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Completed

NCT Number: NCT04945187

Patient-Reported Outcomes Among Women Wtih Gynecological Cancer (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.

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Key information

Conditions

Gynecologic Cancer Adnexal Diseases Endocrine Gland Neoplasms Endocrine System Diseases Endometrial Cancer Endometrial Neoplasms Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Gonadal Disorders Gynecologic Neoplasm Neoplasms Neoplasms by Site Ovarian Cancer Ovarian Diseases Ovarian Neoplasms Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Copenhagen University Hospital, Rigshospitalet

Copenhagen, Denmark, 2100

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Nurse-led consultations based on electronic patient-reported outcomes

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

Interested in participating?

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Sponsors and collaborators

Lead sponsor

Rigshospitalet, Denmark

Other

Collaborators

  • The Novo Nordic Foundation

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jun 30, 2021
Registry last updated
Sep 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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