protocolSection identificationModule nctId: NCT06294041, orgStudyIdInfo id: UEC23/52, briefTitle: INvestigating the Value of Early Sleep Therapy, acronym: INVEST, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-01, primaryCompletionDateStruct date: 2025-06-01, completionDateStruct date: 2025-06-01, studyFirstPostDateStruct date: 2024-03-05, lastUpdatePostDateStruct date: 2024-03-05, sponsorCollaboratorsModule leadSponsor name: University of Strathclyde, class: OTHER, collaborators name: University of Oxford, collaborators name: University of Glasgow, collaborators name: NHS Greater Glasgow and Clyde, collaborators name: NHS Grampian, descriptionModule briefSummary: 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., conditionsModule conditions: Acute Insomnia (Disorder), designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Due to the nature of the SRT intervention, the research nurse, patients and most of the study team cannot be blinded to treatment allocation. However, the statistician will be blinded to treatment allocation (i.e., SRT or SHE) until after analysis is complete, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Sleep Restriction Therapy (SRT), interventions name: Sleep Hygiene Education (SHE), outcomesModule primaryOutcomes measure: Recruitment rates, primaryOutcomes measure: Retention rates, primaryOutcomes measure: Intervention fidelity: Therapist adherence, primaryOutcomes measure: Intervention fidelity: Patient engagement, primaryOutcomes measure: Intervention fidelity: Control group contamination, primaryOutcomes measure: Outcome measure completion, primaryOutcomes measure: Intervention acceptability, secondaryOutcomes measure: Improvement in insomnia severity, secondaryOutcomes measure: Improvement in mental health [depression], secondaryOutcomes measure: Improvement in mental health [anxiety], secondaryOutcomes measure: Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F), secondaryOutcomes measure: Improvement in rest-activity rhythms, secondaryOutcomes measure: Improvement in sleep [estimates of subjective sleep], secondaryOutcomes measure: Measure of health related quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False