Marshall Andrea, Donnelly Peter, Elbeltagi Nada, Gasson Sophie, Broadfield Amy, Hopkins Amy, Hartup Sue, Turner Lesley, Young Annie, Watson Eila K, Dunn Janet A
Warwick Clinical Trials Unit, University of Warwick, Coventry, UK.
Torbay and South Devon NHS Foundation Trust, Torquay, UK.
Health Qual Life Outcomes. 2025 Jul 1;23(1):67. doi: 10.1186/s12955-025-02396-6.
Mammo-50, a randomised phase III trial, demonstrated that for women aged 50 years or older and 3-years post breast cancer diagnosis, less frequent mammograms (2-yearly after conservation surgery; 3-yearly after a mastectomy) were non-inferior to annual mammograms in terms of detection of recurrences, or new breast primaries. It is important to assess Quality of life (QoL) in this population to ensure no detriment is associated with a less frequent mammographic surveillance schedule.
A mixed methods QoL sub-study was undertaken to explore potential differences between the trial arms in terms of fear of recurrence, QoL and distress levels and to explore patient reported experiences. Participants were asked to complete a questionnaire booklet annually whilst on the trial. Longitudinal random effects regression models were fitted to assess changes in QoL over time and across trial arms. Free text data were collected on participants worries or concerns.
5235 women were randomised between April 2014 and September 2018, from 114 UK sites of which 4488 women (86%) returned a baseline QoL booklet. With a median 5.7 years follow-up (8.7 years post-curative-surgery), no differences between trial arms were identified for any of the QoL scales measured. Themes identified from the free text data included co-morbidities, family problems and side-effects of hormone therapy.
There were no differences in any of the QoL scales between the trial arms of Mammo-50, implying that less frequent mammographic surveillance does not adversely impact participants’ QoL. Women were concerned with co-morbidities or family problems and side-effects of treatment rather than worries about having less frequent mammograms.
ISRCTN48534559, 26 February 2014.
Mammo - 50是一项随机III期试验，结果表明，对于年龄在50岁及以上且乳腺癌诊断后3年的女性，较少频率的乳房X光检查（保乳手术后每2年一次；乳房切除术后每3年一次）在复发或新发原发性乳腺癌的检测方面不劣于每年一次的乳房X光检查。评估该人群的生活质量（QoL）很重要，以确保较低频率的乳房X光监测方案不会带来不利影响。
开展了一项混合方法的生活质量子研究，以探讨试验组在复发恐惧、生活质量和痛苦程度方面的潜在差异，并探索患者报告的经历。参与者在试验期间每年被要求完成一本问卷手册。采用纵向随机效应回归模型来评估生活质量随时间和试验组的变化。收集了关于参与者担忧的自由文本数据。
2014年4月至2018年9月期间，114个英国研究地点的5235名女性被随机分组，其中4488名女性（86%）返回了基线生活质量手册。中位随访时间为5.7年（治愈性手术后8.7年），在所测量的任何生活质量量表上，未发现试验组之间存在差异。从自由文本数据中确定的主题包括合并症、家庭问题和激素治疗的副作用。
Mammo - 50试验组之间的任何生活质量量表均无差异，这意味着较低频率的乳房X光监测不会对参与者的生活质量产生不利影响。女性关注的是合并症或家庭问题以及治疗的副作用，而非对乳房X光检查频率降低的担忧。
ISRCTN48534559，2014年2月26日。
