Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
NCT ID: NCT04152512
Last Updated: 2023-11-01
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
153 participants
OBSERVATIONAL
2019-08-29
2027-10-31
Brief Summary
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Detailed Description
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Information about:
* General and vulvar-cancer-specific quality of life before and after any treatment for newly diagnosed vulvar cancer
* Treatment-related morbidity after any treatment for newly diagnosed vulvar cancer
* Unmet needs of patients with newly diagnosed vulvar cancer
* Satisfaction with care after any treatment for newly diagnosed vulvar cancer in Sweden.
OUTLINE:
The study is planned as a prospective, longitudinal multi-centre study in Sweden. Since 2017, the treatment of vulvar cancer patients has been accredited to four tertiary referral university hospitals in Sweden; the Sahlgrenska University hospital in Gothenburg, the Linköping University hospital, the Skåne University hospital in Lund and the Karolinska University hospital in Stockholm.
150 patients are estimated for inclusion during a time frame of about 18 months.
Eligible patients will be asked to complete a validated questionnaire at different points of time (before and after treatment). Calculating a response rate of about 50% - 60%, this will result in at least 80 completed questionnaires.
The questionnaires consist of the following parts:
* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-C30
* European Organisation for Research and Treatment of Cancer (EORTC)-QLQ-VU-34 (Vulva-specific module)
* Hospital Depression and Anxiety Scale (HADS)
* Supportive Care Needs Survey Short Form, excerpt (SCNS-SF34)
* European Organisation for Research and Treatment of Cancer (EORTC)-PATSAT (Patient Satisfaction), excerpt
* Demographic data
* 25 self-constructed (and validated) questions
RESULTS:
Results are expected to be available in 2021.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Whole Cohort
Whole cohort administration of questionnaire at 7 times
Questionnaire administration
Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
Interventions
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Questionnaire administration
Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
Eligibility Criteria
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Inclusion Criteria
* Informed consent
Exclusion Criteria
18 Years
FEMALE
No
Sponsors
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University Hospital, Linkoeping
OTHER
Skane University Hospital
OTHER
Sahlgrenska University Hospital
OTHER
Karolinska University Hospital
OTHER
Responsible Party
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Diana Zach
MD, senior consultant
Principal Investigators
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Diana Zach, MD
Role: PRINCIPAL_INVESTIGATOR
Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
Locations
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Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital
Gothenburg, , Sweden
Linkopings University Hospital
Linköping, , Sweden
Skanes University Hospital Lund
Lund, , Sweden
Countries
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References
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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.
Other Identifiers
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2018/1402-31/1
Identifier Type: -
Identifier Source: org_study_id
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