Clinical trial NCT04152512: 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
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Vulvar Cancer
Quality of Life
Keywords: Questionnaire
EORTC QLQ C30 + VU34
Hospital Depression and Anxiety Scale
EORTC-PATSAT
Supportive Care Needs Survey Short Form
Lead sponsor: Karolinska University Hospital
Sponsor class: OTHER
Collaborators: name: University Hospital, Linkoeping
name: Skane University Hospital
name: Sahlgrenska University Hospital
First posted: 2019-11-05
Enrollment: 153
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.

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.

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

Primary outcomes:
measure: Global quality of life
timeFrame: 1 year after end of treatment
measure: Vulvar-cancer-specific quality of life
timeFrame: 1 year after end of treatment
Secondary outcomes:
measure: Satisfaction with Care
timeFrame: 3--4 months after end of treatment
measure: Depression and anxiety
timeFrame: 1 year after end of treatment.
measure: Unmet needs
timeFrame: 3-4 months after end of treatment.
Other outcomes:
Locations:
city: Stockholm
country: Sweden
facility: Karolinska University Hospital
state: Stockholms Lan
city: Gothenburg
country: Sweden
facility: Sahlgrenska University Hospital
city: Linkoping
country: Sweden
facility: Linkopings University Hospital
city: Lund
country: Sweden
facility: Skanes University Hospital Lund
Study officials:
affiliation: Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
name: Diana Zach, MD
role: PRINCIPAL_INVESTIGATOR
References: