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

April 18, 2024 updated by: Stiftung Swiss Tumor Institute

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Zürich, Switzerland, 8002
        • Praxis für Gynäkologie und Geburtshilfe
      • Zürich, Switzerland, 8008
        • Interdisziplinäre Medizin Zürich (IMZ)
    • Zürich
      • Schlieren, Zürich, Switzerland, 8952
        • Spital Limmattal Frauenklinik
      • Zollikerberg, Zürich, Switzerland, 8125
        • Gynäkologische Onkologie Spital Zollikerberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Women ≥ 18 years old with a primary ovarian cancer diagnosis.

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Overall survival three years after end of therapy
Time Frame: 3 years
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 Frame: 3 years
Time to Recurrence
3 years
Total number of tumor relapses
Time Frame: 3 years
Total number of tumor relapses occurring in the follow-up period
3 years
Well-being
Time Frame: 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
3 years
Amount and frequency of patient data entries
Time Frame: 3 years
Amount and frequency of patient data entries
3 years
Platinum-sensitivity and the patients' platinum free interval (PFI)
Time Frame: 3 years
Platinum-sensitivity and the patients' platinum free interval (PFI)
3 years
Number and type of unplanned hospitalizations and emergencies.
Time Frame: 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.
3 years
Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse
Time Frame: 3 years
Symptoms that led to further diagnostic measures (imaging diagnostics and CA-125 testing) and possibly the detection of tumor relapse
3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Stiftung Swiss Tumor Institute

Collaborators

Klinik Hirslanden, Zurich
Manja Gideon Foundation

Investigators

  • Principal Investigator: Pius Wyss, Prof.Dr.med, Swiss Tumor Institue

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 13, 2021

Primary Completion (Actual)

November 13, 2023

Study Completion (Actual)

November 13, 2023

Study Registration Dates

First Submitted

April 22, 2022

First Submitted That Met QC Criteria

April 22, 2022

First Posted (Actual)

April 28, 2022

Study Record Updates

Last Update Posted (Actual)

April 22, 2024

Last Update Submitted That Met QC Criteria

April 18, 2024

Last Verified

April 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-D0052

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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