CancerNCT05501990
Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients
A study testing Health intervention based on intelligent applet in people with Cancer, run by Ruijin Hospital at 1 site in China.
Trial summary
In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cancer
- What is being tested?
- Health intervention based on intelligent applet
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 800 participants
- Where
- 1 siteChina
- Study dates
- 1 Jul 2023to 31 Dec 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign and date informed consent;
- Commit to abide by the research procedures and cooperate with the implementation of the whole research process ;
- Can adhere to and cooperate with research intervention;
- Tumor patients;
- Patients/family members can use smart phones to access the Internet;
- Patients/family members have sufficient cognitive and reading ability;
- No mental illness;
- No serious visual impairment
Who cannot join
- Equipped with specific devices (such as cardiac pacemaker);
- Those who do not meet the conditions listed in the inclusion criteria.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Ruijin Hospital，Shanghai Jiao Tong University School of Medicine
Shanghai, 200025
Lei Huang, PhD, MD, 0086 021 64370045, huangleizhenting@126.com
About this study
In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. We designed an applet based on mobile intelligent electronic devices with a doctor-patient dual interface for the perioperative management of cancer patients and verified its applicability in the general population. This study aims to specifically improve the applet according to the characteristics of cancer patients, use it to accurately manage and intervene cancer patients, and establish a rapid doctor-patient communication platform, hoping to improve prognosis.
- Conditions
- Cancer
- Being tested
- Health intervention based on intelligent applet
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Health intervention based on intelligent appletBehavioural
Patients are jointly managed by a MDT team based on the applet. The supportive intervention based on the applet mainly includes three parts: Nutrition, psychology, and patient management which includes four main parts: Cancer patient education, self-management, patient community, and real-time communication.
| Study group | Role | What they receive |
|---|---|---|
| Health intervention based on intelligent applet | Experimental | Health interventions using electronic applet, including nutrition, psychology, and patient self-management components. Receives: Behavioral: Health intervention based on intelligent applet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acceptability of the applet by cancer patients as assessed by questionnaire
Investigated by a questionnaire with 33 questions, and compared with other mobile medical methods to explore the accessibility
Measured: 3 months
Acceptability of the applet by medical oncology staff as assessed by questionnaire
The questionnaire includes 22 questions, collecting information on attitude feedback, time input, and training cost of medical staff using the mobile medical applet
Measured: 3 months
Secondary outcomes (3)
Self-reported quality of life as assessed by ED-5Q-5L scale
EQ-5D-5L is a set of standardized scales for measuring health status, including 5 dimensions (1-5 points for each dimension) and a VAS for overall assessment of health status. Developed by the European Society for quality of life, it can provide a simple and universal health measurement method for clinical and economic evaluation.
Measured: 3 months
Psychological status as assessed by the HADS scale
Hospital Anxiety and Depression Scale (HADS): A self screening questionnaire composed of 7 anxiety subscales and 7 depression subscales. The total score of each subscale is between 0 and 21. The higher the total score, the more serious the anxiety or depression.
Measured: 3 months
Symptom distress as assessed by the MD Anderson symptom scale
Symptom distress is assessed with MD Anderson symptom scale, which is composed of 13 symptom severity and 6 symptom interference subscales. It is used to assess the interference of symptoms to patients' daily life. The item scores range from 1 to 10. The higher the average score, the more serious the symptom.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2022
- Study start1 Jul 2023
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CancerStudies of the same condition, open and under way.
- More trials run by Ruijin HospitalThe sponsor's other registered studies.
- 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
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 800 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ruijin Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, lei huang, Ruijin Hospital
- Investigators
- Lei Huang, PhD, MD, Principal investigator, Ruijin Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05501990
- Sponsor's protocol ID
- RJODLH-001
- Status last verified
- Dec 2023
- First submitted
- 10 Aug 2022
- Last updated
- 21 Dec 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Accessibility and Feasibility of Intelligent Applet for Health Intervention of Cancer Patients
- ClinicalTrials.gov ID
- NCT05501990
- Acronym / sponsor ID
- RJODLH-001
- Conditions
- Cancer
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 800 participants (estimated)
- Lead sponsor
- Ruijin HospitalUniversity, hospital or other
- Study start
- 1 Jul 2023 (actual)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 16 Aug 2022 (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.
In the 5G era with the revolutionary improvement of network speed, digital medical care has brought great convenience to health services. There is a lack of mobile medical data on cancer care worldwide. We designed an applet based on mobile intelligent electronic devices with a doctor-patient dual interface for the perioperative management of cancer patients and verified its applicability in the general population. This study aims to specifically improve the applet according to the characteristics of cancer patients, use it to accurately manage and intervene cancer patients, and establish a rapid doctor-patient communication platform, hoping to improve prognosis.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Health intervention based on intelligent applet | Experimental | Behavioral: Health intervention based on intelligent appletHealth interventions using electronic applet, including nutrition, psychology, and patient self-management components. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Sign and date informed consent;
- Commit to abide by the research procedures and cooperate with the implementation of the whole research process ;
- Can adhere to and cooperate with research intervention;
- Tumor patients;
- Patients/family members can use smart phones to access the Internet;
Key exclusion criteria (2 listed)
- Equipped with specific devices (such as cardiac pacemaker);
- Those who do not meet the conditions listed in the inclusion criteria.
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 |
|---|---|---|
| Health intervention based on intelligent appletPatients are jointly managed by a MDT team based on the applet. The supportive intervention based on the applet mainly includes three parts: Nutrition, psychology, and patient management which includes four main parts: Cancer patient education, self-management, patient community, and real-time communication. | Behavioural | Health intervention based on intelligent applet |
Primary outcome
Acceptability of the applet by cancer patients as assessed by questionnaire
Time frame: 3 months
Investigated by a questionnaire with 33 questions, and compared with other mobile medical methods to explore the accessibility
Acceptability of the applet by medical oncology staff as assessed by questionnaire
Time frame: 3 months
The questionnaire includes 22 questions, collecting information on attitude feedback, time input, and training cost of medical staff using the mobile medical applet
3 secondary outcomes
Self-reported quality of life as assessed by ED-5Q-5L scale
Time frame: 3 months
Psychological status as assessed by the HADS scale
Time frame: 3 months
Symptom distress as assessed by the MD Anderson symptom scale
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Dec 2023.
- Individual participant dataSharing planned: No
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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.
Lei Huang, PhD, MD principal investigator
Ruijin 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 Health intervention based on intelligent applet in people with Cancer, run by Ruijin Hospital 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 8 inclusion and 2 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 Dec 2023. 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 Lei Huang, PhD, MD (0086 021 64370045, huangleizhenting@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acceptability of the applet by cancer patients as assessed by questionnaire (time frame: 3 months). The study lists 2 primary outcomes in all. 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 Dec 2023.