Malignant Tumor, Psychological Distress
Conditions
Brief summary
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.
Interventions
None listed
Sponsors
Gang Chen, MD
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* (1) Confirmed malignant tumors by imaging or pathology (such as hepatobiliary carcinoma, gastric cancer, breast cancer, lung cancer, etc.) * (2) Planning to receive or currently undergoing systemic treatment (such as surgery, chemotherapy, TACE, targeted therapy, etc.) * (3) Age ≥18 years old * (4) Sign the informed consent form and voluntarily participate in this study
Exclusion criteria
* (1) Combined with severe systemic diseases (such as severe cardiovascular and cerebrovascular diseases) * (2) There is severe cognitive impairment and it is impossible to complete the questionnaire assessment * (3) Incomplete clinical data or loss to follow-up
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Objective Response Rate (ORR) by mRECIST (%) | at 4-12 weeks after treatment initiation. | Proportion of participants achieving complete response (CR) or partial response (PR) based on mRECIST criteria, measured on contrast-enhanced CT/MRI. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life (EORTC QLQ-C30) | through out treatment, average of 3 years | 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. |
| Treatment Adherence (MMAS-8) | within one month after treatment | Adherence will be evaluated by researchers using the 8-item Morisky Medication Adherence Scale (MMAS-8). |
| OS (month) | through study completion, an average of 3 years | OS defined as time from treatment initiation to death from any cause. |
| PFS(months) | through study completion, an average of 3 years | PFS defined as time from treatment initiation to radiologically confirmed disease progression (mRECIST) or death from any cause, whichever occurs first. |
| GAD-7 | baseline | The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire used to identify and grade the severity of generalized anxiety symptoms. |
| HAMD | baseline | 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. |
| PHQ-9 | baseline | 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. |
Countries
China
Outcome results
None listed