Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials

May 22, 2020 updated by: National Institutes of Health Clinical Center (CC)

Exploring the Influence of Psychosocial Distress and Lifetime Trauma Exposure on Traumatic Stress Among Oncology Patients on Clinical Trials

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....

Study Overview

Status

Completed

Conditions

Detailed Description

Background:

  • The American College of Surgeons requires accredited cancer hospitals to screen for distress.
  • Providers at the NIH CC do not uniformly screen for traumatic stress in oncology patients but have observed innumerable patients with deficits in social functioning, difficulty adhering to treatment, and trouble coping due to oncology related traumatic stress.
  • A seminal distress study reported the prevalence of distress for 14 cancer diagnoses was as high as 43.4% with prevalence of distress in the 30% range for the diagnoses covered in this study.
  • It has been shown that a cancer diagnosis represents a threat to life and bodily integrity and can create a sense of loss of social and occupational roles, causing one s adaptive capacity to become overwhelmed.
  • In oncology patients, the literature reports that symptoms or traumatic stress range from 20% with early stage cancer to 80% in those with recurrent disease.
  • The outcome of this study will provide information about traumatic stress, aid in the identification of it, and provide guidance on trauma informed care for this population.

Objectives:

  • 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.
  • We will also describe the relationship between psychosocial distress and TSS in the context of the number of lifetime traumas experienced by patients enrolled on a clinical trial at the NIH for cancer treatment.

Eligibility:

  • Patients receiving treatment at the NIH CC will be recruited from four diagnostic groups: leukemia, lymphoma, mesothelioma, and prostate.
  • Inclusion criteria include: diagnosed and treated for one of four types of cancer (patients can have any stage of one of these four types of cancer and can be at any point in the treatment continuum); aged 18 and over; able to understand and willing to sign a written informed consent document to participate in this study; enrolled in a clinical trial and actively followed on at the NIH CC.

Design:

  • This study is an exploratory cross-sectional survey design.
  • Data from the standardized measures (e.g. BSI-18, LEC-5, and the PCL-5) and demographic and medical history from the medical charts will describe the sample.
  • Protocol participation is estimated to take approximately 10-15 minutes per patient.
  • To address the primary objective, a backwards stepwise process will be used to identify covariate variables that will be used in the final model. This will allow for the data to present naturally occurring gaps in p-values to inform significance.
  • Bi-variate analysis such as t-tests to compare means, time since diagnosis, time since clinical trials participation (e.g. treatment) and demographics, will be used to explore differences and relationships among the main variables and the demographic and illness-related variables.

Study Type

Observational

Enrollment (Actual)

55

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Maryland
      • Bethesda, Maryland, United States, 20892
        • National Institutes of Health Clinical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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 eligibility criteria.

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Control
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Single Group of patients with Cancer
Patients with cancer (lymphoma, leukemia, prostate cancer, and mesothelioma) on clinical trials at the NIH Clinical Center.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Traumatic Stress Symptoms
Time Frame: Single Time Point
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.
Single Time Point

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Institutes of Health Clinical Center (CC)

Investigators

  • Principal Investigator: Jennifer D Hendricks, National Institutes of Health Clinical Center (CC)

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 10, 2016

Primary Completion (Actual)

April 27, 2020

Study Completion (Actual)

May 22, 2020

Study Registration Dates

First Submitted

October 27, 2016

First Submitted That Met QC Criteria

October 27, 2016

First Posted (Estimate)

October 28, 2016

Study Record Updates

Last Update Posted (Actual)

May 26, 2020

Last Update Submitted That Met QC Criteria

May 22, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 170010
  • 17-CC-0010

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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