C56
Conditions
Interventions
Group 1: The aim of this study is to measure activity during chemotherapy and subsequent maintenance therapy with Niraparib and the effects of the drug on quality of life. Various questionnaires and a
all standardized questionnaires on general health. There is also a questionnaire that has been specially compiled for the study.
Each patient is individually documented on her treatment and medical h
Sponsors
Nord-Ostdeutsche Gesellschaft für Gynäkologische -NOGGO e.V.
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: • Female participant must be 18 years or older • Participant must be able to understand the study procedures and agree to participate in the study by providing written informed consent (before 5th chemotherapy cycle) • Able to complete questionnaires independently • Histologically diagnosed relapsed OC, fallopian tube cancer, or primary peritoneal cancer • Patients under chemotherapy with no signs of progression before cycle 5 and planed for two additional chemotherapy cycles • Patients eligible for Niraparib maintenance therapy according to SmPC being able to take oral medications • Patients must be willing to wear the activity tracker (bracelet) during the entire observation period Sub-Study (NIRvertical): • Only patients with first relapse of ovarian cancer at time of progression (before surgery or chemotherapy)
Exclusion criteria
Exclusion criteria: • Known hypersensitivity to the components of the product (Niraparib) • Pregnancy or breast feeding • Patients who have completed chemotherapy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| • Assessment of activity levels over the entire observation period (chemotherapy and maintenance therapy phase with niraparib) • The data are collected at each visit from the 5th cycle of chemotherapy until the end of the 3-month niraparib treatment and evaluated after the follow-up (after 3 and 6 months). This corresponds to a total observation period of approx. 1 year • For each visit, patients complete questionnaires (SF-12, FACT-F, QLQ-C30 & OV28, PRO CTCAE) and carry an "Activity Tracker" throughout the entire observation period | — |
Secondary
| Measure | Time frame |
|---|---|
| • Evaluation or comparison of changes in QoL in the chemotherapy phase with the maintenance therapy phase • The data are collected at each visit from the 5th cycle of chemotherapy until the end of the 3-month niraparib treatment and evaluated after the follow-up (after 3 and 6 months). • For each visit, patients complete questionnaires (SF-12, FACT-F, QLQ-C30 & OV28, PRO CTCAE) and carry an "Activity Tracker" throughout the entire observation period • Assessment of the correlation between QoL (measured by questionnaires) and activity level measured by an activity tracker at different time points | — |
Countries
Germany
Contacts
Public ContactAnne-Sophie Gimpel
Nord-Ostdeutsche Gesellschaft für Gynäkologische -NOGGO e.V.
Outcome results
None listed