Clinical trial · Observational
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study
NCT04152512CI-TRIAL-00070955PROVEactive not recruitingClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The aim of this prospective, longitudinal Swedish multi-center study is to assess the quality of life, treatment-related morbidity, unmet needs and satisfaction with care after treatment for vulvar cancer, evaluated by a validated questionnaire.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Quality of Life | — | UNRESOLVED | — |
| Vulvar Cancer | Malignant Vulvar Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Questionnaire administration | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- Whole Cohort
- description
- Whole cohort administration of questionnaire at 7 times
- interventionNames
- Behavioral: Questionnaire administration
Primary outcomes (2)
- measure
- Global quality of life
- timeFrame
- 1 year after end of treatment
- description
- Measured by the European Organisation of Research and Treatment of Cancer (EORTC)-QLQ-C30-questionnaire. Measurement on a scale between 0-and 100. Higher values represent better quality of life. A change of at least 5-8 points is regarded as clinically significant.
- measure
- Vulvar-cancer-specific quality of life
- timeFrame
- 1 year after end of treatment
- description
- Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Primary diagnosis of vulvar cancer, all stages, all planned treatments * Informed consent Exclusion Criteria: * Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
References
Publications (1)
- DERIVEDZach D, Jensen PT, Falconer H, Kolkova Z, Bohlin KS, Kjolhede P, Raices Cruz I, Avall-Lundqvist E, Floter Radestad A. The impact of local symptoms on health-related quality of life in vulvar cancer survivors-A nationwide prospective study. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1517-1529. doi: 10.1111/aogs.15164. Epub 2025 Jun 9. PMID 40490985