Skip to main content
OpenTrials
Completed

NCT Number: NCT05537870

The Effectiveness of Nurse Navigators in Cancer Care

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Neoplasms Mental Disorders Nurse-Patient Relations Psychiatric Disorder

Age range

20 year–100 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Wan Fang Hospital, Taipei Medical University

Taipei, Wenshan District, 116, Taiwan

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

cancer nurse navigator care

Behavioral

oncology case manager care combined with cancer nurse navigator care

case manager care

Behavioral

case manager care (usual care)

Primary outcomes

  1. Perceived benefits scale (PBS), questionnaires to measure self-efficacy

    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.

    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.

  2. The Patient Assessment of Chronic Illness Care (PACIC), questionnaires to measure patient' experience

    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.

    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.

  3. Distress Thermometer and Problem List (DT), questionnaires to measure emotional distress and psychological problems

    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.

    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.

  4. Hospital Anxiety and Depression Scale (HADS), questionnaires to measure anxiety and depression

    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.

    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.

  5. Demoralization Scale- Mandarin Version (DS-MV), questionnaires to measure demoralization

    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.

    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.

Secondary outcomes

  1. The retention rate

    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.

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

  2. The completion rate

    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.

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

  3. The survival rate

    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.

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

  4. The mortality rate

    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.

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

  5. The untreated rate of cancer within 3 months

    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

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

Sponsors and collaborators

Lead sponsor

Taipei Medical University

Other

Registry information

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Sep 13, 2022
Registry last updated
Sep 23, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.