Clinical trial NCT05352217: The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer
Official title: The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Patient Reported Outcome Measures
Ovarian Neoplasms
Keywords: ePRO
PRO
Electronic Patient Reported Outcome
Ovarian Cancer
Lead sponsor: Stiftung Swiss Tumor Institute
Sponsor class: OTHER
Collaborators: name: Klinik Hirslanden, Zurich
name: Manja Gideon Foundation
First posted: 2022-04-28
Enrollment: 7
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women ≥ 18 years old with a primary ovarian cancer diagnosis.

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Overall survival three years after end of therapy
timeFrame: 3 years
Secondary outcomes:
measure: Time to Recurrence
timeFrame: 3 years
measure: Total number of tumor relapses
timeFrame: 3 years
measure: Well-being
timeFrame: 3 years
measure: Amount and frequency of patient data entries
timeFrame: 3 years
measure: Platinum-sensitivity and the patients' platinum free interval (PFI)
timeFrame: 3 years
measure: Number and type of unplanned hospitalizations and emergencies.
timeFrame: 3 years
measure: Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse
timeFrame: 3 years
Other outcomes:
Locations:
city: Schlieren
country: Switzerland
facility: Spital Limmattal Frauenklinik
state: Zürich
city: Zollikerberg
country: Switzerland
facility: Gynäkologische Onkologie Spital Zollikerberg
state: Zürich
city: Zürich
country: Switzerland
facility: Praxis für Gynäkologie und Geburtshilfe
city: Zürich
country: Switzerland
facility: Interdisziplinäre Medizin Zürich (IMZ)
Study officials:
affiliation: Swiss Tumor Institue
name: Pius Wyss, Prof.Dr.med
role: PRINCIPAL_INVESTIGATOR
References: