Examining the Feasibility of an Application-Based Patient-Reported Outcome Monitoring for Breast Cancer Patients: A Pretest for the PRO B Study.

In preparation for the PRO B study which aims to examine the effects of an app-based intensified patient-reported outcome (PRO) monitoring for metastatic breast cancer patients, prior assessment of its feasibility was carried out. Sixteen breast cancer patients visiting the breast cancer unit at Charité were recruited and downloaded an app connected to an ePRO system. They received electronic questionnaires on two occasions (baseline and the following week) and were subsequently contacted for a semi-structured phone interview for evaluation. Eleven participants answered at least one questionnaire. Some participants did not receive any or only a part of the questionnaires due to technical problems with the app. Participants who completed the evaluation questionnaire (n = 6) were overall satisfied with the weekly PRO questionnaire. All interviewed (n = 11) participants thought it was feasible to answer the PRO questionnaires on a weekly basis for one year, as planned in the PRO B study. The pretest revealed a need for major technical adjustments to the app because push notifications about the receipt of new questionnaires were not displayed on some smartphone models. Due to the low number of participants, generalization of the findings is limited to our specific context and study. Nevertheless, we could conclude that if technical aspects of the app were improved, the PRO B study could be implemented as planned. The ePRO questionnaire was considered feasible and adequate from the patients' perspectives.

Real-world reference scores for EORTC QLQ-C30 and EORTC QLQ-BR23 in early breast cancer patients.

PURPOSE: To deliver patient-reported outcome (PRO) reference data for breast cancer and various other breast diseases to facilitate the interpretation of PRO scores during routine breast cancer treatment. METHODS: To determine reference baseline values for the PRO measures EORTC QLQ-C30 and EORTC QLQ-BR23, PRO data captured in the breast cancer centre at Charité - Universitätsmedizin Berlin from 2016 to 2021 were evaluated. As part of the clinical routine, ambulatory patients were asked to answer a digital survey regarding their medical history, current health status and health-related quality of life using the aforementioned questionnaires prior to their doctor's appointment in the outpatient breast clinic. Adjusted linear and variable dispersion beta regression models were used to compare different diagnosis groups. RESULTS: A total of 3689 patients were included in the digital PRO program, of which 1478 were eligible for this study; 729 had invasive breast cancer or ductal carcinoma in situ, 270 patients were diagnosed with fibroadenoma and 479 patients had other breast diseases such as cysts, mastopathy or abscesses. Overall, patients with breast cancer reported worse scores in almost all domains except for role functioning, sexual functioning and body image. Compared to previously published reference scores for early breast cancer, the current data show a more pronounced impact on perceived emotional and cognitive functioning. CONCLUSION: The results of this study are of high value for the interpretation of PROs and facilitate their use in clinical practice and clinical trials. The scores indicate an urgent need for psychosocial support prior to treatment.

PRO B: evaluating the effect of an alarm-based patient-reported outcome monitoring compared with usual care in metastatic breast cancer patients-study protocol for a randomised controlled trial.

BACKGROUND: Despite the progress of research and treatment for breast cancer, still up to 30% of the patients afflicted will develop distant disease. Elongation of survival and maintaining the quality of life (QoL) become pivotal issues guiding the treatment decisions. One possible approach to optimise survival and QoL is the use of patient-reported outcomes (PROs) to timely identify acute disease-related burden. We present the protocol of a trial that investigates the effect of real-time PRO data captured with electronic mobile devices on QoL in female breast cancer patients with metastatic disease. METHODS: This study is a randomised, controlled trial with 1:1 randomisation between two arms. A total of 1000 patients will be recruited in 40 selected breast cancer centres. Patients in the intervention arm receive a weekly request via an app to complete the PRO survey. Symptoms will be assessed by study-specific optimised short forms based on the EORTC QLQ-C30 domains using items from the EORTC CAT item banks. In case of deteriorating PRO scores, an alarm is sent to the treating study centre as well as to the PRO B study office. Following the alarm, the treating breast cancer centre is required to contact the patient to inquire about the reported symptoms and to intervene, if necessary. The intervention is not specified and depends on the clinical need determined by the treating physician. Patients in the control arm are prompted by the app every 3 months to participate in the PRO survey, but their response will not trigger an alarm. The primary outcome is the fatigue level 6 months after enrolment. Secondary endpoints include among others hospitalisations, use of rescue services and overall QoL. DISCUSSION: Within the PRO B intervention group, we expect lower fatigue levels 6 months after intervention start, higher levels of QoL, less unplanned hospitalisations and less emergency room visits compared to controls. In case of positive results, our approach would allow a fast and easy transfer into clinical practice due to the use of the already nationwide existing IT infrastructure of the German Cancer Society and the independent certification institute OnkoZert. TRIAL REGISTRATION: DRKS (German Clinical Trials Register) DRKS00024015 . Registered on 15 February 2021.

Measuring Quality of Life Using Patient-Reported Outcomes in Real-World Metastatic Breast Cancer Patients: The Need for a Standardized Approach.

Metastatic breast cancer (MBC) patients are almost always treated to minimize the symptom burden, and to prolong life without a curative intent. Although the prognosis of MBC patients has improved in recent years, the median survival after diagnosis is still only 3 years. Therefore, the health-related quality of life (HRQoL) should play a leading role in making treatment decisions. Heterogeneity in questionnaires used to evaluate the HRQoL in MBC patients complicates the interpretability and comparability of patient-reported outcomes (PROs) globally. In this review, we aimed to provide an overview of PRO instruments used in real-world MBC patients and to discuss important issues in measuring HRQoL. Routinely collecting symptom information using PROs could enhance treatment evaluation and shared decision-making. Standardizing these measures might help to improve the implementation of PROs, and facilitates collecting and sharing data to establish valid comparisons in research. This is a prerequisite to learn about how they could impact the clinical care pathway. In addition, the prognostic value of intensified PRO collection throughout therapy on survival and disease progression is promising. Future perspectives in the field of PROs and MBC are described.

A Pilot Study Evaluating the Effects of Magtrace® for Sentinel Node Biopsy in Breast Cancer Patients Regarding Care Process Optimization, Reimbursement, Surgical Time, and Patient Comfort Compared With Standard Technetium99.

BACKGROUND: Sentinel lymph node biopsy after technetium-99 (Tc99) localization is a mainstay of oncologic breast surgery. The timing of Tc99 injection can complicate operating room schedules, which can cause increasing overall costs of care and patient discomfort. METHODS: This study compared 59 patients who underwent breast cancer surgery including sentinel lymph node biopsy. Based on the surgeon's choice, 29 patients were treated with Tc99, and 30 patients received the iron-based tracer, Magtrace. The primary outcomes were time spent on the care pathway and operating time from commissioning of the probe to removal of the sentinel node. The secondary outcomes were patient pain levels and reimbursement. RESULTS: The mean time spent on the preoperative breast cancer care pathway was significantly shorter for the Magtrace group (5.4 ± 1.3 min) than for the Tc99 group (82 ± 20 min) (p < 0.0001). The median time from probe usage to sentinel node extirpation was slightly but not significantly shorter in the Magtrace group (5 min; interquartile range [IQR], 3-15 min vs 10 min; IQR, 7-15 min; p = 0.151). Reimbursement and pain levels remained unchanged, and the hospital length of stay was similar in the two groups (Magtrace: 5.1 ± 2.3 days vs Tc99: 4.5 ± 3.2 days). CONCLUSIONS: Magtrace localization shortened the preoperative care pathway and did not affect surgical time or reimbursement. Once established, it could allow for cost reduction and improve patient comfort.

Training courses on hereditary breast and ovarian cancer to strengthen cross-sectoral care in underserved areas.

OBJECTIVE: To strengthen cross-sectoral care by disseminating specialized knowledge about hereditary breast and ovarian cancer across underserved areas. METHODS: We report on a training course about genetic counseling and testing of hereditary breast and ovarian cancer patients for gynecologists from certified cancer centers. In total, 50 gynecologists attended the course which was offered once annually between 2017 and 2019. Before and after the course, participants were asked to answer a self-assessment questionnaire and completed the training with a multiple-choice test. The results of the self-assessments and knowledge tests were analyzed to steadily improve the training. RESULTS: The self-assessments imply a perceived increase in certainty regarding the inclusion criteria for specialized genetic counseling, pedigree analysis, and contents of the initial consultation. Both the knowledge tests and self-assessments showed that participants had difficulties in interpreting and differentiating between age-specific and lifetime risks. CONCLUSION: The courses successfully conveyed knowledge necessary to identify patients at risk and to provide timely genetic analyses even in rural areas. PRACTICE IMPLICATIONS: The results are a promising basis for creating additional training courses addressing specialists in hospitals and gynecological practices. Further education of physicians might improve cross-sectoral cooperation and thereby enable specialized care supply in rural areas.

Correction to: Intraoperative indocyanine green fluorescence imaging in breast surgery.

In the original article published, some of the superscript characters in Table 1 (column p value with superscript references to the footnotes) were incorrectly inserted by the typesetters.

A German Study Comparing Standard Wire Localization With Magnetic Seed Localization of Non-palpable Breast Lesions.

BACKGROUND: Exact localization of non-palpable breast lesions is necessary to ensure that the correct lesion is removed. Conventional methods come with several disadvantages. PATIENTS AND METHODS: We compared 28 patients who underwent breast-conserving surgery for a non-palpable lesion. By surgeon choice, 14 patients were assigned to undergo magnetic seed localization and 14 underwent standard wire localization. The primary outcome was the operative time, and secondary outcome was the patient pain level. RESULTS: The mean age was 52±10 (SD) years in the seed arm, and 55±13 years in the wire arm. The median time from skin incision to tumor extraction was not significantly different between the two groups. Patients in the wire localized group significantly more often reported pain during coughing/breathing, movement, and sleep. CONCLUSION: Using seed localization at Charité Breast Center did not lead to a significant decrease in operative time but might allow time savings once established, while increasing patient comfort and reducing organizational burden.

Intraoperative indocyanine green fluorescence imaging in breast surgery.

BACKGROUND: Since postoperative complications after reconstructive breast surgery are often related to drastic increases of patient suffering and treatment costs, several devices were developed in order to avoid them. In this respect, the intraoperative fluorescence angiography with indocyanine green (ICG) provides promising results by detecting ischemic skin intraoperatively. METHODS: Women who underwent reconstructive breast surgery at the breast center at Charité between April and December 2017 were included in the analysis. General patient characteristics, medical history, type of surgery, as well as postoperative parameters, complications and patient reported outcomes were compared between patients operated using ICG fluorescence angiography and conventionally operated patients. RESULTS: Among 68 patients with breast reconstruction 36 (52.9%) were operated with the ICG angiography device and 32 (47.1%) without. No significant differences regarding patient demographics, medical history, and surgical procedure were found. Wound healing disorders occurred in 11.1% of the ICG group and in 9.4% of the control group. About 11% of both groups developed major complications which required revision surgery. Complication rates and patient reported outcome did not differ significantly. Across both groups, only the risk factor resection weight (≥ 500 g) was significantly associated with wound healing disorders (RR = 6.80; 95%CI 1.93-23.81; p = 0.022). CONCLUSION: The purchase of a device for intraoperative ICG angiography might not be reasonable for every breast center. Further research in a larger cohort and prospective manner should be done to determine if the addition of ICG to breast reconstructive surgery in the German setting really leads to improved patient care.