A Randomized Controlled Trial: Evaluating the Sleep, Cancer and Rest (SleepCaRe) Trial to Improve Health‐Related Quality of Life in Women Undergoing Chemotherapy for Breast Cancer

ABSTRACT Purpose Advances in cancer treatment have led to improved survival rates, but challenges related to health‐related quality of life (HRQoL) persist, often exacerbated by sleep disturbances. We present a pre‐registered, secondary analysis of HRQoL from a trial of sleep interventions among women with early or advanced breast cancer receiving chemotherapy. Patients and Methods This 6‐week, multisite, remotely‐delivered, randomized controlled trial compared Cognitive Behavioral Therapy for Insomnia (CBT‐I), Bright Light Therapy (BLT), their combination (CBT‐I + BLT), and an active control (Sleep Hygiene Education, SHE) on HRQoL as measured by the PROMIS‐Preference score (anchors: 0 “Dead” to 1 “Full health”) at baseline, mid‐point (3‐weeks), post‐intervention (6‐weeks), and follow‐ups (3 p = 0.012). In contrast, BLT showed no significant effects (all p ≥ 0.519). No CBT‐I × BLT interaction was observed (all p ≥ 0.759). Clinically meaningful improvement (≥ MID) was observed in 71.2% of CBT‐I participants. Within‐group analyses from baseline to post‐intervention showed the largest HRQoL improvements in CBT‐I and CBT‐I + BLT groups (both b = 0.14; p < 0.001); smaller gains were observed in BLT and SHE groups ( b = 0.07–0.09; p ≤ 0.024). No significant changes were observed in any group at 6‐month follow‐up (all p ≥ 0.096). Exploratory analyses suggested benefits of BLT in patients with metastatic disease and greater insomnia severity. Conclusion CBT‐I was associated with clinically meaningful improvements in HRQoL during chemotherapy. These findings support the integration of CBT‐I into supportive care and highlight the need for tailored approaches for patients with advanced disease or persistent insomnia symptoms. Trial registration ACTRN12620001133921