Clinical trial NCT05537870: The Effectiveness of Nurse Navigators in Cancer Care
Official title: The Effectiveness of Nurse Navigators in Cancer Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Neoplasms
Nurse-Patient Relations
Psychiatric Disorder
Keywords: Navigator
Lead sponsor: Taipei Medical University
Sponsor class: OTHER
First posted: 2022-09-13
Enrollment: 191
Sex: ALL
Minimum age (years): 20
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

Eligibility criteria: 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.

Primary outcomes:
measure: Perceived benefits scale (PBS), questionnaires to measure self-efficacy
timeFrame: 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.
measure: The Patient Assessment of Chronic Illness Care (PACIC), questionnaires to measure patient' experience
timeFrame: 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.
measure: Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems
timeFrame: 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.
measure: Hospital Anxiety and Depression Scale (HADS), questionnaires to measure anxiety and depression
timeFrame: 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.
measure: Demoralization Scale- Mandarin Version (DS-MV), questionnaires to measure demoralization
timeFrame: 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 outcomes:
measure: The retention rate
timeFrame: At the sixth month, statistical analysis was performed based on the report indicators of the retention rate obtained from the hospital medical record information.
measure: The completion rate
timeFrame: At the sixth month, statistical analysis was performed based on the report indicators of the completion rate obtained from the hospital medical record information.
measure: The survival rate
timeFrame: At the sixth month, statistical analysis was performed based on the report indicators of the survival rate obtained from the hospital medical record information.
measure: The mortality rate
timeFrame: At the sixth month, statistical analysis was performed based on the report indicators of the mortality rate obtained from the hospital medical record information.
measure: The untreated rate of cancer within 3 months
timeFrame: 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
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Wan Fang Hospital, Taipei Medical University
state: Wenshan District
Study officials:
affiliation: Taipei Medical Unviersity
name: hsiu-ju Chang, PhD
role: STUDY_CHAIR
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