NCT04152512

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

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

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 153 (actual)
• Sponsor: Karolinska University Hospital · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Vulvar Cancer
• Quality of Life

Interventions

Type	Name	Description
BEHAVIORAL	Questionnaire administration	Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment

Timeline

• Start date: 2019-08-29
• Primary completion: 2027-02-01
• Completion: 2027-10-01
• First posted: 2019-11-05
• Last updated: 2023-11-01

Locations

4 sites across 1 country: Sweden