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

Rigshospitalet

Status: Enrolling

Conditions: Endometrial Cancer; Gynecologic Neoplasm; Gynecologic Cancer; Ovarian Cancer

Treatments: Other: Nurse-led consultations based on electronic patient-reported outcomes

Study type: Interventional

Funder types: Other

Identifiers

NCT04945187

Copenhagen University Hospital

Details and patient eligibility

About

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.

Full 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.

Enrollment: 130 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Non-Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

---

130 participants in 2 patient groups

Standard care

No Intervention group

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.

Intervention group

Experimental 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.

Treatment:

Other: Nurse-led consultations based on electronic patient-reported outcomes