Article Text
Abstract
Introduction Sleep disturbance is commonly experienced by cancer survivors, with rates ranging from 25-59%. Often this can be due to vasomotor symptoms (VMS), particularly in women who are ineligible for menopause hormonal therapy.
Methods The MAC Study ((NCT04766229) was a prospective, single arm, phase 2 trial examining the impact of a composite intervention consisting of -Non-hormonal pharmacotherapy to manage VMS -Digital CBT for insomnia (dCBT-I) through Sleepio (BigHealth) -Self-management strategies for VMS, -Nominated support person. The trial met its primary endpoint, improvement cancer-specific global quality of life (QOL), here we present data on sleep outcomes as a secondary end point.
Results 204 women (82% history of breast cancer). were recruited, with a median age of 49, (range 28 – 66). 93% met diagnosis criteria for insomnia (SCI<16) at baseline, which reduced to 45.2% at 6 months (p<0.001). The mean SCI score increased from 8.5 (SEM 0.4) to 17.3 (SEM0.5) at 6 months (p<0.0005). Clinically relevant changes were seen in sleep parameters, with sleep onset latency reducing by 13.6 minutes after completion of dCBT-I (p<0.001). A 35 minute reduction in wakefulness after sleep onset was also seen (p<0.001) alongside a 29.1% improvement in sleep quality (p<0.001). Comparison of breast cancer and non-breast cancer patients demonstrated the intervention was equally effective in both groups.
Conclusion/Implications The MAC study demonstrated that a targeted composite intervention can improve sleep and self-reported insomnia symptoms for women with troublesome VMS after a cancer diagnosis, which contributed to an improvement in cancer specific global QOL.