Clinical trial NCT06938945: Remote Symptom Monitoring on Patient-Reported Outcomes With Nudge Strategies Among Patients With Tumor in China
Official title: Remote Symptom Monitoring on Patient-Reported Outcomes With Nudge Strategies Among Patients With Tumor in China: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Hepatocellular Carcinoma (HCC)
Lead sponsor: Peking University
Sponsor class: OTHER
First posted: 2025-04-22
Enrollment: 500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to design a digital PRO intervention model applicable to patients with hepatocellular carcinoma, and The main questions it aims to answer are:

* Can symptom management through patients' regular completion of the PRO scale promote self-understanding, self-management and timely seeking of medical help, enable healthcare professionals to accurately and efficiently understand how patients really feel and respond in a timely manner, and ultimately improve health outcomes?
* Can digital interventions significantly improve outcomes such as symptom control and quality of life in cancer patients? Researchers divided participants into an intervention group and a control group and compared them to see if digital interventions could improve patient health outcomes.

Participants will:

* Subjects in the intervention group will be asked to report symptom information weekly (7-day natural week, hereafter) via the public number, and the back office will give symptom management advice or issue alerts based on the filling. Control subjects will not receive PRO intervention.
* Participants can offer to withdraw from the study at any time.


Eligibility criteria: Inclusion Criteria:

1. The patients are aged between 18 and 75 years old;
2. The patients have been diagnosed with locally advanced or metastatic liver cancer through pathological or imaging examinations;
3. The patients are currently receiving or have completed PD-1 monotherapy or PD-1 combination therapy;
4. The patients can participate in this study as per the requirements of the research protocol;
5. The patients voluntarily sign the informed consent form.

Exclusion Criteria:

1. The patients have cognitive impairment or are unable to clearly identify their own symptoms and feelings;
2. The patients are illiterate or unable to understand the research content for other reasons;
3. The patients are currently participating in other clinical trials that may affect this study.

Primary outcomes:
measure: Health-Related quality of life
timeFrame: 6 months
Secondary outcomes:
measure: Change in patient-reported hepatocellular carcinoma symptoms
timeFrame: 6 months
measure: Mental health
timeFrame: 6 months
measure: Survival period
timeFrame: 6 months
measure: Treatment satisfaction
timeFrame: 6 months
measure: Treatment compliance
timeFrame: 6 months
measure: The number of times the official account functions are used
timeFrame: 6 months
measure: The number of visits to the outpatient department, inpatient department and emergency department
timeFrame: 6 months
measure: Direct medical costs
timeFrame: 6 months
measure: Direct non-medical costs
timeFrame: 6 months
measure: Indirect cost
timeFrame: 6 months
measure: Health State Utility
timeFrame: 6 months
Other outcomes:
Locations:
city: Haidian
country: China
facility: China Center for Health Development Studies, Peking University
state: Beijing
Study officials:
References: