Psychological DistressDistress RTNCT07698782
Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy
A study testing Systematic monitoring in people with Psychological Distress and Clinical Outcomes, run by Chulabhorn Cancer Center at 1 site in Thailand.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychological Distress, Clinical Outcomes, Cancer Patients Undergoning Radiotherapy
- What is being tested?
- Systematic monitoring
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 374 participants
- Where
- 1 siteThailand
- Study dates
- 2 May 2025to 30 Jun 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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:
Read more
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.
Read the 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.
- Being tested
- Systematic monitoring
- Keywords
- Psychological Distress, Radiotherapy, Advanced Cancer, NCCN Distress Thermometer, Treatment Adherence, Socioeconomic Factors
- Medical subject headings
- Treatment Adherence and Compliance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Systematic monitoringOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Systematic monitoring |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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
Measured: 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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2026
- Study start2 May 2025
- Primary completion27 Oct 2025
- Study completion30 Jun 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Psychological DistressStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- 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.
- Masking
- None (open label)
- Enrolment
- 374 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulabhorn Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Saengrawee Thanthong, Chulabhorn Cancer Center
- Investigators
- Saengrawee Thanthong, Study director, Chulabhorn Royal Academy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07698782
- Sponsor's protocol ID
- 039/2564
- Acronym
- Distress RT
- Status last verified
- Jul 2026
- First submitted
- 7 Jul 2026
- Last updated
- 13 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 41769304Fabian 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.
PubMed 37165119Bunchuailua 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.
PubMed 41131799Paek 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.
PubMed 27933235Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
PubMed 31538028Park 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.
PubMed 40229622Mitchell 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.
PubMed 21251875Miroshnychenko 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.
PubMed 33844943
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Advanced Cancer Stage and Healthcare Coverage Predict Longitudinal Psychological Distress and Clinical Outcomes in Patients Undergoing Radiotherapy
- ClinicalTrials.gov ID
- NCT07698782
- Acronym / sponsor ID
- Distress RT / 039/2564
- Keywords
- Psychological Distress, Radiotherapy, Advanced Cancer, NCCN Distress Thermometer, Treatment Adherence, Socioeconomic Factors
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 374 participants (actual)
- Lead sponsor
- Chulabhorn Cancer CenterUniversity, hospital or other
- Study start
- 2 May 2025 (actual)
- Primary completion
- 27 Oct 2025 (actual)
- Study completion
- 30 Jun 2026 (actual)
- First posted
- 13 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy | Experimental | Other: Systematic monitoringThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Systematic monitoringThis 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. | Other | Longitudinal monitoring of psychological distress in cancer outpatients undergoing radiotherapy |
Primary outcome
Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course
Time frame: 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.
1 secondary outcome
Identification of independent predictors of moderate-to-severe psychological distress
Time frame: 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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2026.
- Background: PubMed 41769304Bussaba 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.
- Background: PubMed 37165119Fabian 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.
- Background: PubMed 41131799Bunchuailua 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.
- Background: PubMed 27933235Paek 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.
- Background: PubMed 31538028Ownby KK. Use of the Distress Thermometer in Clinical Practice. J Adv Pract Oncol. 2019 Mar;10(2):175-179. Epub 2019 Mar 1.
- Background: PubMed 40229622Park 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.
- Background: PubMed 21251875Mitchell 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.
- Background: PubMed 33844943Miroshnychenko 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Saengrawee Thanthong study director
Chulabhorn Royal Academy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Systematic monitoring in people with Psychological Distress and Clinical Outcomes, run by Chulabhorn Cancer Center at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in psychological distress severity scores as measured by the NCCN Distress Thermometer throughout the radiotherapy course (time frame: 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07698782, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Jul 2026.