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Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy

NCT07698782 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 374

Last updated 2026-07-13

No results posted yet for this study

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.

Conditions

  • Psychological Distress
  • Clinical Outcomes
  • Cancer Patients Undergoning Radiotherapy

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.

Sponsors & Collaborators

  • Chulabhorn Cancer Center

    lead OTHER

Principal Investigators

  • Saengrawee Thanthong · Chulabhorn Royal Academy

Study Design

Allocation
NA
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-02
Primary Completion
2025-10-27
Completion
2026-06-30

Countries

  • Thailand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07698782 on ClinicalTrials.gov