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Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy (Distress RT)

7. července 2026 aktualizováno: Saengrawee Thanthong, Chulabhorn Cancer Center

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

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.

Přehled studie

Postavení

Dokončeno

Podmínky

Intervence / Léčba

Detailní popis

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.

Typ studie

Intervenční

Zápis (Aktuální)

374

Fáze

  • Nelze použít

Kontakty a umístění

Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.

Studijní místa

  • Thajsko
    • Bangkok
      • Bangkok, Bangkok, Thajsko, 10210
        • Chulabhorn Hospital

Kritéria účasti

Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.

Kritéria způsobilosti

Věk způsobilý ke studiu

  • Dospělý
  • Starší dospělý

Přijímá zdravé dobrovolníky

Ne

Popis

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.

Studijní plán

Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.

Jak je studie koncipována?

Detaily designu

  • Primární účel: Podpůrná péče
  • Přidělení: N/A
  • Intervenční model: Přiřazení jedné skupiny
  • Maskování: Žádné (otevřený štítek)

Zbraně a zásahy

Skupina účastníků / Arm
Intervence / Léčba
Experimentální: Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy
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.
Jiný: 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.

Co je měření studie?

Primární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course
Časové okno: 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.
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

Sekundární výstupní opatření

Měření výsledku
Popis opatření
Časové okno
Identification of independent predictors of moderate-to-severe psychological distress
Časové okno: 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
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)

Spolupracovníci a vyšetřovatelé

Zde najdete lidi a organizace zapojené do této studie.

Sponzor

Chulabhorn Cancer Center

Vyšetřovatelé

  • Ředitel studie: Saengrawee Thanthong, Chulabhorn Royal Academy

Publikace a užitečné odkazy

Osoba odpovědná za zadávání informací o studiu tyto publikace poskytuje dobrovolně. Mohou se týkat čehokoli, co souvisí se studiem.

Obecné publikace

Termíny studijních záznamů

Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.

Hlavní termíny studia

Začátek studia (Aktuální)

2. května 2025

Primární dokončení (Aktuální)

27. října 2025

Dokončení studie (Aktuální)

30. června 2026

Termíny zápisu do studia

První předloženo

7. července 2026

První předloženo, které splnilo kritéria kontroly kvality

7. července 2026

První zveřejněno (Aktuální)

13. července 2026

Aktualizace studijních záznamů

Poslední zveřejněná aktualizace (Aktuální)

13. července 2026

Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality

7. července 2026

Naposledy ověřeno

1. července 2026

Více informací

Termíny související s touto studií

Klíčová slova

Další relevantní podmínky MeSH

Další identifikační čísla studie

  • 039/2564

Plán pro data jednotlivých účastníků (IPD)

Plánujete sdílet data jednotlivých účastníků (IPD)?

NE

Popis plánu IPD

Confidentiality Protocols: The study protocol approved by the Institutional Review Board of the Chulabhorn Royal Academy explicitly states that all participant data will be kept strictly confidential and will be presented only as an aggregate overview.

Data Protection: All personally identifiable information has been removed from the final dataset to ensure anonymization.

Data Destruction: In accordance with the ethical considerations defined in the "Methods for maintaining volunteer confidentiality," the investigators have committed to destroying all recording data and deleting the dataset immediately upon the completion of the research project.

Access Restrictions: The protocol specifies that data is stored in a locked secure cabinet accessible only to the primary investigators to prevent unauthorized viewing.

Consequently, there is no plan to share individual participant data (IPD) with outside researchers, as doing so would conflict with the established privacy protections.

Informace o lécích a zařízeních, studijní dokumenty

Studuje lékový produkt regulovaný americkým FDA

Ne

Studuje produkt zařízení regulovaný americkým úřadem FDA

Ne

Tyto informace byly beze změn načteny přímo z webu clinicaltrials.gov. Máte-li jakékoli požadavky na změnu, odstranění nebo aktualizaci podrobností studie, kontaktujte prosím register@clinicaltrials.gov. Jakmile bude změna implementována na clinicaltrials.gov, bude automaticky aktualizována i na našem webu .

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