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

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Brief Title

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

Official Title

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

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.
    


Study Type

Observational


Primary Outcome

Global quality of life

Secondary Outcome

 Satisfaction with Care

Condition

Vulvar Cancer

Intervention

Questionnaire administration

Study Arms / Comparison Groups

 Whole Cohort
Description:  Whole cohort administration of questionnaire at 7 times

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

150

Start Date

August 29, 2019

Completion Date

February 2021

Primary Completion Date

February 2021

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Diana Zach, MD, +46851775922, [email protected]

Location Countries

Sweden

Location Countries

Sweden

Administrative Informations


NCT ID

NCT04152512

Organization ID

2018/1402-31/1


Responsible Party

Principal Investigator

Study Sponsor

Karolinska University Hospital

Collaborators

 University Hospital, Linkoeping

Study Sponsor

Diana Zach, MD, Principal Investigator, Karolinska University Hospital, Karolinska Institute, Stockholm, Sweden


Verification Date

February 2020