Clinical trial NCT05045976: 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 type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Colorectal Neoplasms
Keywords: colorectal cancer
web-based interactive self-management support
health-related quality of life
self-efficacy
emotion distress
supportive care needs
symptom distress
healthy life styles
Lead sponsor: National Taipei University of Nursing and Health Sciences
Sponsor class: OTHER
Collaborators: name: Ministry of Science and Technology, Taiwan
name: Mackay Memorial Hospital
name: Cathay General Hospital
First posted: 2021-09-16
Enrollment: 160
Sex: ALL
Minimum age (years): 20
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study participants will be randomly assigned 1:1 to the intervention or the control group by the stratified permuted block randomization and block 4, 6, 8 will be used. The randomization will be stratified by cancer stage (stage I-IIA; stage IIB-III). The Sealed Envelope software (Sealed Envelope Ltd., 2016) will be used to generate the random sequences and sealed envelopes will be used to conceal the assignment of each participant.
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Change of Functional Assessment of Cancer Therapy- Colorectal
timeFrame: Change from Baseline to 2, 4, and 6 months
Secondary outcomes:
measure: International Physical Activity Questionnaire
timeFrame: Baseline, 2, 4, and 6 months
measure: Cancer Behavior Inventory-Brief Version
timeFrame: Change from Baseline to 6 months
measure: Supportive Care Needs Survey
timeFrame: Baseline, 2, 4, and 6 months
measure: M.D. Anderson Symptom Inventory
timeFrame: Baseline, 2, 4, and 6 months
Other outcomes:
Locations:
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: Cathay General Hospital
Study officials:
affiliation: National Taipei University of Nursing and Health Sciences
name: Tsae Jyy Wang, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.