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Efficacy of Web-based Self-management Support Intervention on Health Outcomes in Patients With Colorectal Cancer

N

National Taipei University of Nursing and Health Sciences

Status

Enrolling

Conditions

Colorectal Neoplasms

Treatments

Other: Web-based interactive self-management support program

Study type

Interventional

Funder types

Other

Identifiers

NCT05045976
NTUNHS-107EH12-37

Details and patient eligibility

About

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.

Full 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.

Enrollment

160 estimated patients

Sex

All

Ages

20 to 75 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

160 participants in 2 patient groups

Experimental group
Experimental group
Description:
The experimental group will receive the web-based interactive self-management support intervention.
Treatment:
Other: Web-based interactive self-management support program
Control group
No Intervention group
Description:
The control group will receive usual care and regular patients education.

Trial contacts and locations

2

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Central trial contact

Ting Ru Lin, MS; Tsae Jyy Wang, PhD

Data sourced from clinicaltrials.gov

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