Methods
Breast Cancer, cognitive symptoms, breast cancer, malignancy, psychiatric, primary tumour, substance abuse
BREAST CANCER, METASTATIC DISEASE, BREAST CANCER
We conducted a longitudinal, multicentre, parallel, unblinded, randomised controlled trial (RCT). All participants gave written, informed consent, and the study had ethical and regulatory approval (approval number: 2019/ETH12998). The trial was prospectively registered with Australian New Zealand Clinical Trials Registry (ACTRN12612001041842).The study population was initially restricted to breast cancer survivors, who had received at least three cycles of adjuvant chemotherapy, completed any chemotherapy, radiotherapy, and immunotherapy (e.g. trastuzumab) within the last 6–60 months; self-reported cognitive change on the 2-item European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 Cognitive Functioning scale (EORTC-CF) [Key exclusion criteria included: recurrent or metastatic disease; ECOG performance status ≥ 2; any major pre-existing neurological condition, co-morbidity, psychiatric history, or substance abuse, that could interfere with cognitive performance; prior malignancy within the last 5 years; or previous chemotherapy.Participants were recruited from nine Sydney hospitals (via referral from clinical staff of survivors reporting cognitive symptoms) or self-referral via the Australian National Breast Cancer Foundation research register (which sent out intermittent emails to registrants informing them of recruiting studies), or our free-call phone number. Participants were randomly allocated (1:1:1) to the APT intervention, CST intervention, or control group. Randomisation was managed centrally using an interactive voice response system and treatment allocation was determined by minimisation, with participants stratified by: institution, primary tumour type (breast cancer vs. other), hormonal treatment (yes/no).