The Effectiveness of Nurse Navigators in Cancer Care

Not Applicable

Completed

• Conditions: Neoplasms; Nurse-Patient Relations; Psychiatric Disorder
• Interventions: Behavioral: cancer nurse navigator care; Behavioral: case manager care

• Registration Number: NCT05537870
• Lead Sponsor: Taipei Medical University

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).

Study Timeline

• Study Start: 2019-01-17
• Primary Completion: 2020-07-31
• Study Completion: 2020-07-31
• Study First Submitted: 2022-08-29
• Status Verified: 2022-09
• Study First Submitted QC: 2022-09-09
• Study First Posted: 2022-09-13
• Last Update Submitted: 2022-09-21
• Last Update Posted: 2022-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 191

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cancer navigator care	cancer nurse navigator care	experimental group: case manager care combined cancer nurse navigator care
case manager care	case manager care	control group: only case manager care(usual care)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
The survival rate	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
The completion rate	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
The mortality rate	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
The retention rate	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
The untreated rate of cancer within 3 months	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

Trial Locations

Locations (1)

Wan Fang Hospital, Taipei Medical University; 🇨🇳 Taipei, Wenshan District, Taiwan