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

NCT07193329 | Recruiting DMC

• 1 other identifier: KY2025-235
• Study Type: observational
• Target: 2,000
• Locations: 1 country
• Sites: 1

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.

Conditions

Psychological Distress; Malignant Tumor

Outcome Measures

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.

  at 4-12 weeks after treatment initiation.

Other Outcomes (7)

• PFS(months)

  through study completion, an average of 3 years

• Quality of Life (EORTC QLQ-C30)

  through out treatment, average of 3 years

• Treatment Adherence (MMAS-8)

  within one month after treatment

Study Arms (2)

Malignant Tumor Patients with Psychological Distress

Malignant Tumor Patients without Psychological Distress

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with malignant tumors who were treated at the First Affiliated Hospital of Wenzhou Medical University from July 2025 to July 2028

You may qualify if:

• (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

You may not qualify if:

• (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

Sponsors & Collaborators

• Gang Chen, MD: lead

Study Sites (1)

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

RECRUITING

MeSH Terms

Conditions

Neoplasms

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: M.D., Ph.D., Professor

Study Record Dates

• First Submitted: July 22, 2025
• First Posted: September 25, 2025
• Study Start: July 22, 2025
• Primary Completion (Estimated): July 1, 2028
• Study Completion (Estimated): July 1, 2028
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: 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.
• Access Criteria: 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.

Locations

CN (1)