The Effectiveness of Nurse Navigators in Cancer Care
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Taipei Medical University
- Enrollment
- 191
- Locations
- 1
- Primary Endpoint
- Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (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.
Eligibility Criteria
- Ages
- 20 Years to 100 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
cancer navigator care
experimental group: case manager care combined cancer nurse navigator care
Intervention: cancer nurse navigator care (Behavioral)
case manager care
control group: only case manager care(usual care)
Intervention: case manager care (Behavioral)
Outcomes
Primary Outcomes
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.
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.
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.
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.
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.
Secondary Outcomes
- 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.)
- 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.)
- 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.)
- 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.)
- 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)
Investigators
Chang, Hsiu-Ju
professor
Taipei Medical University