Endometrial Cancer, Gynecologic Cancer, Gynecologic Neoplasm, Ovarian Cancer
Conditions
Keywords
Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life
Brief summary
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.
Detailed description
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.
Interventions
OTHERNurse-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.
Sponsors
The Novo Nordic Foundation
Rigshospitalet, Denmark
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
A prospective, sequential cohort study with comparisons between non-equivalent groups.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Women ≥ 18 years * 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
* Severe cognitive impairments/psychiatric disorder * Participating in other interventional clinical trials
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months. | Change from baseline to 9 months. | EORTC QLQ C-30, a higher score indicates better quality of life (range 0-100). Measured at four time-points. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months. | Change from baseline to 9 months. | Includes 28 questions. Measured at four time-points. |
| Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months. | 9 months; at baseline (0 months), 3, 6 and 9 months. | Includes 24 questions. Measured at four time-points. |
| Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months. | Change from baseline to 9 months. | Includes 14 questions, addressing anxiety and depressive symptoms with 7 items each in the previous 7 days. Measured at four time-points. |
| Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months. | Change from baseline to 9 months. | A 6-item scale measuring patient's perceived self-efficacy on a 10 point Likert Scale. Measured at four time-points. |
| Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms. | Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days. | Scale 0-4, where 0 is no/nothing and 4 is severe. |
Countries
Denmark
Contacts
Primary ContactMille Christiansen
Backup ContactKarin Piil
Outcome results
None listed