Clinical trial · Interventional
Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy
Advanced Cancer Stage and Healthcare Coverage Predict Longitudinal Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Cancer Patients Undergoning Radiotherapy | — | UNRESOLVED | — |
| Clinical Outcomes | — | UNRESOLVED | — |
| Psychological Distress | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Systematic monitoring | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy
- description
- This arm consists of a single purposive cohort of 374 cancer outpatients who are observed across eight distinct phases: a pre-treatment baseline (T0), weekly assessments during the 2-to-8-week radiotherapy course, and a one-month post-treatment follow-up (T2). The focus of this arm is the naturalistic observation of fluctuating psychological distress levels and their correlation with clinical outcomes such as treatment adherence and unplanned hospitalizations.
- interventionNames
- Other: Systematic monitoring
Primary outcomes (1)
- measure
- Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course
- timeFrame
- Participants are assessed at eight distinct time points: Baseline (T0): Prior to the initiation of radiotherapy. Weekly Monitoring (T1-Tn): Once per week throughout the 2-to-8-week Follow-up (T2): One month after completion
- description
- The global psychological burden is quantified using the NCCN Distress Thermometer (DT), a single-item visual analog scale ranging from 0 (no distress) to 10 (extreme distress). A score of ≥ 4 is established as the clinical cut-off point, indicating moderate-to-severe distress that warrants multidisciplinary intervention.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients diagnosed with cancer who are receiving treatment through radiotherapy. * Individuals aged 18 years or older. * Ability to communicate effectively and understand the Thai language. * Voluntary agreement to participate in the research project. Exclusion Criteria: * Presence of emergency medical conditions or a clinical necessity to receive treatment by other methods. * Inability to attend follow-up monitoring assessments as dictated by the study protocol. * Participants who request to withdraw from the project during the study period. * Failure to complete the full course of radiotherapy treatment due to disease progression. * A physician's diagnosis of a brain or neurological condition that interferes with the patient's ability to perceive or assess their own symptoms.
References
Publications (8)
- BACKGROUNDBussaba P, Sowanna N, Kanchanasurakit S, Lamkham N, Srivichaiwong N, Limsakul T. Survival Time Difference Between High and Low Symptom Burden Considering Physical and Emotional Symptoms Among Terminal Cancer Patients. J Gen Fam Med. 2026 Feb 27;27(2):e70106. doi: 10.1002/jgf2.70106. eCollection 2026 Mar. PMID 41769304
- BACKGROUNDFabian A, Ruhle A, Domschikowski J, Trommer M, Wegen S, Becker JN, Wurschi G, Boeke S, Sonnhoff M, Fink CA, Kasmann L, Schneider M, Bockelmann E, Treppner M, Mehnert-Theuerkauf A, Krug D, Nicolay NH; Young DEGRO Group. Psychosocial distress in cancer patients undergoing radiotherapy: a prospective national cohort of 1042 patients in Germany. J Cancer Res Clin Oncol. 2023 Sep;149(11):9017-9024. doi: 10.1007/s00432-023-04837-5. Epub 2023 May 10. PMID 37165119
- BACKGROUNDBunchuailua W, Kapol N, Krichanchai S, Krongkaew W, Andres EB. Quality of Life Among Thai Patients With Advanced Cancer: Findings From the APPROACH Study. Asia Pac J Clin Oncol. 2026 Apr;22(2):308-318. doi: 10.1111/ajco.70037. Epub 2025 Oct 23. PMID 41131799
- BACKGROUNDPaek SC, Meemon N, Wan TT. Thailand's universal coverage scheme and its impact on health-seeking behavior. Springerplus. 2016 Nov 10;5(1):1952. doi: 10.1186/s40064-016-3665-4. eCollection 2016. PMID 27933235
- BACKGROUNDOwnby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1. PMID 31538028
- BACKGROUNDPark H, Kang D, Lee TH, Oh D. Dynamics in distress and quality of life in patients undergoing radiation therapy: a prospective cohort study. Support Care Cancer. 2025 Apr 14;33(5):379. doi: 10.1007/s00520-025-09371-3. PMID 40229622
- BACKGROUNDMitchell AJ, Chan M, Bhatti H, Halton M, Grassi L, Johansen C, Meader N. Prevalence of depression, anxiety, and adjustment disorder in oncological, haematological, and palliative-care settings: a meta-analysis of 94 interview-based studies. Lancet Oncol. 2011 Feb;12(2):160-74. doi: 10.1016/S1470-2045(11)70002-X. Epub 2011 Jan 19.