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

Sponsor

Stiftung Swiss Tumor Institute (Other)

Overall Status

Recruiting

CT.gov ID

NCT05352217

Collaborator

Klinik Hirslanden, Zurich (Other), Manja Gideon Foundation (Other)

340

Enrollment

Locations

Anticipated Duration (Months)

Patients Per Site

1.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Patient Reported Outcome Measures Ovarian Neoplasms	Device: Mobile app ovarian cancer followup (ePRO)

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 Design

Study Type:

Observational

Anticipated Enrollment :

340 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Actual Study Start Date :

Dec 13, 2021

Anticipated Primary Completion Date :

Dec 14, 2026

Anticipated Study Completion Date :

Dec 14, 2026

Outcome Measures

Primary Outcome Measures

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

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
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 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
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)
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.
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Spital Limmattal Frauenklinik	Schlieren	Zürich	Switzerland	8952
2	Gynäkologische Onkologie Spital Zollikerberg	Zollikerberg	Zürich	Switzerland	8125
3	Praxis für Gynäkologie und Geburtshilfe	Zürich		Switzerland	8002
4	Interdisziplinäre Medizin Zürich (IMZ)	Zürich		Switzerland	8008