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

NCT05045976 | Unknown

• 1 other identifier: NTUNHS-107EH12-37
• Study Type: interventional
• Target: 160
• Locations: 1 country
• Sites: 2

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.

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

Outcome Measures

Primary Outcomes (1)

• Change of Functional Assessment of Cancer Therapy- Colorectal

  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.

  Change from Baseline to 2, 4, and 6 months

Secondary Outcomes (4)

• International Physical Activity Questionnaire

  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

• M.D. Anderson Symptom Inventory

  Baseline, 2, 4, and 6 months

Study Arms (2)

Experimental group

EXPERIMENTAL

The experimental group will receive the web-based interactive self-management support intervention.

Other: Web-based interactive self-management support program

Control group

NO INTERVENTION

The control group will receive usual care and regular patients education.

Interventions

Web-based interactive self-management support program OTHER

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.

Experimental group

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Diagnosed with severe psychological diseases or having a poor mental state preventing cooperate with research measures
• Not able to communicate verbally or with writing

Sponsors & Collaborators

• National Taipei University of Nursing and Health Sciences: lead
• Ministry of Science and Technology, Taiwan: collaborator
• Mackay Memorial Hospital: collaborator
• Cathay General Hospital: collaborator

Study Sites (2)

Mackay Memorial Hospital

Taipei, 104, Taiwan

RECRUITING

Cathay General Hospital

Taipei, 106, Taiwan

RECRUITING

Related Publications (2)

• 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.

  PMID: 28921391 BACKGROUND

• 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.

  PMID: 26041682 BACKGROUND

MeSH Terms

Conditions

Colorectal Neoplasms

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases

Study Officials

• Tsae Jyy Wang, PhD

  National Taipei University of Nursing and Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tsae Jyy Wang, PhD

CONTACT

886911246130; tsaejyy@ntunhs.edu.tw

Ting Ru Lin, MS

CONTACT

886918405503; r0004467@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, School of Nursing, National Taipei University of Nursing and Health Sciences, Taipei, Taiwan

Model Details: 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.

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 16, 2021
• Study Start: September 19, 2021
• Primary Completion: July 31, 2023
• Study Completion: December 31, 2023
• Last Updated: March 27, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

TW (2)