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

Quality of Life Clinical Trial

— PROVE  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04152512
• Other study ID #: 2018/1402-31/1
• Status: Active, not recruiting
• Start date: August 29, 2019
• Est. completion date: October 2027

Study information

• Verified date: October 2023
• Source: Karolinska University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 153
• Est. completion date: October 2027
• Est. primary completion date: February 2027
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Quality of Life
• Vulvar Cancer
• Vulvar Neoplasms

Intervention

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

Locations

Country	Name	City	State
Sweden	Sahlgrenska University Hospital	Gothenburg
Sweden	Linkopings University Hospital	Linkoping
Sweden	Skanes University Hospital Lund	Lund
Sweden	Karolinska University Hospital	Stockholm	Stockholms Lan

Sponsors (4)

Lead Sponsor	Collaborator
Karolinska University Hospital	Sahlgrenska University Hospital, Sweden, Skane University Hospital, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Global quality of life	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.	1 year after end of treatment
Primary	Vulvar-cancer-specific quality of life	Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.	1 year after end of treatment
Secondary	Satisfaction with Care	Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.	3--4 months after end of treatment
Secondary	Depression and anxiety	Measured by the Hospital Anxiety and Depression Index (HADS)-questionnaire. Higher scores represent more depression and anxiety	1 year after end of treatment.
Secondary	Unmet needs	Measured by the Supportive Care Needs Survey-Short Form (SCNS-SF)-34-questionnaire. Higher scores represent higher needs.	3-4 months after end of treatment.