JOURNAL ONKOLOGIE – STUDIE
Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire
Rekrutierend
NCT-Nummer:
NCT04655066
Studienbeginn:
April 2018
Letztes Update:
04.12.2020
Wirkstoff:
-
Indikation (Clinical Trials):
Pelvic Floor Disorders
Geschlecht:
Alle
Altersgruppe:
Erwachsene (18+)
Phase:
-
Sponsor:
St. Josefs-Hospital Wiesbaden GmbH
Collaborator:
-
Kontakt
Kontakt:
Phone: +496111771500
E-Mail: bgabriel@joho.de» Kontaktdaten anzeigen
Kontakt:
Phone: +496111770
E-Mail: bblauschneider@joho.de» Kontaktdaten anzeigen
Studienlocations (1 von 1)
Studien-Informationen
Brief Summary:The multimodal therapy of gynecological malignancies and breast cancer often leads to an
impairment of the pelvic floor function. This has a major impact on the quality of life of
cancer patients. The aim of the study is to record and analyze the potential subjective
impairment of the bladder, bowel and sexual function under systemic tumor therapy as well as
possible influencing factors by means of validated disease-specific questionnaires. to find
possible starting points for the prevention and treatment of the symptoms.
Ein-/Ausschlusskriterien
Inclusion Criteria:- Breastcancer under tumor therapy
- Gynecological carcinoma under tumor therapy
Exclusion Criteria:
- none
Studien-Rationale
Primary outcome:1. Primary Endpoint (Time Frame - 12 months):
The primary endpoint and basis for the sample size calculation is the incidence of clinically relevant deteriorations in the total score of pelvic floor function. Bladder function, bowel function, sedimentation problems and sexual function, QoL are recorded using scores using the validated German pelvic floor questionnaire
Secondary outcome:
1. Secondary Endpoint (Time Frame - 12 months):
Type of tumor (breast cancer, ovarian cancer, cervical cancer, endometrial cancer, vulvar cancer), TNM stage, body weight, height, age, type of tumor therapy, number of previous therapies (chemoline), parity, mode of delivery, nicotine abuse, medication, previous surgery.
Quelle: ClinicalTrials.gov
