NCT06337773

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.

Trial Health

65
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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
110

participants targeted

Target at P50-P75 for not_applicable depression

Timeline
8mo left

Started Mar 2024

Typical duration for not_applicable depression

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress79%
Mar 2024Dec 2026

First Submitted

Initial submission to the registry

March 17, 2024

Completed
3 days until next milestone

Study Start

First participant enrolled

March 20, 2024

Completed
9 days until next milestone

First Posted

Study publicly available on registry

March 29, 2024

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 30, 2024

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 25, 2026

Expected
Last Updated

March 29, 2024

Status Verified

March 1, 2024

Enrollment Period

6 months

First QC Date

March 17, 2024

Last Update Submit

March 22, 2024

Conditions

Keywords

depressionyoung colorectal cancer survivorsprecision nursing education

Outcome Measures

Primary Outcomes (1)

  • The depression symptoms on young colorectal cancer survivors

    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 Outcomes (4)

  • 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).

  • 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).

  • 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).

Study Arms (2)

Treatment group

EXPERIMENTAL

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

Control group

NO INTERVENTION

As usual

Interventions

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

Treatment group

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2024

First Posted

March 29, 2024

Study Start

March 20, 2024

Primary Completion

September 30, 2024

Study Completion (Estimated)

December 25, 2026

Last Updated

March 29, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

No plan to share individual participant data.