Bilthoven

Researchers are monitoring the effectiveness and safety of Autologous Fat Transfer AFT with pre-expansion as a method for full breast reconstruction in female breast cancer patients. This multicenter, prospective cohort study follows the BREAST trial and aims to evaluate quality of life, aesthetic outcomes, complications, oncological safety, and cost-effectiveness of AFT. All participants will receive AFT in this observational study. Participants will undergo breast reconstruction using Autologous Fat Transfer combined with an external expansion device. This procedure is offered to women who have had or will have a mastectomy, including preventive mastectomy. The study focuses on assessing various outcomes over several years, with particular attention to quality of life and aesthetic results at two years, and oncological safety up to five years after treatment. During the study, participants will be monitored for breast-related quality of life, aesthetic results, any complications, oncological safety, and the cost-effectiveness of the procedure. These outcomes will be assessed through regular follow-ups and evaluations over a period of two to five years. The study is led by Maastricht University Medical Center and aims to provide comprehensive information on this breast reconstruction method.

The trial investigates the effects of neoadjuvant radiotherapy NART on acute post-surgical complications following mastectomy and immediate breast reconstruction in women with breast cancer. Researchers aim to determine whether NART can reduce complications compared to the standard postmastectomy radiotherapy PMRT, which is associated with higher complication rates and poorer cosmetic outcomes. This pilot study focuses on assessing the safety of NART in this setting, with future studies planned to evaluate long-term quality of life and cancer outcomes if complication rates are acceptable. Participants will receive neoadjuvant radiotherapy consisting of 15 sessions of 2.67 Gy each, delivered five times per week, starting 6 to 8 weeks after the last chemotherapy treatment if applicable. Approximately 2 to 6 weeks after completing radiotherapy, patients will undergo mastectomy with immediate breast reconstruction using either a silicone implant or autologous tissue, commonly the Deep Inferior Epigastric Perforator DIEP flap. This single-arm interventional pilot study will include twenty female breast cancer patients who require mastectomy and radiotherapy and desire immediate reconstruction. During the study, participants will be monitored for acute post-surgical complications up to three months after their latest reconstructive surgery. Researchers will assess treatment-related adverse events, patient-reported satisfaction with breasts and well-being using the BREAST-Q questionnaire, and cosmetic results as rated by physicians. Additional evaluations include the timing of any adjuvant therapy and pathological response in the mastectomy specimen. Participants will also complete questionnaires about cosmetic outcomes and quality of life, requiring about 15 to 30 minutes each. The total study duration includes surgery, radiotherapy, and follow-up assessments within a few months.

This research aims to evaluate the effectiveness and treatment processes of the Hold Me TightLet Me Go HmTLmG course designed to improve parent-adolescent relationships. The study focuses on families with adolescents aged 12 to 18 who experience problems worsened by stressful parent-adolescent interactions. The trial applies self-reports, audio observations, and interviews to assess changes in relationship satisfaction and negative interaction patterns. The intervention includes a group course for parents from 4 to 6 families, consisting of four group sessions featuring psycho-education and skills training. Additionally, each family participates in three individual sessions one with the adolescent, one with the parents, and one with both together. The course covers topics such as adolescent needs, emotional validation, and communication skills, with exercises and role plays to practice these skills. Participants undergo a screening intake session, followed by assessments at multiple points before treatment, during treatment, and at follow-up. Measurements include questionnaires for parents and adolescents, interviews, and audio recordings of sessions. The timeline includes a waiting period of about five weeks, a treatment phase of six weeks, and a follow-up period of eight weeks. Researchers will measure changes in relationship satisfaction, negative patterns, adolescents psychological needs, support seeking, quality of life, and emotional responsiveness.

Researchers are studying women with node-positive breast cancer who receive neoadjuvant systemic therapy NST, which includes chemotherapy with or without immunotherapy. The study aims to understand the safety and quality of life effects of using less invasive methods compared to more invasive axillary staging and treatment after NST. This is important because patients whose lymph nodes show no remaining cancer after NST may not benefit from extensive lymph node removal, but more evidence is needed about the safety and impact of less invasive approaches. This multicenter observational study collects detailed information on patients treated with NST for node-positive breast cancer. It gathers data about the cancer, staging methods before and after NST, and treatment details from medical records. Patients complete questionnaires about their quality of life at diagnosis, and then 1 and 5 years later. The study database is maintained by the Netherlands Cancer Registry and aims to inform future treatment guidelines. Participants provide information through patient-reported outcome measures and undergo regular clinical follow-up to monitor disease-free survival, breast cancer-specific survival, overall survival, and rates of cancer recurrence in the lymph nodes over five years. Quality of life is assessed using several validated tools at baseline and during follow-up. The study results will help balance treatment decisions between less and more invasive options and support shared decision making for women with this breast cancer type.