Ignite Creation Date:
2025-12-26 @ 10:44 PM
Ignite Modification Date:
2026-03-09 @ 11:02 PM
Study NCT ID:
NCT04152512
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-11-01
First Post:
2019-10-27
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
Sponsor:
Karolinska University Hospital
Organization:
Study Overview
Official Title:
Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
PROVE
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.
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: