Quality of life and patient reported outcomes in the UK Mammo-50 randomised trial of annual versus less frequent mammographic surveillance in people with breast cancer aged 50 years and over

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BACKGROUND: 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. METHODS: 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. RESULTS: 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. CONCLUSIONS: 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. TRIAL REGISTRATION: ISRCTN48534559, 26 February 2014.

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