INvestigating the Value of Early Sleep Therapy (INVEST)

A Pilot Randomised Control Trial of Sleep Restriction Therapy Versus Sleep Hygiene Education for Newly Diagnosed Breast Cancer Patients With Acute Insomnia

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Acute Insomnia (Disorder)
• Intervention / Treatment: Behavioral: Sleep Restriction Therapy (SRT); Behavioral: Sleep Hygiene Education (SHE)

Detailed Description

The primary aim of this project is to assess the feasibility and inform the design of a full-scale RCT of SRT for newly diagnosed breast cancer patients with acute insomnia. Secondary aims of this project are to assess the effects of SRT alongside a sleep hygiene education (SHE) control on sleep, rest-activity rhythms, and mental health.

Participants will be recruited from breast cancer results clinics in two study sites. Our target population is newly diagnosed, non-metastatic patients whose primary cancer treatment is surgery. Participants will go through initial screening and will be sent an online participant information sheet and consent form. Once consent form is signed, marking enrolment in the study, the second stage of screening will commence. It involves assessing current sleep status (based on diagnostic criteria for acute insomnia) current psychiatric symptoms and review of other relevant medical information (diagnosis of other sleep disorders, other medical and psychiatric disorders). This is to confirm the diagnosis of acute insomnia and establish that there are no medical or psychiatric conditions that might preclude someone from taking part in the study. Once eligibility is ascertained, patients will be randomly assigned to SRT or the SHE control group. The investigators aim to randomise 50 patients (n=25 in each trial arm).

After randomisation to SRT or SHE, patients will be sent an email with a link to complete a baseline (pre-intervention) assessment of sleep, fatigue, and mental health. Patients will also be required to complete the consensus sleep diary and wear an actigraphy device for 7 days prior to commencement of SRT/SHE to record sleep and rest/activity rhythms. After completion of the baseline assessment, patients will either be referred to the research nurse for commencement of the SRT protocol or provided with the SHE resource. At 6 weeks, and 3 months post-randomisation, patients will be requested to complete the same battery of questionnaires as during the baseline assessment. Following completion of the final study assessment (3 months post-randomisation), those randomised to the SHE condition will be offered the opportunity to complete the SRT protocol without the requirement to complete any further assessments.

Interventions: Sleep Restriction Therapy (SRT)

SRT is a manualised, adaptive, behavioural insomnia intervention that is a key active ingredient within multi-component CBT-I. Those randomised to the SRT arm will receive two online sessions supported by two telephone calls over a 4-week intervention phase. SRT will be delivered by trained research nurses.

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.

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Leanne Fleming, PhD; Phone Number: 01415482573; Email: l.fleming@strath.ac.uk
• Study Contact Backup: Name: Solveiga Zibaite, PhD; Email: solveiga.zibaite@strath.ac.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Sleep Hygiene Education	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.
Other: Sleep Restriction Therapy (SRT)	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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Recruitment rates	Enrolment logs for all consenting patients. Pre-screen failure logs for patients who meet inclusion criteria but are not enrolled	Screening
Retention rates	Completion of outcome measures	3 months post randomisation
Intervention fidelity: Therapist adherence	Independent clinician review of recorded SRT sessions and completion of fidelity rating scale	6 weeks post randomisation
Intervention fidelity: Patient engagement	Intervention attendance logs completion of fidelity rating scale	During intervention phase
Intervention fidelity: Control group contamination	Client Service Receipt Inventory	6 weeks and 3 months post randomisation
Outcome measure completion	Completion of study questionnaires	Baseline, 6 weeks and 3 months post randomisation
Intervention acceptability	semi-structured interviews with 10 patients from SRT arm, 5 from SHE arm and with 5 members of clinical staff	Beginning 8 weeks post-randomisation to approx. 1 year after start of recruitment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in insomnia severity	Insomnia Severity Index (ISI)	Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [depression]	Patient Health Questionnaire 9 (PHQ-9)	Baseline, 6 weeks and 3 months post-randomisation
Improvement in mental health [anxiety]	Generalised Anxiety Disorders - 7 (GAD-7)	Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F)	Functional Assessment of Cancer Therapy -	Baseline, 6 weeks and 3 months post-randomisation
Improvement in rest-activity rhythms	Actigraphy	Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Improvement in sleep [estimates of subjective sleep]	Sleep Diary	Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation
Measure of health related quality of life	EQ-5D-5L	Baseline, 6 weeks and 3 months post-randomisation

Collaborators and Investigators

• Sponsor: University of Strathclyde
• Collaborators: University of Oxford; NHS Greater Glasgow and Clyde; NHS Grampian; University of Glasgow

Study record dates

Study Major Dates

• Study Start (Estimated): April 1, 2024
• Primary Completion (Estimated): June 1, 2025
• Study Completion (Estimated): June 1, 2025

Study Registration Dates

• First Submitted: February 15, 2024
• First Submitted That Met QC Criteria: February 27, 2024
• First Posted (Estimated): March 5, 2024

Study Record Updates

• Last Update Posted (Estimated): March 5, 2024
• Last Update Submitted That Met QC Criteria: February 27, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: breast cancer; prehabilitation; acute insomnia; sleep restriction therapy
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Sleep Initiation and Maintenance Disorders
• Other Study ID Numbers: UEC23/52

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No