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NCT Number: NCT04152512

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

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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Vulvar Cancer Anxiety Disorders Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Mental Disorders Neoplasms Neoplasms by Site Quality of Life Urogenital Diseases Urogenital Neoplasms Vulvar Diseases Vulvar Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Karolinska University Hospital, Stockholm, Stockholm County, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Questionnaire Administration

Behavioral

Questionnaire administration (4 different forms: pre-treatment, 3-4 months after treatment, 1 year after treatment, 2-5 years (yearly) after treatment

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Satisfaction with Care

    Time frame: 3--4 months after end of treatment

    Measured by EORTC-PATSAT-questionnaire. Higher score represent higher satisfaction with care.

  2. Depression and anxiety

    Time frame: 1 year after end of treatment.

    Measured by the Hospital Anxiety and Depression Index (HADS)-questionnaire. Higher scores represent more depression and anxiety

  3. Unmet needs

    Time frame: 3-4 months after end of treatment.

    Measured by the Supportive Care Needs Survey-Short Form (SCNS-SF)-34-questionnaire. Higher scores represent higher needs.

Sponsors and collaborators

Lead sponsor

Karolinska University Hospital

Other

Collaborators

  • Sahlgrenska University Hospital
  • Skane University Hospital
  • University Hospital, Linkoeping

Registry information

Official study title

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

Acronym: PROVE

Important dates

Study start
2019
Primary completion
2027
Study completion
2027
First posted
Nov 5, 2019
Registry last updated
Nov 1, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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