Neoplasms, Nurse-Patient Relations, Psychiatric Disorder
Conditions
Keywords
Navigator
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).
Interventions
BEHAVIORALcancer nurse navigator care
oncology case manager care combined with cancer nurse navigator care
BEHAVIORALcase manager care
case manager care (usual care)
Sponsors
Taipei Medical University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
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
Sex/Gender
ALL
Age
20 Years to 100 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 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 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 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 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 |
Countries
Taiwan
Outcome results
None listed