Solid Tumor, AdultNCT06469268
Development and Application Study of ePRO Software for Managing Cancer Patients Throughout the Treatment Period
A study testing Epro software in people with Solid Tumor, Adult, run by Shikai Wu at 1 site in China.
Trial summary
After receiving chemotherapy, targeted therapy, immunotherapy and other drug treatments, tumor patients often experience various adverse reactions such as bone marrow suppression, diarrhea, pneumonia, etc. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Solid Tumor, Adult
- What is being tested?
- Epro software
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 22 May 2024to 3 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Histopathology confirmed as malignant tumor;
- ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1;
- The expected survival time was ≥6 months;
- Intended to receive systemic antitumor therapy (Cisplatin/oxaliplatin regimen);
- Proficient in using ePRO software after training;
Who cannot join
- Patients who were unable to operate the ePRO system without compliance or after repeated training
- The chemotherapy regimen did not contain cisplatin or oxaliplatin
- According to the investigator's assessment, the subjects had other factors that might lead to their forced termination of the study, such as non-compliance with the protocol, other serious diseases requiring combined treatment, serious abnormal laboratory test values of clinical significance, family or social factors, and circumstances that may affect the safety of the subjects or the collection of trial data
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Peking University First Hospital Ethics Committee
Beijing, Beijing Municipality, 100034
Rui Huang, 010-55119025, 416982188@qq.com
Shikai Wu
About this study
Official title: Development and Application Study of ePRO (Patient Reported Outcome) Software for Managing Cancer Patients Throughout the Treatment Period
After receiving chemotherapy, targeted therapy, immunotherapy and other drug treatments, tumor patients often experience various adverse reactions such as bone marrow suppression, diarrhea, pneumonia, etc. However, due to the limited capacity of the hospital, if patients who are discharged home cannot timely detect and deal with severe drug adverse reactions, it will cause harm to their bodies and even threaten their life safety. With the rapid development of network communication, many foreign institutions have tried to develop ePRO software based on patient symptom reports. This type of software is used to monitor drug adverse reactions and provide timely feedback to the attending physician for medical intervention. Existing studies have shown that the application of this type of ePRO software significantly reduces the severity of drug adverse reactions on patients and significantly prolongs survival time.
In this study, the investigators plan to collaborate with Shenzhen 123 Digital Medical Group Co., Ltd. to design and develop a tumor ePRO software that allows outpatient treatment period patients who are discharged home to regularly self-assess the severity of drug adverse reactions and automatically feed back the scoring results to the department's monitoring center. Doctors will make timely diagnosis and treatment based on each patient's score results in order to maximize patient safety after treatment at home. The results of this study will provide better follow-up care for tumor patients who are discharged home after anti-tumor treatment by significantly improving the safety of outpatient treatment period patients with tumors and thereby improving patient survival time and quality.
- Conditions
- Solid Tumor, Adult
- Being tested
- Epro software
- Keywords
- Epro, peritherapeutic period, safety, Efficacy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epro softwareDevice
EPRO software：patients with symptoms will fill in report forms via the software, when the data upload to the terminal, the doctor according to the results of the upload ePRO corresponding medical assessment,and give advises.
| Study group | Role | What they receive |
|---|---|---|
| Group A | No intervention | This was the routine observation group, 50 patients were enrolled in the group. After receiving antineoplastic drug treatment, they were discharged home, and the treatment-related adverse reactions were observed and intervention according to the routine process. |
| Group B | Experimental | This was the ePRO study group: A total of 50 patients were enrolled in this group. After receiving anti-tumor drug treatment, the ePRO system was installed through the mobile phone. After training, the patients could skillfully use the ePRO system. Receives: Device: Epro software |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of health-related quality of life
Use EThe EORTC QLG Core Questionnaire（EORTC QLQ-C30 ）to evaluate the effect of ePRO software on the quality of life of patients during the chemotherapy period.
The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.The scale contains 30 questions, including treatment response, physical symptoms, mental state, etc. The first 28 options were scored on a scale of 1-4, with a low score indicating a good quality of life or mild symptoms; The last two questions is about Quality of life or health which were scored on a scale of 1-7, with lower scores indicating poorer quality of life or health.
Measured: 3 weeks after taking part in this clinical trial
Secondary outcomes (2)
Compliance
To evaluate the compliance of ePRO software in patients during clinical trial.During this clinical trial the investigators will offer the same electronic questionnaire to both two groups.At the end of the study, the researchers will analyze the proportion of patients in the two groups who completed the questionnaire.A higher percentage of completions in that group means better compliance
Measured: 3 weeks after taking part in this clinical trial
Incidence of treatment-related severe adverse reactions
The effect of ePRO software on the incidence of treatment-related severe adverse reactions.At the end of the study, the researchers will compare the adverse reactions that occurred during the trial between the two groups of patients according to ctcae4.0.
Measured: 3 weeks after taking part in this clinical trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2024
- Study start22 May 2024
- Primary completion12 Dec 2024 (estimated)
- Study completion3 Jan 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Solid Tumor, AdultStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Enrolled patients who received cisplatin or oxaliplatin were randomly assigned to one of two groups. Group A was the routine observation group, 50 patients were enrolled in the group. After receiving antineoplastic drug treatment, they were discharged home, and the treatment-related adverse reactions were observed and intervention according to the routine process. Group B was the ePRO study group: A total of 50 patients were enrolled in this group. After receiving anti-tumor drug treatment, the ePRO system was installed through the mobile phone. After training, the patients could skillfully use the ePRO system.
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shikai Wu
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Shikai Wu, Peking University First Hospital
- Investigators
- Shikai Wu, Principal investigator, Peking Univerisity First Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06469268
- Sponsor's protocol ID
- ePRO-001
- Status last verified
- Jun 2024
- First submitted
- 29 May 2024
- Last updated
- 21 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development and Application Study of ePRO (Patient Reported Outcome) Software for Managing Cancer Patients Throughout the Treatment Period
- ClinicalTrials.gov ID
- NCT06469268
- Acronym / sponsor ID
- ePRO-001
- Conditions
- Solid Tumor, Adult
- Keywords
- Epro, peritherapeutic period, safety, Efficacy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Shikai WuUniversity, hospital or other
- Study start
- 22 May 2024 (actual)
- Primary completion
- 12 Dec 2024 (estimated)
- Study completion
- 3 Jan 2025 (estimated)
- First posted
- 21 Jun 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
After receiving chemotherapy, targeted therapy, immunotherapy and other drug treatments, tumor patients often experience various adverse reactions such as bone marrow suppression, diarrhea, pneumonia, etc. However, due to the limited capacity of the hospital, if patients who are discharged home cannot timely detect and deal with severe drug adverse reactions, it will cause harm to their bodies and even threaten their life safety. With the rapid development of network communication, many foreign institutions have tried to develop ePRO software based on patient symptom reports. This type of software is used to monitor drug adverse reactions and provide timely feedback to the attending physician for medical intervention. Existing studies have shown that the application of this type of ePRO software significantly reduces the severity of drug adverse reactions on patients and significantly prolongs survival time.
In this study, the investigators plan to collaborate with Shenzhen 123 Digital Medical Group Co., Ltd. to design and develop a tumor ePRO software that allows outpatient treatment period patients who are discharged home to regularly self-assess the severity of drug adverse reactions and automatically feed back the scoring results to the department's monitoring center. Doctors will make timely diagnosis and treatment based on each patient's score results in order to maximize patient safety after treatment at home. The results of this study will provide better follow-up care for tumor patients who are discharged home after anti-tumor treatment by significantly improving the safety of outpatient treatment period patients with tumors and thereby improving patient survival time and quality.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
- Model description
- Enrolled patients who received cisplatin or oxaliplatin were randomly assigned to one of two groups. Group A was the routine observation group, 50 patients were enrolled in the group. After receiving antineoplastic drug treatment, they were discharged home, and the treatment-related adverse reactions were observed and intervention according to the routine process. Group B was the ePRO study group: A total of 50 patients were enrolled in this group. After receiving anti-tumor drug treatment, the ePRO system was installed through the mobile phone. After training, the patients could skillfully use the ePRO system.
| Arm | Type | Receives |
|---|---|---|
| Group A | No intervention | –This was the routine observation group, 50 patients were enrolled in the group. After receiving antineoplastic drug treatment, they were discharged home, and the treatment-related adverse reactions were observed and intervention according to the routine process. |
| Group B | Experimental | Device: Epro softwareThis was the ePRO study group: A total of 50 patients were enrolled in this group. After receiving anti-tumor drug treatment, the ePRO system was installed through the mobile phone. After training, the patients could skillfully use the ePRO system. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Histopathology confirmed as malignant tumor;
- ECOG (Eastern Cooperative Oncology Group) performance status score: 0-1;
- The expected survival time was ≥6 months;
- Intended to receive systemic antitumor therapy (Cisplatin/oxaliplatin regimen);
- Proficient in using ePRO software after training;
Key exclusion criteria (3 listed)
- Patients who were unable to operate the ePRO system without compliance or after repeated training
- The chemotherapy regimen did not contain cisplatin or oxaliplatin
- According to the investigator's assessment, the subjects had other factors that might lead to their forced termination of the study, such as non-compliance with the protocol, other serious diseases requiring combined treatment, serious abnormal laboratory test values of clinical significance, family or social factors, and circumstances that may affect the safety of the subjects or the collection of trial data
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Epro softwareEPRO software：patients with symptoms will fill in report forms via the software, when the data upload to the terminal, the doctor according to the results of the upload ePRO corresponding medical assessment,and give advises. | Device | Group B |
Primary outcome
Change of health-related quality of life
Time frame: 3 weeks after taking part in this clinical trial
Use EThe EORTC QLG Core Questionnaire（EORTC QLQ-C30 ）to evaluate the effect of ePRO software on the quality of life of patients during the chemotherapy period. The EORTC QLG Core Questionnaire (EORTC QLQ-C30) is a 30 item instrument meant to assess some of the different aspects that define the quality of life of cancer patients.The scale contains 30 questions, including treatment response, physical symptoms, mental state, etc. The first 28 options were scored on a scale of 1-4, with a low score indicating a good quality of life or mild symptoms; The last two questions is about Quality of life or health which were scored on a scale of 1-7, with lower scores indicating poorer quality of life or health.
2 secondary outcomes
Compliance
Time frame: 3 weeks after taking part in this clinical trial
Incidence of treatment-related severe adverse reactions
Time frame: 3 weeks after taking part in this clinical trial
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2024.
Related trials for Solid Tumor, Adult
Active, not recruitingPhase 1/2
A Beta-only IL-2 ImmunoTherapY Study
Advanced Solid Tumor, Unresectable Solid Tumor
Active, not recruiting
Virtual Art Therapy Assisted Re-Integration to Improve Biopsychosocial Outcomes in Adolescent and Young Adult Cancer Survivors, AVATARS Trial
Malignant Solid Neoplasm, Hematopoietic and Lymphatic System Neoplasm
RecruitingPhase 1
A Study to Evaluate the Safety,Pharmacokinetics,Pharmacodynamics,and Efficacy of TJ037130 in Adult Participants With Advanced Solid Tumors
Solid Tumor, Metastatic Ovary Cancer
RecruitingObservational study
NCI Childhood Cancer Data Initiative (CCDI) Led Pediatric, Adolescent, and Young Adult Rare Cancer Registry for Very Rare Solid Tumors
Very Rare Tumors, Very Rare Cancers
RecruitingEarly Phase 1
Indocyanine Green (ICG) Guided Sentinel Lymph Node Mapping for Pediatric Visceral Solid Tumors
Solid Tumor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Shikai Wu principal investigator
Peking Univerisity First Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Epro software in people with Solid Tumor, Adult, run by Shikai Wu at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shikai Wu ((86)18910715326, skywu4329@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of health-related quality of life (time frame: 3 weeks after taking part in this clinical trial). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2024.