NCT04642417

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
66

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2020

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 29, 2020

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

November 5, 2020

Completed
19 days until next milestone

First Posted

Study publicly available on registry

November 24, 2020

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

April 5, 2023

Status Verified

December 1, 2021

Enrollment Period

1.2 years

First QC Date

November 5, 2020

Last Update Submit

April 2, 2023

Conditions

Keywords

Colorectal cancer surgeryLiteracyDietary fiber food literacyDietary fiberexperiential learning

Outcome Measures

Primary Outcomes (1)

  • Bowel Symptom

    LARS; minimum to maximum scores by 5-42, higher is mean severe bowel symptoms

    20 minutes

Secondary Outcomes (2)

  • Dietary Fiber food Literacy

    50 minutes

  • food frequency

    20 minutes

Study Arms (2)

Experimental

EXPERIMENTAL

intervention give experience dietary fiber literacy

Other: dietary fiber literacyOther: routine care

No Intervention

NO INTERVENTION

give standard education

Interventions

education

Experimental

routine care

Experimental

Eligibility Criteria

Age20 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Taiwan University Hospital

Taipei, Test2, test3, Taiwan

Location

MeSH Terms

Conditions

Literacy

Condition Hierarchy (Ancestors)

CommunicationBehavior

Study Officials

  • Been-Ren Lin

    National Taiwan University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
Using a randomization design, investigators randomly placed the number into the envelope. This procedure was concealed from the provider or patients.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 5, 2020

First Posted

November 24, 2020

Study Start

October 29, 2020

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

April 5, 2023

Record last verified: 2021-12

Locations