Abstract P5-08-04: Mammo-50: Mammographic Surveillance in Early Breast Cancer Patients Aged over 50 Years – Patient Reported Outcomes 3 Years Post Diagnosis

Abstract Introduction: There is a lack of evidence or consensus on the optimum frequency and duration of mammographic surveillance and follow-up for breast cancer patients aged 50 years and older at diagnosis. Mammo-50 will provide clinicians with valuable, risk-adjusted information to guide their future practice and is due to report December 2023. Quality of life (QoL) was assessed in a sub-study of the main trial. Methods: A multi-centre, randomised controlled, phase III trial of annual mammography versus 2-yearly for conservation surgery and 3-yearly for mastectomy patients with an observational cohort to explore reasons for non-participation. The trial randomised 5235 women between April 2014 and September 2018 and a further 915 registered in the cohort; 90% of women agreed to participate in the QoL sub-study. QoL questionnaires were completed at trial entry (3 years post-surgery) and then annually for up to 10 years. The distress thermometer was used as a patient reported measure of distress and concerns throughout the trial. The trial team contacted the patient’s clinical care team informing them of the reasons causing patients’ high levels of distress. Results: A total of 4521 (74%) women completed the distress thermometer at baseline. Of these, 289 (6.4%) reported high levels of distress (score 8-10), 825 (18.2%) medium levels of distress (score 5-7), 2033 (45.0%) low levels of distress (1-4) and 1374 (30.4%) reported no distress. Levels of distress were similar across clinical characteristics including surgery type, disease type and ER status, but differed for hormone therapy use (p=0.004). Women who had stopped hormone therapy tended to have higher levels of distress than those who had never had hormone therapy or for whom hormone therapy was ongoing. The most common reasons for causing high levels of distress (score, 8-10) in the 289 patients were sleep problems and/or nightmares (135 (47%)), fatigue, exhaustion or extreme tiredness (132 (46%)), worry, fear or anxiety (111 (38%)), hot flushes (94 (33%)), pain (89 (31%)), memory or concentration (84 (29%)) and sadness or depression (84 (29%)) of patients. Conclusions: Within the Mammo-50 trial, 6.4% of women reported high levels of distress upon trial entry. A quarter of women reported high/medium levels of distress with sleep, fatigue, worry, hot flushes, memory and sadness/depression being the main concerns. Levels of distress were highest in those women who had stopped hormone therapy. These results have been fed back to the UK NCRI breast cancer symptom management group whose remit it is to identify and provide guidelines for supporting women with unmet needs. Acknowledgement and disclaimer: This study is funded by the NIHR HTA programme (project ref. 11/25/03). The views expressed are those of the author(s) and not necessarily those of the NIHR or the Department of Health and Social Care. Citation Format: Amy F. Campbell, Andrea Marshall, Janet A. Dunn, Peter K. Donnelly, Andy J. Evans, Nada I. Elbeltagi, David A. Cameron, Riccardo A. Audisio, Lesley Turner, Eila Watson, Sophie J. Gasson, Annie M. Young, Alastair M. Thompson, Mammo-50 Trial Management Group. Mammo-50: Mammographic surveillance in early breast cancer patients aged over 50 years – patient reported outcomes 3 years post diagnosis [abstract]. In: Proceedings of the 2022 San Antonio Breast Cancer Symposium; 2022 Dec 6-10; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2023;83(5 Suppl):Abstract nr P5-08-04.