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| Name | Class |
|---|---|
| The Novo Nordic Foundation | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard care | No Intervention | 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. | |
| Intervention group | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Nurse-led consultations based on electronic patient-reported outcomes | Other | The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mille Christiansen | Contact | +45 35456347 | mille.guldager.christiansen@regionh.dk | |
| Karin Piil | Contact | karin.piil@regionh.dk |
| Name | Affiliation | Role |
|---|---|---|
| Mille Christiansen | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Copenhagen University Hospital, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D010051 | Ovarian Neoplasms |
| D016889 | Endometrial Neoplasms |
| ID | Term |
|---|---|
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D005831 | Genital Diseases, Female |
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A prospective, sequential cohort study with comparisons between non-equivalent groups.
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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. |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
| D014594 | Uterine Neoplasms |
| D014591 | Uterine Diseases |