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

Karolinska University Hospital

Status: Active, not recruiting

Conditions: Vulvar Cancer; Quality of Life

Treatments: Behavioral: Questionnaire administration

Study type: Observational

Funder types: Other

Identifiers

NCT04152512

2018/1402-31/1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 153 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

153 participants in 1 patient group

Whole Cohort

Description:

Whole cohort administration of questionnaire at 7 times

Treatment:

Behavioral: Questionnaire administration