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Brief Title: Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer
Official Title: Efficacy of an Interactive Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer: A Mixed-methods Study
Study ID: NCT05045976
Brief Summary: The study aims to test the efficacy of a web-based interactive self-management support intervention on the primary outcome, quality of life, secondary outcomes, symptom distress, emotional distress, physical activity, and the mediation effects of self-efficacy, and supportive care needs in colorectal cancer patients.
Detailed Description: Colorectal cancer is the most commonly diagnosed cancer in Taiwan. With proper treatments, most patients can be long-term survivors. However, patients often suffered long-term consequences of the disease and its treatment side effects. In addition, unhealthy lifestyles will further impact on patient's prognosis and quality of life. Face-to-face or web-based self-management support interventions can help colorectal cancer patients to achieve a healthy lifestyle and better adjustment. However, they are costly and may not be assessable for a certain population. Therefore, it is necessary to develop the most cost-effective interventions for patients with colorectal cancer. 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.
Minimum Age: 20 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Mackay Memorial Hospital, Taipei, , Taiwan
Cathay General Hospital, Taipei, , Taiwan
Name: Tsae Jyy Wang, PhD
Affiliation: National Taipei University of Nursing and Health Sciences
Role: PRINCIPAL_INVESTIGATOR