Cancer Patients Undergoning Radiotherapy, Clinical Outcomes, Psychological Distress
Conditions
Keywords
Psychological Distress, Radiotherapy, Advanced Cancer, NCCN Distress Thermometer, Treatment Adherence, Socioeconomic Factors
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.
Detailed description
Study Rationale and Objective: Psychological distress in cancer patients is a recognized catalyst for negative clinical outcomes, yet it remains under-monitored in many tertiary care settings. This research was designed as a prospective longitudinal study to move beyond single-point prevalence surveys and capture the fluctuating nature of distress throughout the radiotherapy (RT) trajectory. The primary objective was to evaluate the longitudinal patterns of distress and identify independent clinical and socioeconomic predictors that correlate with treatment adherence and unplanned healthcare utilization. Operational Framework: The study tracked a purposive sample of 374 cancer outpatients across eight distinct assessment phases: Baseline (T0): Pre-treatment assessment of demographic, socioeconomic, and clinical status. Weekly Monitoring (T1-T8): Real-time tracking of distress levels and symptom accumulation throughout the typical 2- to 8-week RT course. Follow-up (T9): Post-treatment assessment one month after the completion of radiotherapy. Multidimensional Assessment: Distress was quantified using the NCCN Distress Thermometer (DT), a 0-10 visual analogue scale, with a score≥4 triggering clinical concern. To identify the specific drivers of this distress, participants utilized a 42-item Problem List covering five critical domains: Physical: Monitoring the accumulation of RT-related side effects such as fatigue, pain, and changes in appearance. Practical: Identifying logistical barriers, including financial instability (specifically under the Universal Coverage Scheme), transportation difficulties, and work interference. Psychological: Tracking anxiety, fear, and sadness. Social/Family: Assessing caregiving burdens and relationship stressors. Spiritual: Exploring concerns regarding faith and the meaning of life. Statistical Focus: The study employed multivariate ordinal logistic regression to isolate independent predictors of distress severity while controlling for age and gender. This rigorous analysis aimed to confirm how clinical factors, such as Advanced Cancer Stage (III-IV), and socioeconomic factors, such as Healthcare Coverage type, significantly increase the risk of high psychological burden. By correlating these predictors with tangible clinical outcomes, including significant weight changes, missed appointments, and unplanned hospital admissions, the study provides an evidence-based rationale for a multidisciplinary, holistic nursing approach in oncology departments.
Interventions
OTHERSystematic 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
Chulabhorn Cancer Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course | 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 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | This outcome measure focuses on isolating specific clinical and socioeconomic variables that significantly increase the risk of a patient reaching a Distress Thermometer (DT) score of ≥ 4. The study utilizes multivariate ordinal logistic regression to evaluate the predictive power of factors such as Cancer Stage (III-IV vs. 0-II), Healthcare Coverage type (Universal Coverage Scheme vs. Civil Servant benefits), and Treatment Intent (Palliative vs. Curative). By identifying these independent predictors, the research aims to provide a profile for early identification of high-risk individuals who require immediate multidisciplinary intervention |
Countries
Thailand
Contacts
STUDY_DIRECTORSaengrawee Thanthong
Chulabhorn Royal Academy
Outcome results
None listed