Efficacy of an Interactive Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer: A Mixed-methods Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Colorectal Neoplasms
- Sponsor
- National Taipei University of Nursing and Health Sciences
- Enrollment
- 160
- Locations
- 2
- Primary Endpoint
- Change of Functional Assessment of Cancer Therapy- Colorectal
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Tsae Jyy, Wang
Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan
National Taipei University of Nursing and Health Sciences
Eligibility Criteria
Inclusion Criteria
- •Diagnosed with colorectal cancer (ICD-10 code: C18-C20, C21.8)
- •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
- •Diagnosed with severe psychological diseases or having a poor mental state preventing cooperate with research measures
- •Not able to communicate verbally or with writing
Outcomes
Primary Outcomes
Change of Functional Assessment of Cancer Therapy- Colorectal
Time Frame: Change from Baseline to 2, 4, and 6 months
There are two subscales, 27 items of FACT-General and 9 items of Colorectal Cancer Subscale. Each item is rated on a 5-point Likert scale (0-4). The total score of the 36 items represents the score of the scale. The possible score for the scale ranges from 0 to 136. The higher values represent better quality of life.
Secondary Outcomes
- M.D. Anderson Symptom Inventory(Baseline, 2, 4, and 6 months)
- Cancer Behavior Inventory-Brief Version(Change from Baseline to 6 months)
- Supportive Care Needs Survey(Baseline, 2, 4, and 6 months)
- International Physical Activity Questionnaire(Baseline, 2, 4, and 6 months)