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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Quality of Life; Vulvar Cancer
• Intervention / Treatment: Behavioral: Questionnaire administration

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
• Enrollment (Actual): 153

Contacts and Locations

Study Locations

• Sweden
  • Gothenburg, Sweden
    • Sahlgrenska University Hospital
  • Linkoping, Sweden
    • Linköpings University hospital
  • Lund, Sweden
    • Skånes University hospital Lund
  • Stockholms Lan
    • Stockholm, Stockholms Lan, Sweden, 17776
      • Karolinska University Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Whole Cohort; Whole cohort administration of questionnaire at 7 times	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Satisfaction with Care	Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.	3--4 months after end of treatment
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.
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.

Collaborators and Investigators

• Sponsor: Karolinska University Hospital
• Collaborators: Sahlgrenska University Hospital, Sweden; University Hospital, Linkoeping; Skane University Hospital
• Investigators: Principal Investigator: Diana Zach, MD, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden

Study record dates

Study Major Dates

• Study Start (Actual): August 29, 2019
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): October 1, 2027

Study Registration Dates

• First Submitted: October 27, 2019
• First Submitted That Met QC Criteria: November 1, 2019
• First Posted (Actual): November 5, 2019

Study Record Updates

• Last Update Posted (Actual): November 1, 2023
• Last Update Submitted That Met QC Criteria: October 30, 2023
• Last Verified: October 1, 2023

More Information

Terms related to this study

• Keywords: Questionnaire; EORTC QLQ C30 + VU34; Hospital Depression and Anxiety Scale; EORTC-PATSAT; Supportive Care Needs Survey Short Form
• Additional Relevant MeSH Terms: Neoplasms; Urogenital Neoplasms; Neoplasms by Site; Genital Neoplasms, Female; Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvar Neoplasms
• Other Study ID Numbers: 2018/1402-31/1

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No