NCT04152512

Brief 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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
153

participants targeted

Target at P50-P75 for all trials

Timeline
18mo left

Started Aug 2019

Longer than P75 for all trials

Geographic Reach
1 country

4 active sites

Status
active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress83%
Aug 2019Oct 2027

Study Start

First participant enrolled

August 29, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 27, 2019

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 5, 2019

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2027

Expected
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2027

Last Updated

November 1, 2023

Status Verified

October 1, 2023

Enrollment Period

7.4 years

First QC Date

October 27, 2019

Last Update Submit

October 30, 2023

Conditions

Vulvar CancerQuality of Life

Keywords

QuestionnaireEORTC QLQ C30 + VU34Hospital Depression and Anxiety ScaleEORTC-PATSATSupportive Care Needs Survey Short Form

Outcome Measures

Primary Outcomes (2)

  • 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.

    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.

    1 year after end of treatment

Secondary Outcomes (3)

  • Satisfaction with Care

    3--4 months after end of treatment

  • Depression and anxiety

    1 year after end of treatment.

  • Unmet needs

    3-4 months after end of treatment.

Study Arms (1)

Whole Cohort

Whole cohort administration of questionnaire at 7 times

Behavioral: Questionnaire administration

Interventions

Questionnaire administrationBEHAVIORAL

Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment

Whole Cohort

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.

You may qualify if:

  • Primary diagnosis of vulvar cancer, all stages, all planned treatments
  • Informed consent

You may not qualify if:

  • Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Karolinska University Hospital

Stockholm, Stockholm County, 17776, Sweden

Location

Sahlgrenska University Hospital

Gothenburg, Sweden

Location

Linkopings University Hospital

Linköping, Sweden

Location

Skanes University Hospital Lund

Lund, Sweden

Location

Related Publications (1)

  • Zach 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: 40490985DERIVED

MeSH Terms

Conditions

Vulvar NeoplasmsAnxiety Disorders

Condition Hierarchy (Ancestors)

Genital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsVulvar DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMental Disorders

Study Officials

  • Diana Zach, MD

    Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD, senior consultant

Study Record Dates

First Submitted

October 27, 2019

First Posted

November 5, 2019

Study Start

August 29, 2019

Primary Completion (Estimated)

February 1, 2027

Study Completion (Estimated)

October 1, 2027

Last Updated

November 1, 2023

Record last verified: 2023-10

Locations

SE(4)