Clinical trial · Interventional
Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
Systematic Nurse-Led Consultations Based on Electronic Patient-Reported Outcome Among Women With Gynecological Cancer During Chemotherapy (The CONNECT Study)
NCT04945187CI-TRIAL-00063452completedN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 26, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260926-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Gynecologic Neoplasm | Female Reproductive System Neoplasm | ALIAS | 0.90 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Nurse-led consultations based on electronic patient-reported outcomes | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- NO_INTERVENTION
- label
- Standard care
- description
- 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.
- type
- EXPERIMENTAL
- label
- Intervention group
- description
- 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.
- interventionNames
- Other: Nurse-led consultations based on electronic patient-reported outcomes
Primary outcomes (1)
- measure
- Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.