View clinical trials related to Vulvar Neoplasm.
Filter by:The purpose of this study is to compare "Frozen-Section Directed Excision", which has been a proven method of surgery used in dermatology, versus the current, standard method called "Wide Local Excision" to treat high-grade vulvar dysplasia.
Despite great advances in surgical therapy in the last decades, symptom relief for women with vulvar neoplasia (vulvar cancer and pre-stage of vulvar cancer) is still not optimal. Guidelines of the National Comprehensive Cancer Network recommend using electronic communication media, e.g. applications ("apps") to relieve symptom distress and foster self-management. However, little is known on how effective these communication technologies are, especially in the field of a rare cancer disease like vulvar neoplasia. This mixed methods project aims to examine the effectiveness of a multidimensional mobile app intervention ("WOMAN-PRO III") focusing on possible improvements due to the new mobile app intervention, which consists of three counselling sessions with a gynaecologic-oncology nurse and the use of the mobile app whenever women want for a period of six months, the online version of the "WOMAN-PRO" diary for symptom assessment, the opportunity to send the data to the gynaecology-oncology nurse, disease and treatment related information and evidence-based recommendations, relevant contact data and a chat function for the anonymous exchange with peers (intervention group) compared to three counselling sessions with a gynaecologic-oncology nurse, where they receive written information (control group). Effectiveness will be examined with respect to symptom induced distress, uncertainty and cost effectiveness in women with vulvar neoplasia after surgical treatment across time. The objective of the qualitative study is to assess women's perceived uncertainty and the acceptability, usability, strengths and weaknesses of the mobile app intervention ("WOMAN-PRO III") from patients' and gynaecology-oncology nurses' perspective.
Vulvar cancer is a rare disease that is treated with surgery, radiation and chemotherapy. When tumors are large (greater than 4 cm) or compromise the urethra (urine canal) and the anus, or when it is in the groin lymph nodes, surgery alone is not always able to be performed. In this circumstance, is necessary to add radiotherapy, chemotherapy or both . So far it is not known the best sequence of treatment: surgery, chemotherapy or radiotherapy. The radical surgeries usually need long recovery term both in the region of the vulva and in the region of the groin lymph nodes. When it is performed, convalescence can delay other treatments, like radiotherapy and chemotherapy. On the other hand, the use of radiotherapy and chemotherapy as a first step treatment can result in a complete elimination of the disease in at least 30% of the cases or substantial reduction of its size, allowing less extensive surgery. Investigators intend to use surgery, chemotherapy and radiotherapy in the treatment of vulvar cancer, but in a sequence that has not been studied, in order to increase benefits of these treatments, and reduce morbidity. This study will be offered to patients who have disease of the vulva less than 4 cm (sentinel lymph node), or greater than 4 cm, or illness that compromises urethra and anus, or patients with disease in groin lymph nodes (glands). 1. On the eve of the surgery, investigators will inject dextran-70 labeled with technetium-99 m. Only patients with tumors smaller than 4 cm will do this procedure. 2. On the day of the surgery, the groin lymph nodes will be removed from the inguinal (groin) only. If lymph nodes are disease positive, the vulvectomy will not be performed at this time. Patients will be treated with radiation therapy with concomitant chemotherapy for approximately six weeks. 3. At the end of treatment with chemotherapy and radiotherapy, investigators will perform a surgery to remove the remaining tumor in the vulva.