Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer
NCT ID: NCT05045976
Last Updated: 2023-03-27
Study Results
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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UNKNOWN
NA
160 participants
INTERVENTIONAL
2021-09-19
2023-12-31
Brief Summary
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Detailed Description
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Aim: The study aims is to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, and secondary outcomes, symptom distress, emotional distress, physical activity, nutrition intake, and the mediation effects of self-efficacy, social support, and supportive care needs in colorectal cancer patients.
Design: A multi-center randomized six-month follow-up parallel-group superiority design will be used to test the intervention efficacy. A convenient sample of 160 post-operative colorectal cancer patients (stage I-III) will be recruited and randomized to the control or intervention group. Outcome variables will be assessed on the baseline, 2nd, 4th, and 6th month in both groups.
Instruments: The study instruments include Cancer Behavior Inventory-Brief Version, 34-item Supportive Care Needs Survey, M.D. Anderson Symptom Inventory, The Center for Epidemiologic Studies Depression Scale, International Physical Activity Questionnaire, and FACT-C.
Data analysis: Descriptive analysis will be used to describe patients' demographics, disease variables, and outcome variables. The Chi-square, t-test, and Linear Mixed Model will be used to test the efficacy of the study interventions.
Significance: The study results will provide evidence for the efficacy of the web-based interactive self-management support intervention for enhancing a healthy lifestyle and quality of life in colorectal cancer patients.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
SUPPORTIVE_CARE
NONE
Study Groups
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Experimental group
The experimental group will receive the web-based interactive self-management support intervention.
Web-based interactive self-management support program
The intervention group will receive a 60-90 minute introduction to the web-based interactive self-management support program. They will be instructed to do the weekly online self-assessment on symptoms, emotion, and health behaviors and how to use the web-based program to manage their health by applying self-manage skills and behavior change techniques. The contents of the interactive colorectal cancer self-management website include the following five main components: Health Support Station, Knowledge Supply Station, Sharing Stories, My Dear Friend, and Asking a Nurse.
Control group
The control group will receive usual care and regular patients education.
No interventions assigned to this group
Interventions
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Web-based interactive self-management support program
The intervention group will receive a 60-90 minute introduction to the web-based interactive self-management support program. They will be instructed to do the weekly online self-assessment on symptoms, emotion, and health behaviors and how to use the web-based program to manage their health by applying self-manage skills and behavior change techniques. The contents of the interactive colorectal cancer self-management website include the following five main components: Health Support Station, Knowledge Supply Station, Sharing Stories, My Dear Friend, and Asking a Nurse.
Eligibility Criteria
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Inclusion Criteria
* Received curative surgery with one month
* Cancer stage I-III
* Age between 20 to 75
* Have an access to the internet at home
Exclusion Criteria
* Not able to communicate verbally or with writing
20 Years
75 Years
ALL
No
Sponsors
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Ministry of Science and Technology, Taiwan
OTHER_GOV
Mackay Memorial Hospital
OTHER
Cathay General Hospital
OTHER
National Taipei University of Nursing and Health Sciences
OTHER
Responsible Party
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Tsae Jyy, Wang
Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
Principal Investigators
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Tsae Jyy Wang, PhD
Role: PRINCIPAL_INVESTIGATOR
National Taipei University of Nursing and Health Sciences
Locations
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Mackay Memorial Hospital
Taipei, , Taiwan
Cathay General Hospital
Taipei, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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References
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Fridriksdottir N, Gunnarsdottir S, Zoega S, Ingadottir B, Hafsteinsdottir EJG. Effects of web-based interventions on cancer patients' symptoms: review of randomized trials. Support Care Cancer. 2018 Feb;26(2):337-351. doi: 10.1007/s00520-017-3882-6. Epub 2017 Sep 18.
Berry DL, Blonquist TM, Patel RA, Halpenny B, McReynolds J. Exposure to a patient-centered, Web-based intervention for managing cancer symptom and quality of life issues: impact on symptom distress. J Med Internet Res. 2015 Jun 3;17(6):e136. doi: 10.2196/jmir.4190.
Other Identifiers
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NTUNHS-107EH12-37
Identifier Type: -
Identifier Source: org_study_id
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