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Efficiency of an Electronic Follow-Up Model for Assessing Patient-Reported Outcomes after Cancer Immunotherapy: a Randomized Controlled Trial

Electronic Follow-Up Model for Assessing Patient-Reported Outcomes after Cancer Immunotherapy: a Randomized Controlled Trial

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2100052819
Enrollment
Unknown
Registered
2021-11-05
Start date
2019-09-01
Completion date
Unknown
Last updated
2022-08-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

cancer

Interventions

intervention roup:Set up a medical follow-up team
intervention group:The follow-up system APP was established, which included the common adverse reactions checked by patients and the questionnaire for evaluation end points
intervention group:Assist the patient to register the APP
intervention group:Patients checked the possible side effects every week and uploaded the results of out-of-hospital examination as required
intervention Group:Patients with minor adverse reactions were followed up by telephone
intervention group:The App also included an algorithm for assessing the severity of symptoms or examination results according to NCI-CTCAE. Upon the occurrence of a grade 3 or 4 irAE, an urgency algor
control group:21 days of outpatient or inpatient visits and 3 months of telephone follow-up
control group:visit outpatient department when discomfort

Sponsors

Beijing Cancer Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 1. Diagnosis of cancer by pathology or histology 2. If the immunotherapy criteria are met, immunotherapy will be applied 3. The patients can understand the purpose of the test, voluntarily participate in and sign the informed consent, and are willing to complete the follow-up according to the requirements of the protocol; 4. Clearly aware and able to answer questions correctly 5. Smart mobile devices with 3G/4G/5G functions that can use mobile phones and access the Internet

Exclusion criteria

Exclusion criteria: 1. ECOG score >= 2; 2. The researchers judged life expectancy to be less than six months; 3. According to the judgment of the researcher, patients with accompanying diseases (such as severe mental illness, severe major organ failure, serious heart disease, etc.) that seriously endanger the safety of patients or affect the completion of the study.

Design outcomes

Primary

MeasureTime frame
Treatment completion rate;

Secondary

MeasureTime frame
Incidence of immune-related grade 3-4 serious adverse reactions;Patient mortality due to severe adverse reactions;ER visits;quality of life;

Countries

China

Contacts

Public ContactXiaotian Zhang

Beijing Cancer Hospital

zl54920@bjmu.edu.cn+86 13810995536

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 12, 2026