Vulvar CancerPROVENCT04152512
Quality of Life, Unmet Needs and Satisfaction With Care After Vulvar Cancer
An observational study of Vulvar Cancer and Quality of Life, run by Karolinska University Hospital at 4 sites in Sweden.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Vulvar Cancer, Quality of Life
- What is being tested?
- Questionnaire administration
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 153 participants
- Where
- 4 sitesSweden
- Study dates
- 29 Aug 2019to Oct 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.
Who may be able to join
- Primary diagnosis of vulvar cancer, all stages, all planned treatments
- Informed consent
Who cannot join
- Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
Trial locations and contacts
4 sites in 1 country.
Sweden4 sites
Sahlgrenska University Hospital
Gothenburg
Linkopings University Hospital
Linköping
Skanes University Hospital Lund
Lund
Karolinska University Hospital
Stockholm, Stockholm County, 17776
About this study
Official title: 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.
Read the 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.
- Conditions
- Vulvar Cancer, Quality of Life
- Being tested
- Questionnaire administration
- Keywords
- Questionnaire, EORTC QLQ C30 + VU34, Hospital Depression and Anxiety Scale, EORTC-PATSAT, Supportive Care Needs Survey Short Form
- Medical subject headings
- Vulvar Neoplasms, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Questionnaire administrationBehavioural
Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment
| Study group | Role | What they receive |
|---|---|---|
| Whole Cohort | Whole cohort administration of questionnaire at 7 times Receives: Behavioral: Questionnaire administration |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 1 year after end of treatment
Secondary outcomes (3)
Satisfaction with Care
Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.
Measured: 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
Measured: 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.
Measured: 3-4 months after end of treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2019
- Study start29 Aug 2019
- Primary completionFeb 2027 (estimated)
- Study completionOct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Vulvar CancerStudies of the same condition, open and under way.
- More trials run by Karolinska University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karolinska University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Linkoeping, Skane University Hospital, Sahlgrenska University Hospital
- Responsible party
- Principal investigator, Diana Zach, Karolinska University Hospital
- Investigators
- Diana Zach, MD, Principal investigator, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04152512
- Sponsor's protocol ID
- 2018/1402-31/1
- Acronym
- PROVE
- Status last verified
- Oct 2023
- First submitted
- 27 Oct 2019
- Last updated
- 1 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zach D, Jensen PT, Falconer H, Kolkova Z, Bohlin KS, Kjolhede P, Raices Cruz I, Avall-Lundqvist E, Floter Radestad A. The impact of local symptoms on health-related quality of life in vulvar cancer survivors-A nationwide prospective study. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1517-1529. doi: 10.1111/aogs.15164. Epub 2025 Jun 9.
PubMed 40490985
Study at a glance
From the registry record, last updated by the sponsor on 1 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality of Life, Specific Needs and Satisfaction With Care After Treatment for Vulvar Cancer - a Prospective, Longitudinal Swedish Nationwide Study
- ClinicalTrials.gov ID
- NCT04152512
- Acronym / sponsor ID
- PROVE / 2018/1402-31/1
- 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
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 153 participants (actual)
- Lead sponsor
- Karolinska University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Linkoeping, Skane University Hospital, Sahlgrenska University Hospital
- Study start
- 29 Aug 2019 (actual)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Oct 2027 (estimated)
- First posted
- 5 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Cohort | – | Behavioral: Questionnaire administrationWhole cohort administration of questionnaire at 7 times |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women with newly diagnosed invasive vulvar cancer in Sweden during the study time frame.
Key inclusion criteria (2 listed)
- Primary diagnosis of vulvar cancer, all stages, all planned treatments
- Informed consent
Key exclusion criteria (1 listed)
- Disability to understand and complete the questionnaire due to language difficulties, severe psychiatric illness or dementia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Questionnaire administrationQuestionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment | Behavioural | Whole Cohort |
Primary outcome
Global quality of life
Time frame: 1 year after end of treatment
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.
Vulvar-cancer-specific quality of life
Time frame: 1 year after end of treatment
Measured by the EORTC-QLQ-VU34-questionnaire. Higher values represent higher quality of life.
3 secondary outcomes
Satisfaction with Care
Time frame: 3--4 months after end of treatment
Depression and anxiety
Time frame: 1 year after end of treatment.
Unmet needs
Time frame: 3-4 months after end of treatment.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Nov 2023.
- Derived from this study: PubMed 40490985Zach D, Jensen PT, Falconer H, Kolkova Z, Bohlin KS, Kjolhede P, Raices Cruz I, Avall-Lundqvist E, Floter Radestad A. The impact of local symptoms on health-related quality of life in vulvar cancer survivors-A nationwide prospective study. Acta Obstet Gynecol Scand. 2025 Aug;104(8):1517-1529. doi: 10.1111/aogs.15164. Epub 2025 Jun 9.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Diana Zach, MD principal investigator
Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Vulvar Cancer and Quality of Life, run by Karolinska University Hospital at 4 sites in Sweden.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 1 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Sweden. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Global quality of life (time frame: 1 year after end of treatment). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04152512, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Nov 2023.