The Effectiveness of Nurse Navigators in Cancer Care

NCT ID: NCT05537870

Last Updated: 2022-09-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

191 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-17

Study Completion Date

2020-07-31

Brief Summary

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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

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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).

Conditions

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Neoplasms Nurse-Patient Relations Psychiatric Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants
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.

Study Groups

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cancer navigator care

experimental group: case manager care combined cancer nurse navigator care

Group Type ACTIVE_COMPARATOR

cancer nurse navigator care

Intervention Type BEHAVIORAL

oncology case manager care combined with cancer nurse navigator care

case manager care

control group: only case manager care(usual care)

Group Type PLACEBO_COMPARATOR

case manager care

Intervention Type BEHAVIORAL

case manager care (usual care)

Interventions

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cancer nurse navigator care

oncology case manager care combined with cancer nurse navigator care

Intervention Type BEHAVIORAL

case manager care

case manager care (usual care)

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

20 Years

Maximum Eligible Age

100 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Taipei Medical University

OTHER

Sponsor Role lead

Responsible Party

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Chang, Hsiu-Ju

professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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hsiu-ju Chang, PhD

Role: STUDY_CHAIR

Taipei Medical Unviersity

Locations

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Wan Fang Hospital, Taipei Medical University

Taipei, Wenshan District, Taiwan

Site Status

Countries

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Taiwan

References

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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.

Reference Type BACKGROUND
PMID: 21251875 (View on PubMed)

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.

Reference Type RESULT
PMID: 29395269 (View on PubMed)

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.

Reference Type RESULT
PMID: 15695497 (View on PubMed)

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.

Reference Type RESULT
PMID: 15838407 (View on PubMed)

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.

Reference Type RESULT
PMID: 15386639 (View on PubMed)

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.

Reference Type RESULT
PMID: 15690829 (View on PubMed)

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.

Reference Type RESULT
PMID: 22120003 (View on PubMed)

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.

Reference Type RESULT
PMID: 22727334 (View on PubMed)

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.

Reference Type RESULT
PMID: 11759300 (View on PubMed)

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.

Reference Type RESULT
PMID: 1812841 (View on PubMed)

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.

Reference Type RESULT
PMID: 21542446 (View on PubMed)

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.

Reference Type RESULT
PMID: 9587123 (View on PubMed)

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.

Reference Type RESULT
PMID: 21626611 (View on PubMed)

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.

Reference Type RESULT
PMID: 21542445 (View on PubMed)

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.

Reference Type RESULT
PMID: 6880820 (View on PubMed)

Related Links

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Other Identifiers

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N201809031

Identifier Type: -

Identifier Source: org_study_id

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