Application of Digital Therapeutic in Lung Cancer Whole Process ManagementPhase 3NCT06230445
Effects of Digital Therapeutic in Whole Process Management of Lung Cancer
A Phase 3 study testing UHealth digital therapeutic in people with Application of Digital Therapeutic in Lung Cancer Whole Process Management, run by Sun Yat-sen University at 1 site in China.
Trial summary
This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Application of Digital Therapeutic in Lung Cancer Whole Process Management
- What is being tested?
- UHealth digital therapeutic
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 900 participants
- Where
- 1 siteChina
- Study dates
- 1 Jun 2023to 1 Sep 2028
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with histologically or cytologically confirmed lung cancer;
- Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
- ECOG (Performance status) 0-1;
- Patients aged > 18 years and < 70 years;
- The patients themselves or their family members are familiar with mobile and internet;
Who cannot join
- Patients have disease progression in the screening period;
- Patients with symptomatic brain metastasis;
- Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
- Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
- Women who are pregnant or in the period of breastfeeding.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Hao Long, MD, +86-13802770989, longhao@sysucc.org.cn
About this study
Official title: A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.
- Being tested
- UHealth digital therapeutic
- Keywords
- Digital therapeutic, Whole process management, Lung cancer, Patient follow-up
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UHealth digital therapeuticOther
UHealth digital therapeutic is an application that patients can report their symptoms. If the contents that patients fill in reach the threshold, UHealth application will automatic report to doctor and the doctor will give medical advisement through UHealth digital therapeutic application.
| Study group | Role | What they receive |
|---|---|---|
| UHealth digital therapeutic group | Experimental | The patients in this group will use UHealth application to monitor their symptoms and give medical advisement through digital methods. Receives: Other: UHealth digital therapeutic |
| Regular follow-up group | No intervention | The patients in this group will use paper-based follow-up to monitor their symptoms and give medical advisement in outpatient clinic. |
What is being measured
The primary outcome is the main question the study is designed to answer.
The quality of life after 6 months follow-up
The evaluation of quality of life is based on FACT questionnaire (Version 4.0)
Measured: From enrollment to 6 months after follow-up
Secondary outcomes (7)
The score of anxiety/depression after 6 months follow-up
The evaluation of anxiety/depression is based on HADS questionnaire
Measured: From enrollment to 6 months after follow-up
The physical fitness score at the time of tumor progression
The physical fitness score at the time of tumor progression
Measured: From enrollment to the time of tumor progression (up to 72 months)
The frequency of emergency treatment
The frequency of emergency treatment
Measured: 24 months after enrollment
The frequency of rehospitalization
The frequency of rehospitalization
Measured: 24 months after enrollment
The compliance of follow-up
The evaluation of follow-up compliance is based on the frequency of drop out
Measured: 24 months after enrollment
Disease-free survival
Measured: 24 months after enrollment
Overall survival
Measured: 24 months after enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2024
- Study start1 Jun 2023
- Primary completion1 Mar 2026 (estimated)
- Study completion1 Sep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Application of Digital Therapeutic in Lung Cancer Whole Process ManagementStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 3
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 900 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hao Long, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06230445
- Sponsor's protocol ID
- A2023-002
- Status last verified
- Feb 2024
- First submitted
- 31 Aug 2023
- Last updated
- 26 Feb 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: The participant data will be encrypted and masked before uploading.
Publications
Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
PubMed 26644527Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
PubMed 28586821Dai W, Feng W, Zhang Y, Wang XS, Liu Y, Pompili C, Xu W, Xie S, Wang Y, Liao J, Wei X, Xiang R, Hu B, Tian B, Yang X, Wang X, Xiao P, Lai Q, Wang X, Cao B, Wang Q, Liu F, Liu X, Xie T, Yang X, Zhuang X, Wu Z, Che G, Li Q, Shi Q. Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2022 Mar 20;40(9):988-996. doi: 10.1200/JCO.21.01344. Epub 2022 Jan 7.
PubMed 34995100
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Randomized, Open-label Trial of Digital Therapeutic vs Regular Follow-up in Whole Process Management of Lung Cancer
- ClinicalTrials.gov ID
- NCT06230445
- Acronym / sponsor ID
- A2023-002
- Keywords
- Digital therapeutic, Whole process management, Lung cancer, Patient follow-up
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 900 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2026 (estimated)
- Study completion
- 1 Sep 2028 (estimated)
- First posted
- 30 Jan 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.
This trial will randomize patients into two groups, the treatment group will use the digital therapeutic application named 'UHealth' for the whole process management and the control group will use regular follow-up. The trial aims to look into the difference between quality of life, anxiety/depression index, emergency treatment times, hospital admission rate, treatment compliance, OS, DFS and follow-up cost.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| UHealth digital therapeutic group | Experimental | Other: UHealth digital therapeuticThe patients in this group will use UHealth application to monitor their symptoms and give medical advisement through digital methods. |
| Regular follow-up group | No intervention | –The patients in this group will use paper-based follow-up to monitor their symptoms and give medical advisement in outpatient clinic. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with histologically or cytologically confirmed lung cancer;
- Patients have received surgery, neoadjuvant therapy, adjuvant therapy, radiotherapy or other chemotherapy, such as cytotoxic chemotherapy, targeted therapy and immunotherapy;
- ECOG (Performance status) 0-1;
- Patients aged > 18 years and < 70 years;
- The patients themselves or their family members are familiar with mobile and internet;
Key exclusion criteria (5 listed)
- Patients have disease progression in the screening period;
- Patients with symptomatic brain metastasis;
- Patients with dementia, schizophrenia or other psychological diseases that may affect the cognitive behavior;
- Other medical, mental or psychological condition which in the opinion of the investigator would not permit the patient to complete the study or understand the patient information;
- Women who are pregnant or in the period of breastfeeding.
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 |
|---|---|---|
| UHealth digital therapeuticUHealth digital therapeutic is an application that patients can report their symptoms. If the contents that patients fill in reach the threshold, UHealth application will automatic report to doctor and the doctor will give medical advisement through UHealth digital therapeutic application. | Other | UHealth digital therapeutic group |
Primary outcome
The quality of life after 6 months follow-up
Time frame: From enrollment to 6 months after follow-up
The evaluation of quality of life is based on FACT questionnaire (Version 4.0)
7 secondary outcomes
The score of anxiety/depression after 6 months follow-up
Time frame: From enrollment to 6 months after follow-up
The physical fitness score at the time of tumor progression
Time frame: From enrollment to the time of tumor progression (up to 72 months)
The frequency of emergency treatment
Time frame: 24 months after enrollment
The frequency of rehospitalization
Time frame: 24 months after enrollment
The compliance of follow-up
Time frame: 24 months after enrollment
Disease-free survival
Time frame: 24 months after enrollment
Overall survival
Time frame: 24 months after enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2024.
- Background: PubMed 26644527Basch E, Deal AM, Kris MG, Scher HI, Hudis CA, Sabbatini P, Rogak L, Bennett AV, Dueck AC, Atkinson TM, Chou JF, Dulko D, Sit L, Barz A, Novotny P, Fruscione M, Sloan JA, Schrag D. Symptom Monitoring With Patient-Reported Outcomes During Routine Cancer Treatment: A Randomized Controlled Trial. J Clin Oncol. 2016 Feb 20;34(6):557-65. doi: 10.1200/JCO.2015.63.0830. Epub 2015 Dec 7.
- Background: PubMed 28586821Basch E, Deal AM, Dueck AC, Scher HI, Kris MG, Hudis C, Schrag D. Overall Survival Results of a Trial Assessing Patient-Reported Outcomes for Symptom Monitoring During Routine Cancer Treatment. JAMA. 2017 Jul 11;318(2):197-198. doi: 10.1001/jama.2017.7156.
- Results publication: PubMed 34995100Dai W, Feng W, Zhang Y, Wang XS, Liu Y, Pompili C, Xu W, Xie S, Wang Y, Liao J, Wei X, Xiang R, Hu B, Tian B, Yang X, Wang X, Xiao P, Lai Q, Wang X, Cao B, Wang Q, Liu F, Liu X, Xie T, Yang X, Zhuang X, Wu Z, Che G, Li Q, Shi Q. Patient-Reported Outcome-Based Symptom Management Versus Usual Care After Lung Cancer Surgery: A Multicenter Randomized Controlled Trial. J Clin Oncol. 2022 Mar 20;40(9):988-996. doi: 10.1200/JCO.21.01344. Epub 2022 Jan 7.
- Individual participant dataSharing planned: Undecided. The participant data will be encrypted and masked before uploading.
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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing UHealth digital therapeutic in people with Application of Digital Therapeutic in Lung Cancer Whole Process Management, run by Sun Yat-sen University 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 5 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: looking for participants now, as of the sponsor's last update on 26 Feb 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Long, MD (+86-13802770989, longhao@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The quality of life after 6 months follow-up (time frame: From enrollment to 6 months after follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06230445, which also lists 3 linked publications.
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 26 Feb 2024.