Hepatocellular Carcinoma (HCC)
Conditions
Brief summary
The goal of this clinical trial is to design a digital PRO intervention model applicable to patients with hepatocellular carcinoma, and The main questions it aims to answer are: * Can symptom management through patients' regular completion of the PRO scale promote self-understanding, self-management and timely seeking of medical help, enable healthcare professionals to accurately and efficiently understand how patients really feel and respond in a timely manner, and ultimately improve health outcomes? * Can digital interventions significantly improve outcomes such as symptom control and quality of life in cancer patients? Researchers divided participants into an intervention group and a control group and compared them to see if digital interventions could improve patient health outcomes. Participants will: * Subjects in the intervention group will be asked to report symptom information weekly (7-day natural week, hereafter) via the public number, and the back office will give symptom management advice or issue alerts based on the filling. Control subjects will not receive PRO intervention. * Participants can offer to withdraw from the study at any time.
Interventions
BEHAVIORALDigitized patient-reported outcomes
Patients fill out the PRO scale regularly online through a specific cell phone program or website, which intelligently analyzes the patient's physical condition, gives symptom management recommendations (which are based on clinical guidelines and expert consensus, and are updated monthly by oncology clinical experts during the study period), and sends alerts to clinical caregivers when the scale scores are abnormal.
Sponsors
Wei Xiaoping
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
The inclusion criteria for the participants are: (1) aged 18 to 75 years, (2) clinically diagnosed as HCC, (3) treated with immunotherapy, (4) able and willing to use smartphones or tablets to complete the follow-up process according to protocol and (5) can understand Mandarin Chinese. The
Exclusion criteria
are: (1) cognitive deficits that would preclude recognizing of their own symptoms and feelings, (2) unable to understand the research content and/or questionnaires, (3) is going to take or having taken surgical resection or liver transplant, (4) currently participating in other clinical trials that may affect this study, or (5) having other malignant tumours.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Health-Related quality of life | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | EORTC QLQ-C30 Quality of Life Scale(European Organization for Research and Treatment of Cancer Quality of Life Questionnaire) The EORTC QLQ-C30 (Version 3) uses for the questions 1 to 28 a 4-point scale. The scale scores from 1 to 4: 1 ("Not at all"), 2 ("A little"), 3 ("Quite a bit") and 4 ("Very much"). Half points are not allowed. The range is 3. For the raw score, less points are considered to have a better outcome. The EORTC QLQ-C30 (Version 3) uses for the questions 29 and 30 a 7-points scale. The scale scores from 1 to 7: 1 ("very poor") to 7 ("excellent"). Half points are not allowed. The range is 6. First of all, raw score has to be calculated with mean values. Afterwards linear transformation is performed to be comparable. More points are considered to have a better outcome. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in patient-reported hepatocellular carcinoma symptoms | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | PRO questionnaire |
| Mental health | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | PHQ-9 Scale((Patient Health Questionnaire-9) The total score can range from 0 to 27. Higher scores indicate greater severity of depression. |
| Survival period | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | — |
| Treatment satisfaction | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | PRO questionnaire |
| Treatment compliance | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | The Morisky Medication Adherence Scale (MMAS-8) The total score of the MMAS-8 scale is the sum of the scores of 8 questions. The score range is 0 to 8 points. The higher the score, the better the medication compliance. A score of 8 indicates good compliance; A score of 6 to 7 indicates moderate compliance. A score less than 6 indicates poor compliance. |
| The number of times the official account functions are used | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | The native statistics system of the WeChat Official Account backend |
| The number of visits to the outpatient department, inpatient department and emergency department | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | PRO questionnaire |
| Direct medical costs | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | — |
| Direct non-medical costs | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | — |
| Indirect cost | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | — |
| Health State Utility | Baseline, Week 4 (post-intervention),Week 18(post-intervention) | EuroQol 5-Dimension 5-Level (EQ-5D-5L) The scale measures quality of life on a 5-component scale.For each dimension, based on the level selected by the respondents, the score for that level is given respectively, with the highest being 5 points and the lowest being 1 point. Then add up the scores of all dimensions to obtain the score of the entire rating scale, with a maximum of 25 points and a minimum of 5 points.The higher the score, the lower the health state utility. |
Countries
China
Contacts
CONTACTYiqi Xia
Outcome results
None listed