Needs and preferences of breast cancer survivors regarding outcome-based shared decision-making about personalised post-treatment surveillance.

PURPOSE: In this study, we explored how patients experience current information provision and decision-making about post-treatment surveillance after breast cancer. Furthermore, we assessed patients' perspectives regarding less intensive surveillance in case of a low risk of recurrence. METHODS: We conducted semi-structured interviews with 22 women in the post-treatment surveillance trajectory in seven Dutch teaching hospitals. RESULTS: Although the majority of participants indicated a desire for shared decision-making (SDM) about post-treatment surveillance, participants experienced no SDM. Information provision was often suboptimal and unstructured. Participants were open for using risk information in decision-making, but hesitant towards less intensive surveillance. Perceived advantages of less intensive surveillance were: less distressing moments, leaving the patient role behind, and lower burden. Disadvantages were: fewer moments for reassurance, fear of missing recurrences, and a higher threshold for aftercare for side effects. CONCLUSIONS: SDM about post-treatment surveillance is desirable. Although women are hesitant about less intensive surveillance, they are open to the use of personalised risk assessment for recurrences in decision-making about surveillance. IMPLICATIONS FOR CANCER SURVIVORS: To facilitate SDM about post-treatment surveillance, the timing and content of information provision should be improved. Risk information should be provided in an accessible and understandable way. Moreover, fear of cancer recurrence and other personal considerations should be addressed in the process of SDM.

Supporting Shared Decision-making About Surveillance After Breast Cancer With Personalized Recurrence Risk Calculations: Development of a Patient Decision Aid Using the International Patient Decision AIDS Standards Development Process in Combination With a Mixed Methods Design.

BACKGROUND: Although the treatment for breast cancer is highly personalized, posttreatment surveillance remains one-size-fits-all: annual imaging and physical examination for at least five years after treatment. The INFLUENCE nomogram is a prognostic model for estimating the 5-year risk for locoregional recurrences and second primary tumors after breast cancer. The use of personalized outcome data (such as risks for recurrences) can enrich the process of shared decision-making (SDM) for personalized surveillance after breast cancer. OBJECTIVE: This study aimed to develop a patient decision aid (PtDA), integrating personalized risk calculations on risks for recurrences, to support SDM for personalized surveillance after curative treatment for invasive breast cancer. METHODS: For the development of the PtDA, the International Patient Decision Aids Standards development process was combined with a mixed methods design inspired by the development process of previously developed PtDAs. In the development, 8 steps were distinguished: establishing a multidisciplinary steering group; definition of the end users, scope, and purpose of the PtDA; assessment of the decisional needs of end users; defining requirements for the PtDA; determining the format and implementation strategy for the PtDA; prototyping; alpha testing; and beta testing. The composed steering group convened during regular working-group sessions throughout the development process. RESULTS: The "Breast Cancer Surveillance Decision Aid" consists of 3 components that support the SDM process: a handout sheet on which personalized risks for recurrences, calculated using the INFLUENCE-nomogram, can be visualized and which contains an explanation about the decision for surveillance and a login code for a web-based deliberation tool; a web-based deliberation tool, including a patient-reported outcome measure on fear of cancer recurrence; and a summary sheet summarizing patient preferences and considerations. The PtDA was assessed as usable and acceptable during alpha testing. Beta testing is currently ongoing. CONCLUSIONS: We developed an acceptable and usable PtDA that integrates personalized risk calculations for the risk for recurrences to support SDM for surveillance after breast cancer. The implementation and effects of the use of the "Breast Cancer Surveillance Decision Aid" are being investigated in a clinical trial.

Effectiveness and implementation of SHared decision-making supported by OUTcome information among patients with breast cancer, stroke and advanced kidney disease: SHOUT study protocol of multiple interrupted time series.

INTRODUCTION: Within the value-based healthcare framework, outcome data can be used to inform patients about (treatment) options, and empower them to make shared decisions with their health care professional. To facilitate shared decision-making (SDM) supported by outcome data, a multicomponent intervention has been designed, including patient decision aids on the organisation of post-treatment surveillance (breast cancer); discharge location (stroke) and treatment modality (advanced kidney disease), and training on SDM for health care professionals. The SHared decision-making supported by OUTcome information (SHOUT) study will examine the effectiveness of the intervention and its implementation in clinical practice. METHODS AND ANALYSIS: Multiple interrupted time series will be used to stepwise implement the intervention. Patients diagnosed with either breast cancer (N=630), stroke (N=630) or advanced kidney disease (N=473) will be included. Measurements will be performed at baseline, three (stroke), six and twelve (breast cancer and advanced kidney disease) months. Trends on outcomes will be measured over a period of 20 months. The primary outcome will be patients' perceived level of involvement in decision-making. Secondary outcomes regarding effectiveness will include patient-reported SDM, decisional conflict, role in decision-making, knowledge, quality of life, preferred and chosen care, satisfaction with the intervention, healthcare utilisation and health outcomes. Outcomes regarding implementation will include the implementation rate and a questionnaire on the health care professionals' perspective on the implementation process. ETHICS AND DISSEMINATION: The Medical research Ethics Committees United in Nieuwegein, the Netherlands, has confirmed that the Medical Research Involving Human Subjects Act does not apply to this study. Bureau Onderzoek & Innovatie of Santeon, the Netherlands, approved this study. The results will contribute to insight in and knowledge on the use of outcome data for SDM, and can stimulate sustainable implementation of SDM. TRIAL REGISTRATION NUMBER: NL8374, NL8375 and NL8376.

Daily Oral Ibandronate With Adjuvant Endocrine Therapy in Postmenopausal Women With Estrogen Receptor-Positive Breast Cancer (BOOG 2006-04): Randomized Phase III TEAM-IIB Trial.

PURPOSE: For postmenopausal patients with breast cancer, previous subgroup analyses have shown a modest benefit from adjuvant bisphosphonate treatment. However, the efficacy of oral nitrogen-containing bisphosphonates such as ibandronate is unclear in this setting. TEAM-IIB investigates adjuvant ibandronate in postmenopausal women with estrogen receptor-positive (ER+) breast cancer. METHODS: TEAM-IIB is a randomized, open-label, multicenter phase III study. Postmenopausal women with stage I-III ER+ breast cancer and an indication for adjuvant endocrine therapy (ET) were randomly assigned 1:1 to 5 years of ET with or without oral ibandronate 50 mg once daily for 3 years. Major ineligibility criteria were bilateral breast cancer, active gastroesophageal problems, and health conditions that might interfere with study treatment. Primary end point was disease-free survival (DFS), analyzed in the intention-to-treat population. RESULTS: Between February 1, 2007, and May 27, 2014, 1,116 patients were enrolled, 565 to ET with ibandronate (ibandronate arm) and 551 to ET alone (control arm). Median follow-up was 8.5 years. DFS was not significantly different between the ibandronate and control arms (HR, 0.97; 95% CI, 0.76 to 1.24; log-rank P = .811). Three years after random assignment, DFS was 94% in the ibandronate arm and 91% in the control arm. Five years after random assignment, this was 89% and 86%, respectively. In the ibandronate arm, 97/565 (17%) of patients stopped ibandronate early because of adverse events. Significantly more patients experienced GI issues, mainly dyspepsia, in the ibandronate arm than in the control arm (89 [16%] and 54 [10%], respectively; P < .003). Eleven patients in the ibandronate arm developed osteonecrosis of the jaw. CONCLUSION: In postmenopausal women with ER+ breast cancer, adjuvant ibandronate 50 mg once daily does not improve DFS and should not be recommended as part of standard treatment regimens.

Follow-up after breast cancer: Variations, best practices, and opportunities for improvement according to health care professionals.

OBJECTIVE: Follow-up after breast cancer can be divided into surveillance and aftercare. It remains unclear how follow-up can ideally be organised from the perspective of health care professionals (HCPs). The aim of this study was to gain insight in the organisation of follow-up in seven Dutch teaching hospitals and to identify best practices and opportunities for improvement of breast cancer (all stages) follow-up as proposed by HCPs. METHODS: Semi-structured in-depth group interviews were performed, one in each of the participating hospitals, with in total 16 HCPs and 2 patient advocates. To describe the organisation of follow-up, transcripts were analysed using a deductive approach. Best practices and opportunities were derived using an inductive approach. RESULTS: Variation was found in the organisation of aftercare, especially in timing, frequency, and disciplines of involved HCPs. Less variation was observed for surveillance, which was guided by the national guideline. Best practices focused on case management and adequate collaboration between HCPs of different disciplines. Mentioned opportunities were improving the structured monitoring of patients' needs and a comprehensive guideline for organisation and content of aftercare. CONCLUSIONS: Variation in follow-up existed between hospitals. Shared decision-making (SDM) about surveillance is desirable to ensure that surveillance matches the patient needs, preferences, and personal risk for recurrences.

Efficacy of Internet-Based Cognitive Behavioral Therapy for Treatment-Induced Menopausal Symptoms in Breast Cancer Survivors: Results of a Randomized Controlled Trial.

PURPOSE: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms. PATIENTS AND METHODS: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large. RESULTS: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency. CONCLUSION: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.

[Breast-conserving surgery and radiotherapy as a one-day procedure]. / Borstsparende ingreep en bestraling in dagbehandeling.

A single dose of irradiation to the lumpectomy cavity alone after breast-conserving surgery in breast cancer patients has been available in the Netherlands since 2011. This new treatment modality is used in the Haaglanden Medical Centre in The Hague and in the Catharina Hospital in Eindhoven. The goal of intraoperative radiation therapy is to limit the patient burden caused by whole breast irradiation, while maintaining excellent local tumour control. The technique is used only in patients with a low probability of recurrent disease in the breast. Approximately 150 patients receive intraoperative radiation therapy each year In the Netherlands, an estimated 4,000 breast cancer patients were eligible in 2013 for this new treatment technique or another method of partial breast irradiation. In both hospitals the results are closely monitored. Only 15 of the first 200 patients experienced a side effect within a period of 3 months after intraoperative radiation therapy. These side effects were successfully treated either with antibiotics or with surgery.

[Diabetic mastopathy]. / Diabetische mastopathie.

BACKGROUND: Diabetic mastopathy is a rare condition, which is clinically not easily to differentiate from breast cancer. CASE DESCRIPTION: A 32-year-old woman, with a long-standing history of insulin-dependent diabetes mellitus presented at the breast outpatient clinic with a firm palpable, painless mass in her right breast. Mammography and ultrasound examination showed, respectively, slight asymmetry with dense glandular tissue and a hypoechoic area with posterior shadowing. MR mammography showed no suspicious abnormalities. Histopathological examination revealed fibrous tissue with lymphocytic inflammation. The combination of clinical presentation, history of diabetes mellitus, and histological findings led to a diagnosis of diabetic mastopathy. CONCLUSION: A palpable breast abnormality in a woman with diabetes mellitus can be caused by diabetic mastopathy. Knowledge of this condition by the disciplines involved can prevent over-diagnosis and unnecessary interventions.

Patterns and determinants of surgical management of screen detected breast cancer in the South-East Netherlands.

INTRODUCTION: Patients with screen detected breast cancer tend to have small, non-palpable tumours with favourable characteristics for breast conserving surgery (BCS). The aims of this study were to analyse patterns in surgical management in patients with screen detected breast cancer and to determine factors predictive of the need for a re-operation after BCS (re-excision or secondary mastectomy). METHODS: Patient data were retrieved from the population based Eindhoven Cancer Registry, which covers 14 hospitals in de south of the Netherlands. Data of patients aged 50-74 years, diagnosed with operable, invasive, non-metastasised, T1 or T2 tumours in the period from 1999 to 2005 were linked to the patients recorded by the Dutch Breast Screening Organisation to identify the screen-detected cancers. RESULTS: A total of 5657 patients were diagnosed with early stage invasive breast cancer. In 2822 of the 5657 patients (50%) breast cancer was detected by screening. Eighty percent of the screen-detected breast cancers was smaller than 2 cm. Of all 2822 patients with screen-detected cancer 82% underwent primary BCS. From 1999 until 2006 the percentage of re-excisions after this primary BCS decreased from 14% to 8% and the percentage of secondary mastectomies decreased from 23% to 8%. Primary BCS rates ranged from 64% to 93% between the 14 hospitals. Multivariable analyses showed that tumour size >2 cm, lobular histology, axillary nodal tumour involvement and poor differentiation of the tumour were associated with a statistically significant increase in the risk of re-operation after BCS. CONCLUSION: The need for a second operation after breast conserving surgery in patients with screen-detected breast cancer has decreased significantly in the southern Netherlands since 1999. However, considerable variation in surgical approach and re-operation rate between hospitals was observed.