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

NCT ID: NCT06938945

Last Updated: 2025-05-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

500 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-24

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Hepatocellular Carcinoma (HCC)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Intervention Group: receive PRO(patient reported outcomes) interventions

Group Type EXPERIMENTAL

Digitized patient-reported outcomes

Intervention Type BEHAVIORAL

Patients fill out the PRO scale regularly online through a specific cell phone program or website, which intelligently analyzes the patient's physical condition, gives symptom management recommendations (which are based on clinical guidelines and expert consensus, and are updated monthly by oncology clinical experts during the study period), and sends alerts to clinical caregivers when the scale scores are abnormal.

Control Group:usual care (not receive PRO intervention)

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Digitized patient-reported outcomes

Patients fill out the PRO scale regularly online through a specific cell phone program or website, which intelligently analyzes the patient's physical condition, gives symptom management recommendations (which are based on clinical guidelines and expert consensus, and are updated monthly by oncology clinical experts during the study period), and sends alerts to clinical caregivers when the scale scores are abnormal.

Intervention Type BEHAVIORAL

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Wei Xiaoping

OTHER

Sponsor Role lead

Responsible Party

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Wei Xiaoping

PhD Candidate,China Center for Health Development Studies, Peking University

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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China Center for Health Development Studies, Peking University

Haidian, Beijing Municipality, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yiqi Xia

Role: CONTACT

+86 137 2033 7686

Facility Contacts

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Yiqi Xia

Role: primary

+86 137 2033 7686

Other Identifiers

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IRB00001052-24066

Identifier Type: -

Identifier Source: org_study_id

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