Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy

NCT07698782 | Completed DMC

• 1 other identifier: 039/2564
• Study Type: interventional
• Target: 374
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Psychological Distress; Radiotherapy; Advanced Cancer; NCCN Distress Thermometer; Treatment Adherence; Socioeconomic Factors

Outcome Measures

Primary Outcomes (1)

• Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course

  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.

  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

Secondary Outcomes (1)

• Identification of independent predictors of moderate-to-severe psychological distress

  Analysis is conducted using data collected from the pre-treatment baseline (T0) through the completion of the 2-to-8-week radiotherapy course and the one-month post-treatment follow-up (T2)

Study Arms (1)

Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy

EXPERIMENTAL

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.

Other: Systematic monitoring

Interventions

Systematic monitoring OTHER

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.

Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Chulabhorn Cancer Center: lead

Study Sites (1)

Chulabhorn Hospital

Bangkok, Bangkok, 10210, Thailand

Location

Related Publications (8)

• Bussaba 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 BACKGROUND

• Fabian 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 BACKGROUND

• Bunchuailua 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 BACKGROUND

• Paek 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 BACKGROUND

• Ownby 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 BACKGROUND

• Park 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 BACKGROUND

• Mitchell 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.

  PMID: 21251875 BACKGROUND

• Miroshnychenko A, Rae C, Tsangaris E, Breakey VR, D'Agostino N, Klassen AF. Clinical and Demographic Factors Associated with Distress in Adolescent and Young Adults with Cancer. J Adolesc Young Adult Oncol. 2021 Dec;10(6):682-689. doi: 10.1089/jayao.2020.0196. Epub 2021 Apr 12.

  PMID: 33844943 BACKGROUND

MeSH Terms

Conditions

Treatment Adherence and Compliance

Condition Hierarchy (Ancestors)

Health Behavior; Behavior

Study Officials

• Saengrawee Thanthong

  Chulabhorn Royal Academy

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: This research is a prospective longitudinal cohort study tracking 374 cancer outpatients throughout their radiotherapy trajectory. The model utilizes a repeated-measures framework to capture the fluctuating nature of psychological distress and its correlation with clinical results. Operational Phases: Baseline (T0): Pre-treatment assessment to establish demographic, clinical, and socioeconomic profiles. Active Monitoring (T1-Tn): Real-time weekly tracking during the 2-8 week radiotherapy course to monitor cumulative side effects and mid-treatment distress peaks. Follow-up (T2): A final assessment conducted one month post-treatment to evaluate recovery or persistent burden. Clinical Trigger Model: Global distress is quantified via the NCCN Distress Thermometer (DT). Specific independent predictors impact the probability of a patient reaching this intervention threshold.

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 13, 2026
• Study Start: May 2, 2025
• Primary Completion: October 27, 2025
• Study Completion: June 30, 2026
• Last Updated: July 13, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)