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Trial Title:
Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors
NCT ID:
NCT06337773
Condition:
Depression
Conditions: Official terms:
Colorectal Neoplasms
Depression
Conditions: Keywords:
depression
young colorectal cancer survivors
precision nursing education
Study type:
Interventional
Study phase:
N/A
Overall status:
Not yet recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Supportive Care
Masking:
Single (Outcomes Assessor)
Intervention:
Intervention type:
Behavioral
Intervention name:
8-weeks's on-line precision nursing education program
Description:
The intervention involved 8-weeks's on-line precision nursing education program,
including Qigong exercise, and mindfulness training.
Arm group label:
Treatment group
Summary:
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.
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.
Criteria for eligibility:
Criteria:
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
Gender:
All
Minimum age:
20 Years
Maximum age:
50 Years
Healthy volunteers:
No
Start date:
March 20, 2024
Completion date:
December 25, 2026
Lead sponsor:
Agency:
Fooyin University
Agency class:
Other
Source:
Fooyin University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06337773
