Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors

March 22, 2024 updated by: Fooyin University

Developing the Precision Nursing Education Program Through the E-flipped Classroom Model to Improve the Quality of Life Among Young Colorectal Cancer Survivors

This study is aimed to demonstrate the long-term effectiveness of 8-week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

Background: In recent years, there has been an increase in case number of patients with young colon cancer (YCC). After curative treatment, YCC survivors have more opportunities to meet physical, social and economic burdens. Furthermore, YCC survivors may suffer poor quality of life and depression symptoms related to disease treatments and specific post-treatment care intervention is in unmet need.

Objective: The precision nursing education program will be developed through the eflipped classroom model, including the care of physical symptom based on the patients' needs, Qigong exercise, and mindfulness training. To evaluate the effect of these interventions, the questionnaire of the quality of life of YCC survivors will be employed.

Method: A randomized controlled trial containing 110 patients aged between 20 and 50 years old will be conducted. After completion of curative operation and adjuvant treatments, the subjects will be randomly assigned to a control group, in which routine nursing education care will be provided, and an intervention group, in which 8-week precision nursing education program through the e-flipped classroom model will be applied. The outcome measures include EORTC QLQ-C30, EORTC QLQ-CR29, BDI Depression Scale, Constructed Meaning Scale and FFMQ. The time-points of outcome measures include pre-intervention, post-intervention (at the end of the intervention), and 3, 6 and 9 months after the end of intervention. Univariate analyses will be performed to examine the intervention outcomes among basic characteristics of subjects. Correlation analyses will be performed to investigate the relationships between intervention outcomes and different variables. Comparisons of mean scores in the dependent variables between the experimental group and control group over the five time-points will be used in the generalization of estimating equation models.

Contribution: This study is aimed to demonstrate the long-term effectiveness of 8- week precision nursing education program through the e-flipped classroom model for YCC survivors and provide a compliant strategy to improve quality of life and emotional status of these patients.

Study Type

Interventional

Enrollment (Estimated)

110

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • survivor was diagnosed as colon, rectal, colorectal, or/and anal cancer
  • aged at least 20 years
  • have had completed cancer treatments within the five years prior to enrolling in the study.
  • agree and obtain written consent
  • could using the online media(ex: Zoom or Google meet..) to attend intervention course

Exclusion Criteria:

  • diagnosed with stage IV cancer
  • had a recurrence of CRC cancer
  • had the other type cancer diagnosis
  • now are undering cancer treatment

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
The survivors receiving 8 weeks (90 mins per weeks) on-line percious nursing education intervention
Behavioral: 8-weeks's on-line precision nursing education program
The intervention involved 8-weeks's on-line precision nursing education program, including Qigong exercise, and mindfulness training.
No Intervention: Control group
As usual

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The depression symptoms on young colorectal cancer survivors
Time Frame: Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
The 21-item Beck Depression Inventory-II (BDI-II) is using to measure the depression syptoms. It comprised of 21 items. The total score range of BDI-II was from 0 to 63, with higher scores indicating greater severity of depression. The BDI-II cutoff point for clinical depression is a total score of >13.
Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dispositional mindfulness status on young colorectal cancer survivors
Time Frame: Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
The 39-item Five Facet Mindfulness Questionnaire24 measures dispositional mindfulness including observing, describing, acting of awareness, nonjudging, and nonreactivity to inner experience. Participants indicated their responses on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of dispositional mindfulness. The Cronbach's alpha for the full scale in this study was 0.87.
Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
General quality of life on young colorectal cancer survivors
Time Frame: Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
General quality of life are measuring by the EORTC QLQ-C30. EORCT QLQ-C30 measures CRC patients' general physical status that consisted including functions and symptoms status. The ranges of these two scales were from 0 to 100, with higher scores indicating the higher levels of function status and symptoms distress.
Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
Colorectal specific quality of life on young colorectal cancer survivors
Time Frame: Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
Colorectal specific quality of life are measuring by the QLQ- CR29. EORTC QLQ-CR29 measures CRC patients' colorectal functions and symptoms.The ranges of these two scales were from 0 to 100, with higher scores indicating the higher levels of function status and symptoms distress.
Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
Cancer threat appraisal on young colorectal cancer survivors
Time Frame: Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).
Constructed Meaning Scale (CMS)15 measures participants' cancer threat appraisal. The CMS relies on eight items to measure patients' perceptions with respect to identifying CRC, their interpersonal re- lationships, and their future lives. The ratings are made on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with lower scores indicating a more negative cancer meaning status and appraisal of CRC as a greater threat.
Baseline (T0) and then week 8 (the end of the intervention) (T1), the 3rd month (T2), the 6th month (T3), and the 9th month (T4).

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fooyin University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

March 20, 2024

Primary Completion (Estimated)

September 30, 2024

Study Completion (Estimated)

December 25, 2026

Study Registration Dates

First Submitted

March 17, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 29, 2024

Study Record Updates

Last Update Posted (Actual)

March 29, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • B-BR-112-036

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

No plan to share individual participant data.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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