Clinical trial NCT06337773: Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors
Official title: Developing the Precision Nursing Education Program Through the E-flipped Classroom Model to Improve the Quality of Life Among Young Colorectal Cancer Survivors
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Depression
Keywords: depression
young colorectal cancer survivors
precision nursing education
Lead sponsor: Fooyin University
Sponsor class: OTHER
First posted: 2024-03-29
Enrollment: 110
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

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

Primary outcomes:
measure: The depression symptoms on young colorectal cancer survivors
timeFrame: 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 outcomes:
measure: Dispositional mindfulness status on young colorectal cancer survivors
timeFrame: 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).
measure: General quality of life on young colorectal cancer survivors
timeFrame: 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).
measure: Colorectal specific quality of life on young colorectal cancer survivors
timeFrame: 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).
measure: Cancer threat appraisal on young colorectal cancer survivors
timeFrame: 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).
Other outcomes:
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