Digital symptom monitoring for liver cancer patients in China
Electronic Symptom Monitoring of Patient-Reported Outcomes Among Patients With Hepatocellular Carcinoma During Immunotherapy (PRIME-HCC): Protocol for a Randomised Controlled Trial
This study is testing if a digital tool that helps liver cancer patients report their symptoms weekly can improve their health and communication with doctors.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Peking University Academic / other |
| Drugs / interventions | immunotherapy |
| Locations | 1 site (Haidian, Beijing Municipality) |
| Trial ID | NCT06938945 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a digital intervention model for patients with hepatocellular carcinoma (HCC) that focuses on patient-reported outcomes (PRO). Participants will be divided into an intervention group, which will report their symptoms weekly through a digital platform, and a control group. The study seeks to determine if regular symptom reporting can enhance self-management, improve communication with healthcare providers, and ultimately lead to better health outcomes. The effectiveness of this digital approach will be evaluated by comparing health outcomes between the two groups.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 diagnosed with locally advanced or metastatic liver cancer who are undergoing or have completed PD-1 therapy.
Not a fit: Patients with cognitive impairments or those unable to understand their symptoms may not benefit from this study.
Why it matters
Potential benefit: If successful, this intervention could significantly enhance symptom management and quality of life for liver cancer patients.
How similar studies have performed: Other studies have shown promise in using digital interventions for symptom management in cancer patients, indicating a potential for success in this approach.
Eligibility criteria
Show full inclusion / exclusion criteria
The inclusion criteria for the participants are: (1) aged 18 to 75 years, (2) clinically diagnosed as HCC, (3) treated with immunotherapy, (4) able and willing to use smartphones or tablets to complete the follow-up process according to protocol and (5) can understand Mandarin Chinese. The exclusion criteria are: (1) cognitive deficits that would preclude recognizing of their own symptoms and feelings, (2) unable to understand the research content and/or questionnaires, (3) is going to take or having taken surgical resection or liver transplant, (4) currently participating in other clinical trials that may affect this study, or (5) having other malignant tumours.
Where this trial is running
Haidian, Beijing Municipality
- China Center for Health Development Studies, Peking University — Haidian, Beijing Municipality, China (Recruiting)
Study contacts
- Study coordinator: Yiqi Xia
- Email: 2211110248@stu.pku.edu.cn
- Phone: +86 137 2033 7686
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.