The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A multicenter randomized controlled phase II study Silvia Raphaelis a, ⁎, Hanna Mayer a , Stefan Ott b , Michael D. Mueller c , Enikö Steiner d , Elmar Joura e , Beate Senn f,g a Department of Nursing Science, University of Vienna, Alser Strasse 23, 1080 Vienna, Austria b Lecturer for Business Mathematics and Statistics, University of Applied Sciences FHS St. Gallen, Rosenbergstrasse 59, 9001 St. Gallen, Switzerland c Department of Obstetrics and Gynecology, Inselspital, University Hospital Bern, Effingerstrasse 102, 3010 Berne, Switzerland d Department of Obstetrics and Gynecology, Vienna General University Hospital, Währinger Gürtel 18-20, 1090 Vienna, Austria e Department of Obstetrics and Gynecology and Comprehensive Cancer Center, Medical University of Vienna, Spitalgasse 23, 1090 Vienna, Austria f Institute for Applied Nursing Sciences IPW-FHS, University of Applied Sciences FHS St. Gallen, Rosenbergstrasse 59, 9001 St. Gallen, Switzerland g Sydney Nursing School, The University of Sydney, Mallett Street 88, 2050 Camperdown, NSW, Australia HIGHLIGHTS • This is the first study testing support programs in women with vulvar neoplasia. • Symptom prevalence decreased in women with counseling by a clinical relevant degree. • The results justify testing counseling in a phase III trial. abstract article info Article history: Received 25 February 2017 Received in revised form 28 April 2017 Accepted 30 April 2017 Available online xxxx Objective. To determine whether written information and/or counseling based on the WOMAN-PRO II Program decreases symptom prevalence in women with vulvar neoplasia by a clinically relevant degree, and to explore the differences between the 2 interventions in symptom prevalence, symptom distress prevalence, and symptom experience. Methods. A multicenter randomized controlled parallel-group phase II trial with 2 interventions provided to patients after the initial diagnosis was performed in Austria and Switzerland. Women randomized to written in- formation received a predefined set of leaflets concerning wound care and available healthcare services. Women allocated to counseling were additionally provided with 5 consultations by an Advanced Practice Nurse (APN) between the initial diagnosis and 6 months post-surgery that focused on symptom management, utilization of healthcare services, and health-related decision-making. Symptom outcomes were simultaneously measured 5 times to the counseling time points. Results. A total of 49 women with vulvar neoplasia participated in the study. Symptom prevalence decreased in women with counseling by a clinically relevant degree, but not in women with written information. Sporad- ically, significant differences between the 2 interventions could be observed in individual items, but not in the total scales or subscales of the symptom outcomes. Conclusions. The results indicate that counseling may reduce symptom prevalence in women with vulvar neoplasia by a clinically relevant extent. The observed group differences between the 2 interventions slightly favor counseling over written information. The results justify testing the benefit of counseling thoroughly in a comparative phase III trial. © 2017 Elsevier Inc. All rights reserved. Keywords: Vulvar neoplasms Randomized controlled trials Symptoms Oncology nursing Advanced practice nursing Patient education as topic 1. Introduction The term vulvar neoplasia includes high-grade squamous intraepithelial lesions of the vulva (vulvar HSIL) as a precancerous Gynecologic Oncology xxx (2017) xxx–xxx ⁎ Corresponding author. E-mail address: silvia.mona.raphaelis@univie.ac.at (S. Raphaelis). YGYNO-976725; No. of pages: 9; 4C: http://dx.doi.org/10.1016/j.ygyno.2017.04.024 0090-8258/© 2017 Elsevier Inc. All rights reserved. Contents lists available at ScienceDirect Gynecologic Oncology journal homepage: www.elsevier.com/locate/ygyno Please cite this article as: S. Raphaelis, et al., The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia: A mult..., Gynecol Oncol (2017), http://dx.doi.org/10.1016/j.ygyno.2017.04.024