Background: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and... Show moreBackground: Shared decision-making (SDM) is particularly important in oncology as many treatments involve serious side effects, and treatment decisions involve a trade-off between benefits and risks. However, the implementation of SDM in oncology care is challenging, and clinicians state that it is difficult to apply SDM in their actual workplace. Training clinicians is known to be an effective means of improving SDM but is considered time consuming. Objective: This study aims to address the effectiveness of an individual SDM training program using the concept of deliberate practice. Methods: This multicenter, single-blinded randomized clinical trial will be performed at 12 Dutch hospitals. Clinicians involved in decisions with oncology patients will be invited to participate in the study and allocated to the control or intervention group. All clinicians will record 3 decision-making processes with 3 different oncology patients. Clinicians in the intervention group will receive the following SDM intervention: completing e-learning, reflecting on feedback reports, performing a self-assessment and defining 1 to 3 personal learning questions, and participating in face-to-face coaching. Clinicians in the control group will not receive the SDM intervention until the end of the study. The primary outcome will be the extent to which clinicians involve their patients in the decision-making process, as scored using the Observing Patient Involvement-5 instrument. As secondary outcomes, patients will rate their perceived involvement in decision-making, and the duration of the consultations will be registered. All participating clinicians and their patients will receive information about the study and complete an informed consent form beforehand. Results: This trial was retrospectively registered on August 03, 2021. Approval for the study was obtained from the ethical review board (medical research ethics committee Delft and Leiden, the Netherlands [N20.170]). Recruitment and data collection procedures are ongoing and are expected to be completed by July 2022; we plan to complete data analyses by December 2022. As of February 2022, a total of 12 hospitals have been recruited to participate in the study, and 30 clinicians have started the SDM training program. Conclusions: This theory-based and blended approach will increase our knowledge of effective and feasible training methods for clinicians in the field of SDM. The intervention will be tailored to the context of individual clinicians and will target the knowledge, attitude, and skills of clinicians. The patients will also be involved in the design and implementation of the study. Show less
Hoekman, E.J.; Louwe, L.A.; Rooijers, M.; Westerlaken, L.A.J. van der; Klijn, N.F.; Pilgram, G.S.K.; ... ; Hilders, C.G.J.M. 2020
Introduction The likelihood of survival after cancer treatment among young women with cancer has increased considerably, quality of life after treatment has drawn more attention. However, in young... Show moreIntroduction The likelihood of survival after cancer treatment among young women with cancer has increased considerably, quality of life after treatment has drawn more attention. However, in young fertile women, fertility preservation is an important issue with regard to quality of life. One of the options of fertility preservation is ovarian tissue cryopreservation. The purpose of this follow-up study is to present our clinical experiences and evaluate the long-term follow up of ovarian cryopreservation to improve future patient selection. Material and methods From July 2002 to December 2015 at the Leiden University Hospital, the Netherlands, 69 young women underwent ovarian tissue cryopreservation when they were at risk of iatrogenic premature ovarian insufficiency. Follow-up data with regard to ovarian function were obtained until October 2018, from medical records and questionnaires. Results Of the 69 women in whom ovarian tissue cryopreservation was performed, 12 died (15.9%), 57 were approached to participate, of which 6 were lost to follow up. The indications for ovarian tissue cryopreservation were malignant (81.1%) and benign (18.9%) diseases in which gonadotoxic treatment was scheduled. In total, twenty women (39.2%) are known to have premature ovarian insufficiency due to gonadotoxic treatment. Fifteen women conceived spontaneously, and delivered 25 babies. In this cohort, the usage rate of autotransplantation is 8.7% (7/69). In total, nine autotransplantations of cryopreserved ovarian tissue were performed in seven patients (of which 1 ovarian tissue cryopreservation was performed in another hospital) after which 6 babies were born to four women, giving a live-birth rate of 57%. Conclusions Ovarian tissue cryopreservation followed by autotransplantation is an effective method to restore fertility (live-birth rate of 57%). The usage rate of 8.7% (6/69) indicates that more knowledge about the risk of premature ovarian insufficiency after gonadotoxic treatment is needed to be able to offer ovarian tissue cryopreservation more selectively. Show less
Veenendaal, H. van; Weijden, T. van der; Ubbink, D.T.; Stiggelbout, A.M.; Mierlo, L.A. van; Hilders, C.G.J.M. 2018
OBJECTIVE: It is not well-known how women receiving counselling consultation about fertility preservation (FP) in the Netherlands perceive the information provision about and referral for FP in the... Show moreOBJECTIVE: It is not well-known how women receiving counselling consultation about fertility preservation (FP) in the Netherlands perceive the information provision about and referral for FP in the oncology setting. The aim of this study was to qualitatively explore women's experiences with the (process of) information provision about the gonadotoxic effects of cancer treatment and about FP and the decision-making process and to obtain their recommendation for improvements. METHODS: Semi-structured interviews with female patients with cancer who had received a counselling consultation on FP (at 18-40 years of age). RESULTS: Thirty-four interviews were held (response rate 64%). Information provision was considered to be important. Overall, women were satisfied with the timing and the content of the information, but women were less positive about the need to be assertive to get information, and the multiplicity of decisions and actions to be carried out in a very short time frame. CONCLUSIONS: Information provision on gonadotoxic effects of cancer treatment and about FP was overall deemed sufficient, timely and important. Women recommended standardization of the information provision, improvement of communication among clinicians and medical centres, and availability of FP-specific patient information materials to improve future information provision processes. Show less
Abstract Background. The aim of this study was to obtain feedback from, and reach consensus among different experts who are or have been involved in information provision about FP, regarding the ... Show moreAbstract Background. The aim of this study was to obtain feedback from, and reach consensus among different experts who are or have been involved in information provision about FP, regarding the (procedure of) information provision about Fertility Preservation (FP) and use of a web-based decision aid (DA) about FP to create optimal conditions for the implementation of the DA-website, as we prepare to implement a DA about FP in the Netherlands. Material and methods. A two round Delphi study in which experts (patients and clinicians) rated their (dis)agreement with a list of statements (Rounds 1, 2), and additional online forum to discuss dissensus (Round 3). We assessed opinions about FP, web-based DAs, and about the procedure of informing patients. Answer categories ranged from 1 (totally disagree) to 5 (totally agree). Consensus was considered significant when at least 80% of the experts scored either the lowest or the highest two categories. Results. Experts reached rapid consensus on all five statements about the use of a DA (5/5; 100%), and all eight statements about which patients should be offered information about FP (8/8; 100%). However opinions about FP (4/11 statements; 36%), and procedural aspects such as who should inform the patient (6/10 statements; 60%) and when (3/10 statements; 30%) remained for discussion in round 3. In the online discussion some level of agreement was reached for these statements after all. Conclusion. It was deemed important that FP options exist. Every eligible patient should receive at least some (general) information about FP, soon after diagnosis. Detailed information should be provided by a fertility expert at a later moment. Exact timing and amount of information should be adjusted to patient's needs and situational context. A DA-website can offer a fair contribution to this. Show less
