DepressionNCT06337773
Developing the Precision Nursing Education Program to Young Colorectal Cancer Survivors
A study testing 8-weeks's on-line precision nursing education program in people with Depression, run by Fooyin University at 1 site in Taiwan.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Depression
- What is being tested?
- 8-weeks's on-line precision nursing education program
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteTaiwan
- Study dates
- 22 Apr 2024to 1 Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- diagnosed with stage IV cancer
- had a recurrence of CRC cancer
- had the other type cancer diagnosis
- now are undering cancer treatment
Trial locations and contacts
1 site in 1 country.
About this study
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
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.
Read the 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.
- Conditions
- Depression
- Being tested
- 8-weeks's on-line precision nursing education program
- Keywords
- depression, young colorectal cancer survivors, precision nursing education
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
8-weeks's on-line precision nursing education programBehavioural
The intervention involved 8-weeks's on-line precision nursing education program, including Qigong exercise, and mindfulness training.
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | The survivors receiving 8 weeks (90 mins per weeks) on-line percious nursing education intervention Receives: Behavioral: 8-weeks's on-line precision nursing education program |
| Control group | No intervention | As usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
The 39-item Five Facet Mindfulness Questionnaire24 measures dispositional mindfulness including observing, describing, acting of awareness, nonjudging, and nonreactivity to inner experience. Participants indicated their responses on a 5-point Likert scale ranging from 1 (never or very rarely true) to 5 (very often or always true), with higher scores indicating higher levels of dispositional mindfulness. The Cronbach's alpha for the full scale in this study was 0.87.
Measured: 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
General quality of life are measuring by the EORTC QLQ-C30. EORCT QLQ-C30 measures CRC patients' general physical status that consisted including functions and symptoms status. The ranges of these two scales were from 0 to 100, with higher scores indicating the higher levels of function status and symptoms distress.
Measured: 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
Colorectal specific quality of life are measuring by the QLQ- CR29. EORTC QLQ-CR29 measures CRC patients' colorectal functions and symptoms.The ranges of these two scales were from 0 to 100, with higher scores indicating the higher levels of function status and symptoms distress.
Measured: 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
Constructed Meaning Scale (CMS)15 measures participants' cancer threat appraisal. The CMS relies on eight items to measure patients' perceptions with respect to identifying CRC, their interpersonal re- lationships, and their future lives. The ratings are made on a 4-point Likert scale ranging from 1 (strongly disagree) to 4 (strongly agree), with lower scores indicating a more negative cancer meaning status and appraisal of CRC as a greater threat.
Measured: 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).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start22 Apr 2024
- Primary completion13 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fooyin University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337773
- Sponsor's protocol ID
- B-BR-112-036
- Status last verified
- Sep 2026
- First submitted
- 17 Mar 2024
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share individual participant data.
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06337773
- Acronym / sponsor ID
- B-BR-112-036
- Conditions
- Depression
- Keywords
- depression, young colorectal cancer survivors, precision nursing education
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Fooyin UniversityUniversity, hospital or other
- Study start
- 22 Apr 2024 (actual)
- Primary completion
- 13 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Behavioral: 8-weeks's on-line precision nursing education programThe survivors receiving 8 weeks (90 mins per weeks) on-line percious nursing education intervention |
| Control group | No intervention | –As usual |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (4 listed)
- diagnosed with stage IV cancer
- had a recurrence of CRC cancer
- had the other type cancer diagnosis
- now are undering cancer treatment
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 8-weeks's on-line precision nursing education programThe intervention involved 8-weeks's on-line precision nursing education program, including Qigong exercise, and mindfulness training. | Behavioural | Treatment group |
Primary outcome
The depression symptoms on young colorectal cancer survivors
Time frame: 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.
4 secondary outcomes
Dispositional mindfulness status on young colorectal cancer survivors
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: No. No plan to share individual participant data.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 8-weeks's on-line precision nursing education program in people with Depression, run by Fooyin University at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The depression symptoms on young colorectal cancer survivors (time frame: 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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.