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).
Leanne FlemingSolveiga ZibaiteSimon D KyleKathleen BoydVivien GreenJames MansellBeatrix ElsbergerDavid YoungPublished in: PloS one (2024)
This trial is the first to explore the value of sleep prehabilitation for newly diagnosed breast cancer patients.This will be the first trial to assess the feasibility of delivering SRT during breast cancer treatment, providing valuable insight into its tolerability and preliminary effectiveness.An embedded process evaluation will assess the acceptability of SRT, providing insight into potential optimisation of the intervention and recommendations for enhancing its future scalability and translation within cancer care.Due to the nature of the SRT intervention, nurse therapists and patients cannot be blinded to treatment allocation, increasing the risk of bias.
Keyphrases
- study protocol
- newly diagnosed
- randomized controlled trial
- open label
- sleep quality
- placebo controlled
- clinical trial
- phase iii
- physical activity
- phase ii
- primary care
- healthcare
- double blind
- end stage renal disease
- ejection fraction
- systematic review
- chronic kidney disease
- mesenchymal stem cells
- cell therapy
- combination therapy
- risk assessment
- replacement therapy
- smoking cessation