BACKGROUND:The COVID-19 pandemic may induce post-traumatic stress disorder (PTSD) symptoms among patients with cancer, who also face adaptations to their treatment. The authors assessed the occurrence of PTSD symptoms, investigated pandemic-induced adjustments in medical oncology practice in patients with cancer, and explored risk factors for PTSD and the association between PTSD symptoms, insomnia, and quality of life (QoL). METHODS: This prospective French study was conducted in patients with solid/hematologic tumors who were receiving medical treatment in the day care departments of 2 cancer centers during the lockdown. Adjustments to medical oncology practice were collected from medical records. PTSD (measured using the Impact of Event Scale-Revised), insomnia (measured using the Insomnia Severity Index), QoL (measured using the Functional Assessment of Cancer Therapy-General instrument), and cognitive complaints (measured using the Functional Assessment of Cancer Therapy-Cognitive Function instrument) were collected through validated questionnaires. RESULTS: Clinical data and questionnaires were available for 734 and 576 patients, respectively. The median patient age was 64 years, and 69% of patients were women. Twenty-one percent of patients had PTSD. Twenty-seven percent (95% CI, 23%-30%) had an adjustment in their medical oncology program, including adjournments (29%), treatment interruptions (16%), modified treatment plans (27%), or adapted monitoring (27%). Women and patients experiencing an adjustment in oncology practice had a higher odds of PTSD (odds ratio= 2.10 [95% CI, 1.07-4.14] and 1.65 [95% CI, 1.03-2.63]; P < .05). PTSD symptoms were correlated with worse scores for QoL, cognition, and insomnia. CONCLUSIONS: Twenty-one percent of patients with cancer experienced PTSD symptoms associated with poor QoL during the first COVID-19-induced lockdown. Medical oncology practice was adjusted in approximately one-quarter of patients and was associated with the occurrence of PTSD symptoms. Psychosocial support should be offered in cancer centers to promote emotional resilience and avoid PTSD symptoms in patients. Cancer 2021;0:1-10.

Background: Patients with cancer may be particularly vulnerable to psychological consequences of the COVID-19 pandemic. We studied the prevalence and evolution of posttraumatic stress symptoms (PTSS) in patients with cancer during the pandemic waves, and we investigated factors associated with high symptoms. Methods: COVIPACT is a 1-year longitudinal prospective study of French patients with solid/hematologic malignancies receiving treatment during the first nationwide lockdown. PTSS were measured every 3 months from April 2020 using the Impact of Event Scale–Revised. Patients also completed questionnaires on their quality of life, cognitive complaints, insomnia, and COVID-19 lockdown experience. Results: Longitudinal analyses involved 386 patients with at least one PTSS assessment after baseline (median age, 63 years; 76% female). Among them, 21.5% had moderate/severe PTSS during the first lockdown. The rate of patients reporting PTSS decreased at lockdown release (13.6%), increased again at second lockdown (23.2%), and slightly declined from the second release period (22.7%) to the third lockdown (17.5%). Patients were grouped into 3 trajectories of evolution. Most patients had stable low symptoms throughout the period, 6% had high baseline symptoms slowly decreasing over time, and 17.6% had moderate symptoms worsening during the second lockdown. Female sex, feeling socially isolated, worrying about COVID-19 infection, and using psychotropic drugs were associated with PTSS. PTSS were associated with impaired quality of life, sleep, and cognition. Conclusions: Approximately one-fourth of patients with cancer experienced high and persistent PTSS over the first year of the COVID-19 pandemic and may benefit from psychological support. ClinicalTrials.gov identifier: NCT04366154

Background: Cancer patients may be particularly vulnerable to psychological consequences of the COVID-19 pandemic and successive lockdowns. We studied the prevalence and evolution of post-traumatic stress disorder (PTSD) symptoms in cancer patients during the pandemic waves, and investigated factors associated with high symptoms. Methods: COVIPACT is a one-year longitudinal prospective study of French patients with solid/hematologic malignancy receiving treatment during the first nationwide lockdown. PTSD symptoms were measured every 3 months from April 2020 using the Impact of Event Scale-Revised. Patients also completed validated questionnaires on quality of life (QoL), cognitive complaints and insomnia, and a survey on their COVID-19 lockdown experience. Results: Longitudinal analyses involved 386 patients with at least one PTSD assessment after baseline (median age 63, 76% female). Among them, 21.5% had moderate/severe PTSD symptoms during the first lockdown. The rate of patients reporting PTSD symptoms decreased at lockdown release (13.6%), increased again at second lockdown (23.2%), and slightly declined from the second release period (22.7%) to the third lockdown (17.5%). Patients were grouped into three trajectories of evolution. Most patients had stable low symptoms throughout the period, 6% had high baseline symptoms slowly decreasing over time, and 17.6% had moderate symptoms worsening during second lockdown. Female sex, feeling socially isolated, worrying about COVID-19 infection, and using psychotropic drugs were associated with PTSD symptoms. PTSD symptoms were associated with impaired QoL, sleep and cognition. Conclusions: Around a quarter of cancer patients presented high and persistent PTSD symptoms over the first year of the COVID-19 pandemic and may benefit from psychological support.

12123 Background: Sudden COVID-19 pandemic has enforced social restrictions across the globe, including social distancing, curfews and total lockdowns, which persist in many parts of the world. Beyond these measures, cancer patients have faced up to the threat of the risk of severe COVID-19 infections and the adaptations of medical oncology practices, with potential impact on their psychological well-being. We aimed to follow Post-Traumatic Stress Disorder (PTSD) symptoms and other Patient-Reported Outcomes (PROs) over this period among cancer patients from the French COVIPACT study. Methods: The COVIPACT study (NCT04366154) included patients with solid/hematologic malignancy receiving medical treatment during the first lockdown in outpatient departments of two cancer centers. Patients were asked to fulfill validated questionnaires on PTSD symptoms (IES-R), insomnia (ISI), quality of life (FACT-G) and cognition (FACT-Cog) at baseline (M0, first lockdown, Apr/May 2020), 3 months (M3, post-lockdown, Jul/Aug 2020) and 6 months (M6, second lockdown, Oct/Nov 2020). PTSD was defined as an IES-R score ≥33 and moderate/severe insomnia as an ISI score ≥15. Higher values on the FACT-G (range 0-108) and FACT-Cog (PCI subscale range 0-72) indicated better quality of life and cognition, respectively. Changes in PROs over time were assessed using mixed models for repeated measures. Results: Among the 734 patients included in COVIPACT, 579, 347 and 328 completed the questionnaires at M0, M3 and M6, respectively: median age, 64 years, 72% women, 59% metastatic status. Patients were mostly treated for breast (44%), lung, head and neck (20%), digestive (16%) and gynecologic cancers (11%). We observed a J-shaped evolution of PTSD over time, affecting 21.2% of patients during the first lockdown, 13.6% the post-lockdown and 23.6% during the second lockdown (p for time < 0.001). Moreover, patients reported linear deterioration of cognitive function over follow-up (p < 0.001). No change was observed in any dimension of quality of life (p for time = 0.06). 24.3%, 27.1% and 28.1% of the patients reported insomnia at M0,M3 and M6 (p for time = 0.35). At each time, PTSD was associated with more insomnia, worst quality of life and cognitive complain. At all the times, ≥50% of patients with PTSD reported insomnia compared to ≤23% in non-PTSD patients (p < 0.001). In addition, there was a clinically significant difference of ≥16 points on the FACT-G and ≥8 points on the FACT-Cog PCI between PTSD and non-PTSD patients (p < 0.001) at the all times. Conclusions: More than 20% of patients have developed PTSD during the different periods of lockdown, with strong association with poor quality of life, cognitive complain and insomnia. Psychosocial support promoting emotional resilience should be largely offered to cancer patients to prevent and/or reduce PTSD. Clinical trial information: NCT04366154.

IntroductionCOVID‐19 outbreak rapidly spread since early 2020 leading to the implementation of nationwide lockdowns. To cope with this sudden change, management guidelines were quickly published to adapt oncological care, with potential impact on cancer outcomes.MethodsWe conducted a retrospective comparative cohort study to assess the impact of the COVID‐19 outbreak in 2020 on cancer outcomes in metastatic patients. Two cohorts of metastatic patients receiving intravenous (iv) therapy in a French oncological day care hospital were assessed: a 2020 cohort during the first French lockdown, and a 2018 historical cohort before the COVID‐19 pandemic. We performed a propensity score analysis to match patients from the two cohorts. After one‐year follow‐up, we compared progression‐free survival (PFS) and overall survival (OS) between cohorts. Adaptations of medical oncological treatments in 2020 were also analysed.ResultsThe 376 patients of the 2020 cohort were matched with 376 of the 2018 cohort. No SARS‐CoV‐2 infection was observed in the 2020 cohort. The adjusted PFS was significantly shorter in 2020 compared to 2018 (HR = 1.23; 95% CI: 1.03–1.46), as well as among patients without treatment adaptation compared to matched patients of the 2018 cohort (HR = 1.33; 95% CI: 1.10–1.61). We did not observe any significant difference of PFS among the group with treatment adaptations. OS was not significantly different.ConclusionMetastatic cancer patients treated during the first lockdown had a higher risk of disease progression 1 year after COVID‐19 outbreak. However, oncological treatment adaptations or SARS‐CoV‐2 infections do not explain these results. A longer follow‐up is needed to observe the impact on OS.