Feasibility and potential effectiveness of nurse-led video-coaching interventions for childhood, adolescent, and young adult cancer survivors: the REVIVER study.

BACKGROUND: Childhood, adolescent, and young adult (CAYA) cancer survivors, at risk for late effects, including cancer-related fatigue, cardiovascular issues, and psychosocial challenges, may benefit from interventions stimulating behaviour adjustments. Three nurse-led eHealth interventions (REVIVER) delivered via video calls and elaborating on person-centred care, cognitive behaviour therapy and/or motivational interviewing were developed. These interventions target: 1) fatigue management, 2) healthier lifestyle behaviours, and 3) self-efficacy and self-management. This study aimed to assess the feasibility and potential effectiveness of the REVIVER interventions for CAYA cancer survivors and healthcare professionals. METHODS: In a single-group mixed methods design, CAYA cancer survivors aged 16-54, more than five years post-treatment, were enrolled. Feasibility, assessed via Bowen's outcomes for feasibility studies, included acceptability, practicality, integration and implementation, demand and adherence. Qualitative data from semi-structured interviews and a focus group interview with survivors and healthcare professionals supplemented the evaluation. Paired sample t-tests assessed changes in self-reported quality of life, fatigue, lifestyle, self-management, and self-efficacy at baseline (T0), post-intervention (T1), and 6-month follow-up (T2). RESULTS: The interventions and video consults were generally acceptable, practical, and successfully integrated and implemented. Success factors included the nurse consultant (i.e., communication, approach, and attitude) and the personalised approach. Barriers included sustainability concerns, technical issues, and short intervention duration. Regarding demand, 71.4%, 65.4%, and 100% of eligible CAYA cancer survivors engaged in the fatigue (N = 15), lifestyle (N = 17) and empowerment (N = 3) intervention, respectively, with 5, 5 and 2 participants interviewed, correspondingly. Low interest (demand) in the empowerment intervention (N = 3) and dropout rates of one-third for both fatigue and empowerment interventions were noted (adherence). Improvements in quality of life, fatigue (fatigue intervention), lifestyle (lifestyle intervention), self-efficacy, and self-management were evident among survivors who completed the fatigue and lifestyle interventions, with medium and large effect sizes observed immediately after the intervention and six months post-intervention. CONCLUSIONS: Our study demonstrates the feasibility of nurse-led video coaching (REVIVER interventions) despite lower demand for the empowerment intervention and lower adherence to the fatigue and empowerment interventions. The medium and high effect sizes found for those who completed the interventions hold potential clinical significance for future studies investigating the effectiveness of the REVIVER interventions.

Toward implementation of an evidence-based intervention for fear of cancer recurrence: Feasibility in real-world psycho-oncology practice.

OBJECTIVE: Few evidence-based interventions addressing high levels of fear of cancer recurrence (FCR) have been implemented. Understanding how these might be implemented is crucial to bridge the research-practice gap. This study investigated the feasibility of implementing the blended Survivors' Worries of Recurrent Disease (SWORD) intervention in real-world psycho-oncology practice. METHODS: SWORD was offered for 15 months (2021-2022) as the standard care for clinical FCR in a university hospital, a general hospital, and psycho-oncological center. We evaluated using a mixed-methods design six feasibility outcomes based on Bowen's framework: demand, limited effectiveness, degree of execution, acceptability, practicality, and integration. Anonymous data were collected for all oncology patients on referral. Study participants completed questionnaires before and after treatment, including the Cancer Worry Scale (CWS-6) as the primary measure of effectiveness. Qualitative data included interviews with patients and psychologists, and field notes. RESULTS: Regarding demand, 81 of 644 patients referred (13%) were eligible for SWORD. The uptake of SWORD was 79% (n = 63/80) and the completion rate 73% (n = 46/63). SWORD was effective in reducing FCR (p < 0.001, ηp2  = 0.694). Regarding execution, a variability in the length, planning and number of treatment sessions was found between different settings. Adherence to the treatment manual's content was high (89%). Regarding acceptability, most patients were satisfied with SWORD (average 8.2/10) and psychologists valued the blended format. Psychologists reported SWORD was practical to deliver given their knowledge and skills. Although differences between settings were found, SWORD integrated well into practice. Referral for FCR and a reluctance to contract new eHealth providers were barriers for implementation. CONCLUSIONS: Despite differences between healthcare settings, the implementation of SWORD was evaluated well. The feasibility of SWORD in different settings should inform a national implementation strategy.

Consensus based recommendations for the diagnosis of serous tubal intraepithelial carcinoma: an international Delphi study.

AIM: Reliably diagnosing or safely excluding serous tubal intraepithelial carcinoma (STIC), a precursor lesion of tubo-ovarian high-grade serous carcinoma (HGSC), is crucial for individual patient care, for better understanding the oncogenesis of HGSC, and for safely investigating novel strategies to prevent tubo-ovarian carcinoma. To optimize STIC diagnosis and increase its reproducibility, we set up a three-round Delphi study. METHODS AND RESULTS: In round 1, an international expert panel of 34 gynecologic pathologists, from 11 countries, was assembled to provide input regarding STIC diagnosis, which was used to develop a set of statements. In round 2, the panel rated their level of agreement with those statements on a 9-point Likert scale. In round 3, statements without previous consensus were rated again by the panel while anonymously disclosing the responses of the other panel members. Finally, each expert was asked to approve or disapprove the complete set of consensus statements. The panel indicated their level of agreement with 64 statements. A total of 27 statements (42%) reached consensus after three rounds. These statements reflect the entire diagnostic work-up for pathologists, regarding processing and macroscopy (three statements); microscopy (eight statements); immunohistochemistry (nine statements); interpretation and reporting (four statements); and miscellaneous (three statements). The final set of consensus statements was approved by 85%. CONCLUSION: This study provides an overview of current clinical practice regarding STIC diagnosis amongst expert gynecopathologists. The experts' consensus statements form the basis for a set of recommendations, which may help towards more consistent STIC diagnosis.

Patient-guided dose reduction of tyrosine kinase inhibitors in chronic myeloid leukaemia (RODEO study): study protocol for a prospective, multicentre, single-arm trial.

BACKGROUND: Dose reduction of tyrosine kinase inhibitors (TKI) in patients with chronic myeloid leukaemia (CML) with an optimal response to TKIs may support cost-effective medication use by maintaining therapeutic effectiveness while reducing adverse events and medication costs. As the choice for dose reduction depends on patients' individual needs and preferences, a patient-centred approach is warranted. Therefore, a study to evaluate the effectiveness of patient-guided dose reduction in patients with CML who are in a major or deep molecular response is designed. METHODS: This study is a prospective, multicentre, single-arm study. 147 patients with CML (aged ≥ 18 years) in chronic phase, who are treated with imatinib, bosutinib, dasatinib, nilotinib or ponatinib, and have reached at least major molecular response (defined as having BCR-ABL levels < 0.1% for an uninterrupted period of 6 months) are eligible. Patients will use an online patient decision aid and a shared decision making consultation will be held, after which patients who choose to will receive a personalised, lower TKI dose. Primary outcome is the proportion of patients with intervention failure at 12 months after dose reduction, defined as patients who have restarted their initial dose due to (expected) loss of major molecular response. For this, BCR-ABL1 levels will be analysed from blood samples drawn at baseline, 6 weeks after dose reduction and 3-monthly thereafter. Secondary outcomes include the proportion of patients with intervention failure at 6 and 18 months after dose reduction. Other outcomes include differences before and after dose reduction regarding the number and severity of patient-reported side effects; quality of life; beliefs about medicines; and medication adherence. Patients' level of decisional conflict and regret after choosing dose reduction will be assessed, as will the decisional process experienced by patients and healthcare providers. DISCUSSION: Outcomes of this trial using a personalised approach will provide clinical and patient-reported data to guide future dose reduction of TKIs in CML. If the strategy appears to be effective, it may be implemented as another valid option to offer next to standard of care to prevent potential unnecessary exposure to higher TKI doses in this selected group of patients. TRIAL REGISTRATION: EudraCT number 2021-006581-20.

Evaluating the capacity of the distress thermometer to detect high fear of cancer recurrence.

OBJECTIVES: Fear of cancer recurrence (FCR) is common and burdensome to patients, but often remains undetected. Oncology professionals report need for tools to improve FCR detection in routine care. Oncology care guidelines recommend the Distress Thermometer (DT) for distress screening, but it has not been validated for FCR. This study evaluated the capacity of the DT and accompanying problem list to detect FCR. METHODS: Amalgamated data of two studies with 149 breast cancer and 74 colorectal cancer survivors were used. We evaluated the Dutch DT including the DT score, problem list fears item and emotional domain score using Receiver Operating Characteristic analyses. The Dutch Cancer Worry Scale-6 (CWS-6) was used as reference measure, with validated cut-off scores ≥10 and ≥12 for high FCR. Sensitivity, specificity, negative and positive predictive values were calculated. RESULTS: The DT score showed poor performance in discriminating between low and high FCR. The recommended cut-off ≥4 had low sensitivity (65% for CWS-6≥10; 72% for CWS-6 ≥12) and specificity (67% and 58%). No other cut-off had an acceptable combination of sensitivity and specificity. The fears item had low sensitivity (29% and 44.9%) and high specificity (95% and 94%). The emotional domain score had fair performance in discriminating between low and high FCR but there was no cut-off with acceptable sensitivity and specificity. CONCLUSION: The DT as currently recommended in oncology care guidelines is not suitable to effectively detect FCR in routine care. To improve patients access to psychosocial care, it should be investigated how FCR-specific measures can be integrated in oncology practice.

TUBectomy with delayed oophorectomy as an alternative to risk-reducing salpingo-oophorectomy in high-risk women to assess the safety of prevention: the TUBA-WISP II study protocol.

BACKGROUND: Risk-reducing salpingectomy with delayed oophorectomy has gained interest for individuals at high risk for tubo-ovarian cancer as there is compelling evidence that especially high-grade serous carcinoma originates in the fallopian tubes. Two studies have demonstrated a positive effect of salpingectomy on menopause-related quality of life and sexual health compared with standard risk-reducing salpingo-oophorectomy. PRIMARY OBJECTIVE: To investigate whether salpingectomy with delayed oophorectomy is non-inferior to the current standard salpingo-oophorectomy for the prevention of tubo-ovarian cancer among individuals at high inherited risk. STUDY HYPOTHESIS: We hypothesize that postponement of oophorectomy after salpingectomy, to the age of 40-45 (BRCA1) or 45-50 (BRCA2) years, compared with the current standard salpingo-oophorectomy at age 35-40 (BRCA1) or 40-45 (BRCA2) years, is non-inferior in regard to tubo-ovarian cancer risk. TRIAL DESIGN: In this international prospective preference trial, participants will choose between the novel salpingectomy with delayed oophorectomy and the current standard salpingo-oophorectomy. Salpingectomy can be performed after the completion of childbearing and between the age of 25 and 40 (BRCA1), 25 and 45 (BRCA2), or 25 and 50 (BRIP1, RAD51C, and RAD51D pathogenic variant carriers) years. Subsequent oophorectomy is recommended at a maximum delay of 5 years beyond the upper limit of the current guideline age for salpingo-oophorectomy. The current National Comprehensive Cancer Network (NCCN) guideline age, which is also the recommended age for salpingo-oophorectomy within the study, is 35-40 years for BRCA1, 40-45 years for BRCA2, and 45-50 years for BRIP1, RAD51C, and RAD51D pathogenic variant carriers. MAJOR INCLUSION/EXCLUSION CRITERIA: Premenopausal individuals with a documented class IV or V germline pathogenic variant in the BRCA1, BRCA2, BRIP1, RAD51C, or RAD51D gene who have completed childbearing are eligible for participation. Participants may have a personal history of a non-ovarian malignancy. PRIMARY ENDPOINT: The primary outcome is the cumulative tubo-ovarian cancer incidence at the target age: 46 years for BRCA1 and 51 years for BRCA2 pathogenic variant carriers. SAMPLE SIZE: The sample size to ensure sufficient power to test non-inferiority of salpingectomy with delayed oophorectomy compared with salpingo-oophorectomy requires 1500 BRCA1 and 1500 BRCA2 pathogenic variant carriers. ESTIMATED DATES FOR COMPLETING ACCRUAL AND PRESENTING RESULTS: Participant recruitment is expected to be completed at the end of 2026 (total recruitment period of 5 years). The primary outcome is expected to be available in 2036 (minimal follow-up period of 10 years). TRIAL REGISTRATION NUMBER: NCT04294927.

First step in implementation of opportunistic salpingectomy for prevention of ovarian cancer: Current care and its determinants.

INTRODUCTION: Opportunistic salpingectomy (OS) refers to additional removal of the fallopian tubes during abdominal surgery performed for another medical indication, as prevention for ovarian cancer. As OS has been inconsistently implemented, its clinical practice varies worldwide. To reduce this variation, insight is required into current clinical practice and its determinants. Therefore, the study aim was to determine the implementation of counseling and performance of OS between 2015 and 2018, and its patient, surgical, physician, and hospital characteristics. MATERIAL AND METHODS: Retrospective study using electronic medical records from six different Dutch hospitals: two academic, two large teaching, and two non-teaching hospitals. Patients were considered eligible for OS if they underwent elective non-obstetric abdominal surgery for a gynecological indication from January 2015 through December 2018. Primary outcomes were uptake of counseling and performance of OS. Multilevel multivariable logistic regression analyses were conducted to identify characteristics associated with OS. RESULTS: A total of 3214 patients underwent elective non-obstetric abdominal surgery for a gynecological indication and were eligible for OS. Counseling on OS increased significantly from 2.9% in 2015 to 29.4% in 2018. In this period, 440 patients were counseled on OS, of which 95.9% chose OS. Performance of OS increased significantly from 6.9% in 2015 to 44.5% in 2018. Counseling for and performance of OS were more likely in patients who had surgery by laparoscopic approach, were counseled by a gynecological resident, or had more than three contact moments before surgery. Additionally, OS was less likely in patients who had vaginal surgery. CONCLUSIONS: Although the uptake of OS increased from 2015 to 2018, the majority of patients who were eligible for OS were not counseled and did not undergo OS. Its clinical practice varies on patient, surgery, and physician characteristics. Therefore, an implementation strategy tailored to associated determinants is recommended.

Effectiveness of digital care platform CMyLife for patients with chronic myeloid leukemia: results of a patient-preference trial.

BACKGROUND: Two most important factors determining treatment success in chronic myeloid leukemia (CML) are adequate medication compliance and molecular monitoring albeit still being suboptimal. The CMyLife platform is an eHealth innovation, co-created with and for CML patients, aiming to improve their care, leading to an increased quality of life and the opportunity of hospital-free care. OBJECTIVE: To explore the effectiveness of CMyLife in terms of information provision, patient empowerment, medication compliance, molecular monitoring, and quality of life. METHODS: Effectiveness of CMyLife was explored using a patient-preference trial. Upon completion of the baseline questionnaire, participants actively used (intervention group) or did not actively use (questionnaire group) the CMyLife platform for at least 6 months, after which they completed the post-intervention questionnaire. Scores between the intervention group and the questionnaire group were compared with regard to the within-subject change between baseline and post-measurement using Generalized Estimating Equation models. RESULTS: At baseline, 33 patients were enrolled in the questionnaire group and 75 in the intervention group. Online health information knowledge improved significantly when actively using CMyLife and patients felt more empowered. No significant improvements were found regarding medication compliance and molecular monitoring, which were already outstanding. Self-reported effectiveness showed that patients experienced that using CMyLife improved their medication compliance and helped them to oversee their molecular monitoring. Patients using CMyLife reported more symptoms but were better able to manage these. CONCLUSIONS: Since hospital-free care has shown to be feasible in time of the COVID-19 pandemic, eHealth-based innovations such as CMyLife could be a solution to maintain the quality of care and make current oncological health care services more sustainable. TRIAL REGISTRATION: ClinicalTrials.gov NCT04595955 , 22/10/2020.

Web-based Guidance for Assisted Reproductive Technology With an Online App (myFertiCare): Quantitative Evaluation With the HOT-fit Framework.

BACKGROUND: Assisted reproductive technologies (ARTs) are considered to be physically and mentally stressful. During their treatment trajectory, couples express high information and communication needs. They appreciate using the internet to obtain fertility-related information. In a previous study, we developed myFertiCare, an eHealth tool providing personalized information and interactive functionalities for infertile couples in order to improve patient-centered care. The app has already been successful in qualitative evaluations of usability. OBJECTIVE: The aim of the current study is to quantitatively evaluate the implementation of myFertiCare by using the human, organizational, and technology-fit (HOT-fit) framework and to study the effects of using myFertiCare on couples' knowledge about infertility, their experience of the burden of infertility, and their experience of patient-centered care. With these results, implementation can be further improved, and patient-centered care can be enhanced. METHODS: A quantitative study was performed based on the HOT-fit framework using validated questionnaires focusing on the human, organizational, and technology domains. Questions were added on the effect of using myFertiCare on couples' knowledge about infertility and treatment. Questions regarding the burden of infertility, the burden of infertility treatment, and the experience of patient-centeredness were based on the main items of the validated fertility quality of life (FertiQoL) and Patient-Centredness Questionnaire-Infertility questionnaires, respectively. Also, nonusers of the app were included to explore motivations for not using the app and identify opportunities for improvement. Finally, user data were analyzed to provide insight into multiple variables concerning app use. RESULTS: In the human and technology domains, myFertiCare showed good system usability, high user satisfaction, and high information and interface quality. In the organizational domain, implementation was considered to be sufficient by both patients and staff. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. User data showed that women were the main app users and that use of the app gradually declined during the treatment trajectory. CONCLUSIONS: A multi-faceted online app, myFertiCare, has been successfully evaluated quantitatively for implementation by using the HOT-fit framework. Use of the app increased knowledge about the treatment, improved coping with the treatment, and enhanced the experience of patient-centeredness. App use could be improved by creating more publicity. By providing myFertiCare, professionals in fertility care are supported in guiding patients through their treatment trajectory and in delivering patient-centered care.

Improvement, Implementation, and Evaluation of the CMyLife Digital Care Platform: Participatory Action Research Approach.

BACKGROUND: The evaluation of a continuously evolving eHealth tool in terms of improvement and implementation in daily practice is unclear. The CMyLife digital care platform provides patient-centered care by empowering patients with chronic myeloid leukemia, with a focus on making medication compliance insightful, discussable, and optimal, and achieving optimal control of the biomarker BCR-ABL1. OBJECTIVE: The aim of this study was to investigate to what extent the participatory action research approach is suitable for the improvement and scientific evaluation of eHealth innovations in daily clinical practice (measured by user experiences) combined with the promotion of patient empowerment. METHODS: The study used iterative cycles of planning, action, and reflection, whereby participants' experiences (patients, health care providers, the CMyLife team, and app suppliers) with the platform determined next actions. Co-design workshops were the foundation of this cyclic process. Moreover, patients filled in 2 sets of questionnaires for assessing experiences with CMyLife, the actual use of the platform, and the influence of the platform after 3 and at least 6 months. Data collected during the workshops were analyzed using content analysis, which is often used for making a practical guide to action. Descriptive statistics were used to characterize the study population in terms of information related to chronic myeloid leukemia and sociodemographics, and to describe experiences with the CMyLife digital care platform and the actual use of this platform. RESULTS: The co-design workshops provided insights that contributed to the improvement, implementation, and evaluation of CMyLife and empowered patients with chronic myeloid leukemia (for example, simplification of language, and improvement of the user friendliness of functionalities). The results of the questionnaires indicated that (1) the platform improved information provision on chronic myeloid leukemia in 67% (33/49) of patients, (2) the use of the medication app improved medication compliance in 42% (16/38) of patients, (3) the use of the guideline app improved guideline adherence in 44% (11/25) of patients, and (4) the use of the platform caused patients to feel more empowered. CONCLUSIONS: A participatory action research approach is suited to scientifically evaluate digital care platforms in daily clinical practice in terms of improvement, implementation, and patient empowerment. Systematic iterative evaluation of users' needs and wishes is needed to keep care centered on patients and keep the innovation up-to-date and valuable for users.

Primary prevention of ovarian cancer: a patient decision aid for opportunistic salpingectomy.

BACKGROUND: The discovery of the fallopian tube epithelium as the origin of high-grade serous ovarian cancer has brought a new option for ovarian cancer prevention. The fallopian tubes have no known function after completion of childbearing and can be removed to reduce the lifetime risk of ovarian cancer. Although the lifetime risk in the general population does not justify preventive surgery in itself, salpingectomy can be performed during abdominal surgery for other indications, also known as an opportunistic salpingectomy. The popularity of opportunistic salpingectomy is increasing worldwide; however, the variation between gynecologists and hospitals in their advice on opportunistic salpingectomy occurs because of the remaining uncertainty of evidence. Therefore, whether a woman can make her own decision depends on the hospital or gynecologist she visits. We aimed to lower this practice variation by providing standardized and unbiased counseling material. OBJECTIVE: We aimed to develop and test a patient decision aid for opportunistic salpingectomy in women undergoing pelvic gynecologic surgery to either retain the ovaries or opt for sterilization. STUDY DESIGN: We followed a systematic development process based on the International Patient Decision Aid Standards. Data were collected between June 2019 and June 2020, using both qualitative and quantitative methods. The development process that occurred in collaboration with patients and healthcare professionals was overseen by a multidisciplinary steering group and was divided into 4 phases: (1) assessment of decisional needs using individual telephone interviews and questionnaires; (2) development of content and format based on decisional needs, current literature, and guidelines; (3) alpha testing and the first revision round; and (4) alpha testing and the second revision round. RESULTS: An outline of the patient decision aid was developed on the basis of decisional needs, current literature, and guidelines. It became clear that the decision aid should consist of 2 separate paths: one with information specifically for salpingectomy in addition to abdominal surgery and one for salpingectomy as a sterilization method. Both paths contained information on the anatomy and function of ovaries and fallopian tubes, risk reduction of ovarian cancer, and potential benefits and risks of opportunistic salpingectomy. Moreover, the sterilization path contains information on various sterilization methods and risks of unwanted pregnancy. The patient decision aid was developed as an online tool that includes information chapters, a knowledge quiz, consideration statements, and a summary detailing the patient's preferences and considerations. Adjustments were made following alpha testing round 1. The improved patient decision aid was subjected to usability tests (alpha testing round 2), in which it scored an "excellent" in tests with patients and a "good" in tests with gynecologists. Furthermore, our patient decision aid met the requirements of 45 of 49 applicable items from the International Patient Decision Aid Standards criteria. CONCLUSION: In collaboration with patients and healthcare professionals, a patient decision aid was developed on opportunistic salpingectomy and salpingectomy as a sterilization method. Both patients and gynecologists believed it is a useful tool that supports patients in making an informed decision whether to undergo an opportunistic salpingectomy and supports the counseling process by gynecologists.

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.

Exploration of fertility and early menopause related information needs and development of online information for young breast cancer survivors.

BACKGROUND: Approximately half of premenopausal women diagnosed with breast cancer desire to conceive after they finish treatment. Counseling about the risk of infertility prior to cancer treatment has been proven to improve quality of life after cancer treatment. As a result of this, guidelines focus on informing women on this topic prior to treatment. However, it is equally important to provide fertility related information after primary treatment has been completed, when the wish to conceive might become actual. Therefore, the aim of this study was to identify the fertility and early menopause related information needs of young breast cancer survivors and to design, develop and implement online information material with input of stakeholders. METHODS: A phenomenological qualitative study consisting of four phases was performed: identification of information needs through semi-structured interviews from a professional perspective (1) and a patient perspective (2). Exploration of stakeholders perspective regarding development and implementation of online information material (3) and development and implementation of the information material (4). RESULTS: Professionals indicated that there are no guidelines regarding the provision of fertility related information during cancer survivorship. Survivors reported unmet information needs. Women identified the following as most important information needs (a) fertility preservation options, (b) the risk of menopause or infertility, and (c) long term consequences of early menopause. A wide range of stakeholders involved in breast cancer care were interviewed. Based on their proposed design the information material was implemented on a nationwide website aiming at informing and supporting breast cancer patients. CONCLUSIONS: Fertility and early menopause related information needs of young breast cancer survivors and their professionals were identified. Information material has been designed, developed and nationally implemented. This way, professionals in breast cancer care are provided with an information tool that helps them meet the information needs and preferences of their patients.

Roles of general practitioners in shared decision-making for patients with cancer: A qualitative study.

OBJECTIVE: The shared decision-making (SDM) process for the treatment of pancreatic and oesophageal cancer primarily takes place with healthcare professionals (HCPs) in the hospital setting. This study aims to explore the perspectives of general practitioners (GPs) on their possible roles during this SDM process, their added value and their requirements for involvement in SDM. METHODS: Semi-structured interviews were conducted with 12 GPs about their views on SDM for patients with cancer. The interviews were analysed by two researchers using an inductive open coding approach. RESULTS: Five potential roles in SDM were described by the interviewed GPs, of which the role as 'coach' of the patient was mentioned by all. GPs see their main added value as their long-standing relationship with the patient. To be able to participate optimally in SDM, GPs indicated that they need to be kept up to date during the patient's care process and should receive enough medical information about treatment options and contextual information. CONCLUSION: GPs see different potential roles for themselves when involved in SDM. Hospital HCPs that want to facilitate GP involvement should take the initiative, provide the GPs with enough and timely information and must be easy to consult.

A comprehensive eHealth implementation guide constructed on a qualitative case study on barriers and facilitators of the digital care platform CMyLife.

BACKGROUND: Substantial proliferation of eHealth has enabled a move in patient-centred cancer care from the traditional in-person care model to real-time, dynamic, and technology supported on-demand care. However, in general, the uptake of these innovations is low. Studies show that eHealth is helpful in providing patient empowerment through e.g. providing high quality and timely information, enabling self-monitoring and shared decision making, but dropout rates are high and guidance for optimal implementation is lacking. AIM: To explore barriers to and facilitators for nationwide implementation and consolidation of CMyLife, a multi-component, patient-centred, digital care platform, and to construct a comprehensive implementation guide for launching digital care platforms in daily clinical practice. METHODS: The first qualitative case study of a digital care platform like CMyLife was performed including five focus group- and eighteen in-depth interviews with stakeholders. Data were collected using a semi-structured interview guide, based on the frameworks of Grol and Flottorp. Transcripts of the interviews were analysed and barriers and facilitators were identified and categorized according to the frameworks. An iterative process including participation of main stakeholders and using the CFIR-ERIC framework led to creating a comprehensive implementation guide for digital care platforms. RESULTS: In total, 45 barriers and 41 facilitators were identified. Main barriers were lack of connectivity between information technology systems, changing role for both health care providers and patients, insufficient time and resources, doubts about privacy and security of data, and insufficient digital skills of users. Main facilitators mentioned were motivating patients and health care providers by clarifying the added value of use of a digital care platform, clear business case with vision, demonstrating (cost) effectiveness, using an implementation guide, and educating patients and health care providers about how to use CMyLife. Based on these barriers and facilitators a clear and comprehensive implementation guide was developed for digital care platforms. CONCLUSION: Several barriers to and facilitators for implementation were identified, a clear overview was presented, and a unique comprehensive implementation guide was developed for launching future digital care platforms in daily clinical practice. The next step is to validate the implementation guide in other (oncological) diseases.

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.

Improving Interdisciplinary Communication: Barriers and Facilitators for Implementation of Standardized Structured Reporting in Oncology.

BACKGROUND: Standardized structured reporting (SSR) improves quality of diagnostic cancer reporting and interdisciplinary communication in multidisciplinary team (MDT) meetings, resulting in more adequate treatment decisions and better health outcomes. However, use of SSR varies widely among pathologists, but might be encouraged by MDT members (MDTMs). Our objectives were to identify barriers and facilitators (influencing factors) for SSR implementation in oncologic pathology from the perspective of MDTMs and their determinants. METHODS: In a multimethod design, we identified influencing factors for SSR implementation related to MDT meetings, using 5 domains: (1) innovation factors, (2) individual professional factors, (3) social setting factors, (4) organizational factors, and (5) political and legal factors. Four focus groups with MDTMs in urologic, gynecologic, and gastroenterologic oncology were conducted. We used an eSurvey among MDTMs to quantify the qualitative findings and to analyze determinants affecting these influencing factors. RESULTS: Twenty-three MDTMs practicing in 9 oncology-related disciplines participated in the focus groups and yielded 28 barriers and 28 facilitators in all domains. The eSurvey yielded 211 responses. Main barriers related to lack of readability of SSR: difficulties with capturing nuances (66%) and formulation of the conclusion (43%); lack of transparency in the development (50%) and feedback processes of SSR templates (38%); and lack of information exchange about SSR between pathologists and other MDTMs (45%). Main facilitators were encouragement of pathologists' SSR use by MDTMs (90%) and expanding the recommendation of SSR use in national guidelines (80%). Oncology-related medical discipline and MDT type were the most relevant determinants for SSR implementation barriers. CONCLUSIONS: Although SSR makes diagnostic reports more complete, this study shows important barriers in implementing SSR in oncologic pathology. The next step is to use these factors for developing and testing implementation tools to improve SSR implementation.

Patients' and professionals' perspectives on implementation of opportunistic salpingectomy: a mixed-method study.

BACKGROUND: To prevent ovarian cancer, several international societies have issued guidelines which recommend to discuss opportunistic salpingectomy with women undergoing pelvic surgery after completion of childbearing. The opportunistic salpingectomy refers to the additional removal of Fallopian tubes during pelvic surgery for another indication to reduce the risk of developing ovarian cancer. These recommendations emphasize the importance of counselling on benefits and risks of opportunistic salpingectomy but offer no guidance on their implementation in daily practice. The lack of a tailored implementation strategy has resulted in a wide variation in current practice. To reduce this practice variation, we identified influencing factors on implementing opportunistic salpingectomy from patients' and professionals' perspectives. METHODS: We conducted a mixed-method study between 2019 and 2020 throughout the Netherlands. In a qualitative phase, we conducted interviews with gynecologic patients (N = 11) and their professionals (N = 20) to explore barriers and facilitators, using an interview guide. In the quantitative phase, we quantified these barriers and facilitators among patients who underwent a hysterectomy or sterilization and were counselled on the opportunistic salpingectomy (N = 77), and members of the Dutch Society of Obstetrics and Gynecology (N = 204), using questionnaires. For both phases, barriers and facilitators were classified into the following domains: innovation, patient, healthcare professional, social setting, organization, and economic and political context. RESULTS: For patients, main barriers were lack of knowledge about: the existence of the opportunistic salpingectomy (45%), size of the surgery (44%) and its associated possible disadvantages (37%). In addition, patients attributed their reluctance to concerns about the removal of healthy organs (46%). For professionals, main barriers were: patients' lack of knowledge of the size of surgery (85%) and its associated possible disadvantages (77%), the gap in evidence on long term risks and benefits (43%), the lack of feasibility in certain patients and during vaginal surgery (66%). Both patients (41%) and professionals (67%) identified the need for counselling material as facilitator. CONCLUSION: To reduce the variety in care regarding opportunistic salpingectomy, consensus and uniform counselling is needed. Including the opportunistic salpingectomy in gynecological guidelines and a decision aid for counselling could serve as tools to facilitate implementation.

External validation of a prediction model on vaginal birth after caesarean in a The Netherlands: a prospective cohort study.

OBJECTIVES: Discussing the individual probability of a successful vaginal birth after caesarean (VBAC) can support decision making. The aim of this study is to externally validate a prediction model for the probability of a VBAC in a Dutch population. METHODS: In this prospective cohort study in 12 Dutch hospitals, 586 women intending VBAC were included. Inclusion criteria were singleton pregnancies with a cephalic foetal presentation, delivery after 37 weeks and one previous caesarean section (CS) and preference for intending VBAC. The studied prediction model included six predictors: pre-pregnancy body mass index, previous vaginal delivery, previous CS because of non-progressive labour, Caucasian ethnicity, induction of current labour, and estimated foetal weight ≥90th percentile. The discriminative and predictive performance of the model was assessed using receiver operating characteristic curve analysis and calibration plots. RESULTS: The area under the curve was 0.73 (CI 0.69-0.78). The average predicted probability of a VBAC according to the prediction model was 70.3% (range 33-92%). The actual VBAC rate was 71.7%. The calibration plot shows some overestimation for low probabilities of VBAC and an underestimation of high probabilities. CONCLUSIONS: The prediction model showed good performance and was externally validated in a Dutch population. Hence it can be implemented as part of counselling for mode of delivery in women choosing between intended VBAC or planned CS after previous CS.

Nationwide implementation of a decision aid on vaginal birth after cesarean: a before and after cohort study.

OBJECTIVES: Woman with a history of a previous cesarean section (CS) can choose between an elective repeat CS (ERCS) and a trial of labor (TOL), which can end in a vaginal birth after cesarean (VBAC) or an unplanned CS. Guidelines describe women's rights to make an informed decision between an ERCS or a TOL. However, the rates of TOL and vaginal birth after CS varies greatly between and within countries. The objective of this study is to asses nation-wide implementation of counselling with a decision aid (DA) including a prediction model, on intended delivery compared to care as usual. We hypothesize that this may result in a reduction in practice variation without an increase in cesarean rates or complications. METHODS: In a multicenter controlled before and after cohort study we evaluate the effect of nation-wide implementation of a DA. Practice variation was defined as the standard deviation (SD) of TOL percentages. RESULTS: A total of 27 hospitals and 1,364 women were included. A significant decrease was found in practice variation (SD TOL rates: 0.17 control group vs. 0.10 intervention group following decision aid implementation, p=0.011). There was no significant difference in the ERCS rate or overall CS rates. A 21% reduction in the combined maternal and perinatal adverse outcomes was seen. CONCLUSIONS: Nationwide implementation of the DA showed a significant reduction in practice variation without an increase in the rate of cesarean section or complications, suggesting an improvement in equality of care.