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

Stiftung Swiss Tumor Institute7 enrolled

Overview

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.

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.

Study Type

OBSERVATIONAL

Enrollment

Conditions

Patient Reported Outcome Measures Ovarian Neoplasms

Interventions

Mobile app ovarian cancer followup (ePRO)DEVICE

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (4)

Spital Limmattal Frauenklinik

Schlieren, Canton of Zurich, Switzerland

Gynäkologische Onkologie Spital Zollikerberg

Zollikerberg, Canton of Zurich, Switzerland

Praxis für Gynäkologie und Geburtshilfe

Zurich, Switzerland

Interdisziplinäre Medizin Zürich (IMZ)

Zurich, Switzerland

Outcomes

Primary Outcomes

Overall survival three years after end of therapy

Overall survival three years after the end of primary therapy / start of follow-up

Time frame: 3 years

Secondary Outcomes

Time to Recurrence

Time frame: 3 years

Total number of tumor relapses

Total number of tumor relapses occurring in the follow-up period

Time frame: 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 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

Time frame: 3 years

Amount and frequency of patient data entries

Time frame: 3 years

Platinum-sensitivity and the patients' platinum free interval (PFI)

Time frame: 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.

Data from ClinicalTrials.gov

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