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NCT04541784
Effectiveness of an App Intervention to Reduce Postsurgical Symptom Distress in Patients With Vulvar Neoplasia
NA trial testing WOMAN-PRO III in Vulvar Neoplasm in 18 participants. Completed in 31 August 2021.
31 August 2021
Quick facts
| Lead sponsor | St.Gallen University of Applied Sciences |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | supportive care |
| Enrollment | 18 |
| Start date | 1 May 2019 |
| Primary completion | 31 August 2021 |
| Estimated completion | 31 August 2021 |
| Sites | 4 locations across Switzerland |
Drugs / interventions tested
- WOMAN-PRO III
- Three counselling sessions with gynaecology-oncology nurses
Conditions studied
- Vulvar Neoplasm — all drugs for Vulvar Neoplasm →
Sponsor
St.Gallen University of Applied Sciences
Who can join
18 and older, female only, with Vulvar Neoplasm. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Verify or expand the search:
- PubMed search for NCT04541784
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Related trials
Other recruiting trials for Vulvar Neoplasm
Currently open trials in the same condition.
- NCT05934851 — A Study Evaluating the Effect of Frozen-Section Directed Excision Surgery on Vulvar Dysplasia · NA · recruiting
Other St.Gallen University of Applied Sciences trials
Trials by the same sponsor.
- NCT06999616 — Physical Activity in Cancer Patients in an Oncology Day Clinic - Implementing a Person-centered Program Led by Nurses · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04541784 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by St.Gallen University of Applied Sciences
- Last refreshed: 22 September 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04541784.
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