Evidence map›Paper›PMID 40490985›Full record

Observational studyActa obstetricia et gynecologica Scandinavica2025

The impact of local symptoms on health-related quality of life in vulvar cancer survivors-A nationwide prospective study.

Diana Zach, Pernille T Jensen, Henrik Falconer, Zuzana Kolkova, Katja Stenström Bohlin, Preben Kjølhede, Ivette Raices Cruz, Elisabeth Åvall-Lundqvist, Angelique Flöter Rådestad

Registry-linked trialAbstract readMulticenter StudyObservational Study
In one paragraph

Observational study in Acta obstetricia et gynecologica Scandinavica, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04152512 (Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study), 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
–field-weighted citation impact
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.

NCT04152512 active not recruitingnot on this map

Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study

TypeobservationalSponsorKarolinska University HospitalRan2019 to 2027Enrolled153ConditionsVulvar Cancer, Quality of LifeArmsQuestionnaire administration
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Determining core quality of life outcomes for patients with vulvar cancer and their partners: a Delphi consensus study.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  2. Observational
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

9 authors.

Diana ZachDepartment of Gynecological Cancer, Karolinska University Hospital, Stockholm, Sweden.ORCID 0000-0002-2871-5951
Pernille T JensenDepartment of Gynecology and Obstetrics, Aarhus University Hospital, Aarhus, Denmark.
Henrik FalconerDepartment of Gynecological Cancer, Karolinska University Hospital, Stockholm, Sweden.
Zuzana KolkovaDepartment of Obstetrics and Gynecology, Skåne University Hospital, Department of Clinical Sciences, Lund University, Lund, Sweden.
Katja Stenström BohlinDepartment of Obstetrics and Gynecology, Sahlgrenska University Hospital, Sahlgrenska Academy, Gothenburg University, Gothenburg, Sweden.ORCID 0000-0002-9064-8454
Preben KjølhedeDepartment of Obstetrics and Gynecology, Linköping University, Linköping, Sweden.ORCID 0000-0001-5702-4116
Ivette Raices CruzInstitute of Environmental Medicine, Biostatistics Core Facilities, Karolinska Institutet, Stockholm, Sweden.
Elisabeth Åvall-LundqvistDepartment of Biomedical and Clinical Sciences, Linköping University, Linköping, Sweden.
Angelique Flöter RådestadDepartment of Women's and Children's Health, Karolinska Institutet, Stockholm, Sweden.ORCID 0000-0002-1068-9732

Funding

Kommunfullmäktige, Stockholms Stad 502434Radiumhemmets Forskningsfonder 009618Swedish Society for Gynaecologic Oncology Scholarship 2018
6 · The paper itself

Abstract

introductionVulvar cancer may cause serious local symptoms that may impact negatively on the woman's health-related quality of life (HRQOL). However, knowledge about the prevalence of vulvar and lymphedema symptoms at diagnosis and during follow-up is limited. The aim of this study was to evaluate the longitudinal development of vulvar and lymphedema symptoms as well as the trajectory of HRQOL in women with vulvar cancer. Furthermore, associations between vulvar symptoms and HRQOL were investigated. MATERIAL AND

methodsIn this nationwide prospective cohort study, women completed validated patient-reported outcome measures; the EORTC-QLQ C30 and the EORTC-QLQ-VU34 at diagnosis, three, and 12 months post-treatment. Mean scores of symptom- and functioning scales were calculated over time. Heatmaps were used to visualize proportional changes in the prevalence of symptoms at baseline and 12 months after treatment. Linear mixed-effects models with patient-specific random intercepts were specified to estimate changes in mean scores of HRQOL over time. Additionally, adjusted linear mixed-effects models were applied to investigate the effect of the most prevalent vulvar symptom on HRQOL. The study has been registered at ClinicalTrials.gov (NCT04152512).

resultsBetween 2019 and 2021, 153 women consented to participate in the study, and 140 (92%) completed the patient-reported outcome measures at least once. In total, 105 (69%) completed the patient-reported outcome measures at all three time points. The most prevalent reported symptom was itchy, irritated skin in the vulva, which decreased from 82% at diagnosis to 56% 12 months after treatment. All vulvar symptoms, except narrowing of the vaginal entrance, improved over time but persisted in large proportions of the women. Women with severe vulvar symptoms reported a significant decline in HRQOL. A deterioration of leg swelling symptoms was reported by 33% of the women. Emotional-, role-, social-, and cognitive functioning, global and mental health improved significantly after treatment.

conclusionLocal vulvar symptoms were highly prevalent at diagnosis; however, as most aspects of HRQOL, they improved significantly during the first year of follow-up. Severe vulvar symptoms were associated with impaired HRQOL. Symptoms of leg lymphedema increased after treatment. © 2025 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

Indexed as

Cancer SurvivorsLymphedemaQuality of LifeVulvar NeoplasmsAdultAgedFemaleHumansMiddle AgedPatient Reported Outcome MeasuresProspective Studiesclinical oncologylymphedemapatient reported outcomesquality of lifevulvar cancer

Identifiers

PMID40490985
PMCPMC12283167

What OpenQuestion holds

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LicenceCC BY-NC-ND
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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.