Managing chemotherapy side effects with a smartphone symptom app plus telenursing
Evaluation of the Effectiveness of Managing Chemotherapy Side Effects Using ePRO and a Standardized Telenursing Program for Cancer Patients
This trial tests whether a smartphone symptom-reporting app combined with a standardized telenursing program helps adults starting first-cycle chemotherapy for gastric, lung, breast, or colon cancer manage treatment side effects.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 414 (estimated) |
| Ages | 19 Years and up |
| Sex | All |
| Sponsor | Ulsan University Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 5 sites (Busan and 4 other locations) |
| Trial ID | NCT07405931 on ClinicalTrials.gov |
What this trial studies
This is a multicenter randomized controlled trial in South Korea comparing a digital health platform (Smart Cancer Care Plus) plus standardized telenursing to usual care for adults beginning first-cycle chemotherapy with a new anticancer agent. Participants use a smartphone app to report symptoms (ePRO), receive guidance for self-management, and get follow-up and coaching from trained telenurses according to a standardized protocol. The trial measures clinical outcomes and healthcare costs to determine both effectiveness and cost-effectiveness of the combined digital-plus-telecare approach. Enrollment requires the ability to read and use a smartphone and provision of informed consent at one of the participating hospitals.
Who should consider this trial
Good fit: Ideal candidates are adults (≥19 years) with early or advanced gastric, lung, breast, or colon cancer who are starting first-cycle chemotherapy with a new anticancer drug, can use a smartphone easily, and can read and understand Korean.
Not a fit: Patients with significant communication barriers (cognitive, visual, or hearing impairment), those who cannot read Korean, those unable to use a smartphone, or those not starting a first-cycle chemotherapy are unlikely to benefit from this program.
Why it matters
Potential benefit: If successful, this approach could reduce uncontrolled chemotherapy side effects, lower emergency visits or hospital stays, and improve patients' comfort and quality of life while potentially saving healthcare costs.
How similar studies have performed: Previous oncology studies using electronic patient-reported outcomes and telehealth have shown improved symptom control and fewer acute care visits, though combining a standardized telenursing protocol with an integrated ePRO platform is less extensively tested.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * Individuals who have difficulty communicating due to cognitive impairment, visual impairment, hearing impairment, or other reasons * Individuals who cannot read, write, or understand Korean * Other individuals deemed inappropriate for participation by the investigators
Where this trial is running
Busan and 4 other locations
- Kosin University Gospel Hospital — Busan, South Korea (Recruiting)
- National Cancer Center, Korea — Goyang, South Korea (Recruiting)
- Gachon University Gil Medical Center — Incheon, South Korea (Not_yet_recruiting)
- Gyeongsang National University — Jinju, South Korea (Recruiting)
- Ulsan University Hospital — Ulsan, South Korea (Recruiting)
Study contacts
- Principal investigator: Sujin Koh, Doctor of Philoshophy — Ulsan University Hospital
- Study coordinator: Minseon Song, bachelor's degree
- Email: 9204564@uuh.ulsan.kr
- Phone: +82522507018
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.