INvestigating the Value of Early Sleep Therapy

Summary

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.

Conditions

• Acute Insomnia (Disorder)

Interventions

BEHAVIORAL

Sleep Restriction Therapy (SRT)

SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Our SRT protocol involves standardising and (where required) limiting a patient's time in bed with the aim of increasing homeostatic sleep pressure, over-riding cognitive and physiological arousal, and strengthening circadian control of sleep. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. The intervention will be delivered by trained research nurses

BEHAVIORAL

Sleep Hygiene Education (SHE)

SHE will be delivered via a booklet that provides information about lifestyle changes (e.g., reducing exercise in the evening, light snack before bedtime, reducing caffeine) and changes to the bedroom environment (e.g., dark room, comfortable mattress, optimal room temperature). Patients in the SHE condition will be instructed to implement the SHE advice over a 4-week period. One week after randomisation to SHE, the RA will telephone patients to check they understand the SHE advice and answer any questions they may have. SHE has successfully been used as a control condition in other trials evaluating SRT and does not have any therapeutic benefit for individuals with insomnia but is often part of usual care, so is a credible alternative to SRT.

Sponsors & Collaborators

• University of Oxford

  collaborator OTHER

• University of Glasgow

  collaborator OTHER

• NHS Greater Glasgow and Clyde

  collaborator OTHER

• NHS Grampian

  collaborator OTHER_GOV

• University of Strathclyde

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

OTHER

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2024-04-01

Primary Completion

2025-06-01

Completion

2025-06-01