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| Name | Class |
|---|---|
| University Hospital, Linkoeping | OTHER |
| Skane University Hospital | OTHER |
| Sahlgrenska University Hospital | OTHER |
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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.
PRIMARY OBJECTIVES:
Information about:
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:
RESULTS:
Results are expected to be available in 2021.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Whole Cohort | Whole cohort administration of questionnaire at 7 times |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Questionnaire administration | Behavioral | Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Satisfaction with Care | Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care. | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.
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| Name | Affiliation | Role |
|---|---|---|
| Diana Zach, MD | Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska University Hospital | Stockholm | Stockholm County | 17776 | Sweden | ||
| Sahlgrenska University Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40490985 | Derived | 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. |
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| ID | Term |
|---|---|
| D014846 | Vulvar Neoplasms |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| 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. | 3-4 months after end of treatment. |
| Gothenburg |
| Sweden |
| Linkopings University Hospital | Linköping | Sweden |
| Skanes University Hospital Lund | Lund | Sweden |
| D014845 |
| Vulvar Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D001523 | Mental Disorders |