Bilthoven

Researchers are evaluating the use of Autologous Fat Transfer (AFT) with pre-expansion as a full breast reconstruction method for female breast cancer patients who have undergone or will undergo mastectomy. This multicenter prospective cohort study aims to monitor the quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. The study builds on the previous BREAST trial that compared AFT with implant-based reconstruction, but here all patients receive AFT. Participants in this study will undergo full breast reconstruction using AFT combined with an external expansion device. This procedure is offered to women who have had or are candidates for mastectomy, including those undergoing preventive mastectomy. The external expansion device must be worn by participants to assist the reconstruction process. There is no comparator group in this study as all patients receive the AFT treatment. During the study, participants will be followed for at least two years to evaluate breast-related quality of life and other outcomes. Researchers will monitor safety, aesthetic results, and complications throughout this period. Patients will be assessed regularly to track their progress and any adverse effects related to the treatment, with particular attention to oncological safety and overall well-being after reconstruction.

Researchers are investigating the effects of neoadjuvant radiotherapy (NART) followed by mastectomy and immediate breast reconstruction in female breast cancer patients. This pilot study focuses on assessing the rate of acute post-surgical complications within three months after the latest reconstructive surgery. The goal is to determine if NART can avoid the negative effects seen with postmastectomy radiotherapy (PMRT), such as increased complications and poor cosmetic outcomes, potentially leading to better quality of life and shorter overall treatment times. The study involves delivering NART approximately 6-8 weeks after the last chemotherapy session if chemotherapy is given. The radiotherapy dose consists of 15 fractions of 2.67 Gy each, administered five times per week. About 2-6 weeks after completing radiotherapy, patients will undergo mastectomy with immediate breast reconstruction, either using a silicone implant or autologous tissue such as the Deep Inferior Epigastric Perforator (DIEP) flap. This approach contrasts with standard treatment where radiotherapy is given after mastectomy and reconstruction, which can lead to higher complication rates. Participants will be closely monitored for post-surgical complications three months after their final reconstructive surgery. Researchers will collect data on surgical outcomes and complications to evaluate the safety of this treatment sequence. The study also involves questionnaires about cosmetic results and quality of life. If complication rates are acceptable, further research will follow to assess long-term quality of life and oncological outcomes. The total participation includes the treatment period and follow-up assessments at three months post-surgery.

Researchers are evaluating the effectiveness of a group course called Hold Me Tight/Let Me Go (HmT/LmG) designed to improve relationships between parents and adolescents aged 12 to 18. The course targets families experiencing stressful parent-adolescent relationships that may worsen adolescent problems. This study uses a within-subject design with three phases: a waiting period averaging five weeks, a six-week treatment phase, and an eight-week follow-up to measure changes in relationship satisfaction and negative interaction patterns over time. The intervention includes four group sessions for parents, focusing on psycho-education and skills training such as recognizing negative interaction patterns, emotional validation, and supportive limit-setting. Additionally, there are three individual sessions involving adolescents and parents: one with the adolescent alone, one with the parents, and one with both together. These sessions include interviews, role plays, and exercises to restore secure bonds and improve communication. The program is delivered in groups of 4 to 6 families and incorporates emotion-focused therapy principles. Participants will attend intake and group sessions, complete questionnaires before, during, and after the treatment, and participate in interviews and recordings to assess relationship dynamics. Researchers will monitor changes in relationship satisfaction and negative patterns from baseline through follow-up. The study includes detailed assessments using paper questionnaires and online surveys, along with audio recordings of sessions, to evaluate the course's impact and understand the mechanisms behind its effects.

Researchers are studying breast cancer patients who have cancer that has spread to lymph nodes and are treated with neoadjuvant systemic therapy (NST), which includes chemotherapy and sometimes immunotherapy. The study focuses on how to best check and treat the lymph nodes after NST, comparing less invasive methods to the traditional axillary lymph node dissection (ALND). The goal is to see if less invasive techniques can offer similar cancer control and quality of life benefits. This multicenter observational study includes patients with positive lymph nodes who receive NST followed by breast and axillary treatment. Data on patient characteristics, tumor details, staging before and after NST, and treatments will be collected into a national database. Patients will complete quality of life questionnaires at diagnosis, and then 1 and 5 years later to understand the impact of different axillary treatment strategies. Participants will be followed for 5 years to evaluate disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer returning in the lymph nodes. Quality of life will be measured using multiple questionnaires over time. The study aims to provide evidence to improve national guidelines and support shared decision-making about axillary treatment options for node positive breast cancer patients.