The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer
- Conditions
- Patient Reported Outcome MeasuresOvarian Neoplasms
- Registration Number
- NCT05352217
- Lead Sponsor
- Stiftung Swiss Tumor Institute
- Brief Summary
The study is designed as an observational cohort study, aiming to evaluate, whether a structured recording of symptoms by a mobile app contributes insight in the follow-up modalities of ovarian cancer patients.
- Detailed Description
The observational study will examine different follow-up modalities for ovarian cancer patients with the ultimate goal of improving follow-up strategies for an improved well-being and better clinical outcomes. The primary objective is to quantify the effects of conservative clinical diagnostics by collecting symptoms via ePRO in addition to intensive diagnostics (CA-125 testing, imaging diagnostics) during follow-up, on survival, time to clinical recurrence and well-being.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 7
- Women aged ≥ 18 years
- Between diagnosis and the first follow-up visit after the end of their antineoplastic treatment (systemic therapy or surgical treatment) for ovarian cancer.
- German, English, French, or Italian speaking
- Personal smartphone (iOS or Android system); one of the latest three main versions
• Patients whose compliance must be questioned, e.g. due to a psychiatric disorder, private life situation or insufficient knowledge on smartphone use and do not have a suitable caregiver to assist them with symptom reporting.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Overall survival three years after end of therapy 3 years Overall survival three years after the end of primary therapy / start of follow-up
- Secondary Outcome Measures
Name Time Method Time to Recurrence 3 years Time to Recurrence
Total number of tumor relapses 3 years Total number of tumor relapses occurring in the follow-up period
Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse 3 years Symptoms that led to further diagnostic measures (imaging diagnostics and CA-125 testing) and possibly the detection of tumor relapse
Number and type of unplanned hospitalizations and emergencies. 3 years Unplanned hospitalizations and emergencies are defined as additional consultations outside of planned therapy or control visits at the treatment center or with the investigator, as well as unplanned visits to other physicians (e.g., GP) or emergency services.
Amount and frequency of patient data entries 3 years Amount and frequency of patient data entries
Platinum-sensitivity and the patients' platinum free interval (PFI) 3 years Platinum-sensitivity and the patients' platinum free interval (PFI)
Well-being 3 years Well-being according to the ECOG Performance Status
GRADE ECOG PERFORMANCE STATUS 0 Fully active, able to carry on all pre-disease performance without restriction
1. Restricted in physically strenuous activity but ambulatory and able to carry out work of a light or sedentary nature, e.g., light house work, office work
2. Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours
3. Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours
4. Completely disabled; cannot carry on any selfcare; totally confined to bed or chair
5. Dead
Trial Locations
- Locations (4)
Spital Limmattal Frauenklinik
🇨🇭Schlieren, Zürich, Switzerland
Gynäkologische Onkologie Spital Zollikerberg
🇨🇭Zollikerberg, Zürich, Switzerland
Interdisziplinäre Medizin Zürich (IMZ)
🇨🇭Zürich, Switzerland
Praxis für Gynäkologie und Geburtshilfe
🇨🇭Zürich, Switzerland