NCT04945187

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
130

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2021

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 11, 2021

Completed
6 days until next milestone

Study Start

First participant enrolled

May 17, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 30, 2021

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2024

Completed
Last Updated

January 26, 2023

Status Verified

January 1, 2023

Enrollment Period

2.7 years

First QC Date

May 11, 2021

Last Update Submit

January 23, 2023

Conditions

Gynecologic CancerGynecologic NeoplasmOvarian CancerEndometrial Cancer

Keywords

Patient-reported outcomeElectronic patient-reported outcomeNurse-led consultationsQuality of life

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    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.

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

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

    Change from baseline to 9 months.

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

    Change from baseline to 9 months.

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

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

Study Arms (2)

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.

Other: Nurse-led consultations based on electronic patient-reported outcomes

Interventions

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.

Intervention group

Eligibility Criteria

Age18 Years+
Sexfemale(Gender-based eligibility)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Severe cognitive impairments/psychiatric disorder
  • Participating in other interventional clinical trials

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Copenhagen University Hospital, Rigshospitalet

Copenhagen, 2100, Denmark

RECRUITING

MeSH Terms

Conditions

Genital Neoplasms, FemaleOvarian NeoplasmsEndometrial Neoplasms

Condition Hierarchy (Ancestors)

Urogenital NeoplasmsNeoplasms by SiteNeoplasmsGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersUterine NeoplasmsUterine Diseases

Study Officials

  • Mille Christiansen

    Rigshospitalet, Denmark

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Mille Christiansen

CONTACT

+45 35456347mille.guldager.christiansen@regionh.dk

Karin Piil

CONTACT

karin.piil@regionh.dk

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SEQUENTIAL
Model Details: A prospective, sequential cohort study with comparisons between non-equivalent groups.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor, Clinical Oncologist, Consultant, DMSc

Study Record Dates

First Submitted

May 11, 2021

First Posted

June 30, 2021

Study Start

May 17, 2021

Primary Completion

February 1, 2024

Study Completion

February 1, 2024

Last Updated

January 26, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

DK(1)