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

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. 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 30 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.

- 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.