NCT05776680

Brief Summary

When the patient's mood has not yet reached a moderate to high severity level, psychological support is usually provided by the clinical nurses. However, the result of past research showed that the needs of patients and their caregivers were not satisfied with the psychological level. Scholars pointed out that it may be related to factors such as excessive clinical workload or insufficient psychological support and care capacity. In addition, under the influence of COVID-19 in the past two years, medical staff are facing more physical and mental pressure. Oncology nurses have a heavy workload and are affected by the COVID 19 epidemic, which reflects that nurses need psychological support. Therefore, this study intends to reduce stress through remote physical and mental support activities, and use the Internet to intervene in guided relaxation and meditation. Considering the scheduling of clinical nurses, a remote and unstructured course content that does not require continuity will be selected, and then advanced to provide the empathetic care skills of oncology nurses.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable cancer

Timeline
Completed

Started Aug 2022

Typical duration for not_applicable cancer

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 22, 2022

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

November 3, 2022

Completed
5 months until next milestone

First Posted

Study publicly available on registry

March 20, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2024

Completed
Last Updated

November 6, 2024

Status Verified

November 1, 2024

Enrollment Period

1.2 years

First QC Date

November 3, 2022

Last Update Submit

November 4, 2024

Conditions

CancerPsychologicalOncologyEmpathy

Keywords

cancerOncology nursePsychological supportEmpathyTraining course

Outcome Measures

Primary Outcomes (1)

  • Physical and Psychological Symptoms Scale

    Oncology nurses' physical and psychological state were measured by physical and psychological state survey. It use Numerical Rating Scale(VRS) 0-10. It is a 11 Point Likert Scale (e. g. 0 is no pain; 10 is unbearable pain).

    2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)

Secondary Outcomes (4)

  • Self efficacy scale (GSES)

    2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)

  • Communication ability scale

    2 time points: Time 1 (before the psychological support course) ; Time 2 (6 months after the psychological support course)

  • Efferson Empathy Scale

    2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)

  • Functional Assessment of Chronic Illness Therapy - Spiritual Well-Being （FACIT-Sp）

    2 time points: Time 1 (before the psychological support course) ; Time 2 ( 6 months after the psychological support course)

Study Arms (2)

Psychological Support Course

EXPERIMENTAL

60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .

Other: Psychological support

Control group

NO INTERVENTION

Participants in control group will receive usual course.

Interventions

Psychological supportOTHER

60-minute once or twice a week for 6 months of Initial Remote Psychological Support Course .

Psychological Support Course

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Over 20 years old (inclusive)
  • Oncology nurses currently working in clinical practice

You may not qualify if:

  • Those who are unwilling or unable to participate in this course training for a full one- year period.
  • Those who have registered for the advanced oncology nursing course organized by the Society in the current year.
  • Control group
  • Over 20 years old (inclusive)
  • Oncology nurses currently working in clinical practice
  • Those who have registered for the advanced oncology nursing course organized by the Society in the current year
  • Those who have participated in multiple oncology psychological care courses, those who are unwilling or unable to participate in the training of distance psychological support courses for a full one-year period.
  • Those who participate in the advanced course of oncology nursing are unwilling or unable to participate in the data evaluation of the complete bi-annual time point.
  • Those who have participated in this research project.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, 802, Taiwan

RECRUITING

MeSH Terms

Conditions

Neoplasms

Central Study Contacts

Yun Hsiang Lee, PhD

CONTACT

886 2 23123456yhlee338@ntu.edu.tw

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 3, 2022

First Posted

March 20, 2023

Study Start

August 22, 2022

Primary Completion

October 31, 2023

Study Completion

December 31, 2024

Last Updated

November 6, 2024

Record last verified: 2024-11

Locations

TW(1)