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NCT Number: NCT07193329

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

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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Key information

Conditions

Psychological Distress Malignant Tumor Neoplasms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

First Affiliated Hospital of Wenzhou Medical University

Wenzhou, Zhejiang, 325000, China

Location status: Recruiting

Location contact

Gang Chen, MD

CONTACT

[email protected]

86+13616619566

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Objective Response Rate (ORR) by mRECIST (%)

    Time frame: 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 outcomes

  1. PFS(months)

    Time frame: 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.

  2. Quality of Life (EORTC QLQ-C30)

    Time frame: 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.

  3. Treatment Adherence (MMAS-8)

    Time frame: within one month after treatment

    Adherence will be evaluated by researchers using the 8-item Morisky Medication Adherence Scale (MMAS-8).

  4. OS (month)

    Time frame: through study completion, an average of 3 years

    OS defined as time from treatment initiation to death from any cause.

  5. PHQ-9

    Time frame: 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.

  6. GAD-7

    Time frame: baseline

    The Generalized Anxiety Disorder-7 (GAD-7) is a 7-item questionnaire used to identify and grade the severity of generalized anxiety symptoms.

  7. HAMD

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Gang Chen, MD

Other

Registry information

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Sep 25, 2025
Registry last updated
Sep 25, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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