Brief Title
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
Official Title
Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study
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.
Study Type
Observational
Primary Outcome
Global quality of life
Secondary Outcome
Satisfaction with Care
Condition
Vulvar Cancer
Intervention
Questionnaire administration
Study Arms / Comparison Groups
Whole Cohort
Description: Whole cohort administration of questionnaire at 7 times
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Behavioral
Estimated Enrollment
153
Start Date
August 29, 2019
Completion Date
February 2023
Primary Completion Date
November 2022
Eligibility Criteria
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
Gender
Female
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Diana Zach, MD, ,
Location Countries
Sweden
Location Countries
Sweden
Administrative Informations
NCT ID
NCT04152512
Organization ID
2018/1402-31/1
Responsible Party
Principal Investigator
Study Sponsor
Karolinska University Hospital
Collaborators
University Hospital, Linkoeping
Study Sponsor
Diana Zach, MD, Principal Investigator, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
Verification Date
August 2021