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Evaluation of the Subjectively Perceived Pelvic Floor Function in Patients With Gynecological Tumors and Breast Cancer Under Systemic Tumor Therapy Using a Validated Questionnaire

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ClinicalTrials.gov Identifier: NCT04655066
Recruitment Status : Recruiting
First Posted : December 4, 2020
Last Update Posted : December 4, 2020
Sponsor:
Information provided by (Responsible Party):
St. Josefs-Hospital Wiesbaden GmbH

Study Description
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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.

Condition or disease
Pelvic Floor Disorders

Study Design
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Study Type : Observational [Patient Registry]
Estimated Enrollment : 200 participants
Observational Model: Case-Only
Time Perspective: Prospective
Target Follow-Up Duration: 3 Years
Official Title: PANTHERA-Studie "Pelvic Floor Disorders in Patients Under ANtineoplastic THERApy"
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

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Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Measures :
  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.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Sampling Method:   Non-Probability Sample
Study Population
Patients with gynecological tumors and breast cancer under systemic tumor therapy
Criteria

Inclusion Criteria:

  • Breastcancer under tumor therapy
  • Gynecological carcinoma under tumor therapy

Exclusion Criteria:

  • none
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04655066


Contacts
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Contact: Boris Gabriel, Prof. Dr. med. +496111771500 bgabriel@joho.de
Contact: Bettina Blau-Schneider, Dr. med. +496111770 bblauschneider@joho.de

Locations
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Germany
St. Josefs-Hospital Wiesbaden GmbH Recruiting
Wiesbaden, Germany, 65189
Sponsors and Collaborators
St. Josefs-Hospital Wiesbaden GmbH
More Information
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Responsible Party: St. Josefs-Hospital Wiesbaden GmbH
ClinicalTrials.gov Identifier: NCT04655066    
Other Study ID Numbers: PANTHERA
First Posted: December 4, 2020    Key Record Dates
Last Update Posted: December 4, 2020
Last Verified: December 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pelvic Floor Disorders
Pregnancy Complications