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

January 23, 2023 updated by: Helle Pappot, Rigshospitalet, Denmark

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

130

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.
Time Frame: Change from baseline to 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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.
Time Frame: Change from baseline to 9 months.
Includes 28 questions. Measured at four time-points.
Change from baseline to 9 months.
Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.
Time Frame: 9 months; at baseline (0 months), 3, 6 and 9 months.
Includes 24 questions. Measured at four time-points.
9 months; at baseline (0 months), 3, 6 and 9 months.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.
Time Frame: Change from baseline to 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.
Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.
Time Frame: Change from baseline to 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.
Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms.
Time Frame: Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.
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.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Rigshospitalet, Denmark

Collaborators

The Novo Nordic Foundation

Investigators

  • Principal Investigator: Mille Christiansen, Rigshospitalet, Denmark

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 17, 2021

Primary Completion (Anticipated)

February 1, 2024

Study Completion (Anticipated)

February 1, 2024

Study Registration Dates

First Submitted

May 11, 2021

First Submitted That Met QC Criteria

June 21, 2021

First Posted (Actual)

June 30, 2021

Study Record Updates

Last Update Posted (Estimate)

January 26, 2023

Last Update Submitted That Met QC Criteria

January 23, 2023

Last Verified

January 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Copenhagen University Hospital (The Danish Cancer Society:R344-A19341, Novo Nordisk Foundation: NNF22OC0080425)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Gynecologic Cancer

Clinical Trials on Nurse-led consultations based on electronic patient-reported outcomes

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in China

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe