The Effectiveness of Nurse Navigators in Cancer Care

September 21, 2022 updated by: Chang, Hsiu-Ju, Taipei Medical University
Cancer patients will be recruited from the Taipei Cancer Center of Taipei Medical University. This study was divided into two phases. The first phase adopted cross-sectional study design with questionnaires to analyze the potential predictors of depressive symptoms among cancer patients. The second stage was adopted experimental study design to explore the effectiveness of nurse navigators in cancer care.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The first phase analyze the potential predictors include the following: socio-demographic characteristics, disease characteristics, lifestyle, perceived benefits, cancer patient' experience with medical service, emotional distress, anxiety, and demoralization.

The second phase will be experimental study.Thus, subjects were randomly sampled and divided into 2 groups: experimental group and control group. Subjects in the experimental group will receive oncology case manager care combined with cancer nurse navigator care, while subjects in the control group will be designed as regular care, which only care with cancer case managers. Both groups will receive long-term follow-up analysis (pre-intervention, post-intervention - 3 months, and 6 months). Outcome measures include the following: perceived benefits, emotional distress, depression and anxiety, demoralization, cancer patient' experience with medical service, and medical report indicators (retention rate, completion rate, survival rate, mortality rate, untreated cancer within 3 months).

Study Type

Interventional

Enrollment (Actual)

191

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
    • Wenshan District
      • Taipei, Wenshan District, Taiwan, 116
        • Wan Fang Hospital, Taipei Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 100 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Cancer patients for the first time at the cancer center clinic of the university hospital
  2. Older than 20 years old
  3. Ability to communicate and read
  4. The case voluntarily participated in the study and signed the consent form

Exclusion Criteria:

  1. People with mental disorders who have schizophrenia, personality disorder, mental retardation, or organic brain disorder.
  2. Patient with brain metastasis.
  3. Patients who receive hospice palliative care or other treatment programs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: cancer navigator care
experimental group: case manager care combined cancer nurse navigator care
Behavioral: cancer nurse navigator care
oncology case manager care combined with cancer nurse navigator care
Placebo Comparator: case manager care
control group: only case manager care(usual care)
Behavioral: case manager care
case manager care (usual care)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Perceived benefits scale (PBS), questionnaires to measure self-efficacy
Time Frame: Mainly consists of repeated measurements at three time points (Baseline, 3th month, and 6th month). Changes in scores on the PBS questionnaire after intervention were assessed using baseline scores as reference values.
Questionnaires to measure self-efficacy collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in PBS at three time points.
Mainly consists of repeated measurements at three time points (Baseline, 3th month, and 6th month). Changes in scores on the PBS questionnaire after intervention were assessed using baseline scores as reference values.
The Patient Assessment of Chronic Illness Care (PACIC), questionnaires to measure patient' experience
Time Frame: Mainly consists of repeated measurements at three time points (Baseline, 3th month, and 6th month). Changes in scores on the PACIC questionnaire after intervention were assessed using baseline scores as reference values.
Questionnaires to measure patient' experience with medical service collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in PACIC at three time points.
Mainly consists of repeated measurements at three time points (Baseline, 3th month, and 6th month). Changes in scores on the PACIC questionnaire after intervention were assessed using baseline scores as reference values.
Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems
Time Frame: Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the DT questionnaire after intervention were assessed using baseline scores as reference values.
Questionnaires to measure emotional distress and psychological problems collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in DT at three time points.
Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the DT questionnaire after intervention were assessed using baseline scores as reference values.
Hospital Anxiety and Depression Scale (HADS), questionnaires to measure anxiety and depression
Time Frame: Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the HADS questionnaire after intervention were assessed using baseline scores as reference values.
Questionnaires to measure anxiety and depression collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in HADS at three time points.
Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the HADS questionnaire after intervention were assessed using baseline scores as reference values.
Demoralization Scale- Mandarin Version (DS-MV), questionnaires to measure demoralization
Time Frame: Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the DS-MV questionnaire after intervention were assessed using baseline scores as reference values.
Questionnaires to measure demoralization collected at three time points (baseline, 3th month, and 6th month). Evaluate the effectiveness of interventions in HADS at three time points.
Mainly consists of repeated measurements at three time points (baseline, 3th month, and 6th month). Changes in scores on the DS-MV questionnaire after intervention were assessed using baseline scores as reference values.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The retention rate
Time Frame: At the sixth month, statistical analysis was performed based on the report indicators of the retention rate obtained from the hospital medical record information.
Medical report indicators of the retention rate collected at 6th month
At the sixth month, statistical analysis was performed based on the report indicators of the retention rate obtained from the hospital medical record information.
The completion rate
Time Frame: At the sixth month, statistical analysis was performed based on the report indicators of the completion rate obtained from the hospital medical record information.
Medical report indicators of the completion rate collected at 6th month
At the sixth month, statistical analysis was performed based on the report indicators of the completion rate obtained from the hospital medical record information.
The survival rate
Time Frame: At the sixth month, statistical analysis was performed based on the report indicators of the survival rate obtained from the hospital medical record information.
Medical report indicators of the survival rate collected at 6th month
At the sixth month, statistical analysis was performed based on the report indicators of the survival rate obtained from the hospital medical record information.
The mortality rate
Time Frame: At the sixth month, statistical analysis was performed based on the report indicators of the mortality rate obtained from the hospital medical record information.
Medical report indicators of the mortality rate collected at 6th month
At the sixth month, statistical analysis was performed based on the report indicators of the mortality rate obtained from the hospital medical record information.
The untreated rate of cancer within 3 months
Time Frame: At the sixth month, statistical analysis was performed based on the report data of the untreated rate of cancer within 3 months obtained from the hospital medical record information
Medical report indicators of the untreated rate of cancer within 3 months collected at 6th month
At the sixth month, statistical analysis was performed based on the report data of the untreated rate of cancer within 3 months obtained from the hospital medical record information

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Taipei Medical University

Investigators

  • Study Chair: hsiu-ju Chang, PhD, Taipei Medical Unviersity

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 17, 2019

Primary Completion (Actual)

July 31, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

August 29, 2022

First Submitted That Met QC Criteria

September 9, 2022

First Posted (Actual)

September 13, 2022

Study Record Updates

Last Update Posted (Actual)

September 23, 2022

Last Update Submitted That Met QC Criteria

September 21, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • N201809031

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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