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Original Article

Influence of psychosocial distress on traumatic stress symptoms among oncology patients in clinical trials

Cunningham, Schuyler C.a,∗; Wakim, Paulb; Hendricks, Jennifera; Cassidy, Quinna; Teigen, Erina; BrintzenhofeSzoc, Karlynnc

Author Information
Journal of Psychosocial Oncology Research and Practice: June 2020 - Volume 2 - Issue 2 - p e21
doi: 10.1097/OR9.0000000000000021
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Abstract

1 Introduction

More than one-third of people diagnosed with cancer experience levels of distress that would benefit from psychosocial interventions.[1] Distress is an unpleasant emotional reaction that interferes with a patient's ability to cope with their cancer diagnosis, symptoms, and/or treatment.[2] Distress is reported to be as high as 43% in the oncology population and can be debilitating for people with cancer.[1,3] Increased psychosocial distress is associated with decreased treatment adherence, barriers in communication between patient and provider, increased health care costs, and poorer quality of life.[4–9]

A growing body of literature explores the prevalence of PTSD and subsyndromal levels of PTSD in the oncology population. A cancer diagnosis and treatment pose threats to life and bodily integrity, often resulting in a sense of loss of social and occupational roles, overwhelming a patient's adaptive capacity, and leading to the development of barriers to effective treatment participation.[4,8–10]

Studies indicate that among adults with cancer, the prevalence of PTSD is between 7% and 14% by self-report, whereas 6% report current PTSD and just under 13% through structured diagnostic interviews. Subsyndromal levels of PTSD, based on structured diagnostic interviews, were reported in 10% to b20% of adults with cancer.[11] Mundy et al[12] found that the onset of PTSD and subsyndromal PTSD occurred among 35% and 27%, respectively, of breast cancer patient participants over the course of treatment. Moreover, symptoms of traumatic stress symptomatology (TSS) among people with cancer can interfere with functioning at a rate of 20% with early stage cancer to as high as 80% in those with recurrent disease.[4,13] Several studies have shown that advanced disease may be associated with increased variety and severity of TSS compared to those at the time of diagnosis.[4,13–15] The literature also notes empirical support for the use of a trauma-informed psychosocial support model of care for this population.[4,14]

Most research was conducted using the criteria of PTSD according to the DSM-IV-TR, which explicitly allows for a life-threatening illness as the PTSD stressor.[16] In the current DSM-5, the revision of the definition of medically based trauma for diagnosing PTSD made a cancer-related PTSD diagnosis more challenging.[17] Noncatastrophic, life-threatening stressors, such as cancer, no matter how severe, no longer explicitly qualify as a PTSD antecedent.[17] DSM-5 requires that a medical event must be sudden and catastrophic, such as waking during surgery or experiencing anaphylactic shock, to qualify. The updated DSM-5 definition does not change that the abundance of emotional and physiological symptoms experienced by cancer patients and that some of these symptoms may be trauma-related, which is well documented in the literature.[13,14]

Although there is literature discussing psychosocial distress in people with cancer in general, nothing was found exploring the prevalence of distress among cancer patients on cancer clinical trials. One study exploring how Institutional Reviews Board members assessed the ratio of risks and benefits of cancer participating in phase II cancer clinical trials was found. They reported that 93% of the members believed participation in phase II cancer clinical trials would result in psychological distress beyond that experienced by the diagnosis itself.[18] Furthermore, there is limited discussion of TSS among people with cancer or a history of cancer. For this paper, TSS is on a continuum from no or low levels of symptoms to high levels of symptoms, which may result in a diagnosis of PTSD.

1.1 Stress model theory

This study was guided by the Transactional Model of Stress and Coping, also called the Stress Model Theory (SMT). This theory was developed by Lazarus and Folkman and expanded over the past 3 decades.[19–21] SMT uses cognitive, motivational, and relational theories to illustrate how emotions are generated due to a stressful event, the outcome of an appraisal of the event, and how coping mediates between the appraisal and outcome or reaction to the event.[19–23]

One of the major expansions of SMT was the inclusion of preevent factors that influence how one reacts to a stressor or event.[19–21] The pre-event factors include person factors and situation factors. Lifetime traumatic events are an aspect of preevent experiences, both personal and situational. Demographics and pre-existing aspects of the individual are predisposing. Illness-related data combine both information that might influence situational factors and the actual stressful event. All of these factors contribute to an emotional reaction as depicted in Figure 1. The outcome of the preevent experiences may result in psychosocial distress and traumatic stress in people with cancer.

Figure 1
Figure 1:
Emotional reaction as described by the Stress Model Theory[15,19].

1.2 Purpose of the study

The paucity of literature exploring the presence of distress or TSS in people with cancer enrolled in clinical trials leaves providers unaware of the prevalence and the possible impact on this population. The purpose of this study was to explore demographics and illness-related variables, psychosocial distress, lifetime traumas experienced, and levels of TSS in people with leukemia, lymphoma, mesothelioma, or prostate cancer who were enrolled in clinical trials at the National Institutes of Health (NIH) Clinical Center (CC). This sample was selected due to convenience.

2 Methods

2.1 Design

This exploratory study utilized a cross-sectional survey design. Data were collected from eligible participants one time using the standardized measures described below, as well as participants’ electronic medical charts. The study had been scoped for a sample size of 300; however, due to limited resources, the study was closed when it reached a sample of 55.

2.2 Instrumentation

The Brief Symptoms Inventory (BSI-18) was used to measure distress. It is a self-report instrument that measures psychosocial distress over the previous 7 days using an 18-item, 5-point Likert scale with a response set of 0 (not at all) to 4 (extremely).[24] Scores from the BSI-18 produce a global symptoms index (GSI) for psychological distress and subscale scores.[24] The BSI-18 has been shown to be reliable with an overall α = .71 to 0.85.[25] In cancer patients, Cronbach alpha for the full scale was .87.[1] The BSI-18 is normed and validated with oncology patients and survivors over 18 years’ old.[25] Only the GSI was used in the analysis.

The number of exposures to lifetime traumas were identified using the Lifetime Event Checklist (LEC-5) to control for non-cancer related events known to cause traumatic stress. The LEC-5 is a 17-item, self-report instrument developed by the U.S. Department of Veterans Affairs (VA).[26] Each item asks participants to identify their experience of a specific type of potentially traumatic event: “happened to me,” “witnessed it,” “learned about it,” “part of my job,” “not sure,” and “does not apply.”[27] The LEC-5 was developed following the publication of the DSM-5.[26]

Although there are no current psychometric data available for the LEC-5, it is based on the LEC-4; changes to the LEC-5 are minimal.[28,29] The LEC-4 is reliable with a mean Kappa of 0.61 and test–retest of .82 with strong convergent validity with instruments measuring exposure to trauma and trauma-related psychopathology.[30]

Levels of TSS were measured using the PTSD Checklist (PCL-5).[30] This free instrument is a 20-item, self-report instrument with a Likert scale to measure symptoms of PTSD developed by the VA.[30] The PCL-5 was used only to identify level of TSS. The PCL-5 is reported to be reliable (α = .94, r = .94) and to have strong convergent validity in adults (r = .74–.85).[31]

Demographic and illness-related data were collected through a demographic survey and retrieval from electronic medical records. Data collected from the electronic medical record of each participant included: diagnosis, date of diagnosis, treatments received through NIH protocols, and Eastern Cooperative Oncology Group (ECOG) Scale of Performance Status. Collection of these data was made through the Biomedical Translational Research Informatics System (BTRIS) of participants’ records in the Clinical Research Information System (CRIS).

2.3 Inclusion/exclusion criteria

Participants were eligible if they had a diagnosis of one of the four oncology diagnoses mentioned above, were enrolled on an NIH clinical protocol at CC, were 18 years or older, and had proficiency in English. The specific oncology clinical trial, related to their oncology diagnosis, was not considered. People with HIV/AIDS or who were pregnant were also eligible. The exclusion criteria included inability to meet inclusion criteria or inability to provide informed consent.

2.4 Recruitment and consent process

Participants were recruited from both the inpatient and outpatient settings at the NIH CC. The investigators collaborated with primary medical treatment teams who introduced the study to potential participants, confirmed their interest, and obtained verbal permission to provide their contact information to the investigators for follow-up. Once a potential participant was referred to investigators, a team member led the potential participants through a review of the consent form in person. If in agreement, the informed consent was executed, and data collection began.

2.5 Data collection process

After an investigator explained the questionnaires to the participant, and answered questions, the participant completed the questionnaires. The investigator was available to answer any questions. To ensure that serious psychological distress (eg, suicidal ideation) was immediately addressed, an investigator reviewed question 17 on the BSI-18 at the time of completion. A positive response of ≥2 indicated the participant required an urgent clinical assessment.

2.6 Data analysis

For all analyses, PCL-5 was the dependent variable reflecting TSS. In the bivariate analysis, each of the 6 independent variables (BSI-18, LEC_Happened_to_me, LEC_Witnessed_it, LEC_Learned_about_it, LEC_Part_of_my_job, and diagnosis) was included in a model alone. In the multivariable analysis, they and the following variables were considered as potential predictors of TSS: sex; age (years); race; education level; marital status; religion; sexual orientation; whether a participant received hormone therapy; chemotherapy; radiation therapy; surgery; bone marrow allogeneic transplant; immunotherapy; number of treatments received to date (sum of the above yeses) (0–7); whether the participant was in active treatment at the time of administration of the study questionnaires (yes/no); whether the participant was part of a grafts versus host diseases clinical trial (yes/no); and the participant's ECOG performance status rating (0–5).

All 23 demographic and illness-related variables were considered in the multiple regression analysis as candidate independent variables, allowing anyone of them the possibility to also be used as a control variable. The selection of “important” predictors was based on a stepwise approach using a combination of P value and Schwarz Bayesian information criterion as selection criteria.[32] Instruments with missing data were considered complete if at least 80% of questions were answered. In those cases, the total scores were ratio-adjusted.[33,34] If <80% of the questions were answered, the instrument total score was considered missing.

2.7 Data availability

The data that support the findings are available upon reasonable request.

3 Results

3.1 Sample description

The final sample included 53 participants. The majority of the participants were male (81%), white (74%), married or partnered (58%), and had a diagnosis of prostate cancer (42%). The mean age was 56.2 (SD = 16.3) with a range from 19 to 84 (see Table 1). At the time of the survey, 43.4% of participants were in active treatment.

Table 1
Table 1:
Description of sample (N = 53).

3.2 Measure description

For all instrument measures, at least 80% of the questions were answered, and therefore none was considered missing. The mean score for the BSI-18 was 8.0 (SD = 9.3). For the PCL-5, the mean was 9.6 (SD = 9.3). The means of the 4 individual LEC-5 scores ranged from 0.6 (SD = 1.6) to 4.1 (SD = 2.2). These results are summarized in Table 2. On the BSI-18, 28% of the sample scored with clinical distress. This prevalence is consistent with the literature.[1]

Table 2
Table 2:
Summary scores of measures (N = 53)

3.3 Bivariate analysis

Bivariate analysis found that the level of distress and TSS had a statistically significant positive relationship (F = 50.99, P < .0001). The bivariate analysis showed a statistically significant positive linear relationship between “happened to me” and TSS (F = 12.73, P = .0008). Additionally, the number of traumatic events across the lifespan and TSS also had a statistically significant positive relationship (F = 9.53, P = .0033). The more often a participant answers affirmatively to “happened to me,” the higher their TSS score is likely to be. Similarly, there was also a statistically significant positive linear relationship between “witnessed it” and TSS (F = 7.34, P = .0092). The more often participants answer affirmatively to “witnessed it” the higher their TSS score is likely to be. Oncology diagnosis (p = 0.58) was not found to be statistically significant.

3.4 Multiple regression

Initially, 23 candidate independent variables were considered for the multivariable analysis; but because ECOG was not consistently reported in medical records, it was excluded. Marital status was not reported by one participant, bringing the effective sample size for analysis to 52.

From the stepwise regression analysis, only 2 variables were selected as best predictors of TSS: psychosocial distress (P < .0001, effect size = .39) and marital status (P = .021, effect size = .041). Together, they explained 56.7% of the TSS variance as reported on the PCL-5 (F = 32.04, P < .0001). Participants with higher levels of distress and those not currently married or partnered were more likely to have higher levels of TSS. More specifically, 1-point increase on the BSI-18 was associated with a 0.67 points increase in the PCL-5 score (95% confidence interval: 0.47–0.87); and participants who were married or partnered had, on average, 4.4 points less on the PCL-5 than those not married or not partnered (95% confidence interval: 0.69–8.11). Model fit diagnostics indicated that model assumptions were reasonably met.

4 Discussion

The bivariate analysis shows positive significant relationships between “it happened to me” and “I witnessed it” and TSS. These relationships suggest that if a participant had an event known to cause TSS, they were more likely to report higher levels of TSS. Therefore, those with risk factors for TSS may be considered at higher risk for greater distress and TSS.

The multiple regression was utilized to identify the combination of variables that is most associated with TSS. Of the 23 candidate independent variables, only levels of distress, as measured by BSI-18, and marital status were selected as “best” predictors of TSS. Participants who reported a higher level of distress, and those not currently married or partnered were more likely to report higher levels of TSS.

The approximate .67-point increase in TSS scores for 1 point in a distress score indicates the relationship between distress and traumatic stress is more important than may be initially recognized. Notably, on average, participants who were married or partnered had a score 4.4 points lower than those who reported not married or partnered. In the multiple regression analysis, the P value for marital status was .021, which may not reflect strong evidence of association, but is still relevant to report given that marital status, in the mostly male sample, can serve as a proxy for social support and therefore may inform future research.

4.1 Future directions

This pilot study offers important initial implications for this population. Repeating this study with a larger sample size will allow for greater power to detect meaningful relationships. These results also suggest that future research should include qualitative approaches to triangulate these findings. Interviews with patients may allow for greater understanding of the stressors, duration, onset, and factors contributing to the psychosocial symptoms following a diagnosis of cancer. Qualitative research could also provide more clarity regarding the relationship between past events in a participant's life known to cause traumatic stress and a potential relationship to TSS as it relates to their cancer experience.

Further research is needed to explore the relationships between the scoring of the BSI-18 and PCL-5 for providers seeking to efficiently screen patients for oncology-related TSS. The BSI-18 may prove sufficient for screening for both distress and TSS.

Expanding investigation of TSS in oncology patients outside of clinical trials may improve generalizability of the findings and develop understanding that cancer is an antecedent of traumatic stress in other medical populations. Further research could provide information on a possible PTSD sub-syndrome, an oncology trauma syndrome, similar to the rape trauma syndrome.[35]

4.2 Study limitations

This pilot study focused on patients with four cancer sites on clinical trial protocols at the NIH CC. This population was used as it was convenient and accessible. Therefore, generalizing to populations dissimilar should be considered before generalizing these findings. The idiosyncrasies of participating in a clinical trial may also be a limiting factor to these results. Additionally, the NIH is a federally funded hospital and does not require insurance payment for services. This study was also limited to an adult population as the instruments were not validated with those younger than 18 years.

An ECOG score was included to rate the medical acuity of participants and shed light on the possible relationships between medical acuity and other variables. The lack of a criterion standard for assigning psychosocial acuity to oncology patients leaves a gap in this potentially important variable.

The PCL-5 is not yet validated for use in oncology settings. Since participants are asked to respond on the PCL-5 based on “a very stressful experience,” this language may not be best aligned for use in patients with cancer given that identifying one stressor may prove difficult.[29]

4.3 Clinical implications

Psychosocial distress is a well-documented challenge for people with cancer.[1,2,4–9,10] Likewise, a cancer diagnosis and the various forms of treatment can be experienced as a life-threatening condition.[4,8,9,11] A threat to life and bodily integrity is a hallmark of traumatic stress and PTSD and the prevalence of PTSD in people with cancer is well documented.[10,17] The updated DSM-5 criterion for PTSD does not explicitly include a cancer diagnosis as a qualifying event for PTSD; neither does it provide diagnostic criteria for syndromes in which traumatic stress exposure is present and the participant may benefit from trauma informed care.[18] It may be that this population is exposed to traumatic stress below the threshold of PTSD but above the threshold of clinically significant distress. Therefore, this study sought to investigate a possible relationship between oncology related distress and TSS in people with cancer. The findings of this study suggest there is a significant relationship between oncology related psychosocial distress and oncology-related traumatic stress.

Conflicts of interest statement

The authors have no conflicts of interest to report.

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Keywords:

Cancer-related traumatic stress; Clinical trials; Oncology trauma syndrome; Psychosocial distress

Copyright © 2020 The Authors. Published by Wolters Kluwer Health Inc., on behalf of the International Psycho-Oncology Society.