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

Primary Purpose

Gynecologic Cancer, Gynecologic Neoplasm, Ovarian Cancer

Status

Recruiting

Phase

Not Applicable

Locations

Denmark

Study Type

Interventional

Intervention

Nurse-led consultations based on electronic patient-reported outcomes

About this trial

This is an interventional supportive care trial for Gynecologic Cancer focused on measuring Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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

Sites / Locations

Copenhagen University Hospital, RigshospitaletRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Standard care

Intervention group

Arm 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: 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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 in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.

Includes 24 questions. Measured at four time-points.

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 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.

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.

Full Information

NCT ID

NCT04945187

First Posted

May 11, 2021

Last Updated

January 23, 2023

Sponsor

Rigshospitalet, Denmark

Collaborators

The Novo Nordic Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04945187

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

May 17, 2021 (Actual)

Primary Completion Date

February 1, 2024 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Rigshospitalet, Denmark

Collaborators

The Novo Nordic Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Gynecologic Cancer, Gynecologic Neoplasm, Ovarian Cancer, Endometrial Cancer

Keywords

Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Sequential Assignment

Model Description

A prospective, sequential cohort study with comparisons between non-equivalent groups.

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

130 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Standard care

Arm Type

No Intervention

Arm 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.

Arm Title

Intervention group

Arm Type

Experimental

Arm Description

Intervention Type

Other

Intervention Name(s)

Nurse-led consultations based on electronic patient-reported outcomes

Intervention Description

The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.

Primary Outcome Measure Information:

Title

Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months.

Description

EORTC QLQ C-30, a higher score indicates better quality of life (range 0-100). Measured at four time-points.

Time Frame

Change from baseline to 9 months.

Secondary Outcome Measure Information:

Title

Change from baseline in disease-specific Quality of life using the EORTC QLQ-OV28 Ovarian Module until 9 months.

Description

Includes 28 questions. Measured at four time-points.

Time Frame

Change from baseline to 9 months.

Title

Change from baseline in disease-specific Quality of life using the EORTC QLQ-EN24 Endometrial Module until 9 months.

Description

Includes 24 questions. Measured at four time-points.

Time Frame

9 months; at baseline (0 months), 3, 6 and 9 months.

Title

Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.

Description

Includes 14 questions, addressing anxiety and depressive symptoms with 7 items each in the previous 7 days. Measured at four time-points.

Time Frame

Change from baseline to 9 months.

Title

Change from baseline in Self-efficacy for managing chronic disease 6-item scale until 9 months.

Description

A 6-item scale measuring patient's perceived self-efficacy on a 10 point Likert Scale. Measured at four time-points.

Time Frame

Change from baseline to 9 months.

Title

Common Terminology Criteria for Adverse Events (CTCAE), an objective grading of the patients symptoms.

Description

Scale 0-4, where 0 is no/nothing and 4 is severe.

Time Frame

Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.

10. Eligibility

Sex

Female

Gender Based

Yes

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

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

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Mille Christiansen

Phone

+45 35456347

mille.guldager.christiansen@regionh.dk

First Name & Middle Initial & Last Name or Official Title & Degree

Karin Piil

karin.piil@regionh.dk

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mille Christiansen

Organizational Affiliation

Rigshospitalet, Denmark

Official's Role

Principal Investigator

Facility Information:

Facility Name

Copenhagen University Hospital, Rigshospitalet

City

Copenhagen

ZIP/Postal Code

2100

Country

Denmark

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Mille Christiansen

Phone

+4535456347

mille.guldager.christiansen@regionh.dk

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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