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The goal of this observational study is to learn about the Psychological Distress in Malignant Tumor Patients about Effects on Treatment Adherence, Outcomes, and Quality of Life. The main question it aims to answer is:
Does Psychological Distress affect Malignant Tumor Patients' Effects on Treatment Adherence, Outcomes, and Quality of Life? Malignant Tumor Patients with or without Psychological Distress will answer GAD-7 and PHQ-9 and their Treatment Adherence, Outcomes, and Quality of Life be recorded for 3 years.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Malignant Tumor Patients with Psychological Distress | |||
| Malignant Tumor Patients without Psychological Distress |
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| Measure | Description | Time Frame |
|---|---|---|
| Objective Response Rate (ORR) by mRECIST (%) | Proportion of participants achieving complete response (CR) or partial response (PR) based on mRECIST criteria, measured on contrast-enhanced CT/MRI. | at 4-12 weeks after treatment initiation. |
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| Measure | Description | Time Frame |
|---|---|---|
| PFS(months) | PFS defined as time from treatment initiation to radiologically confirmed disease progression (mRECIST) or death from any cause, whichever occurs first. | through study completion, an average of 3 years |
| Quality of Life (EORTC QLQ-C30) |
Inclusion Criteria:
Exclusion Criteria:
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Patients with malignant tumors who were treated at the First Affiliated Hospital of Wenzhou Medical University from July 2025 to July 2028
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Wenzhou Medical University | Recruiting | Wenzhou | Zhejiang | 325000 | China |
all IPD collected throughout the trial
The individual participant data (IPD) that underlie the results reported in this article will be made available beginning 6 months after publication and ending 36 months after publication.
Data will be shared with researchers who provide a methodologically sound proposal for use in achieving the aims of a specified research project. Proposals should be directed to corresponding author's email. To gain access, data requesters will need to sign a data access agreement.
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| ID | Term |
|---|---|
| D009369 | Neoplasms |
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Quality of life will be assessed using the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30 (EORTC QLQ-C30), with change from baseline analyzed at follow-up intervals.
| through out treatment, average of 3 years |
| Treatment Adherence (MMAS-8) | Adherence will be evaluated by researchers using the 8-item Morisky Medication Adherence Scale (MMAS-8). | within one month after treatment |
| OS (month) | OS defined as time from treatment initiation to death from any cause. | through study completion, an average of 3 years |
| PHQ-9 | The Patient Health Questionnaire-9 (PHQ-9) is a 9-item self-report tool designed to screen for and assess the severity of depressive symptoms based on DSM criteria. | baseline |
| GAD-7 | The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire used to identify and grade the severity of generalized anxiety symptoms. | baseline |
| HAMD | The Hamilton Depression Rating Scale (HAMD) is a clinician-administered instrument widely used to evaluate the severity of depressive disorders in clinical and research settings. | baseline |