The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer

Study Overview
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Brief Summary
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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
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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.

Official Title
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The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study

Conditions
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Patient Reported Outcome Measures, Ovarian Neoplasms

Intervention / Treatment
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* Device: Mobile app ovarian cancer followup (ePRO)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: • 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Mobile app ovarian cancer followup (ePRO)|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.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival three years after end of therapy | Overall survival three years after the end of primary therapy / start of follow-up | 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time to Recurrence | Time to Recurrence | 3 years | 
| Total number of tumor relapses | Total number of tumor relapses occurring in the follow-up period | 3 years | 
| Well-being | 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 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 Ambulatory and capable of all selfcare but unable to carry out any work activities; up and about more than 50% of waking hours Capable of only limited selfcare; confined to bed or chair more than 50% of waking hours Completely disabled; cannot carry on any selfcare; totally confined to bed or chair Dead | 3 years | 
| Amount and frequency of patient data entries | Amount and frequency of patient data entries | 3 years | 
| Platinum-sensitivity and the patients' platinum free interval (PFI) | Platinum-sensitivity and the patients' platinum free interval (PFI) | 3 years | 
| Number and type of unplanned hospitalizations and emergencies. | 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. | 3 years | 
| Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse | Symptoms that led to further diagnostic measures (imaging diagnostics and CA-125 testing) and possibly the detection of tumor relapse | 3 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PRO, ePRO, Electronic Patient Reported Outcome, Ovarian Cancer