Psychological distress and its effects on treatment adherence, outcomes, and quality of life in people with cancer
Psychological Distress in Malignant Tumor Patients: Effects on Treatment Adherence, Outcomes, and Quality of Life
This study will try to see if anxiety and depression change how adults with cancer stick to treatment, their health outcomes, and their quality of life over three years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 2000 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | First Affiliated Hospital of Wenzhou Medical University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Wenzhou, Zhejiang) |
| Trial ID | NCT07193329 on ClinicalTrials.gov |
What this trial studies
This is an observational, longitudinal study enrolling adults with confirmed malignant tumors who are planning to receive or are receiving systemic cancer treatment. Participants will complete GAD-7 and PHQ-9 questionnaires to measure anxiety and depression, while treatment adherence, clinical outcomes, and quality-of-life measures are recorded during a 3-year follow-up. No experimental interventions are given; the study examines natural variation in psychological distress and links it to adherence and outcomes. Results aim to clarify associations that could inform supportive care and follow-up strategies.
Who should consider this trial
Good fit: Adults (age ≥18) with pathologically or radiologically confirmed malignant tumors who are planning to receive or are receiving systemic cancer treatment and who can complete questionnaires and provide informed consent.
Not a fit: Patients with severe systemic illnesses, major cognitive impairment preventing questionnaire completion, or those likely to have incomplete data or be lost to follow-up are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, the findings could help identify patients who need psychological support to improve treatment adherence and quality of life.
How similar studies have performed: Previous observational research has linked anxiety and depression with poorer adherence, worse clinical outcomes, and lower quality of life in cancer populations, so this study builds on established evidence.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Wenzhou, Zhejiang
- First Affiliated Hospital of Wenzhou Medical University — Wenzhou, Zhejiang, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.