Gynecologic CancerNCT04945187
Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (The CONNECT Study)
A study testing Nurse-led consultations based on electronic patient-reported outcomes in people with Gynecologic Cancer and Gynecologic Neoplasm, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Gynecologic Cancer, Gynecologic Neoplasm, Ovarian Cancer
- What is being tested?
- Nurse-led consultations based on electronic patient-reported outcomes
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteDenmark
- Study dates
- 17 May 2021to 1 Aug 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- Severe cognitive impairments/psychiatric disorder
- Participating in other interventional clinical trials
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Copenhagen University Hospital, Rigshospitalet
Copenhagen, Denmark, 2100
About this study
Official title: 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.
Read the 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.
- Being tested
- Nurse-led consultations based on electronic patient-reported outcomes
- Keywords
- Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life
- Medical subject headings
- Genital Neoplasms, Female, Ovarian Neoplasms, Endometrial Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Nurse-led consultations based on electronic patient-reported outcomesOther
The patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations.
| Study group | Role | What they receive |
|---|---|---|
| Standard care | No intervention | 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 | 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. Receives: Other: Nurse-led consultations based on electronic patient-reported outcomes |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change from baseline to 9 months.
Secondary outcomes (5)
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.
Measured: 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.
Includes 24 questions. Measured at four time-points.
Measured: 9 months; at baseline (0 months), 3, 6 and 9 months.
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.
Measured: Change from baseline to 9 months.
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.
Measured: Change from baseline to 9 months.
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.
Measured: Before each cycle of chemotherapy, in total 6 cycles. A cycle is 21 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2021
- Study start17 May 2021
- Primary completion15 May 2024
- Study completion1 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gynecologic CancerStudies of the same condition, open and under way.
- More trials run by Copenhagen University Hospital, RigshospitaletThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- A prospective, sequential cohort study with comparisons between non-equivalent groups.
- Masking
- None (open label)
- Enrolment
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Copenhagen University Hospital, Rigshospitalet
- Sponsor type
- University, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Responsible party
- Principal investigator, Helle Pappot, Copenhagen University Hospital, Rigshospitalet
- Investigators
- Mille Christiansen, Principal investigator, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04945187
- Sponsor's protocol ID
- Copenhagen University Hospital
- Status last verified
- Sep 2026
- First submitted
- 11 May 2021
- Last updated
- 25 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systematic Nurse-Led Consultations Based on Electronic Patient-Reported Outcome Among Women With Gynecological Cancer During Chemotherapy (The CONNECT Study)
- ClinicalTrials.gov ID
- NCT04945187
- Acronym / sponsor ID
- Copenhagen University Hospital
- Keywords
- Patient-reported outcome, Electronic patient-reported outcome, Nurse-led consultations, Quality of life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Copenhagen University Hospital, RigshospitaletUniversity, hospital or other
- Collaborators
- The Novo Nordic Foundation
- Study start
- 17 May 2021 (actual)
- Primary completion
- 15 May 2024 (actual)
- Study completion
- 1 Aug 2024 (actual)
- First posted
- 30 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- A prospective, sequential cohort study with comparisons between non-equivalent groups.
| Arm | Type | Receives |
|---|---|---|
| Standard care | No intervention | –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 | Other: Nurse-led consultations based on electronic patient-reported outcomesIntervention: 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (2 listed)
- Severe cognitive impairments/psychiatric disorder
- Participating in other interventional clinical trials
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Nurse-led consultations based on electronic patient-reported outcomesThe patients will weekly answer electronic patient-reported outcomes during chemotherapy and the answers will be used proactive in nurse-led consultations. | Other | Intervention group |
Primary outcome
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.
5 secondary outcomes
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.
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.
Change from baseline in Hospital Anxiety and Depression Scale (HADS) until 9 months.
Time frame: 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.
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mille Christiansen principal investigator
Copenhagen University Hospital, Rigshospitalet
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Nurse-led consultations based on electronic patient-reported outcomes in people with Gynecologic Cancer and Gynecologic Neoplasm, run by Copenhagen University Hospital, Rigshospitalet at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Quality of life measured by EORTC QLQ C-30 until 9 months. (time frame: Change from baseline to 9 months.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Sep 2026.