Remote Symptom Monitoring on Patient-Reported Outcomes With Nudge Strategies Among Patients With Tumor in China

Wei Xiaoping

Status: Not yet enrolling

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Behavioral: Digitized patient-reported outcomes

Study type: Interventional

Funder types: Other

Identifiers

NCT06938945

IRB00001052-24066

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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500 participants in 2 patient groups

Intervention Group: receive PRO（patient reported outcomes） interventions

Experimental group

Treatment:

Behavioral: Digitized patient-reported outcomes

Control Group：usual care (not receive PRO intervention)

No Intervention group