NCT05352217

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
7

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Dec 2021

Geographic Reach
1 country

4 active sites

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 13, 2021

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

April 22, 2022

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 28, 2022

Completed
1.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 13, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 13, 2023

Completed
Last Updated

April 22, 2024

Status Verified

April 1, 2024

Enrollment Period

1.9 years

First QC Date

April 22, 2022

Last Update Submit

April 18, 2024

Conditions

Keywords

ePROPROElectronic Patient Reported OutcomeOvarian Cancer

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (7)

  • Time to Recurrence

    3 years

  • Total number of tumor relapses

    3 years

  • Well-being

    3 years

  • Amount and frequency of patient data entries

    3 years

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

    3 years

  • +2 more secondary outcomes

Interventions

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.

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Spital Limmattal Frauenklinik

Schlieren, Canton of Zurich, 8952, Switzerland

Location

Gynäkologische Onkologie Spital Zollikerberg

Zollikerberg, Canton of Zurich, 8125, Switzerland

Location

Praxis für Gynäkologie und Geburtshilfe

Zurich, 8002, Switzerland

Location

Interdisziplinäre Medizin Zürich (IMZ)

Zurich, 8008, Switzerland

Location

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland NeoplasmsNeoplasms by SiteNeoplasmsOvarian DiseasesAdnexal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital Neoplasms, FemaleUrogenital NeoplasmsGenital DiseasesEndocrine System DiseasesGonadal Disorders

Study Officials

  • Pius Wyss, Prof.Dr.med

    Swiss Tumor Institue

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 22, 2022

First Posted

April 28, 2022

Study Start

December 13, 2021

Primary Completion

November 13, 2023

Study Completion

November 13, 2023

Last Updated

April 22, 2024

Record last verified: 2024-04

Locations