Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

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Brief Title

Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

Official Title

Living After a Rare Cancer of the Ovary: Chronic Fatigue, Quality of Life and Late Effects of Chemotherapy

Brief Summary

      While they are documented in patients in remission of testicular cancer, the sequelae of
      chemotherapy and the impact of the disease and its treatments on the living conditions and
      QoL of women in remission of rare ovarian cancer remain poorly explored.

      The coordinator therefore propose a national 2-step case-control study to evaluate 1) chronic
      fatigue and QoL and 2) chemotherapy-related sequelae in adult patients in remission of
      surgery-treated TGMO or TSCS (conservative or not) supplemented with chemotherapy
    



Study Type

Interventional


Primary Outcome

The chronic fatigue by questionnaires

Secondary Outcome

 The fertility monitoring by questionnaires

Condition

Germ Cell Tumor

Intervention

Self-questionnaires of living conditions and quality of life

Study Arms / Comparison Groups

 Interest group (patients treated with chemotherapy)
Description:  Patients will complete several self-questionnaires on living conditions and quality of life. They will also perform a cardiac, pulmonary, auditory and biological assessment

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

Other

Estimated Enrollment

268

Start Date

May 7, 2018

Completion Date

June 2021

Primary Completion Date

June 2021

Eligibility Criteria

        Inclusion Criteria:

          -  Age> 18 years;

          -  Patient with an ovarian malignant germ cell tumor (TGMO) or a stroma tumor and / or
             sex cords (TSCS) treated optimally;

          -  Patient who has had surgery and chemotherapy (interest group) or only a surgery
             (control group);

          -  Patient in remission more than 2 years after the end of the initial treatment;

          -  Relapse authorized if remission more than 2 years after the end of the treatment;

          -  Patient with no other cancers (with the exception of basal cell skin carcinomas, in
             situ cancers of the breast and cervix);

          -  Patient having signed his consent to participate

        Exclusion Criteria:

          -  Pregnant or breastfeeding woman;

          -  Psychiatric pathology that may disrupt the course of the study or prevent the
             interpretation of results;

          -  Person deprived of liberty;

          -  Major subject to a legal protection measure or unable to express his consent.
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Contacts

Florence JOLY, 33 2 31 45 50 02, [email protected]

Location Countries

France

Location Countries

France

Administrative Informations


NCT ID

NCT03418844

Organization ID

VIVROVAIRE TR


Responsible Party

Sponsor

Study Sponsor

Centre Francois Baclesse

Collaborators

 ARCAGY/ GINECO GROUP

Study Sponsor

Florence JOLY, Principal Investigator, Centre François Baclesse


Verification Date

March 2021