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

NCT05352217TerminatedOBSERVATIONAL

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.

Key Facts

Lead Sponsor

Stiftung Swiss Tumor Institute

Enrollment

7

Start Date

2021-12-13

Completion Date

2023-11-13

Study Type

OBSERVATIONAL

Official Title

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

Interventions

Mobile app ovarian cancer followup (ePRO)

Conditions

Patient Reported Outcome MeasuresOvarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

FEMALE

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.

Outcome Measures

Primary Outcomes

Overall survival three years after end of therapy

Overall survival three years after the end of primary therapy / start of follow-up

Time frame: 3 years

Secondary Outcomes

Time to Recurrence

Time to Recurrence

Time frame: 3 years

Total number of tumor relapses

Total number of tumor relapses occurring in the follow-up period

Time frame: 3 years

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 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

Time frame: 3 years

Amount and frequency of patient data entries

Amount and frequency of patient data entries

Time frame: 3 years

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

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

Time frame: 3 years

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.

Time frame: 3 years

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

Time frame: 3 years

Locations

Spital Limmattal Frauenklinik, Schlieren, Switzerland

Gynäkologische Onkologie Spital Zollikerberg, Zollikerberg, Switzerland

Praxis für Gynäkologie und Geburtshilfe, Zurich, Switzerland

Interdisziplinäre Medizin Zürich (IMZ), Zurich, Switzerland

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.

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