Patient Reported Outcome MeasuresECOvarNCT05352217
The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer
An observational study of Patient Reported Outcome Measures and Ovarian Neoplasms, run by Stiftung Swiss Tumor Institute at 4 sites in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Patient Reported Outcome Measures, Ovarian Neoplasms
- What is being tested?
- Mobile app ovarian cancer followup (ePRO)
- Type of treatment
- Medical device
- How many people
- 7 participants
- Where
- 4 sitesSwitzerland
- Study dates
- 13 Dec 2021to 13 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Women ≥ 18 years old with a primary ovarian cancer diagnosis.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
4 sites in 1 country.
Switzerland4 sites
Spital Limmattal Frauenklinik
Schlieren, Canton of Zurich, 8952
Gynäkologische Onkologie Spital Zollikerberg
Zollikerberg, Canton of Zurich, 8125
Praxis für Gynäkologie und Geburtshilfe
Zurich, 8002
Interdisziplinäre Medizin Zürich (IMZ)
Zurich, 8008
About this study
Official title: The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study
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.
Read the 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.
- Being tested
- Mobile app ovarian cancer followup (ePRO)
- Keywords
- ePRO, PRO, Electronic Patient Reported Outcome, Ovarian Cancer
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mobile app ovarian cancer followup (ePRO)Device
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Overall survival three years after end of therapy
Overall survival three years after the end of primary therapy / start of follow-up
Measured: 3 years
Secondary outcomes (7)
Time to Recurrence
Time to Recurrence
Measured: 3 years
Total number of tumor relapses
Total number of tumor relapses occurring in the follow-up period
Measured: 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
- 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
Measured: 3 years
Amount and frequency of patient data entries
Amount and frequency of patient data entries
Measured: 3 years
Platinum-sensitivity and the patients' platinum free interval (PFI)
Platinum-sensitivity and the patients' platinum free interval (PFI)
Measured: 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.
Measured: 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
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Apr 2022
- Study start13 Dec 2021
- Primary completion13 Nov 2023
- Study completion13 Nov 2023
Why it stopped: Accrual rate fell far below needed accrual rate.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Patient Reported Outcome MeasuresStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stiftung Swiss Tumor Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Manja Gideon Foundation
- Responsible party
- Sponsor
- Investigators
- Pius Wyss, Prof.Dr.med, Principal investigator, Swiss Tumor Institue
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05352217
- Sponsor's protocol ID
- 2021-D0052
- Acronym
- ECOvar
- Status last verified
- Apr 2024
- First submitted
- 22 Apr 2022
- Last updated
- 22 Apr 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Possible Influence of Different Follow-up Modalities on Overall Survival in Ovarian Cancer: A Multicenter Observational Cohort Study
- ClinicalTrials.gov ID
- NCT05352217
- Acronym / sponsor ID
- ECOvar / 2021-D0052
- Keywords
- ePRO, PRO, Electronic Patient Reported Outcome, Ovarian Cancer
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Accrual rate fell far below needed accrual rate.
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Stiftung Swiss Tumor InstituteUniversity, hospital or other
- Collaborators
- Klinik Hirslanden, Zurich, Manja Gideon Foundation
- Study start
- 13 Dec 2021 (actual)
- Primary completion
- 13 Nov 2023 (actual)
- Study completion
- 13 Nov 2023 (actual)
- First posted
- 28 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women ≥ 18 years old with a primary ovarian cancer diagnosis.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Device | – |
Primary outcome
Overall survival three years after end of therapy
Time frame: 3 years
Overall survival three years after the end of primary therapy / start of follow-up
7 secondary outcomes
Time to Recurrence
Time frame: 3 years
Total number of tumor relapses
Time frame: 3 years
Well-being
Time frame: 3 years
Amount and frequency of patient data entries
Time frame: 3 years
Platinum-sensitivity and the patients' platinum free interval (PFI)
Time frame: 3 years
Number and type of unplanned hospitalizations and emergencies.
Time frame: 3 years
Symptoms that led to further diagnostic measures and possibly the detection of tumor relapse
Time frame: 3 years
Results and safety
The study was stopped early (reason given: Accrual rate fell far below needed accrual rate.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pius Wyss, Prof.Dr.med principal investigator
Swiss Tumor Institue
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Patient Reported Outcome Measures and Ovarian Neoplasms, run by Stiftung Swiss Tumor Institute at 4 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 22 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Accrual rate fell far below needed accrual rate.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Overall survival three years after end of therapy (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2024.