Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)

Study Overview
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Brief Summary
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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
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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.

Official Title
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Systematic Nurse-Led Consultations Based on Electronic Patient-Reported Outcome Among Women With Gynecological Cancer During Chemotherapy (The CONNECT Study)

Conditions
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Gynecologic Cancer, Gynecologic Neoplasm, Ovarian Cancer, Endometrial Cancer

Intervention / Treatment
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* Other: Nurse-led consultations based on electronic patient-reported outcomes


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Interventional Model Description: A prospective, sequential cohort study with comparisons between non-equivalent groups.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Standard care<br>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. | |
| Experimental: Intervention group<br>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. | Other: Nurse-led consultations based on electronic patient-reported outcomes<br>* The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change 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. | Change from baseline to 9 months. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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. | 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. | 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. | 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. | Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life