Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
NCT ID: NCT04945187
Last Updated: 2023-01-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
130 participants
INTERVENTIONAL
2021-05-17
2024-02-01
Brief Summary
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Detailed Description
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The overall aim of this study is to develop a model of care for systematic nurse-led consultations based on ePRO facilitating symptom management and to investigate how these consultations can be a part of the multidisciplinary treatment regimen for women with ovarian- and endometrial cancer receiving chemotherapy.
Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
SUPPORTIVE_CARE
NONE
Study Groups
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Standard care
No intervention. This arm will continue standard clinical practice consisting of clinical assessment regarding side effects and management before each cycle of chemotherapy conducted by physicians.
No interventions assigned to this group
Intervention group
Intervention: This arm will be assigned to the intervention which will be nurse-led consultations based on electronic patient-reported outcomes. The patients will report ePRO weekly during chemotherapy and the answers will be used proactively in the nurse-led consultations. Nurses will conduct the clinical assessment regarding side effects and management before each cycle of chemotherapy.
Nurse-led consultations based on electronic patient-reported outcomes
The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
Interventions
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Nurse-led consultations based on electronic patient-reported outcomes
The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
Eligibility Criteria
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Inclusion Criteria
* Newly diagnosis of ovarian- or endometrial cancer
* Scheduled to receive first-line standard chemotherapy
* Having an active email, internet access and a device
* Able to understand, read and speak Danish
Exclusion Criteria
* Participating in other interventional clinical trials
18 Years
FEMALE
No
Sponsors
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The Novo Nordic Foundation
OTHER
Rigshospitalet, Denmark
OTHER
Responsible Party
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Helle Pappot
Professor, Clinical Oncologist, Consultant, DMSc
Principal Investigators
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Mille Christiansen
Role: PRINCIPAL_INVESTIGATOR
Rigshospitalet, Denmark
Locations
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Copenhagen University Hospital, Rigshospitalet
Copenhagen, , Denmark
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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Copenhagen University Hospital
Identifier Type: -
Identifier Source: org_study_id
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