Sleepwell: A Trial to Improve Sleep During Chemotherapy for Breast Cancer

Not Applicable

Completed

• Conditions: breast cancer; sleep disruption; Cancer - Breast

• Registration Number: ACTRN12618001255279
• Lead Sponsor: Peter MacCallum Cancer Centre

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-25
• Study Completion: 2020-03-12
• Last Update Posted: 19 April 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 101

Inclusion Criteria

Inclusion criteria include:
1.Diagnosed with any stage primary BC
2.Over 18 years of age
3.Receiving or will receive during the study period intravenous chemotherapy, with or without radiotherapy
4.Able to provide informed consent
5.Able to understand and speak English
6.Able to regularly receive and access emails
7.Able and willing to wear bright light glasses
8.Recruitment and consent occurs at the Peter MacCallum Cancer Centre chemotherapy day unit so participants must have an appointment for chemotherapy at the Peter MacCallum Cancer Centre.

Exclusion Criteria

1.Being male
2.Receiving only neoadjuvant chemotherapy
3.Severe psychiatric disorder
4.Severe substance use disorder
5.History of suffering migraines
6.Individuals with very advanced (habitual bedtime before 8pm and rise time before 4am)/delayed sleep timing (habitual bedtime after 3am and rise time after 11am), or have irregular or non-24 sleep/wake patterns are excluded based on the Duke structured sleep interview.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Symptoms of insomnia assessed via the Insomnia Severity Index (ISI; Bastien, Vallières, & Morin, 2001).[Baseline (Week 0), Midpoint (Week 3), Post-Treatment (Week 6), and Follow-Up (3 months), used to estimate slopes over time. There is no single primary timepoint as we are using the change over time in outcome to define the success/failure of the trial.];Sleep Diary - Sleep Efficiency[Continuously assessed over the 6 weeks of the trial and used to estimate slopes over time. There is no single primary timepoint as we are using the change over time in outcome to define the success/failure of the trial.]