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

Study Overview
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Brief Summary
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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.

Detailed Description
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PRIMARY OBJECTIVES: 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.

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

Conditions
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Vulvar Cancer, Quality of Life

Intervention / Treatment
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* Behavioral: Questionnaire administration


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Whole Cohort<br>Whole cohort administration of questionnaire at 7 times | Behavioral: Questionnaire administration<br>* Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Questionnaire, EORTC QLQ C30 + VU34, Hospital Depression and Anxiety Scale, EORTC-PATSAT, Supportive Care Needs Survey Short Form