Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors

NCT ID: NCT06337773

Last Updated: 2024-03-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Clinical Phase

NA

Total Enrollment

110 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-03-20

Study Completion Date

2026-12-25

Brief Summary

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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

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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.

Conditions

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Depression

Keywords

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depression young colorectal cancer survivors precision nursing education

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Treatment group

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

Group Type EXPERIMENTAL

8-weeks's on-line precision nursing education program

Intervention Type BEHAVIORAL

The intervention involved 8-weeks's on-line precision nursing education program, including Qigong exercise, and mindfulness training.

Control group

As usual

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Fooyin University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Central Contacts

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Li Ting Chen

Role: CONTACT

Phone: 886910770255

Email: [email protected]

Other Identifiers

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B-BR-112-036

Identifier Type: -

Identifier Source: org_study_id