COVIPACT Data Sheds Light on Post-Traumatic Stress Prevalence Among Patients, HCPs Amid COVID-19

The coronavirus disease 2019 (COVID-19) pandemic has increased levels of perceived and post-traumatic stress among oncology providers and patients with cancer alike, according to preliminary data from the COVIPACT study, which suggest a need for psychosocial support resources to promote emotional resilience and reduce the risk of post-traumatic stress in patients on active therapy.

Baseline results from the prospective trial (NCT04366154) presented at the virtual 2020 ESMO Congress showed that “there was a high level of stress among patients,” according to Florence Joly, MD, PhD, who led the data review.

Questionnaire responses collected during the French lockdown between April 8, 2020 and May 29, 2020 indicated that post-traumatic stress, synonymous with “Impact of Event Scale-Revised Scale” (IES-R) and categorized as “high,” “medium,” or “low”—was highest among patients subject to COVID-19–related treatment modifications. Twenty-seven percent of these patients reported a “high” level of IES-R compared with 19% of patients whose therapeutic course was not altered (P = .049).

“Low” IES-R levels were also slightly elevated among patients who experienced a treatment modification (35% vs 32%). “We assessed the pandemic-induced therapeutic modifications of patients’ cancer treatment and the psychological impact on patients and caregivers,” said Joly, head of the department of Medical Oncology at the Comprehensive Cancer Centre François Baclesse in Caen, France. Findings from the baseline analysis indicate that treatment modifications have a “negative impact on stress” in patients, she added.

In contrast with the “high” and “low” IES-R findings, “medium” IES-R was more prevalent among patients who did not have a treatment modification (49% vs 38%). Overall, most of the 575 questionnaires (46%) indicated a medium level of IES-R. Low IES-R accounted for 33% of the questionnaire responses; high IES-R, 21%.

The COVIPACT population included 621 systemic therapy-receiving patients with hematological malignancies or solid tumors from the outpatient departments of 2 respective French cancer centers. Assessing the proportion of patients with treatment modifications in time with the French COVID-19 lockdown was the primary end point of the study, which found that modifications occurred in 27% of patients, and included treatment interruptions in 15%, postponement for 32%, changes to the administration schedule in 19%, and adapted monitoring in 30%. Notably, shifts in administration schedule were more common in patients who initiated treatment during the lockdown (33% vs 15.6%).

Measuring “the psychological impact of the pandemic-related lockdown” on patients was COVIPACT’s secondary end point. This objective encompassed reviews of patient IES-R, perceived stress (PSS), sleep difficulty severity/insomnia (ISI), and quality of life (QoL; included in “FACT-G,” a broad QoL category consisting of 27 items) and cognitive complaint (FACT-COG). Patients were asked to fill out self-questionnaires on these factors. Completed stress-related questionnaires were available for 93% of patients.

Patient-Reported PSS

The stress patterns seen in the IES-R analysis were also observed in the PSS evaluation, conducted among 571 questionnaires. Forty-eight percent, 46%, and 6% of the PSS responses indicated low, medium, and high levels of PSS, respectively. Just as treatment modifications led to a greater likelihood that patients would report “high” IES-R, they also predisposed patients to feel “high” PSS. Nine percent of patients whose treatment was changed said they had high PSS compared with 5% of patients whose treatment was not altered (P = .061). As in the IES-R assessment, low levels of stress, specifically PSS, remained slightly elevated among patients with modifications (50% vs 47%), whereas medium PSS was more commonly experienced by patients who did not experience a treatment modification compared with those who did, at 49% versus 41%.

Regarding insomnia, patients who did not have a treatment modification were moderately less likely to have “no or slight” insomnia (77% vs 75%). The opposite was true for “moderate or severe” insomnia, which affected 25% of patients with a modification and 23% without one, respectively.

Interestingly, despite their effects on patient-reported stress, COVID-19–related treatment modifications did not negatively impact patients’ quality of life from a cognitive standpoint, Joly said. In both patients who did and did not experience treatment alterations, the FACT-COG QoL score was the same, 4.6 (P = .5).

Sense of Accomplishment, PSS Both High Among HCPs

Quantifying the psychological impact of the COVID-19 quarantine not only on patients with cancer but also on medical oncologists and oncology day care unit caregivers was the secondary objective of the COVIPACT study, which fielded questionnaires from 73 respondents. The mostly female caregiver population (n = 59) comprised 35 nurses, 4 nursing assistants, 23 medical oncologists (including 1 hematologist), 5 residents, and 6 contributors in other qualifying but unspecified roles. The median age was 40 years (range, 22-63).

When evaluated in the caregiver cohort, PSS showed that these health care providers (HCPs) were experiencing “high” levels of PSS, Joly said. The continuous PSS score was 16.3 (±7.1). When stratified by “high,” “medium,” and “low,” the PSS scores were 10%, 53%, and 37%, respectively. Most respondents (56%) felt a low level of emotional exhaustion.

Despite observed stress, HCPs reported high levels of professional accomplishment and personal self-efficacy, noted Joly. Specifically, 60% said they felt a high sense of professional accomplishment. Thirty-three percent felt a medium level of personal accomplishment. A fraction of patients (7%) reported only a low perception of accomplishment. Data additionally showed that the personal self-efficacy score was 32.8 (of 40; ±4.5).

Patients and participating HCPs were asked to respond to the questionnaires not only at baseline, but also at 3 and 6 months. Following the presentation of the baseline findings on patient stress and other cognitive and QoL-related factors, the “next step” in the COVIPACT study is “evaluating the evolution of psychosocial parameters” over these 2 periods “after the lockdown among patients and caregivers,” Joly said.

These data, when released, are expected to shed light on the longer-term magnitude of treatment modifications on patients with cancer, as well as the determinants of IPSS for both patients and providers. In the meantime, oncology centers should seek to establish psychosocial support resources for patients receiving active therapy in an effort to minimize IES-R, Joly concluded.

Reference

1. Joly F, Leconte A, Grellard J-M, et al. Impact of the COVID-19 pandemic on management of medical cancer treatments and psychological consequence for the patients. Presented at: 2020 ESMO Virtual Congress; September 19-21, 2020; virtual. Abstract LBA69.