CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 18 enrolled
Drug / intervention
WOMAN-PRO III +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04541784
NCT04541784N/ACompleted

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

St.Gallen University of Applied Sciences·interventional·Posted Sep 9, 2020·Updated Sep 22, 2021

In Brief

A clinical study evaluating WOMAN-PRO III and Three counselling sessions with gynaecology-oncology nurses for Vulvar Neoplasm. Completed, enrolled 18 participants across 4 sites.

Detailed Summary

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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Neoplasm
CountriesSwitzerland

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedSep 9, 2020
Enrollment StartMay 1, 2019
Primary CompletionAug 31, 2021
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 5.8 years ago

Interventions

WOMAN-PRO IIIother

Standardized care and three counselling sessions with a gynaecology-oncology nurse and the use of the mobile app "WOMAN-PRO III".

Three counselling sessions with gynaecology-oncology nursesother

Standardized care, three counselling sessions with a gynaecology-oncology nurse.