Tundra Space

Tundra Space

Clinical Research Directory

Browse clinical research sites, groups, and studies.

Back to Studies
COMPLETED
NCT07698782
NA

Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy

Sponsor: Chulabhorn Cancer Center

View on ClinicalTrials.gov

Summary

The goal of this observational study is to understand the emotional and physical burden (distress) experienced by cancer patients as they go through radiotherapy treatmen. Researchers want to learn what specific problems such as physical symptoms, financial worries, or travel issues most affect a patient's well-being and how those feelings change over the course of several weeks of care. The main questions it aims to answer are: Does high distress lead to negative clinical results, such as missing radiation appointments, significant weight changes, or needing to be admitted to the hospital unexpectedly? Which groups of patients are at the highest risk for severe distress (for example, those with advanced-stage cancer or those using specific types of health insurance)? What are the most common physical, practical, and emotional problems that cause distress during the different phases of treatment? Participants will: Complete a survey about their health history and background before treatment begins. Rate their distress level on a scale of 0 to 10 (using a tool called a Distress Thermometer) and check off specific concerns from a 42-item list each week during their 2 to 8 weeks of radiotherapy. Complete one final follow-up assessment one month after finishing their radiotherapy treatment.

Official title: Advanced Cancer Stage and Healthcare Coverage Predict Longitudinal Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

374

Start Date

2025-05-02

Completion Date

2026-06-30

Last Updated

2026-07-13

Healthy Volunteers

No

Interventions

OTHER

Systematic monitoring

This study utilizes a standardized longitudinal psychological screening protocol to monitor cancer outpatients across eight distinct phases: a pre-treatment baseline (T0), weekly assessments throughout the 2-to-8-week radiotherapy (RT) course (T1-Tn), and a final follow-up one month post-treatment (T2). Participants are screened using the NCCN Distress Thermometer (DT), a 0-10 visual analog scale for global burden, and a 42-item Problem List that identifies specific stressors across five multidimensional domains: physical, psychological, social/family, practical, and spiritual. This longitudinal framework distinguishes the protocol from standard cross-sectional surveys by capturing the real-time accumulation of side effects and secondary distress peaks occurring mid-treatment. In accordance with the hospital's clinical trigger model, a DT score of ≥ 4 is established as the threshold for clinically significant distress, which facilitates immediate referral to a multidisciplinary team.

Locations (1)

Chulabhorn Hospital

Bangkok, Bangkok, Thailand