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Recruiting NCT07193329

Psychological Distress in Malignant Tumor Patients: Effects on Treatment Adherence, Outcomes, and Quality of Life

Observational Psychological Distress Malignant Tumor

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Psychological Distress, Malignant Tumor. Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Primary outcome measures

  • Objective Response Rate (ORR) by mRECIST (%) [Time frame: at 4-12 weeks after treatment initiation.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

China · 1 center
  • First Affiliated Hospital of Wenzhou Medical University — Wenzhou

Identifiers

NCT: NCT07193329 · KY2025-235

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗