Raphaelis, Silvia; Mayer, Hanna; Ott, Stefan; Mueller, Michael D.; Steiner, Enikö; Joura, Elmar; Senn, Beate (2017). 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. Gynecologic oncology, 146(1), pp. 114-122. Elsevier 10.1016/j.ygyno.2017.04.024
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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 6months 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.
Item Type: |
Journal Article (Original Article) |
|---|---|
Division/Institute: |
04 Faculty of Medicine > Department of Gynaecology, Paediatrics and Endocrinology (DFKE) > Clinic of Gynaecology |
UniBE Contributor: |
Mueller, Michael |
Subjects: |
600 Technology > 610 Medicine & health |
ISSN: |
0090-8258 |
Publisher: |
Elsevier |
Language: |
English |
Submitter: |
Monika Zehr |
Date Deposited: |
13 Feb 2018 12:31 |
Last Modified: |
05 Dec 2022 15:10 |
Publisher DOI: |
10.1016/j.ygyno.2017.04.024 |
PubMed ID: |
28483270 |
Uncontrolled Keywords: |
Advanced practice nursing Oncology nursing Patient education as topic Randomized controlled trials Symptoms Vulvar neoplasms |
BORIS DOI: |
10.7892/boris.111023 |
URI: |
https://boris.unibe.ch/id/eprint/111023 |
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