Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
Study Details
Study Description
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| No Intervention: Standard care 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 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
The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
|
Outcome Measures
Primary Outcome Measures
- Quality of life measured by EORTC QLQ C-30. [9 months; at baseline (0 months), 3, 6 and 9 months]
EORTC QLQ C-30, a higher score indicates better quality of life (range 0-100). Differences in quality of life between the standard care and the intervention group will be tested using t-test and analysis of covariance.
Secondary Outcome Measures
- Disease specific quality of life using the EORTC QLQ-OV28 Ovarian Module. [9 months; at baseline (0 months), 3, 6 and 9 months]
Includes 28 questions.Registration of differences in the two groups.
- Disease specific quality of life using the EORTC QLQ-EN24 Endometrial Module [9 months; at baseline (0 months), 3, 6 and 9 months]
Includes 24 questions. Registration of differences in the two groups.
- Hospital Anxiety and Depression Scale (HADS) [9 months; at baseline (0 months), 3, 6 and 9 months]
Includes 14 questions, addressing anxiety and depressive symptoms with 7 items each in the previous 7 days.
- Self-efficacy for managing chronic disease 6-item scale [9 months; at baseline (0 months), 3, 6 and 9 months]
A 6-item scale measuring patient's perceived self-efficacy on a 10 point Likert Scale.
- Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms. [9 months; at baseline (0 months) and every three weeks prior to chemotherapy]
Scale 0-4, where 0 is no/nothing and 4 is severe. Registration of differences in CTCAE.
Eligibility Criteria
Criteria
Inclusion Criteria:
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Women ≥ 18 years
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Newly diagnosis of ovarian- or endometrial cancer
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Scheduled to receive first-line standard chemotherapy
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Having an active email, internet access and a device
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Able to understand, read and speak Danish
Exclusion Criteria:
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Severe cognitive impairments/psychiatric disorder
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Participating in other interventional clinical trials
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Copenhagen University Hospital, Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
- The Novo Nordic Foundation
Investigators
- Principal Investigator: Mille Christiansen, Rigshospitalet, Denmark
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- Copenhagen University Hospital