patients with a single episode of BV in terms of characteristics and interventions performed by general practitioners. RESULTS: We found that patients with recently prescribed antibiotics, and a medical history of sexually transmitted infections and/or Candidiasis significantly more often presented with recurrent BV. Patients with recurrent BV had more remote consultations and less in-person consultations than single-episode patients. The reason for encounter was more often a request for medication. Regarding GPs' diagnostic and therapeutic interventions, microbiological tests were more frequently performed in recurrent BV patients. Moreover, most patients in both groups were prescribed oral metronidazole most frequently. CONCLUSIONS: Our findings might help GPs to better recognise patients at risk of recurrence. GPs could re-evaluate their approach to the diagnosis and treatment of recurrent BV, opting for in-person consultation and using standardised diagnostic criteria and microbiological testing in patients with recurrent complaints. Antibiotic use for other conditions in these patients may lead to new BV episodes.

Cancer-related psychosocial factors and self-reported changes in lifestyle among gynecological cancer survivors: cross-sectional analysis of PROFILES registry data.

PURPOSE: Obesity is prevalent in gynecological cancer survivors and is associated with impaired health outcomes. Concerns due to cancer and its treatment may impact changes in lifestyle after cancer. This study aimed to assess the association between cancer-related psychosocial factors and changes in physical activity and diet, 18 months after initial treatment among gynecological cancer survivors. METHODS: Cross-sectional data from the ROGY Care study were used, including endometrial and ovarian cancer patients treated with curative intent. The Impact of Cancer Scale (IOCv2) was used to assess cancer-related psychosocial factors. Self-reported changes in nutrients/food groups and in physical activity post-diagnosis were classified into change groups (less/equal/more). Multivariable logistic regression models were used to assess associations. RESULTS: Data from 229 cancer survivors (59% endometrial, 41% ovarian, mean age 66 ± 9.5, 70% tumor stage I) were analyzed. In total, 20% reported to eat healthier from diagnosis up to 18 months after initial treatment, 17% reported less physical activity and 20% more physical activity. Health awareness (OR 2.79, 95% CI: 1.38; 5.65), body change concerns (OR 3.04 95% CI: 1.71; 5.39), life interferences (OR 4.88 95% 2.29; 10.38) and worry (OR 2.62, 95% CI: 1.42; 4.85) were significantly associated with less physical activity up to 18 months after initial treatment whereby gastrointestinal symptoms were an important confounder. CONCLUSION(S): This study underlines the need to raise awareness of the benefits of a healthy lifestyle and to provide tailored lifestyle advice, taking into account survivors' health awareness, body change concerns, life interferences, worry and gastrointestinal symptoms, in order to improve health behavior among gynecological cancer survivors. TRIAL REGISTRATION: http://clinicaltrials.gov Identifier: NCT01185626, August 20, 2010.

Cancer worry among BRCA1/2 pathogenic variant carriers choosing surgery to prevent tubal/ovarian cancer: course over time and associated factors.

OBJECTIVE: High cancer risks, as applicable to BRCA1 and BRCA2 pathogenic variant (PV) carriers, can induce significant cancer concerns. We examined the degree of cancer worry and the course of this worry among BRCA1/2-PV carriers undergoing surgery to prevent ovarian cancer, and identified factors associated with high cancer worry. METHODS: Cancer worry was evaluated as part of the multicentre, prospective TUBA-study (NCT02321228) in which BRCA1/2-PV carriers choose either novel risk-reducing salpingectomy with delayed oophorectomy or standard risk-reducing salpingo-oophorectomy. The Cancer Worry Scale was obtained before and 3 and 12 months after surgery. Cancer worry patterns were analysed using latent class growth analysis and associated factors were identified with regression analysis. RESULTS: Of all 577 BRCA1/2-PV carriers, 320 (57%) had high (≥ 14) cancer worry pre-surgery, and 54% had lower worry 12 months post-surgery than pre-surgery. Based on patterns over time, BRCA1/2-PV carriers could be classified into three groups: persistently low cancer worry (56%), persistently high cancer worry (6%), and fluctuating, mostly declining, cancer worry (37%). Factors associated with persistently high cancer concerns were age below 35 (BRCA1) or 40 (BRCA2), unemployment, previous breast cancer, lower education and a more recent BRCA1/2-PV diagnosis. CONCLUSIONS: Some degree of cancer worry is considered normal, and most BRCA1/2-PV carriers have declining cancer worry after gynaecological risk-reducing surgery. However, a subset of these BRCA1/2-PV carriers has persisting major cancer concerns up to 1 year after surgery. They should be identified and potentially offered additional support. CLINICAL TRIAL REGISTRATION: The TUBA-study is registered at ClinicalTrials.gov since December 11th, 2014. Registration number: NCT02321228.

Diagnostic accuracy of mutational analysis along the Müllerian tract to detect ovarian cancer.

OBJECTIVE: Ovarian cancer is known for its poor prognosis, which is mainly due to the lack of early symptoms and adequate screening options. In this study we evaluated whether mutational analysis in cervicovaginal and endometrial samples could assist in the detection of ovarian cancer. METHODS: In this prospective multicenter study, we included patients surgically treated for either (suspicion of) ovarian cancer or for a benign gynecological condition (control group). A cervicovaginal self-sample, a Papanicolaou (Pap) smear, a pipelle endometrial biopsy, and the surgical specimen were analyzed for (potentially) pathogenic variants in eight genes (ARID1A, CTNNB1, KRAS, MTOR, PIK3CA, POLE, PTEN, and TP53) using single-molecule molecular inversion probes. Sensitivity and specificity were calculated to assess diagnostic accuracy. RESULTS: Based on surgical histology, our dataset comprised 29 patients with ovarian cancer and 32 controls. In 83% of the patients with ovarian cancer, somatic (potentially) pathogenic variants could be detected in the final surgical specimen, of which 71% included at least a TP53 variant. In 52% of the ovarian cancer patients, such variants could be detected in either the self-sample, Pap smear, or pipelle. The Pap smear yielded the highest diagnostic accuracy with 26% sensitivity (95% CI 10% to 48%). Overall diagnostic accuracy was low and was not improved when including TP53 variants only. CONCLUSIONS: Mutational analysis in cervicovaginal and endometrial samples has limited accuracy in the detection of ovarian cancer. Future research with cytologic samples analyzed on methylation status or the vaginal microbiome may be relevant.

Cyclic activity of signal transduction pathways in fimbrial epithelium of the human fallopian tube.

INTRODUCTION: The local environment of the fallopian tube represents the optimal conditions for reproductive processes. To maintain tissue homeostasis, signal transduction pathways are thought to play a pivotal role. Enhancing our understanding of functional signal transduction pathway activity is important to be able to clarify the role of aberrant signal transduction pathway activity leading to female subfertility and other tubal diseases. Therefore, in this study we investigate the influence of the hormonal cycle on the activity of key signal transduction pathways in the fimbrial epithelium of morphologically normal fallopian tubes. MATERIAL AND METHODS: We included healthy pre- (n = 17) and postmenopausal (n = 8) patients who had surgical interventions for benign gynecologic conditions. Histologic sections of the fallopian tubes were reviewed by two pathologists and, for the premenopausal patients, hormone serum levels and sections of the endometrium were examined to determine the hormonal phase (early follicular [n = 4], late follicular [n = 3], early luteal [n = 5], late luteal [n = 5]). After laser capture microdissection, total mRNA was extracted from the fimbrial epithelium and real-time quantitative reverse transcription-PCR was performed to determine functional signal transduction pathway activity of the androgen receptor (AR), estrogen receptor (ER), phosphoinositide-3-kinase (PI3K), Hedgehog (HH), transforming growth factor-beta (TGF-ß) and canonical wingless-type MMTV integration site (Wnt) pathways. RESULTS: The early luteal phase demonstrated high AR and ER pathway activity in comparison with the late luteal phase (p = 0.016 and p = 0.032, respectively) and low PI3K activity compared with the late follicular phase (p = 0.036), whereas the late luteal phase showed low activity of HH and Wnt compared with the early follicular phase (both p = 0.016). Signal transduction pathway activity in fimbrial epithelium from postmenopausal patients was most similar to the early follicular and/or late luteal phase with regard to the AR, ER and PI3K pathways. Wnt pathway activity in postmenopausal patients was comparable to the late follicular and early luteal phase. We observed no differences in HH and TGF-ß pathway activity between pre- and postmenopausal samples. The cyclic changes in signal transduction pathway activity suggest a stage-specific function which may affect the morphology and physiology of the human fallopian tube. CONCLUSIONS: We demonstrated cyclic changes in activity of the AR, ER, PI3K, HH and Wnt pathways throughout the hormonal cycle.

Evaluation of a patient decision aid for BRCA1/2 pathogenic variant carriers choosing an ovarian cancer prevention strategy.

OBJECTIVE: Risk-reducing surgery is advised to BRCA1/2 pathogenic variant (PV) carriers around the age of 40 years to reduce ovarian cancer risk. In the TUBA-study, a multicenter preference study (NCT02321228), BRCA1/2-PV carriers are offered a choice: the standard strategy of risk-reducing salpingo-oophorectomy or the novel strategy of risk-reducing salpingectomy with delayed oophorectomy. We evaluated feasibility and effectiveness of a patient decision aid for this choice. METHODS: Premenopausal BRCA1/2-PV carriers were counselled for risk-reducing surgical options in the TUBA-study; the first cohort was counselled without and the second cohort with decision aid. Evaluation was performed using digital questionnaires for participating women and their healthcare professionals. Outcome measures included actual choice, feasibility (usage and experiences) and effectiveness (knowledge, cancer worry, decisional conflict, decisional regret and self-estimated influence on decision). RESULTS: 283 women were counselled without and 282 women with decision aid. The novel strategy was chosen less frequently in women without compared with women with decision aid (67% vs 78%, p = 0.004). The decision aid was graded with an 8 out of 10 by both women and professionals, and 78% of the women would recommend this decision aid to others. Users of the decision aid reported increased knowledge about the options and increased insight in personal values. Knowledge on cancer risk, decisional conflict, decisional regret and cancer worry were similar in both cohorts. CONCLUSIONS: The use of the patient decision aid for risk-reducing surgery is feasible, effective and highly appreciated among BRCA1/2-PV carriers facing the decision between salpingo-oophorectomy or salpingectomy with delayed oophorectomy.

Patients' information coping styles influence the benefit of a survivorship care plan in the ROGY Care Trial: New insights for tailored delivery.

BACKGROUND: In efforts to improve the implementation of survivorship care plans (SCPs), the authors assessed whether the impact of SCPs on patient-reported outcomes differed between patients with an information-seeking coping style (monitoring) versus those with an information-avoiding coping style (blunting). METHODS: In the Registration System Oncological Gynecology (ROGY) Care Trial, 12 hospitals in the Netherlands were randomized to deliver SCP care or usual care. All patients with newly diagnosed endometrial and ovarian cancer in the SCP care arm received an SCP that was generated automatically by their oncology provider through the web-based ROGY registration system. Outcomes (satisfaction with information provision and care, illness perceptions, and health care use) were measured directly after initial treatment and after 6, 12, and 24 months. Information coping style was measured at 12 months after initial treatment. RESULTS: Among patients who had a monitoring coping style (N = 123), those in the SCP care arm reported higher satisfaction with information provision (mean score: 73.9 vs 63.9, respectively; P = .04) and care (mean score: 74.5 vs 69.2, respectively; P = .03) compared with those in the usual care arm. Among patients who had a blunting coping style (N = 102), those in the SCP care arm reported a higher impact of the disease on life (mean score: 5.0 vs 4.5, respectively; P = .02) and a higher emotional impact of the disease (mean score: 5.4 vs 4.2, respectively; P = .01) compared with those in the usual care arm. CONCLUSIONS: SCPs may be beneficial for patients who desire information about their disease, whereas SCPs may be less beneficial for patients who avoid medical information, suggesting a need for tailored SCP delivery to improve survivorship care.

Changes in health-related quality of life among gynecologic cancer survivors during the two years after initial treatment: a longitudinal analysis.

Background: While many cancer survivors experience persistent impairments in health-related quality of life (HRQoL) for extended periods of time, others recover soon after treatment. The aim of this research is to assess changes in health-related quality of life in endometrial and ovarian cancer survivors during two years post initial treatment, and to assess clinical and sociodemographic characteristics associated with those changes. Methods: This prospective population-based cohort study includes longitudinal data of endometrial (N = 221) and ovarian (N = 174) cancer survivors diagnosed between 2011 and 2014. The EORTC QLQ-C30 functioning scales were used to assess HRQoL after initial treatment and after 6, 12 and 24 months. Clinical (stage, treatment and comorbidities) and sociodemographic (age, marital status and socio-economic status) characteristics were obtained from the Netherlands Cancer Registry and through self-administered questionnaires. Linear mixed models were used to assess changes in HRQoL over time and characteristics associated with these changes. Results: Among both endometrial and ovarian cancer patients, HRQoL improved within the first 6 months after initial treatment. Changes in HRQoL were mainly associated with clinical characteristics including comorbidities, treatment and tumor stage, and to a lesser extent with sociodemographic characteristics such as socioeconomic status. However, these associations varied per tumor type. Endometrial cancer survivors, who received radiotherapy and had no comorbidities, reported greater improvements in some HRQoL scales over time. Ovarian cancer patients who received chemotherapy and with advanced tumor stages reported poorer functioning during treatment. Most functioning domains (global health, physical and role functioning) recovered to levels of patients without chemotherapy or with early-stage disease after 12 months, but cognitive and social functioning remained impaired. Conclusion: Some subgroups of patients, including those with multiple comorbidities, with an advanced tumor stage and who received chemotherapy, may be in need of additional support as they are less likely to show improvements in HRQoL over time.

Hysterectomy with opportunistic salpingectomy versus hysterectomy alone.

BACKGROUND: Ovarian cancer has the highest mortality rate of all gynaecological malignancies with an overall five-year survival rate of 30% to 40%. In the past two decades it has become apparent and more commonly accepted that a majority of ovarian cancers originate in the fallopian tube epithelium and not from the ovary itself. This paradigm shift introduced new possibilities for ovarian cancer prevention. Salpingectomy during a hysterectomy for benign gynaecological indications (also known as opportunistic salpingectomy) might reduce the overall incidence of ovarian cancer. Aside from efficacy, safety is of utmost importance, especially due to the preventive nature of opportunistic salpingectomy. Most important are safety in the form of surgical adverse events and postoperative hormonal status. Therefore, we compared the benefits and risks of hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy. OBJECTIVES: To assess the effect and safety of hysterectomy with opportunistic salpingectomy versus hysterectomy without salpingectomy for ovarian cancer prevention in women undergoing hysterectomy for benign gynaecological indications; outcomes of interest include the incidence of epithelial ovarian cancer, surgery-related adverse events and postoperative ovarian reserve. SEARCH METHODS: The Cochrane Gynaecology and Fertility (CGF) Group trials register, CENTRAL, MEDLINE, Embase, PsycINFO, CINAHL and two clinical trial registers were searched in January 2019 together with reference checking and contact with study authors. SELECTION CRITERIA: We intended to include both randomised controlled trials (RCTs) and non-RCTs that compared ovarian cancer incidence after hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For assessment of surgical and hormonal safety, we included RCTs that compared hysterectomy with opportunistic salpingectomy to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. DATA COLLECTION AND ANALYSIS: We used standard methodological procedures recommended by Cochrane. The primary review outcomes were ovarian cancer incidence, intraoperative and short-term postoperative complication rate and postoperative hormonal status. Secondary outcomes were total surgical time, estimated blood loss, conversion rate to open surgery (applicable only to laparoscopic and vaginal approaches), duration of hospital admission, menopause-related symptoms and quality of life. MAIN RESULTS: We included seven RCTs (350 women analysed). The evidence was of very low to low quality: the main limitations being a low number of included women and surgery-related adverse events, substantial loss to follow-up and a large variety in outcome measures and timing of measurements.No studies reported ovarian cancer incidence after hysterectomy with opportunistic salpingectomy compared to hysterectomy without opportunistic salpingectomy in women undergoing hysterectomy for benign gynaecological indications. For surgery-related adverse events, there were insufficient data to assess whether there was any difference in both intraoperative (odds ratio (OR) 0.66, 95% confidence interval (CI) 0.11 to 3.94; 5 studies, 286 participants; very low-quality evidence) and short-term postoperative (OR 0.13, 95% CI 0.01 to 2.14; 3 studies, 152 participants; very low-quality evidence) complication rates between hysterectomy with opportunistic salpingectomy and hysterectomy without opportunistic salpingectomy because the number of surgery-related adverse events was very low. For postoperative hormonal status, the results were compatible with no difference, or with a reduction in anti-Müllerian hormone (AMH) that would not be clinically relevant (mean difference (MD) -0.94, 95% CI -1.89 to 0.01; I2 = 0%; 5 studies, 283 participants; low-quality evidence). A reduction in AMH would be unfavourable, but due to wide CIs, the postoperative change in AMH can still vary from a substantial decrease to even a slight increase. AUTHORS' CONCLUSIONS: There were no eligible studies reporting on one of our primary outcomes - the incidence of ovarian cancer specifically after hysterectomy with or without opportunistic salpingectomy. However, outside the scope of this review there is a growing body of evidence for the effectiveness of opportunistic salpingectomy itself during other interventions or as a sterilisation technique, strongly suggesting a protective effect. In our meta-analyses, we found insufficient data to assess whether there was any difference in surgical adverse events, with a very low number of events in women undergoing hysterectomy with and without opportunistic salpingectomy. For postoperative hormonal status we found no evidence of a difference between the groups. The maximum difference in time to menopause, calculated from the lower limit of the 95% CI and the natural average AMH decline, would be approximately 20 months, which we consider to be not clinically relevant. However, the results should be interpreted with caution and even more so in very young women for whom a difference in postoperative hormonal status is potentially more clinically relevant. Therefore, there is a need for research on the long-term effects of opportunistic salpingectomy during hysterectomy, particularly in younger women, as results are currently limited to six months postoperatively. This limit is especially important as AMH, the most frequently used marker for ovarian reserve, recovers over the course of several months following an initial sharp decline after surgery. In light of the available evidence, addition of opportunistic salpingectomy should be discussed with each woman undergoing a hysterectomy for benign indication, with provision of a clear overview of benefits and risks.

Course of chemotherapy-induced peripheral neuropathy and its impact on health-related quality of life among ovarian cancer patients: A longitudinal study.

OBJECTIVE: Chemotherapy-induced peripheral neuropathy (CIPN) presents itself as sensory peripheral neuropathy (SPN) or motor peripheral neuropathy (MPN). Our aim was to examine the course of SPN and MPN, and their impact on health-related quality of life (HRQoL) among ovarian cancer patients. METHODS: All newly diagnosed ovarian cancer patients from twelve hospitals in the South of the Netherlands were eligible for participation. Patients (N=174) completed questions on CIPN (EORTC QLQ-OV28) and HRQoL (EORTC QLQ-C30) after initial treatment and at 6, 12, and 24months (response rates were 70%, 71%, 58%, and 43% respectively). RESULTS: Generalized linear mixed models showed that among chemotherapy-treated patients (N=98), SPN levels were stable over time. For MPN, symptoms significantly improved at 12months. At 2years, 13% still reported high SPN. Also, 11% still reported high MPN. Regarding HRQoL, patients with high SPN reported a worse physical, role, emotional, social, and cognitive functioning compared to those with low SPN. Moreover, those who changed from low to high SPN over time worsened on physical functioning. For MPN, a worse global quality of life and a worse functioning was reported among patients with high MPN. Also, those who changed from low to high MPN over time worsened on global quality of life and on physical, role, social, and cognitive functioning. CONCLUSIONS: Among chemotherapy-treated ovarian cancer patients, SPN levels were stable over time. In contrast, MPN symptoms significantly improved at 12months. These symptoms seriously impacted HRQoL. Future studies should examine the impact of different treatment decisions and alterations on CIPN, so recommendations can be made to reduce CIPN (prevalence).

Recurrent Cancer Is Associated With Dissatisfaction With Care-A Longitudinal Analysis Among Ovarian and Endometrial Cancer Patients.

OBJECTIVE: The primary aim of this study was to assess the longitudinal impact of a recurrence of gynecological cancer on satisfaction with information provision and care. The secondary aim was to assess the impact of a recurrence on illness perceptions, anxiety, and depression and health-related quality of life. METHODS: This study is a longitudinal analysis from the ROGY Care trial, conducted between 2011 and 2014, including patients with endometrial (n = 215) and ovarian (n = 149) cancer. Patients were invited to complete questionnaires directly after initial treatment and after 6, 12, and 24 months. Satisfaction with information provision and care, illness perceptions, anxiety, and depression were compared before and after the recurrence. Linear mixed-model analyses were conducted to assess the differences in outcomes of patients with a recurrence compared with patients without a recurrence. RESULTS: During 2-year follow-up, 25 patients with endometrial cancer (12%) and 64 patients with ovarian cancer (43%) had recurrent disease, of whom 9 endometrial and 26 ovarian cancer patients completed at least 1 questionnaire after their recurrence was determined. Patients reported lower satisfaction with care after the diagnosis of a recurrence (doctor interpersonal skills, exchange of information between caregivers, and general satisfaction with care) compared with patients without recurrence. In addition, patients reported lower health-related quality of life, more anxiety and depression, and more threatening illness perceptions after diagnosis of a recurrence. CONCLUSIONS: After diagnosis of recurrent disease, endometrial and ovarian cancer patients were less satisfied with care compared with patients without a recurrence. Our findings suggest that patients with recurrent cancer are in need of care that is better tailored to their needs.

Survivorship care plans have a negative impact on long-term quality of life and anxiety through more threatening illness perceptions in gynecological cancer patients: the ROGY care trial.

PURPOSE: Prior results from the registration system oncological gynecology (ROGY) care trial showed that survivorship care plans (SCPs) increased threatening illness perceptions in gynecological cancer survivors, but it remained unclear whether this would result in poorer physical and psychosocial outcomes. The aim of the current study is to assess the direct and indirect effects of SCPs on health-related quality of life (HRQoL) and anxiety and depression, through illness perceptions. METHODS: Twelve hospitals in the South of the Netherlands were randomized to providing 'SCP care' or 'usual care.' Newly diagnosed endometrial and ovarian cancer patients completed questionnaires after initial treatment (endometrial, 221 [75%]; ovarian, 174 [71%]) and after 6, 12, and 24 months. SCPs were automatically generated after initial treatment by the oncology providers through the web-based ROGY. Illness perceptions were measured after initial treatment and HRQoL and anxiety and depression after 6, 12, and 24 months. RESULTS: Structural equation models showed that endometrial cancer patients who experienced more symptoms or concern due to the SCP reported worse social functioning (ß = - 0.82; p = 0.01) and more fatigue, insomnia, pain, and anxiety (ß = 0.58-0.86, p < 0.05) within 12 months after treatment. Ovarian cancer patients who had lower trust that the treatment would cure their disease due to the SCP reported worse emotional functioning 6 months after treatment (ß = 0.27, p = 0.02). CONCLUSIONS: Current results show that SCPs may have negative effects on HRQoL and anxiety in patients who experience more threatening illness perceptions due to the SCP. We should be aware of the potential negative consequences of SCPs. Trial Registration clinicaltrials.gov Identifier: NCT01185626.

A patient decision aid for risk-reducing surgery in premenopausal BRCA1/2 mutation carriers: Development process and pilot testing.

BACKGROUND: BRCA1/2 mutation carriers' choice between risk-reducing salpingo-oophorectomy (RRSO) and salpingectomy with delayed oophorectomy is very complex. Aim was to develop a patient decision aid that combines evidence with patient preferences to facilitate decision making. DESIGN: Systematic development of a patient decision aid in an iterative process of prototype development, alpha testing by patients and clinicians and revisions using International Patient Decision Aid Standards (IPDAS) quality criteria. Information was based on the available literature and current guidelines. A multidisciplinary steering group supervised the process. SETTING AND PARTICIPANTS: Pre-menopausal BRCA1/2 mutation carriers choosing between RRSO and salpingectomy with delayed oophorectomy in Family Cancer Clinics in the Netherlands. MAIN OUTCOME MEASURES: IPDAS quality criteria, relevance, usability, clarity. RESULTS: The patient decision aid underwent four rounds of alpha testing and revisions. Finally, two paper decision aids were developed: one for BRCA1 and one for BRCA2. They both contained a general introduction, three chapters and a step-by-step plan containing a personal value clarification worksheet. During alpha testing, risk communication and information about premature menopause and hormone therapy were the most revised items. The patient decision aids fulfil 37 of 43 (86%) IPDAS criteria for content and development process. DISCUSSION AND CONCLUSIONS: Both BRCA1/2 mutation carriers and professionals are willing to use or offer the developed patient decision aids for risk-reducing surgery. The patient decision aids have been found clear, balanced and comprehensible. Future testing among patients facing the decision should point out its effectiveness in improving decision making.

Illness perceptions and changes in lifestyle following a gynecological cancer diagnosis: A longitudinal analysis.

OBJECTIVE: This study explores patterns of lifestyle change and whether more threatening illness perceptions are associated with lifestyle changes post-treatment for smoking, alcohol consumption and Body Mass Index (BMI) among gynecological cancer patients. METHODS: In total, 395 cancer patients (N=221 endometrial; N=174 ovarian) were included in this secondary analysis of longitudinal data. Lifestyle outcomes were assessed through self-reported questionnaires after initial treatment and 6, 12, and 18months of follow-up. Illness perceptions were assessed with the Brief Illness Perception Questionnaire (BIPQ). Latent class growth curve analyses were conducted to identify patterns of lifestyle change and linear mixed models using between-subject and within-subject effects to explore the association between BIPQ items and alcohol consumption (glasses/week) and BMI (kg/m2). RESULTS: After initial treatment, 15% (N=57) of the patients smoked, 53% (N=203) drank alcohol, and 60% (N=236) were overweight or obese. Overall, smokers made no considerable changes, but one subgroup of low level smokers reported positive decline. A slight decrease was observed for alcohol consumption among low and moderate level alcohol drinker subgroups, whereas BMI remained stable among endometrial cancer patients and increased for ovarian cancer patients. Moreover, patients with lower trust in their treatment to cure the disease drank more alcohol (ß=0.32 glasses/week [95% CI 0.09; 0.56]). CONCLUSIONS: Change in lifestyle after a gynecological cancer treatment is not self-evident. Moreover, more threatening illness perceptions were not related to a healthier lifestyle. This study underlines the need for lifestyle-promoting activities to facilitate lifestyle improvement among gynecological cancer patients.

Cost-effectiveness of laparoscopy as diagnostic tool before primary cytoreductive surgery in ovarian cancer.

OBJECTIVE: To evaluate the cost-effectiveness of a diagnostic laparoscopy prior to primary cytoreductive surgery to prevent futile primary cytoreductive surgery (i.e. leaving >1cm residual disease) in patients suspected of advanced stage ovarian cancer. METHODS: An economic analysis was conducted alongside a randomized controlled trial in which patients suspected of advanced stage ovarian cancer who qualified for primary cytoreductive surgery were randomized to either laparoscopy or primary cytoreductive surgery. Direct medical costs from a health care perspective over a 6-month time horizon were analyzed. Health outcomes were expressed in quality-adjusted life-years (QALYs) and utility was based on patient's response to the EQ-5D questionnaires. We primarily focused on direct medical costs based on Dutch standard prices. RESULTS: We studied 201 patients, of whom 102 were randomized to laparoscopy and 99 to primary cytoreductive surgery. No significant difference in QALYs (utility=0.01; 95% CI 0.006 to 0.02) was observed. Laparoscopy reduced the number of futile laparotomies from 39% to 10%, while its costs were € 1400 per intervention, making the overall costs of both strategies comparable (difference € -80 per patient (95% CI -470 to 300)). Findings were consistent across various sensitivity analyses. CONCLUSION: In patients with suspected advanced stage ovarian cancer, a diagnostic laparoscopy reduced the number of futile laparotomies, without increasing total direct medical health care costs, or adversely affecting complications or quality of life.

PIpelle Prospective ENDOmetrial carcinoma (PIPENDO) study, pre-operative recognition of high risk endometrial carcinoma: a multicentre prospective cohort study.

BACKGROUND: Endometrial carcinoma is the most common gynaecologic malignancy in industrialised countries and the incidence is still rising. Primary treatment is based on preoperative risk classification and consists in most cases of hysterectomy with bilateral salpingo-oophorectomy. In patients with serous and clear cell histology a complete surgical staging is mandatory. However, in routine clinical practice final histology regularly does not correspond with the preoperative histological diagnosis. This results in both over and under treatment. METHODS/DESIGN: The aim of this multicentre, prospective cohort study is to select a panel of prognostic biomarkers to improve preoperative diagnosis of endometrial carcinoma in order to identify those patients that need extended surgery and/or additional treatment. Additionally, we will determine whether incorporation of cervical cytology and comorbidity could improve this preoperative risk classification. All patients treated for endometrial carcinoma in the participating hospitals from September 2011 till December 2013 are included. Patient characteristics, as well as comorbidity are registered. Patients without preoperative histology, history of hysterectomy and/or endometrial carcinoma or no surgical treatment including hysterectomy are excluded. The preoperative histology and final pathology will be reviewed and compared by expert pathologists. Additional immunohistochemical analysis of IMP3, p53, ER, PR, MLH1, PTEN, beta-catenin, p16, Ki-67, stathmin, ARID1A and L1CAM will be performed. Preoperative histology will be compared with the final pathology results. Follow-up will be at least 24 months to determine risk factors for recurrence and outcome. DISCUSSION: This study is designed to improve surgical treatment of endometrial carcinoma patients. A total of 432 endometrial carcinoma patients were enrolled between 2011 and 2013. Follow-up will be completed in 2015. Preoperative histology will be evaluated systematically and background endometrium will be classified. This is the first study incorporating immunohistochemistry, cervical cytology and comorbidity to define the optimal panel of prognostic biomarkers that contribute in clinical decision making in the management of endometrial carcinoma. TRIAL REGISTRATION: Netherlands Trial Register number NTR3503.

Early salpingectomy (TUbectomy) with delayed oophorectomy to improve quality of life as alternative for risk-reducing salpingo-oophorectomy in BRCA1/2 mutation carriers (TUBA study): a prospective non-randomised multicentre study.

BACKGROUND: Risk-reducing salpingo-oophorectomy (RRSO) around the age of 40 is currently recommended to BRCA1/2 mutation carriers. This procedure decreases the elevated ovarian cancer risk by 80-96% but it initiates premature menopause as well. The latter is associated with short-term and long-term morbidity, potentially affecting quality of life (QoL). Based on recent insights into the Fallopian tube as possible site of origin of serous ovarian carcinomas, an alternative preventive strategy has been put forward: early risk-reducing salpingectomy (RRS) and delayed oophorectomy (RRO). However, efficacy and safety of this alternative strategy have to be investigated. METHODS: A multicentre non-randomised trial in 11 Dutch centres for hereditary cancer will be conducted. Eligible patients are premenopausal BRCA1/2 mutation carriers after completing childbearing without (a history of) ovarian carcinoma. Participants choose between standard RRSO at age 35-40 (BRCA1) or 40-45 (BRCA2) and the alternative strategy (RRS upon completion of childbearing and RRO at age 40-45 (BRCA1) or 45-50 (BRCA2)). Women who opt for RRS but do not want to postpone RRO beyond the currently recommended age are included as well. Primary outcome measure is menopause-related QoL. Secondary outcome measures are ovarian/breast cancer incidence, surgery-related morbidity, histopathology, cardiovascular risk factors and diseases, and cost-effectiveness. Mixed model data analysis will be performed. DISCUSSION: The exact role of the Fallopian tube in ovarian carcinogenesis is still unclear. It is not expected that further fundamental research will elucidate this role in the near future. Therefore, this clinical trial is essential to investigate RRS with delayed RRO as alternative risk-reducing strategy in order to improve QoL. TRIAL REGISTRATION: ClinicalTrials.gov ( NCT02321228 ).