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临床试验/NCT06337773
NCT06337773进行中(未招募)不适用

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

Fooyin University1 个研究点 分布在 1 个国家目标入组 110 人开始时间: 2024年4月22日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
进行中(未招募)
入组人数
110
试验地点
1
主要终点
The depression symptoms on young colorectal cancer survivors

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Supportive Care
盲法
Single (Outcomes Assessor)

入排标准

年龄范围
20 Years 至 50 Years(Adult)
性别
All
接受健康志愿者
否

入选标准

  • •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

排除标准

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

研究组 & 干预措施

Treatment group

Experimental

The survivors receiving 8 weeks (90 mins per weeks) on-line percious nursing education intervention

干预措施: 8-weeks's on-line precision nursing education program (Behavioral)

Control group

No Intervention

As usual

结局指标

主要结局

The depression symptoms on young colorectal cancer survivors

时间窗: 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.

次要结局

  • General quality of life on young colorectal cancer survivors(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).)
  • Dispositional mindfulness status on young colorectal cancer survivors(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(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(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).)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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