CClinicalTrials.gg
CompletedNCT05537870Updated Sep 23, 2022

The Effectiveness of Nurse Navigators in Cancer Care

An interventional study of cancer nurse navigator care and case manager care in Neoplasms, Nurse-Patient Relations and Psychiatric Disorder, sponsored by Taipei Medical University. Completed at 1 site in Taiwan. Open to participants aged 20 Years to 100 Years. Per ClinicalTrials.gov, last updated 2022-09-23.

Sponsored by Taipei Medical University · Not applicable, Interventional, and Treatment

From the registry’s dates

  • Registered 3 years 7 months after the study started (first participant enrolled Jan 2019, registered Aug 2022).
Phase
Not applicable
Study type
Interventional
Enrollment
191
Allocation
Randomized
Ages
20 Years to 100 Years
Sex
All
01

Study 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.

Read the 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).

02

Conditions studied

  • Neoplasms
  • Nurse-Patient Relations
  • Psychiatric Disorder

Keywords

  • Navigator
03

In context

Mental Disorders

2,109 studies on the registry are indexed under Mental Disorders; 417 are open to participants now.

This study's enrollment of 191 is above the median of 94 across 1,576 interventional studies indexed under Mental Disorders.

Browse Mental Disorders studies →

Lead sponsor

Taipei Medical University is the lead sponsor of 245 studies on the registry; 56 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years to 100 Years
Sexes eligible
All
Accepts 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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
191 participants (actual)

Study arms

  • Active comparator
    cancer navigator care

    experimental group: case manager care combined cancer nurse navigator care

    Behavioral: cancer nurse navigator care

  • Placebo comparator
    case manager care

    control group: only case manager care(usual care)

    Behavioral: case manager care

Interventions

  • Behavioralcancer nurse navigator care

    oncology case manager care combined with cancer nurse navigator care

  • Behavioralcase manager care

    case manager care (usual care)

06

What researchers measure

Primary outcomes

  1. 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.

    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.

  2. 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.

    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.

  3. 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.

    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.

  4. 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.

    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.

  5. 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.

    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.

Secondary outcomes

  1. The retention rate

    Medical report indicators of the retention rate collected at 6th month

    Time frame: At the sixth month, statistical analysis was performed based on the report indicators of the retention rate obtained from the hospital medical record information.

  2. The completion rate

    Medical report indicators of the completion rate collected at 6th month

    Time frame: At the sixth month, statistical analysis was performed based on the report indicators of the completion rate obtained from the hospital medical record information.

  3. The survival rate

    Medical report indicators of the survival rate collected at 6th month

    Time frame: At the sixth month, statistical analysis was performed based on the report indicators of the survival rate obtained from the hospital medical record information.

  4. The mortality rate

    Medical report indicators of the mortality rate collected at 6th month

    Time frame: At the sixth month, statistical analysis was performed based on the report indicators of the mortality rate obtained from the hospital medical record information.

  5. The untreated rate of cancer within 3 months

    Medical report indicators of the untreated rate of cancer within 3 months collected at 6th month

    Time frame: 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

07

Study locations

1 site
  • Wan Fang Hospital, Taipei Medical University
    Taipei, Wenshan District 116, Taiwan
08

References and documents

Publications

  • 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. PubMed 21251875 ↗
  • 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. PubMed 29395269 ↗
  • 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. PubMed 15695497 ↗
  • 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. PubMed 15838407 ↗
  • 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. Erratum In: Psychooncology. 2004 Nov;13(11):831. PubMed 15386639 ↗
  • 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. PubMed 15690829 ↗
  • 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. PubMed 22120003 ↗
  • 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. PubMed 22727334 ↗
  • 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. PubMed 11759300 ↗
  • 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. PubMed 1812841 ↗
  • 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. PubMed 21542446 ↗
  • 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. PubMed 9587123 ↗
  • 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. PubMed 21626611 ↗
  • 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. PubMed 21542445 ↗
  • 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. PubMed 6880820 ↗

Related links

Individual participant data

Plan to share: No

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Sep 23, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05537870
Lead sponsor
Taipei Medical University
Responsible party
Chang, Hsiu-Ju (professor, Taipei Medical University) — Principal investigator
First posted
Sep 13, 2022
Start date
Jan 17, 2019
Primary completion
Jul 31, 2020
Completion
Jul 31, 2020
Last update
Sep 23, 2022

Study contacts

hsiu-ju Chang, PhD
study chair · Taipei Medical Unviersity

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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