Psychological Distress in Malignant Tumor Patients: Effects on Treatment Adherence, Outcomes, and Quality of Life
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorGang Chen, MD
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
(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
Disqualifiers
(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
Trial population
Patients with malignant tumors who were treated at the First Affiliated Hospital of Wenzhou Medical University from July 2025 to July 2028
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
2,000 Participants
are grouped into 2 trial groupsGroup A: Malignant Tumor Patients with Psychological Distress
Group B: Malignant Tumor Patients without Psychological Distress
Trial outcomes
Primary outcomes
1
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.
Time frame
at 4-12 weeks after treatment initiation.Other outcomes
1
PFS(months)
PFS defined as time from treatment initiation to radiologically confirmed disease progression (mRECIST) or death from any cause, whichever occurs first.
Time frame
through study completion, an average of 3 years2
Quality of Life (EORTC QLQ-C30)
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.
Time frame
through out treatment, average of 3 years3
Treatment Adherence (MMAS-8)
Adherence will be evaluated by researchers using the 8-item Morisky Medication Adherence Scale (MMAS-8).
Time frame
within one month after treatment4
OS (month)
OS defined as time from treatment initiation to death from any cause.
Time frame
through study completion, an average of 3 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Gang Chen, MD
Lead sponsor
First Affiliated Hospital of Wenzhou Medical University
Sponsor institution
Source ClinicalTrials.gov