Effectiveness of a Multidimensional Mobile App Intervention "WOMAN-PRO III" to Reduce Postsurgical Symptom Induced Distress in Patients With Vulvar Neoplasia: A Mixed Methods Project

Vulvar neoplasia - incidence, symptoms and disease's management Although being a rare cancer disease, the incidence of vulvar neoplasia is increasing with a current incidence rate of 3.6 / 100.000 for women with vulvar cancer (Buttmann-Schweiger et al., 2015) and 7 / 100.000 for women with VIN (Anders, Riethdorf, & Löning, 2001). Due to the disease itself and treatment side effects women suffer from a high number of postsurgical symptoms and related distress, such as pain, swelling, or uncertainty (Jefferies & Clifford, 2012; Philp, Mellon, Barnett, D'Abrew, & White, 2017; Senn et al., 2011). Results from literature suggest that women have unmet support needs as talking to healthcare professionals is perceived as difficult and information given by healthcare professionals is described as conflicting and inadequate (Philp et al., 2017). The high symptom prevalence and related distress reported uncertainty as well as the perceived lack of supportive care can lead to hospital readmissions and consequently to the generation of high healthcare costs.

To overcome this lack of supportive care, guidelines focusing on vulvar neoplasia recommend an integrative approach including skilled nursing as a key factor for patient management (Royal College of Obstetricians and Gynaecologists, 2014). Specialist nurses, i.e. Advanced Practice Nurses (APN) can, therefore, play an important role in caring for women with vulvar neoplasia, as shown in the study of Raphaelis et al. (2018) where women received written information and counselling sessions from APNs. However, gaps remain especially in women's disease management beyond the walls of the clinic. Therefore, supportive care interventions are requested to promote women's self-management, especially at home. One possibility might be the use of e-health.

E-health - the changing nature of self-help: E-health has come to be an important avenue for supporting self-management. One integral part of the subject area of e-health is m-health. Within the healthcare system the aim of m-health is to provide electronic solutions on mobile devices, which is also described in the WHO definition of m-health: "M-health covers medical and public health practice supported by mobile devices, such as mobile phones, patient monitoring devices, personal digital assistants (PDAs), and other wireless devices" (World Health Organization, 2011). It is expected to contribute to patients' empowerment as they could take a more active role (European Commission, without date). Especially in chronic disease management, m-health interventions could play an important role in providing information and enabling communication without spatial and temporal restrictions.

Significance: This research will contribute significantly to the knowledge about effects of mobile app interventions in gynaecologic oncology, especially with regard to a reduction of symptom induced distress and improvement of uncertainty in a stigmatized disease like vulvar neoplasia.

Objectives: Primary Objective The study seeks primarily to examine the effectiveness of a multidimensional mobile app intervention, which consists of the use of the mobile app whenever women want for a period of six months and three counselling sessions with a gynaecology-oncology nurse ("WOMAN-PRO III") on symptom induced distress, uncertainty and cost-effectiveness in women with vulvar neoplasia after surgical treatment across time compared to three counselling sessions with a gynaecology-oncology nurse and written information. The secondary objective is to explore women's perceived uncertainty as well as the mobile app's acceptability, usability, strengths and weaknesses by assessing participants' and gynaecology-oncology nurses' experiences.