Clinical trial NCT04945187: Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
Official title: Systematic Nurse-Led Consultations Based on Electronic Patient-Reported Outcome Among Women With Gynecological Cancer During Chemotherapy (The CONNECT Study)
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Gynecologic Cancer
Gynecologic Neoplasm
Ovarian Cancer
Endometrial Cancer
Keywords: Patient-reported outcome
Electronic patient-reported outcome
Nurse-led consultations
Quality of life
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
Collaborators: name: The Novo Nordic Foundation
First posted: 2021-06-30
Enrollment: 130
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Intervention model description: A prospective, sequential cohort study with comparisons between non-equivalent groups.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
timeFrame: Change from baseline to 9 months.
Secondary outcomes:
measure: Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.
timeFrame: Change from baseline to 9 months.
measure: Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.
timeFrame: 9 months; at baseline (0 months), 3, 6 and 9 months.
measure: Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.
timeFrame: Change from baseline to 9 months.
measure: Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.
timeFrame: Change from baseline to 9 months.
measure: Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms.
timeFrame: Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Copenhagen University Hospital, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Mille Christiansen
role: PRINCIPAL_INVESTIGATOR
References: