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

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ClinicalTrials.gov Identifier: NCT03838861
Recruitment Status : Not yet recruiting
First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborators:
Region of Southern Denmark
Danish Cancer Society
Information provided by (Responsible Party):
Stinne Holm Bergholdt, University of Southern Denmark

Brief 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.

Condition or disease Intervention/treatment Phase
Empowerment, Cervical Cancer, Endometrial Cancer, Follow-up, Nurse-led, PROM Behavioral: NEMO: NEw MOdel of follow-up Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Supportive Care
Official Title: A Randomised Clinical Trial Testing the Effect of an Individualised and Patient-centred Follow-up Program for Women With Gynaecological Cancer
Estimated Study Start Date : March 1, 2019
Estimated Primary Completion Date : February 28, 2021
Estimated Study Completion Date : January 28, 2025

Arm Intervention/treatment
Active Comparator: Control
Standard follow-up in doctors setting
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.

Experimental: Intervention
Nurse-led follow-up with focus on empowerment and need assessment by use of ePROMS
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.




Primary Outcome Measures :
  1. Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q) [ Time Frame: Change from baseline (3 months post operative) to 12 months post operative. ]
    The primary outcome is measured as change of the skill and technique acquisition subscale score of the HEI-Q from baseline to 12 months post operative. Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively. Change from baseline to 24 and 36 months post operative are considered as secondary outcomes.


Secondary Outcome Measures :
  1. Patient Empowerment using the Health Education Impact Questionnaire (HEI-Q) [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change in other subscales of the HEI-Q from baseline to 12, 24 and 36 months post operative

  2. Fear of cancer recurrence using the Fear of Cancer Recurrence Inventory (FCRI) [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change in fear of cancer recurrence from baseline to 12, 24 and 36 months respectively.

  3. Health related quality of life using the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ-C30) [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change in Global Health Status and other subscales of the C30 questionnaire from baseline to 12, 24 and 36 months respectively.

  4. Cancer type specific quality of life using the EORTC Endometrial Cancer Module (EORTC QLQ-EN24) [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change from baseline to 12, 24 and 36 months respectively.

  5. Cancer type specific quality of life using the EORTC Cervical Cancer Module (EORTC QLQ-CX24) [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change from baseline to 12, 24 and 36 months respectively.

  6. Health Status using the EuroQol five-Dimensional (EQ5D) measure [ Time Frame: Questionnaires are administered at 3 (baseline), 12, 24 and 36 months after surgery, respectively ]
    Change from baseline to 12, 24 and 36 months respectively.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Female genital cancer patients
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • No adjuvant therapy after surgery
  • Speak and write Danish
  • Mentally capable to adapt to intervention

Exclusion Criteria:

  • Indication for adjuvant therapy after primary surgical treatment

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Responsible Party: Stinne Holm Bergholdt, Principal Investigator, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03838861     History of Changes
Other Study ID Numbers: Stinne1977
First Posted: February 12, 2019    Key Record Dates
Last Update Posted: February 12, 2019
Last Verified: February 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Endometrial Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Diseases
Genital Diseases, Female