Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
- Conditions
- Quality of LifeVulvar Cancer
- Registration Number
- NCT04152512
- Lead Sponsor
- Karolinska University Hospital
- 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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 153
- Primary diagnosis of vulvar cancer, all stages, all planned treatments
- Informed consent
- Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Global quality of life 1 year after end of treatment 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.Vulvar-cancer-specific quality of life 1 year after end of treatment Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.
- Secondary Outcome Measures
Name Time Method Satisfaction with Care 3--4 months after end of treatment Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.
Unmet needs 3-4 months after end of treatment. Measured by the Supportive Care Needs Survey-Short Form (SCNS-SF)-34-questionnaire. Higher scores represent higher needs.
Depression and anxiety 1 year after end of treatment. Measured by the Hospital Anxiety and Depression Index (HADS)-questionnaire. Higher scores represent more depression and anxiety
Trial Locations
- Locations (4)
Karolinska University Hospital
🇸🇪Stockholm, Stockholms Lan, Sweden
Sahlgrenska University Hospital
🇸🇪Gothenburg, Sweden
Linkopings University Hospital
🇸🇪Linkoping, Sweden
Skanes University Hospital Lund
🇸🇪Lund, Sweden
Karolinska University Hospital🇸🇪Stockholm, Stockholms Lan, Sweden