Evolution of post-traumatic stress disorder and patient reported-outcomes during the COVID-19 pandemic among cancer patients of the French longitudinal COVIPACT study.

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, postlockdown, 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.