Clinical trial · Observational
Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials
- 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)
Background: A cancer diagnosis is a threat to life and bodily integrity. This can cause people with cancer to experience traumatic stress. Researchers want to better understand the types of stress and emotional reactions people with cancer experience. They also want to know if the stress people with cancer have had during their life affects their stress related to cancer. Objective: To see if lifetime traumas, along with psychosocial distress, can predict traumatic stress symptoms in people with cancer. Eligibility: People ages 18 and older who have had or are currently getting care from the NIH Clinical Center for one of these cancers: Leukemia Lymphoma Mesothelioma Prostate cancer Design: Participants will be screened with name, date of birth, and diagnosis. Participants will allow access to their medical records. Participants will complete, online or in person, a demographic sheet and 3 questionnaires: The PTSD Checklist for DSM-5: This assesses traumatic stress symptoms and takes 5 10 minutes to complete. The Life Events Checklist for DSM-5: This assesses potentially traumatic life events and takes about 5 minutes to complete. The Brief Symptoms Inventory 18: This assesses psychosocial distress and takes about 4 minutes to complete....
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Leukemia | Leukemia | ONTOLOGY_EXACT | 0.90 |
| Lymphoma | Lymphoma | ONTOLOGY_EXACT | 0.90 |
| Mesothelioma | Malignant Mesothelioma | CURATED_EXACT | 0.92 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (1)
- label
- Single Group of patients with Cancer
- description
- Patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
Primary outcomes (1)
- measure
- Traumatic Stress Symptoms
- timeFrame
- Single Time Point
- description
- A descriptive study to explore the relationships between levels of psychosocial distress and levels of traumatic stress symptoms (TSS) in patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
* INCLUSION CRITERIA: This study is open to all people with or who have been treated for cancer at the NIH CC in Bethesda, Maryland and meet the following criteria. This is done to provide the richest cross-section possible in this availability sample of patients undergoing or post treatment. Eligibility criteria include participants who are: * Currently diagnosed or have been diagnosed with one of four types of cancer: leukemia, lymphoma, mesothelioma, and prostate cancer. Patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum, including active treatment, remission, recurrence, and surveillance or watchful waiting. An oncology diagnosis is considered sufficient for this protocol if it is sufficient for the patient to be enrolled in and actively followed on an oncology protocol at the NIH CC; * Those who are pregnant are eligible to participate; * Those who are HIV positive or have been diagnosed with AIDS in addition to carrying an oncology diagnosis are eligible to participate; * Those who are aged 18 and over, as the research instruments have not been validated in individuals under the age of 18; * Able to understand and willing to sign a written informed consent document to participate in this study; * Enrolled in and actively followed on a clinical trial at the NIH CC. * If applicable, agrees to complete study questionnaires on line. EXCLUSION CRITERIA: * Inability to meet the inclusion criteria; * Inability to provide informed consent; * Individuals with limited English proficiency as the research instruments have not been translated into or validated in languages other than English.
References
Publications (3)
- BACKGROUNDGurevich M, Devins GM, Rodin GM. Stress response syndromes and cancer: conceptual and assessment issues. Psychosomatics. 2002 Jul-Aug;43(4):259-81. doi: 10.1176/appi.psy.43.4.259. PMID 12189252
- BACKGROUNDCella DF, Mahon SM, Donovan MI. Cancer recurrence as a traumatic event. Behav Med. 1990 Spring;16(1):15-22. doi: 10.1080/08964289.1990.9934587. PMID 2322653
- BACKGROUNDZabora J, BrintzenhofeSzoc K, Curbow B, Hooker C, Piantadosi S. The prevalence of psychological distress by cancer site. Psychooncology. 2001 Jan-Feb;10(1):19-28. doi: 10.1002/1099-1611(200101/02)10:13.0.co;2-6. PMID 11180574