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An Individualised and Patient-centred Follow-up Program for Women With Gynaecological Cancer

NCT03838861 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2022-04-22

No results posted yet for this study

Summary

This randomized controlled trial is testing the hypothesis that an individually focused and need-based nurse led follow-up program supported by electronic Patient Reported Outcome Measures for women with gynecological cancer will improve patient's empowerment, quality of life and involvement in the follow-up process besides reducing the patient's fear of cancer recurrence and degree of psychological distress, compared with a doctor led follow-up program. Further, nurse led follow-up by telephone, may reduce resources of the department as well as of the patients.

Conditions

  • Empowerment, Cervical Cancer, Endometrial Cancer, Follow-up, Nurse-led, PROM

Interventions

BEHAVIORAL

NEMO: NEw MOdel of follow-up

The nurse led model is built upon phone contacts with content and intervals individually planned by the nurse and the patient. The individual contacts will be supported by graphic visualisation of ePROMs in REDCap filled out by the patient before each contact including DGCG's disease specific symptom list and the generic European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) (24) supplemented with the relevant disease-specific add-on module (25, 26). The sum scores are visualised with colours to indicate severe problems (red), no problems (green) and mild or moderate problems (yellow and orange), respectively. Hence, alarm symptoms and problem areas are clearly presented to the project nurse and changes can be visualised over time enhancing the interpretation. The patient will be given access to own scoring results to obtain an understanding of the meaning of changes in health status.

Sponsors & Collaborators

  • Region of Southern Denmark

    collaborator OTHER

  • Danish Cancer Society

    collaborator OTHER

  • University of Southern Denmark

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-03-01
Primary Completion
2022-12-31
Completion
2025-01-28

Countries

  • Denmark

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03838861 on ClinicalTrials.gov