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

Ovarian Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04945187
• Other study ID #: Copenhagen University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: May 17, 2021
• Est. completion date: February 1, 2024

Study information

• Verified date: January 2023
• Source: Rigshospitalet, Denmark
• Contact: Mille Christiansen
• Phone: +45 35456347
• Email: mille.guldager.christiansen[@]regionh.dk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 130
• Est. completion date: February 1, 2024
• Est. primary completion date: February 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Endometrial Cancer
• Endometrial Neoplasms
• Genital Neoplasms, Female
• Gynecologic Cancer
• Gynecologic Neoplasm
• Ovarian Cancer

Intervention

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.

Locations

Country	Name	City	State
Denmark	Copenhagen University Hospital, Rigshospitalet	Copenhagen

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	The Novo Nordic Foundation

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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.