The Effectiveness of Nurse Navigators in Cancer Care

Neoplasms Clinical Trial

Official title:

The Effectiveness of Nurse Navigators in Cancer Care

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05537870
• Other study ID #: N201809031
• Status: Completed
• Phase: N/A
• Start date: January 17, 2019
• Est. completion date: July 31, 2020

Study information

• Verified date: September 2022
• Source: Taipei Medical University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 191
• Est. completion date: July 31, 2020
• Est. primary completion date: July 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Mental Disorders
• Neoplasms
• Nurse-Patient Relations
• Problem Behavior
• Psychiatric Disorder

Intervention

Behavioral:
• cancer nurse navigator care
oncology case manager care combined with cancer nurse navigator care
• case manager care
case manager care (usual care)

Locations

Country	Name	City	State
Taiwan	Wan Fang Hospital, Taipei Medical University	Taipei	Wenshan District

Sponsors (1)

Lead Sponsor	Collaborator
Taipei Medical University

Country where clinical trial is conducted

Taiwan, 

References & Publications (15)

Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Nikšic M, Bonaventure A, Valkov M, Johnson CJ, Estève J, Ogunbiyi OJ, Azevedo E Silva G, Chen WQ, Eser S, Engholm G, Stiller CA, Monnereau A, Woods RR, Visser O, Lim GH, Aitken J, Weir HK, Coleman MP; — View Citation

Burgess C, Cornelius V, Love S, Graham J, Richards M, Ramirez A. Depression and anxiety in women with early breast cancer: five year observational cohort study. BMJ. 2005 Mar 26;330(7493):702. Epub 2005 Feb 4. — View Citation

Glasgow RE, Wagner EH, Schaefer J, Mahoney LD, Reid RJ, Greene SM. Development and validation of the Patient Assessment of Chronic Illness Care (PACIC). Med Care. 2005 May;43(5):436-44. — View Citation

Hoffman BM, Zevon MA, D'Arrigo MC, Cecchini TB. Screening for distress in cancer patients: the NCCN rapid-screening measure. Psychooncology. 2004 Nov;13(11):792-9. Erratum in: Psychooncology. 2004 Nov;13(11):831. — View Citation

Kissane DW, Wein S, Love A, Lee XQ, Kee PL, Clarke DM. The Demoralization Scale: a report of its development and preliminary validation. J Palliat Care. 2004 Winter;20(4):269-76. — View Citation

Lee CY, Fang CK, Yang YC, Liu CL, Leu YS, Wang TE, Chang YF, Hsieh RK, Chen YJ, Tsai LY, Liu SI, Chen HW. Demoralization syndrome among cancer outpatients in Taiwan. Support Care Cancer. 2012 Oct;20(10):2259-67. doi: 10.1007/s00520-011-1332-4. Epub 2011 N — View Citation

Linden W, Vodermaier A, Mackenzie R, Greig D. Anxiety and depression after cancer diagnosis: prevalence rates by cancer type, gender, and age. J Affect Disord. 2012 Dec 10;141(2-3):343-51. doi: 10.1016/j.jad.2012.03.025. Epub 2012 Jun 21. — View Citation

Lynch MP, Cope DG, Murphy-Ende K. Advanced practice issues: results of the ONS Advanced Practice Nursing survey. Oncol Nurs Forum. 2001 Nov-Dec;28(10):1521-30. — View Citation

Mitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19. — View Citation

Moorey S, Greer S, Watson M, Gorman C, Rowden L, Tunmore R, Robertson B, Bliss J. The factor structure and factor stability of the hospital anxiety and depression scale in patients with cancer. Br J Psychiatry. 1991 Feb;158:255-9. — View Citation

Neilson KA, Pollard AC, Boonzaier AM, Corry J, Castle DJ, Mead KR, Gray MC, Smith DI, Trauer T, Couper JW. Psychological distress (depression and anxiety) in people with head and neck cancers. Med J Aust. 2010 Sep 6;193(S5):S48-51. — View Citation

O'Connor M, White K, Kristjanson LJ, Cousins K, Wilkes L. The prevalence of anxiety and depression in palliative care patients with cancer in Western Australia and New South Wales. Med J Aust. 2010 Sep 6;193(S5):S44-7. — View Citation

Roth AJ, Kornblith AB, Batel-Copel L, Peabody E, Scher HI, Holland JC. Rapid screening for psychologic distress in men with prostate carcinoma: a pilot study. Cancer. 1998 May 15;82(10):1904-8. — View Citation

Wang GL, Hsu SH, Feng AC, Chiu CY, Shen JF, Lin YJ, Cheng CC. The HADS and the DT for screening psychosocial distress of cancer patients in Taiwan. Psychooncology. 2011 Jun;20(6):639-46. doi: 10.1002/pon.1952. Epub 2011 Mar 15. — View Citation

Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.
Primary	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.
Primary	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.
Primary	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	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.
Secondary	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.
Secondary	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.
Secondary	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.
Secondary	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

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