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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| UHealth digital therapeutic | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The quality of life after 6 months follow-up | The evaluation of quality of life is based on FACT questionnaire (Version 4.0) | From enrollment to 6 months after follow-up |
| Measure | Description | Time Frame |
|---|---|---|
| The score of anxiety/depression after 6 months follow-up | The evaluation of anxiety/depression is based on HADS questionnaire | From enrollment to 6 months after follow-up |
| The physical fitness score at the time of tumor progression |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Hao Long, MD | Contact | +86-13802770989 | longhao@sysucc.org.cn |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Sun Yat-sen University Cancer Center | Recruiting | Guangzhou | Guangdong | 510060 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26644527 | Background | 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. | |
| 28586821 |
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The participant data will be encrypted and masked before uploading.
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| ID | Term |
|---|---|
| D008175 | Lung Neoplasms |
| ID | Term |
|---|---|
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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|
The physical fitness score at the time of tumor progression
| From enrollment to the time of tumor progression (up to 72 months) |
| The frequency of emergency treatment | The frequency of emergency treatment | 24 months after enrollment |
| The frequency of rehospitalization | The frequency of rehospitalization | 24 months after enrollment |
| The compliance of follow-up | The evaluation of follow-up compliance is based on the frequency of drop out | 24 months after enrollment |
| Disease-free survival | 24 months after enrollment |
| Overall survival | 24 months after enrollment |
| Background |
| Basch 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. |
| 34995100 | Result | Dai 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. |
| D008171 |
| Lung Diseases |
| D012140 | Respiratory Tract Diseases |