INvestigating the Value of Early Sleep Therapy

NCT06294041 | Not Yet Recruiting DMC

• 1 other identifier: UEC23/52
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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)

Keywords

acute insomnia; breast cancer; prehabilitation; sleep restriction therapy

Outcome Measures

Primary Outcomes (7)

• 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 Outcomes (7)

• Improvement in insomnia severity

  Baseline, 6 weeks and 3 months post-randomisation

• Improvement in mental health [depression]

  Baseline, 6 weeks and 3 months post-randomisation

• Improvement in mental health [anxiety]

  Baseline, 6 weeks and 3 months post-randomisation

• Improvement in rest-activity rhythms [fatigue]Fatigue (FACT-F)

  Baseline, 6 weeks and 3 months post-randomisation

• Improvement in rest-activity rhythms

  Baseline, throughout the intervention phase, 6 weeks and 3 months post-randomisation

Study Arms (2)

Sleep Restriction Therapy (SRT)

OTHER

Behavioral: Sleep Restriction Therapy (SRT)

Sleep Hygiene Education

OTHER

Behavioral: Sleep Hygiene Education (SHE)

Interventions

Sleep Restriction Therapy (SRT) BEHAVIORAL

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

Sleep Restriction Therapy (SRT)

Sleep Hygiene Education (SHE) BEHAVIORAL

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.

Sleep Hygiene Education

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Pregnancy
• Additional sleep disorder diagnosis (e.g., restless legs syndrome, obstructive sleep apnoea, narcolepsy) or screen "positive" for additional sleep disorder at study screening interview
• Dementia / Mild Cognitive Impairment
• Epilepsy
• Psychosis (schizophrenia, bipolar disorder)
• Current suicidal ideation with intent or attempted suicide within past 2 months
• Night, evening, early morning, or rotating shiftwork
• Current / previous psychological treatment for insomnia during the last 12 months
• Chemotherapy and / or radiotherapy commenced

Sponsors & Collaborators

• University of Strathclyde: lead
• University of Oxford: collaborator
• University of Glasgow: collaborator
• NHS Greater Glasgow and Clyde: collaborator
• NHS Grampian: collaborator

Related Publications (1)

• Fleming L, Zibaite S, Kyle SD, Boyd K, Green V, Mansell J, Elsberger B, Young D. 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). PLoS One. 2024 Aug 14;19(8):e0305304. doi: 10.1371/journal.pone.0305304. eCollection 2024.

  PMID: 39141622 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Leanne Fleming, PhD

CONTACT

01415482573; l.fleming@strath.ac.uk

Solveiga Zibaite, PhD

CONTACT

solveiga.zibaite@strath.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 15, 2024
• First Posted: March 5, 2024
• Study Start: April 1, 2024
• Primary Completion: June 1, 2025
• Study Completion: June 1, 2025
• Last Updated: March 5, 2024

Record last verified: 2024-02