Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
- Conditions
- Gynecologic NeoplasmOvarian CancerGynecologic CancerEndometrial Cancer
- Interventions
- Other: Nurse-led consultations based on electronic patient-reported outcomes
- Registration Number
- NCT04945187
- Lead Sponsor
- Rigshospitalet, Denmark
- 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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 130
- 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
- Severe cognitive impairments/psychiatric disorder
- Participating in other interventional clinical trials
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Intervention group Nurse-led consultations based on electronic patient-reported outcomes 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.
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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.
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 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 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.
Trial Locations
- Locations (1)
Copenhagen University Hospital, Rigshospitalet
🇩🇰Copenhagen, Denmark