INvestigating the Value of Early Sleep Therapy

Twenty percent of breast cancer survivors have insomnia, which is defined as persistent trouble falling and/or staying asleep that results in difficulty functioning during the day. Sleep difficulties often begin at cancer diagnosis, become worse during cancer treatment, and continue into cancer survivorship. Insomnia interferes with daily activities and may cause other mental and physical health problems. It also makes it more difficult to cope with cancer treatment and makes recovery more challenging. For these reasons, it is important to address early signs of sleep problems in cancer patients by offering interventions that may prevent the development of insomnia. Sleep Restriction Therapy is one such intervention, which helps improve night-time sleep by stabilising sleep patterns and reducing time spent in bed awake. Sleep Restriction Therapy has been used successfully to treat chronic insomnia in breast cancer survivors who have completed cancer treatment. However, it has never been tested on newly diagnosed breast cancer patients with early signs of sleep disturbance, who are undergoing cancer treatment. This study will address this knowledge gap by randomly assigning newly diagnosed patients with poor sleep to receive either Sleep Restriction Therapy or a sleep hygiene education (SHE) control intervention. The study will assess sleep and mental health before and after both interventions to determine how feasible and acceptable Sleep Restriction Therapy is to patients and to plan for a future, larger study. Throughout, the investigators will work with patients with lived experience of breast cancer and poor sleep to ensure our study is informed by their expertise.

Sex

All

Minimum age

18 Years

Inclusion Criteria:

Participant is willing and able to give informed consent

Aged 18 years and above

Screen positive for acute insomnia, defined as dissatisfaction with sleep quality or duration, accompanied by other night / daytime symptoms, present for between 2 weeks and 3 months

Newly diagnosed with non-metastatic breast cancer

Primary cancer treatment is surgery

Exclusion Criteria:

* Main study exclusion criteria are limited to conditions contraindicated for SRT or factors that would preclude implementation of SRT.

  1. Pregnancy
  2. Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at study screening interview
  3. Dementia / Mild Cognitive Impairment
  4. Epilepsy
  5. Psychosis (schizophrenia, bipolar disorder)
  6. Current suicidal ideation with intent or attempted suicide within past 2 months
  7. Night, evening, early morning, or rotating shiftwork
  8. Current / previous psychological treatment for insomnia during the last 12 months
  9. Chemotherapy and / or radiotherapy commenced

• DERIVEDFleming L, Zibaite S, Kyle SD, Boyd K, Green V, Mansell J, Elsberger B, Young D. Insomnia prehabilitation in newly diagnosed breast cancer patients: Protocol for a pilot, multicentre, randomised controlled trial comparing nurse delivered sleep restriction therapy to sleep hygiene education (INVEST trial). PLoS One. 2024 Aug 14;19(8):e0305304. doi: 10.1371/journal.pone.0305304. eCollection 2024. PMID 39141622