The Effectiveness of Nurse Navigators in Cancer Care

Study Overview
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Brief Summary
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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
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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).

Official Title
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The Effectiveness of Nurse Navigators in Cancer Care

Conditions
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Neoplasms, Nurse-Patient Relations, Psychiatric Disorder

Intervention / Treatment
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* Behavioral: cancer nurse navigator care
* Behavioral: case manager care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Navigator