LiteracyNCT04642417
Effectiveness of Experiential Learning on Dietary Fiber Literacy
A study testing dietary fiber literacy and routine care in people with Literacy and Bowel Symptoms, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
Acute symptom onset is the most common problem in colorectal cancer surgery, and it is also the source of the most painful impact on patients' lives. The second is the fear of cancer recurrence and complications, and psychological problems such as fear or depression are prone to occur. Read more about this study
- Who is it for?
- Ages 20 to 85 years
- Conditions the study is for
- Literacy, Bowel Symptoms
- What is being tested?
- dietary fiber literacy and routine care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 66 participants
- Where
- 1 siteTaiwan
- Study dates
- 29 Oct 2020to 31 Dec 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- You can read the newspaper yourself.
- Emotions and cognitive functions can be answered without barriers
- After clinical diagnosis of colorectal cancer (stage I-III), the doctor has recommended and arranged for colorectal cancer Surgery.
- Age between 20 to 85 years old.
- Willing to use a computer tablet to conduct a questionnaire survey.
Who cannot join
- Those who are currently receiving chemical drugs or radiation therapy.
- Clinical diagnosis of colorectal cancer stage IV (stage IV); recurrence, metastasis or other cancers
- Diagnosis of mental illness patients.
- Cannot read the newspaper on their own
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of Experiential Learning on Dietary Fiber Literacy and Bowel Symptom Management After Surgery for Colorectal Cancer
Acute symptom onset is the most common problem in colorectal cancer surgery, and it is also the source of the most painful impact on patients' lives. The second is the fear of cancer recurrence and complications, and psychological problems such as fear or depression are prone to occur. Studies have found that colorectal cancer is gradually suffering from complications and symptoms for six months, and even uncontrollable gas, leakage and incontinence, causing frequent occurrence of underwear. , The body and mind are severely impacted, and affect daily activities and quality of life. The problem of initial symptom management after colorectal cancer surgery is highly complex, and patients even have to self-manage diseases and symptoms in the face of physical and psychological adjustment. The provision and consultation of knowledge and information from nursing staff can prepare patients for discharge and meet their needs for knowledge and information, and can help patients achieve effective self-management capabilities.The foundation of health awareness emphasizes health knowledge. Health awareness is a more advanced knowledge achievement; it is the ability to make judgments and decisions in daily life related to health care, disease prevention and health promotion, and is the basic element of achieving self-management of health. Dietary knowledge is also a higher-level knowledge, which reflects dietary knowledge in behavior, food choices and criticism, and reflects on food choices and health decisions. Insufficient dietary knowledge will affect food choices, judgments and decisions, resulting in insufficient diet-related knowledge.Studies have confirmed that the health-related knowledge of cancer patients is significantly related to disease self-management. Only when patients understand their own diseases can they actively participate in self-health management. Nursing staff play a pivotal role in the care of patients with colorectal cancer. Through the knowledge transfer of nursing staff and guiding patients to take care of themselves, they can help improve postoperative dietary intake behaviors, thereby enhancing dietary awareness. Literature review of chronic disease self-management, nursing staff provide patients with sufficient relevant knowledge education, which can enhance patients' self-efficacy and enhance disease self-management ability.
Read the detailed description
Through the re-giving and encouragement of knowledge information, personal behavior control and reframing can be achieved, which can be effective To promote personal health. Nursing staff's consultation and face-to-face interviews can significantly improve patients' health-related knowledge, effective education strategies and assist patients in self-management of disease-related problems.
Experiential learning interaction can deepen the patient's impression and memory, improve the patient's knowledge and skills about the disease, increase patient participation in self-decision-making, improve self-efficacy, present better health-related knowledge, and achieve self-management capabilities. Past studies have also found that telephone tracking and consultation, emails, and giving diet manuals can help patients with colorectal cancer make significant changes in their healthy diet choices.
- Conditions
- Literacy, Bowel Symptoms
- Being tested
- dietary fiber literacy, routine care
- Keywords
- Colorectal cancer surgery, Literacy, Dietary fiber food literacy, Dietary fiber, experiential learning
- Medical subject headings
- Literacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary fiber literacyOther
education
routine careOther
routine care
| Study group | Role | What they receive |
|---|---|---|
| Experimental | Experimental | intervention give experience dietary fiber literacy Receives: Other: dietary fiber literacy; Other: routine care |
| No Intervention | No intervention | give standard education |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bowel Symptom
LARS; minimum to maximum scores by 5-42, higher is mean severe bowel symptoms
Measured: 20 minutes
Secondary outcomes (2)
Dietary Fiber food Literacy
Dietary Fiber Literacy scale；the maximum scores is 41, higher is better
Measured: 50 minutes
food frequency
food frequency questionnaire
Measured: 20 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start29 Oct 2020
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for LiteracyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Model description
- Patients were randomly assigned (1:1) to routine or EL group. EL group received simulated dietary-fiber experiential learning and one dietary application consultation session one month post-surgery, in addition to routine care before discharge.
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 66 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Been-Ren Lin, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642417
- Sponsor's protocol ID
- 202008045RINC
- Status last verified
- Dec 2021
- First submitted
- 5 Nov 2020
- Last updated
- 5 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Experiential Learning on Dietary Fiber Literacy and Bowel Symptom Management After Surgery for Colorectal Cancer
- ClinicalTrials.gov ID
- NCT04642417
- Acronym / sponsor ID
- 202008045RINC
- Conditions
- Literacy, Bowel Symptoms
- Keywords
- Colorectal cancer surgery, Literacy, Dietary fiber food literacy, Dietary fiber, experiential learning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 66 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- 29 Oct 2020 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 24 Nov 2020 (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.
Acute symptom onset is the most common problem in colorectal cancer surgery, and it is also the source of the most painful impact on patients' lives. The second is the fear of cancer recurrence and complications, and psychological problems such as fear or depression are prone to occur. Studies have found that colorectal cancer is gradually suffering from complications and symptoms for six months, and even uncontrollable gas, leakage and incontinence, causing frequent occurrence of underwear. , The body and mind are severely impacted, and affect daily activities and quality of life. The problem of initial symptom management after colorectal cancer surgery is highly complex, and patients even have to self-manage diseases and symptoms in the face of physical and psychological adjustment. The provision and consultation of knowledge and information from nursing staff can prepare patients for discharge and meet their needs for knowledge and information, and can help patients achieve effective self-management capabilities.The foundation of health awareness emphasizes health knowledge. Health awareness is a more advanced knowledge achievement; it is the ability to make judgments and decisions in daily life related to health care, disease prevention and health promotion, and is the basic element of achieving self-management of health. Dietary knowledge is also a higher-level knowledge, which reflects dietary knowledge in behavior, food choices and criticism, and reflects on food choices and health decisions. Insufficient dietary knowledge will affect food choices, judgments and decisions, resulting in insufficient diet-related knowledge.Studies have confirmed that the health-related knowledge of cancer patients is significantly related to disease self-management. Only when patients understand their own diseases can they actively participate in self-health management. Nursing staff play a pivotal role in the care of patients with colorectal cancer. Through the knowledge transfer of nursing staff and guiding patients to take care of themselves, they can help improve postoperative dietary intake behaviors, thereby enhancing dietary awareness. Literature review of chronic disease self-management, nursing staff provide patients with sufficient relevant knowledge education, which can enhance patients' self-efficacy and enhance disease self-management ability.
Detailed description
Through the re-giving and encouragement of knowledge information, personal behavior control and reframing can be achieved, which can be effective To promote personal health. Nursing staff's consultation and face-to-face interviews can significantly improve patients' health-related knowledge, effective education strategies and assist patients in self-management of disease-related problems.
Experiential learning interaction can deepen the patient's impression and memory, improve the patient's knowledge and skills about the disease, increase patient participation in self-decision-making, improve self-efficacy, present better health-related knowledge, and achieve self-management capabilities. Past studies have also found that telephone tracking and consultation, emails, and giving diet manuals can help patients with colorectal cancer make significant changes in their healthy diet choices.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients were randomly assigned (1:1) to routine or EL group. EL group received simulated dietary-fiber experiential learning and one dietary application consultation session one month post-surgery, in addition to routine care before discharge.
| Arm | Type | Receives |
|---|---|---|
| Experimental | Experimental | Other: dietary fiber literacy, Other: routine careintervention give experience dietary fiber literacy |
| No Intervention | No intervention | –give standard education |
Who may qualify
- Ages
- 20 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- You can read the newspaper yourself.
- Emotions and cognitive functions can be answered without barriers
- After clinical diagnosis of colorectal cancer (stage I-III), the doctor has recommended and arranged for colorectal cancer Surgery.
- Age between 20 to 85 years old.
- Willing to use a computer tablet to conduct a questionnaire survey.
Key exclusion criteria (4 listed)
- Those who are currently receiving chemical drugs or radiation therapy.
- Clinical diagnosis of colorectal cancer stage IV (stage IV); recurrence, metastasis or other cancers
- Diagnosis of mental illness patients.
- Cannot read the newspaper on their own
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 |
|---|---|---|
| dietary fiber literacyeducation | Other | Experimental |
| routine careroutine care | Other | Experimental |
Primary outcome
Bowel Symptom
Time frame: 20 minutes
LARS; minimum to maximum scores by 5-42, higher is mean severe bowel symptoms
2 secondary outcomes
Dietary Fiber food Literacy
Time frame: 50 minutes
food frequency
Time frame: 20 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2023.
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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.
Been-Ren Lin principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing dietary fiber literacy and routine care in people with Literacy and Bowel Symptoms, run by National Taiwan University Hospital 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: finished, as of the sponsor's last update on 5 Apr 2023. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Bowel Symptom (time frame: 20 minutes). 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 5 Apr 2023.