Quality of Life, Vulvar Cancer
Conditions
Keywords
Questionnaire, EORTC QLQ C30 + VU34, Hospital Depression and Anxiety Scale, EORTC-PATSAT, Supportive Care Needs Survey Short Form
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.
Interventions
BEHAVIORALQuestionnaire administration
Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
Sponsors
University Hospital, Linkoeping
Skane University Hospital
Sahlgrenska University Hospital
Karolinska University Hospital
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| Satisfaction with Care | 3--4 months after end of treatment | Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care. |
| 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 |
| 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. |
Countries
Sweden
Outcome results
None listed