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: * 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.
Study Type
OBSERVATIONAL
Enrollment
153
Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
Karolinska University Hospital
Stockholm, Stockholm County, Sweden
Sahlgrenska University Hospital
Gothenburg, Sweden
Linkopings University Hospital
Linköping, Sweden
Skanes University Hospital Lund
Lund, Sweden
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.
Time frame: 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.
Time frame: 1 year after end of treatment
Satisfaction with Care
Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.
Time frame: 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
Time frame: 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.
Time frame: 3-4 months after end of treatment.
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