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)

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)

ABSTRACT

Insomnia is a common sleep disorder that affects breast cancer patients, impacting their quality of life. This trial aims to test the feasibility and effectiveness of nurse delivered Sleep Restriction Therapy (SRT) for newly diagnosed breast cancer patients with acute insomnia.

METHODS

The trial will recruit 50 newly diagnosed breast cancer patients with acute insomnia and randomize them to receive either nurse delivered SRT or Sleep Hygiene Education (SHE). SRT will be delivered over 4 weekly sessions, while SHE will be provided in booklet form. Outcomes will be collected at baseline, 6 weeks, and 12 weeks post-randomization.

DISSEMINATION

The trial outcomes will be published in high-impact, peer-reviewed journals and on breast cancer charity websites. The results will inform the development of a full-scale, multicentre trial of SRT for acute insomnia in newly diagnosed breast cancer patients.

STRENGTHS AND LIMITATIONS OF THIS STUDY

This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients. It will provide valuable insight into the feasibility and preliminary effectiveness of delivering SRT during breast cancer treatment. However, due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.

PMID:39141622 | DOI:10.1371/journal.pone.0305304

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