Evidence map›Paper›PMID 32375773›Full record

ArticleBMC women's health2020

The effect of written information and counselling by an advanced practice nurse on resilience in women with vulvar neoplasia six months after surgical treatment and the influence of social support, recurrence, and age: a secondary analysis of a multicenter randomized controlled trial, WOMAN-PRO II.

Sabine Kofler, Andrea Kobleder, Stefan Ott, Beate Senn

Registry-linked trialOpen access · goldAbstract readEvaluation Study
PubMed Full text at PMC Publisher
In one paragraph

Article in BMC women's health, 2020. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01986725 (The Impact of the Self-management Intervention "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence), which is not on this map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
0.1field-weighted citation impact, top 57% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT01986725 phase2completednot on this map

The Impact of the Self-management Intervention "WOMAN-PRO II Program" on Patients With Vulvar Neoplasia to Minimize Post-surgical Symptom Prevalence: A Mixed-Methods Project

TypeinterventionalSponsorSt.Gallen University of Applied SciencesRan2013 to 2015Enrolled45ConditionsVulvar Cancer, Vulvar Intraepithelial NeoplasiaArmsstandardized care (Intervention I), Standardized care + WOMAN-PRO II program (Intervention II)
3 · Its place in the literature

Who cites it

2 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

4 authors at 1 institution in 2 countries.

Sabine KoflerInstitute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland. sa.kofler@gmail.com.
Andrea KoblederInstitute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.
Stefan OttLecturer for Business Mathematics and Statistics, University of Applied Sciences FHS St. Gallen, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.
Beate SennInstitute for Applied Nursing Sciences IPW-FHS, FHS St. Gallen, University of Applied Sciences, Rosenbergstrasse 59, 9001, St. Gallen, Switzerland.
University of Applied Sciences St. Gallen · CH

Funding

Krebsforschung Schweiz KFS-3160-02-2013
6 · The paper itself

Abstract

backgroundWomen with vulvar neoplasia often complain about physical and psychological distress after surgical treatment. Lack of information and support can influence resilience. Whether an information-related intervention through an advanced practice nurse supports resilience and which other factors affect resilience in women with vulvar neoplasia has never been investigated.

methodsThe aims of this study were (a) to analyse whether counselling based on the WOMAN-PRO II program causes a significant improvement in the resilience scores of women with vulvar neoplasia compared to written information and (b) to identify the potential predictors of resilience. A randomized controlled trial was conducted in women with vulvar neoplasia (n = 49) 6 months after surgical treatment in four Swiss hospitals and one Austrian hospital. Analyses of resilience and its predictors were performed using a linear mixed model.

resultsThirty-six women (intervention I, n = 8; intervention II, n = 28) completed the randomized controlled trial. In total, 13 women (26.5%) dropped out of the trial. The resilience score did not differ significantly between the two interventions three and six months after randomisation (p = 0.759). Age (b = .04, p = 0.001), social support (b = .28, p = 0.009), counselling time (b = .03, p = 0.018) and local recurrence (b = -.56, p = 0.009) were identified as significant predictors of resilience in the linear mixed model analyses.

conclusionThe results indicate that the WOMAN-PRO II program as single intervention does not cause a significant change in the resilience scores of women with vulvar neoplasia 6 months after surgery. Predictors that promote or minimise resilience have been identified and should be considered when developing resilience programs for women with vulvar neoplasia. A repetition of the study with a larger sample size is recommended.

trial registrationThe WOMAN-PRO II program was registered in ClinicalTrials.gov NCT01986725 on 18 November 2013.

Indexed as

Resilience, PsychologicalSocial SupportAge FactorsChildCounselingFemaleHumansNeoplasm Recurrence, LocalOutcome Assessment, Health CarePatient Education as TopicPostoperative PeriodRandomized Controlled Trials as TopicTreatment OutcomeVulvar NeoplasmsAPNInfluencing factorsResilienceSurgical treatmentVulvar neoplasia

Identifiers

PMID32375773
PMCPMC7203815
OpenAlexW3021118037

What OpenQuestion holds

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LicenceCC BY
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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.