Systematic nurse-led consultations based on electronic patient-reported outcomes (ePRO) will be tested among women with ovarian - and endometrial cancer receiving first-line chemotherapy.
Women with ovarian- and endometrial cancer often experiences a high disease and treatment-related physical and psychological burden. Patient-reported outcomes (PRO) have the potential to improve patient-clinician communication, symptom management, involvement, and quality of life. Electronic patient-reported outcomes (ePRO) can facilitate appropriate and continuous symptom monitoring reported by the patients. Nurses are with their holistic approach and their specialized knowledge and experience in a prominent position to address and facilitate symptom-management in a multidisciplinary context. 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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Enrollment
130
The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark
RECRUITINGChange from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
EORTC QLQ C-30, a higher score indicates better quality of life (range 0-100). Measured at four time-points.
Time frame: Change from baseline to 9 months.
Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.
Includes 28 questions. Measured at four time-points.
Time frame: Change from baseline to 9 months.
Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.
Includes 24 questions. Measured at four time-points.
Time frame: 9 months; at baseline (0 months), 3, 6 and 9 months.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.
Includes 14 questions, addressing anxiety and depressive symptoms with 7 items each in the previous 7 days. Measured at four time-points.
Time frame: Change from baseline to 9 months.
Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.
A 6-item scale measuring patient's perceived self-efficacy on a 10 point Likert Scale. Measured at four time-points.
Time frame: Change from baseline to 9 months.
Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms.
Scale 0-4, where 0 is no/nothing and 4 is severe.
Time frame: Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.
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