Psychometric properties of patient-reported outcomes Common Terminology Criteria for adverse events (PRO-CTCAE®) in breast cancer patients: The prospective observational multicenter VIP study.

Patients' self-reporting is increasingly considered essential to measure quality-of-life and treatment-related side-effects. However, if multiple patient-reported instruments are used, redundancy may represent an overload for patients. Patient-Reported Outcomes Common Terminology Criteria for Adverse Events (PRO-CTCAE) are a tool allowing direct patients' reporting of side-effects. We tested psychometric properties of a selected list of PRO-CTCAE items, in a cohort of 303 breast cancer patients, using validated instruments for quality of life assessment as anchors. The analysis of convergent validity with HADS (Hospital Anxiety and Depression Scale) and EORTC BR-23 sub-scales, and the analysis of responsiveness with the PGIC (Patients Global Impression of Change) score supported that a selected list of PRO-CTCAE symptoms might represent a standardized, agile tool for both research and practice settings to reduce patient burden without missing relevant information on patient perceptions. Among patients using digital devices, those with a higher education levels required shorter time to fulfil questionnaires. In conclusion, a selected list of PRO-CTCAE items can be considered as a standardized, agile tool for capturing crucial domains of side-effects and quality of life in patients with breast cancer. The study is registered on clinicaltrials.gov (NCT04416672).

Health-Related Quality of Life among Breast Cancer Patients and Influencing Factors in Morocco

Background: Breast cancer is the most common cancer among women in most countries of the world. It is ranked first in females in Morocco (accounting for 33.4% of the total cancer burden) and more than 60% of cases are diagnosed at stage III or IV. During the last decade, health-related quality of life (HRQOL) has become an important aspect of breast cancer treatment. The objective of this study was to describe self-reported HRQOL in patients with breast cancer and to investigate its associations with sociodemographic and clinical variables. Methods: A prospective study was carried out in the main oncology centers in Morocco. Quality of life was measured using the Moroccan Arabic versions of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C 30 (EORTC QLQ C30) and the Breast Cancer-Specific Quality of Life Questionnaire (EORTC QLQ-BR23). Statistical analyses were performed using descriptive statistics and multivariate analyses. Results: A total of 1463 subjects were included in the study, with a mean age of 55.6 (SD. 11.2) years, 70% being married. The majority had stage II (45.9%) and a few cases stage IV (12.9%) lesions. The participants' global health mean score was 68.5 and in "functional scales", social functioning scored the highest (Mean 86.2 (SD=22.7)). The most distressing symptom on the symptom scale was financial difficulties (Mean 63.2 (SD=38.2)). Using the disease specific tool, it was found that future perspective scored the lowest (Mean 40.5 (SD=37.3)). On the symptom scale, arm symptoms scored the highest (Mean 23.6 (SD=21.6)). Significant mean differences were noted for many functional and symptom scales. Conclusion: Our results emphasized that the general HRQOL for our study population is lower than for corresponding populations in other countries. This study provided baseline information on the quality of life for a large sample of Moroccan women diagnosed with breast cancer.