Background The COVID-19 pandemic (officially declared on the 11th of March, 2020), and the resulting measures, are impacting daily life and medical management of breast cancer patients and survivors. We evaluated to what extent these changes have affected quality of life, physical and psychosocial wellbeing of patients (being) treated for breast cancer. Methods This study was conducted within a prospective, multicentre cohort of breast cancer patients and survivors (UMBRELLA). Shortly after the implementation of COVID-19 measures, an extra survey was sent to 1,595 participants, including validated EORTC QLQ-C30/BR23 and HADS questionnaires. Patient-reported outcomes (PROs) were compared to the most recent PROs collected within UMBRELLA pre-COVID-19. The impact of COVID-19 on PROs was assessed using mixed model analysis, adjusting for potential confounders. Results 1,051 patients and survivors (65.9%) completed the survey; 31.1% (n = 327) reported a higher threshold to contact their general practitioner amid the COVID-19 pandemic. A statistically significant deterioration in emotional functioning was observed (82.6 [SD = 18.7] to 77.9 [SD = 17.3], p < .001), and 505 (48.0%, 95%CI = 45.0 to 51.1%) reported moderate to severe loneliness. Small improvements were observed in QoL, physical-, social- and role functioning. In the subgroup of 51 patients under active treatment, social functioning strongly deteriorated (77.3 [95%CI = 69.4 to 85.2] to 61.3 [95%CI = 52.6 to 70.1], p = .002). Conclusion During the COVID-19 pandemic, breast cancer patients and survivors were less likely to contact physicians and experienced a deterioration in their emotional functioning. Patients undergoing active treatment reported a substantial drop in social functioning. One in two reported loneliness that was moderate or severe. Online interventions supporting mental health and social interaction are needed during times of social distancing and lockdowns.

Randomized controlled trials (RCTs)-the gold standard for evaluating the effects of medical interventions-are notoriously challenging in terms of logistics, planning and costs. The cohort multiple randomized controlled trial approach is designed to facilitate randomized trials for pragmatic evaluation of (new) interventions and is a promising variation from conventional pragmatic RCTs. In this paper, we evaluate methodological challenges of conducting an RCT within a cohort. We argue that equally valid results can be obtained from trials conducted within cohorts as from pragmatic RCTs. However, whether this design is more efficient compared with conducting a pragmatic RCT depends on the amount and nature of non-compliance in the intervention arm.

BACKGROUND: Existing patient-reported outcome measures (PROMs) used to assess patients with head and neck cancer have methodologic and content deficiencies. Herein, the development of a PROM that meets a range of clinical and research needs across head and neck oncology is described. METHODS: After development of the conceptual framework, which involved a literature review, semistructured patient interviews, and expert input, patients with head and neck cancer who were treated at Memorial Sloan Kettering Cancer Center were recruited by their surgeon. The FACE-Q Head and Neck Cancer Module was completed by patients in the clinic or was sent by mail. Rasch measurement theory analysis was used for item selection for final scale development and to examine reliability and validity. Scale scores for surgical defect and adjuvant therapy were compared with the cohort average to assess clinical applicability. RESULTS: The sample consisted of 219 patients who completed the draft scales. Fourteen independently functioning scales were analyzed. Item fit was good for all 102 items, and all items had ordered thresholds. Scale reliability was acceptable (person separation index was >0.75 for all scales; Cronbach α values were >.87 for all scales; test-retest ranged from 0.86 to 0.96). The scales performed well in a clinically predictable way, demonstrating functional and psychosocial differences across disease sites and with adjuvant therapy. CONCLUSIONS: The scales forming the FACE-Q Head and Neck Cancer Module were found to be clinically relevant and scientifically sound. This new PROM now is validated and ready for use in research and clinical care.

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