Actively Recruiting

Phase Not Applicable
Age: 19Years +
All Genders
ID07405931

Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients

Led by Ulsan University Hospital · Updated on 2026-02-12

414

Participants Needed

5

Research Sites

26 weeks

Total Duration

On this page

Sponsors

U

Ulsan University Hospital

Lead Sponsor

N

National Cancer Center, Korea

Collaborating Sponsor

AI-Summary

What this Trial Is About

Researchers are assessing the clinical effectiveness and cost-efficiency of a digital health platform designed to help cancer patients manage chemotherapy side effects. This platform combines symptom reporting software called Smart Cancer Care Plus with a standardized telenursing program. The study focuses on adults diagnosed with early or advanced gastric, lung, breast, or colon cancer who are beginning their first cycle of chemotherapy with a new anticancer drug. Participants are randomly assigned to one of three groups: standard care without the digital platform or telenursing, use of Smart Cancer Care Plus alone, or use of Smart Cancer Care Plus combined with standardized telenursing. The telenursing intervention includes structured telephone counseling triggered by severe symptoms or missed weekly symptom reports to ensure timely follow-up and support. Over 12 weeks, researchers will evaluate quality of life using a cancer-specific questionnaire. Additional assessments over six months will examine self-management abilities, overall health ratings, adherence to symptom reporting, chemotherapy adherence, healthcare use, functional status, symptom severity, and satisfaction with the system. Participants will be monitored regularly through digital tools and phone support to track and manage chemotherapy-related side effects throughout the study duration.

CONDITIONS

Brief Title

Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients

Who Can Participate

Age: 19Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 19 years or older
  • Diagnosed with early or advanced gastric, lung, breast, or colon cancer
  • Starting first-cycle chemotherapy with a new anticancer agent
  • Able to use a smartphone without difficulty
  • Willing to provide informed consent to participate in the study
Not Eligible

You will not qualify if you...

  • Difficulty communicating due to cognitive, visual, or hearing impairments
  • Cannot read, write, or understand Korean
  • Deemed inappropriate for participation by the investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Treatment

Duration - 12 weeks

Participants use either standard care, Smart Cancer Care Plus for symptom monitoring, or Smart Cancer Care Plus combined with standardized telenursing for managing chemotherapy side effects during their chemotherapy treatment.

Weekly symptom reporting and monitoring visits

Follow-up

Duration - 6 months

Participants are assessed for self-management, overall health, chemotherapy adherence, healthcare utilization, functional status, symptom severity, and satisfaction for up to 6 months after treatment.

Periodic assessments during follow-up

Trial Site Locations

Total: 5 locations

1

Kosin University Gospel Hospital

Busan, South Korea

Actively Recruiting

2

National Cancer Center, Korea

Goyang, South Korea

Actively Recruiting

3

Gachon University Gil Medical Center

Incheon, South Korea

Not Yet Recruiting

4

Gyeongsang National University

Jinju, South Korea

Actively Recruiting

5

Ulsan University Hospital

Ulsan, South Korea

Actively Recruiting

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Research Team

M

Minseon Song, bachelor's degree

S

Somin Joen, bachelor's degree

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

SUPPORTIVE_CARE

Number of Arms

3

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