TY - JOUR
T1 - The impact of written information and counseling (WOMAN-PRO II Program) on symptom outcomes in women with vulvar neoplasia
T2 - A multicenter randomized controlled phase II study
AU - Raphaelis, Silvia
AU - Mayer, Hanna
AU - Ott, Stefan
AU - Mueller, Michael D.
AU - Steiner, Enikö
AU - Joura, Elmar
AU - Senn, Beate
N1 - Copyright © 2017 Elsevier Inc. All rights reserved.
PY - 2017/7
Y1 - 2017/7
N2 - 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 information 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. Sporadically, 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.
AB - 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 information 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. Sporadically, 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.
KW - Advanced practice nursing
KW - Oncology nursing
KW - Patient education as topic
KW - Randomized controlled trials
KW - Symptoms
KW - Vulvar neoplasms
UR - http://www.scopus.com/inward/record.url?scp=85018775398&partnerID=8YFLogxK
U2 - 10.1016/j.ygyno.2017.04.024
DO - 10.1016/j.ygyno.2017.04.024
M3 - Journal article
C2 - 28483270
AN - SCOPUS:85018775398
SN - 0090-8258
VL - 146
SP - 114
EP - 122
JO - Gynecologic Oncology
JF - Gynecologic Oncology
IS - 1
ER -