Where does OCRA's clinical trial data come from?

OCRA indexes clinical trials from ClinicalTrials.gov, the official U.S. registry maintained by the National Library of Medicine. Trials are matched to diseases, investigators, and funded research tracked across the platform.

How do I find clinical trials for ovarian cancer?

Search by condition, treatment type, trial phase, or NCT identifier. Each trial page shows current status, eligibility criteria, study locations, and a direct link to the ClinicalTrials.gov source record.

How often is clinical trial data updated?

Trial data is refreshed through periodic ingestion from the ClinicalTrials.gov v2 API. Status changes, new enrollments, and newly registered trials are captured during each update cycle.

Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer

NCT04152512Active, Not RecruitingOBSERVATIONAL

Summary

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.

Key Facts

Lead Sponsor

Karolinska University Hospital

Enrollment

153

Start Date

2019-08-29

Completion Date

2027-02-01

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Questionnaire administration

Conditions

Vulvar CancerQuality of Life

Eligibility

Age Range

18 Years+

Sex

FEMALE

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

Outcome Measures

Primary Outcomes

Global quality of life

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.

Time frame: 1 year after end of treatment

Vulvar-cancer-specific quality of life

Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.

Time frame: 1 year after end of treatment

Secondary Outcomes

Satisfaction with Care

Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.

Time frame: 3--4 months after end of treatment

Depression and anxiety

Measured by the Hospital Anxiety and Depression Index (HADS)-questionnaire. Higher scores represent more depression and anxiety

Time frame: 1 year after end of treatment.

Unmet needs

Measured by the Supportive Care Needs Survey-Short Form (SCNS-SF)-34-questionnaire. Higher scores represent higher needs.

Time frame: 3-4 months after end of treatment.

Locations

Karolinska University Hospital, Stockholm, Sweden

Sahlgrenska University Hospital, Gothenburg, Sweden

Linkopings University Hospital, Linköping, Sweden

Skanes University Hospital Lund, Lund, Sweden

Linked Papers

2025-06-09

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

AbstractIntroductionVulvar 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 (NCT 04152512).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).

Linked Investigators

Angelique Flöter Rådestad

Diana Zach

Katja Stenström Bohlin

Preben Kjølhede