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

Ovarian Neoplasms Clinical Trial

— ECOvar  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05352217
• Other study ID #: 2021-D0052
• Status: Terminated
• Start date: December 13, 2021
• Est. completion date: November 13, 2023

Study information

• Verified date: April 2024
• Source: Stiftung Swiss Tumor Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: November 13, 2023
• Est. primary completion date: November 13, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma, Ovarian Epithelial
• Ovarian Neoplasms
• Patient Reported Outcome Measures

Intervention

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.

Locations

Country	Name	City	State
Switzerland	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

Sponsors (3)

Lead Sponsor	Collaborator
Stiftung Swiss Tumor Institute	Klinik Hirslanden, Zurich, Manja Gideon Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Time to Recurrence	Time to Recurrence	3 years
Secondary	Total number of tumor relapses	Total number of tumor relapses occurring in the follow-up period	3 years
Secondary	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
Secondary	Amount and frequency of patient data entries	Amount and frequency of patient data entries	3 years
Secondary	Platinum-sensitivity and the patients' platinum free interval (PFI)	Platinum-sensitivity and the patients' platinum free interval (PFI)	3 years
Secondary	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
Secondary	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