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The Effectiveness of Nurse Navigators in Cancer Care

Primary Purpose

Neoplasms, Nurse-Patient Relations, Psychiatric Disorder

Status
Completed
Phase
Not Applicable
Locations
Taiwan
Study Type
Interventional
Intervention
cancer nurse navigator care
case manager care
Sponsored by
Taipei Medical University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms focused on measuring Navigator

Eligibility Criteria

20 Years - 100 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Wan Fang Hospital, Taipei Medical University

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

cancer navigator care

case manager care

Arm Description

experimental group: case manager care combined cancer nurse navigator care

control group: only case manager care(usual care)

Outcomes

Primary Outcome Measures

Perceived benefits scale (PBS), questionnaires to measure self-efficacy
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.
The Patient Assessment of Chronic Illness Care (PACIC), questionnaires to measure patient' experience
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.
Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems
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.
Hospital Anxiety and Depression Scale (HADS), questionnaires to measure anxiety and depression
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.
Demoralization Scale- Mandarin Version (DS-MV), questionnaires to measure demoralization
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.

Secondary Outcome Measures

The retention rate
Medical report indicators of the retention rate collected at 6th month
The completion rate
Medical report indicators of the completion rate collected at 6th month
The survival rate
Medical report indicators of the survival rate collected at 6th month
The mortality rate
Medical report indicators of the mortality rate collected at 6th month
The untreated rate of cancer within 3 months
Medical report indicators of the untreated rate of cancer within 3 months collected at 6th month

Full Information

First Posted
August 29, 2022
Last Updated
September 21, 2022
Sponsor
Taipei Medical University
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1. Study Identification

Unique Protocol Identification Number
NCT05537870
Brief Title
The Effectiveness of Nurse Navigators in Cancer Care
Official Title
The Effectiveness of Nurse Navigators in Cancer Care
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
January 17, 2019 (Actual)
Primary Completion Date
July 31, 2020 (Actual)
Study Completion Date
July 31, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Taipei Medical University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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.
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Nurse-Patient Relations, Psychiatric Disorder
Keywords
Navigator

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Masking Description
Eligible patient were randomly assigned by the computer random number generator to either intervention or control group. Several methods were used to maintain the treatment blindly, including segregation of assessment and treatment staff and instructions to patients to avoid discussion of treatment assignment with the independent evaluators.
Allocation
Randomized
Enrollment
191 (Actual)

8. Arms, Groups, and Interventions

Arm Title
cancer navigator care
Arm Type
Active Comparator
Arm Description
experimental group: case manager care combined cancer nurse navigator care
Arm Title
case manager care
Arm Type
Placebo Comparator
Arm Description
control group: only case manager care(usual care)
Intervention Type
Behavioral
Intervention Name(s)
cancer nurse navigator care
Intervention Description
oncology case manager care combined with cancer nurse navigator care
Intervention Type
Behavioral
Intervention Name(s)
case manager care
Intervention Description
case manager care (usual care)
Primary Outcome Measure Information:
Title
Perceived benefits scale (PBS), questionnaires to measure self-efficacy
Description
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.
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.
Title
The Patient Assessment of Chronic Illness Care (PACIC), questionnaires to measure patient' experience
Description
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.
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.
Title
Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems
Description
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.
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.
Title
Hospital Anxiety and Depression Scale (HADS), questionnaires to measure anxiety and depression
Description
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.
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.
Title
Demoralization Scale- Mandarin Version (DS-MV), questionnaires to measure demoralization
Description
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.
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.
Secondary Outcome Measure Information:
Title
The retention rate
Description
Medical report indicators of the retention rate collected at 6th month
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.
Title
The completion rate
Description
Medical report indicators of the completion rate collected at 6th month
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.
Title
The survival rate
Description
Medical report indicators of the survival rate collected at 6th month
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.
Title
The mortality rate
Description
Medical report indicators of the mortality rate collected at 6th month
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.
Title
The untreated rate of cancer within 3 months
Description
Medical report indicators of the untreated rate of cancer within 3 months collected at 6th month
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Cancer patients for the first time at the cancer center clinic of the university hospital Older than 20 years old Ability to communicate and read The case voluntarily participated in the study and signed the consent form Exclusion Criteria: People with mental disorders who have schizophrenia, personality disorder, mental retardation, or organic brain disorder. Patient with brain metastasis. Patients who receive hospice palliative care or other treatment programs.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
hsiu-ju Chang, PhD
Organizational Affiliation
Taipei Medical Unviersity
Official's Role
Study Chair
Facility Information:
Facility Name
Wan Fang Hospital, Taipei Medical University
City
Taipei
State/Province
Wenshan District
ZIP/Postal Code
116
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No
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Links:
URL
http://www.who.int/mediacentre/factsheets/fs297/en/.
Description
cancer

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The Effectiveness of Nurse Navigators in Cancer Care

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