The Effectiveness of Nurse Navigators in Cancer Care

NCT05537870 | Completed

• 1 other identifier: N201809031
• Study Type: interventional
• Target: 191
• Locations: 1 country
• Sites: 1

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.

Conditions

Neoplasms; Nurse-Patient Relations; Psychiatric Disorder

Keywords

Navigator

Outcome Measures

Primary Outcomes (5)

• 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.

• 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.

• 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.

• 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.

• 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 Outcomes (5)

• 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 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 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 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 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

Study Arms (2)

cancer navigator care

ACTIVE COMPARATOR

experimental group: case manager care combined cancer nurse navigator care

Behavioral: cancer nurse navigator care

case manager care

PLACEBO COMPARATOR

control group: only case manager care(usual care)

Behavioral: case manager care

Interventions

cancer nurse navigator care BEHAVIORAL

oncology case manager care combined with cancer nurse navigator care

cancer navigator care

case manager care BEHAVIORAL

case manager care (usual care)

case manager care

Eligibility Criteria

• Age: 20 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Taipei Medical University: lead

Study Sites (1)

Wan Fang Hospital, Taipei Medical University

Taipei, Wenshan District, 116, Taiwan

Location

Related Publications (15)

• 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.

  PMID: 21251875 BACKGROUND

• Allemani C, Matsuda T, Di Carlo V, Harewood R, Matz M, Niksic M, Bonaventure A, Valkov M, Johnson CJ, Esteve 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; CONCORD Working Group. Global surveillance of trends in cancer survival 2000-14 (CONCORD-3): analysis of individual records for 37 513 025 patients diagnosed with one of 18 cancers from 322 population-based registries in 71 countries. Lancet. 2018 Mar 17;391(10125):1023-1075. doi: 10.1016/S0140-6736(17)33326-3. Epub 2018 Jan 31.

  PMID: 29395269 RESULT

• 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. doi: 10.1136/bmj.38343.670868.D3. Epub 2005 Feb 4.

  PMID: 15695497 RESULT

• 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. doi: 10.1097/01.mlr.0000160375.47920.8c.

  PMID: 15838407 RESULT

• 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. doi: 10.1002/pon.796.

  PMID: 15386639 RESULT

• 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.

  PMID: 15690829 RESULT

• 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 Nov 27.

  PMID: 22120003 RESULT

• 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.

  PMID: 22727334 RESULT

• 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.

  PMID: 11759300 RESULT

• 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. doi: 10.1192/bjp.158.2.255.

  PMID: 1812841 RESULT

• 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. doi: 10.5694/j.1326-5377.2010.tb03928.x.

  PMID: 21542446 RESULT

• 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. doi: 10.1002/(sici)1097-0142(19980515)82:103.0.co;2-x.

  PMID: 9587123 RESULT

• 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.

  PMID: 21626611 RESULT

• 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. doi: 10.5694/j.1326-5377.2010.tb03927.x.

  PMID: 21542445 RESULT

• Zigmond AS, Snaith RP. The hospital anxiety and depression scale. Acta Psychiatr Scand. 1983 Jun;67(6):361-70. doi: 10.1111/j.1600-0447.1983.tb09716.x.

  PMID: 6880820 RESULT

Related Links

• cancer

MeSH Terms

Conditions

Neoplasms; Mental Disorders

Study Officials

• hsiu-ju Chang, PhD

  Taipei Medical Unviersity

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: professor

Study Record Dates

• First Submitted: August 29, 2022
• First Posted: September 13, 2022
• Study Start: January 17, 2019
• Primary Completion: July 31, 2020
• Study Completion: July 31, 2020
• Last Updated: September 23, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)