The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and Design of a Randomized, Controlled Trial of Four Interventions for Insomnia and Fatigue in Women with Breast Cancer Receiving Chemotherapy

28 Pages Posted: 16 May 2022

See all articles by Jordan Maccora

Jordan Maccora

Monash University - Turner Institute for Brain and Mental Health

Sheila Garland

Memorial University of Newfoundland (MNU)

Maria Ftanou

Peter MacCallum Cancer Centre

Daphne Day

Monash Health

Michelle White

Monash Health

Veronica Aedo Lopez

Monash Health

Duncan Mortimer

Monash University - Centre for Health Economics

Justine Diggens

Peter MacCallum Cancer Centre

Andrew J. K. Phillips

Monash University - Turner Institute for Brain and Mental Health

Rebecca Wallace

Monash University - Turner Institute for Brain and Mental Health

Marliese Alexander

Peter MacCallum Cancer Centre

Frances Boyle

Mater Hospital North Sydney

Lesley Stafford

University of Melbourne - School of Psychological Sciences

Prudence A. Francis

Peter MacCallum Cancer Centre

Bei Bei

Monash University - Turner Institute for Brain and Mental Health

Joshua F. Wiley

Monash University - Turner Institute for Brain and Mental Health

Abstract

Background: Insomnia and fatigue symptoms are common in breast cancer. Active cancer treatment, such as chemotherapy, appears to be particularly disruptive to sleep. Yet, sleep complaints often go unrecognised and under treated within routine cancer care. The abbreviated delivery of cognitive behavioral therapy for Insomnia (CBT-I) and bright light therapy (BLT) may offer accessible and cost-effective sleep treatments in women receiving chemotherapy for breast cancer.

Methods: The Sleep, Cancer and Rest (SleepCaRe) Trial is a 6-month multicentre, randomized, controlled, 2 x 2 factorial, superiority, parallel group trial. Women receiving cytotoxic chemotherapy for breast cancer at tertiary Australian hospitals will be randomly assigned 1:1:1:1 to one of four, non-pharmacological sleep interventions: (a) Sleep Hygiene and Education (SHE); (b) CBT-I; (c) BLT; (d) CBT-I+BLT combined and simultaneously delivered. Each sleep intervention is delivered over 6 weeks, and will comprise an introductory session, a mid-point phone call, and regular emails. The primary (insomnia, fatigue) and secondary (health-related quality of life, rest activity rhythms, sleep-related impairment) outcomes will be assessed via online questionnaires at five time-points: baseline (t0, prior to intervention), mid-point intervention (t2, Week 4), post-intervention (t3, Week 7), 3-months (t4, Week 18), and 6-months follow-up (t5, Week 30).

Conclusions: This study will report novel data concerning the comparative and combined efficacy of CBT-I and BLT during chemotherapy. Findings will contribute to the development of evidence-based early sleep intervention during chemotherapy for breast cancer.

Note:
Clinical Trial Registration Details: Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.

Funding Information: This work was supported by seed funding from Monash University with light glasses provided by Lucimed SA, Belgium. Wiley (1178487) and Bei (1140299) were supported by NHMRC fellowships.

Declaration of Interests: All authors declare that they have no known competing financial interests or personal relationships that could have appeared to influence the work reported in this manuscript.

Ethics Approval Statement: The Human Research Ethics Committee of the Peter MacCallum Cancer Centre approved all study procedures (HREC/55622/PMCC).

Keywords: Cognitive behavioral therapy, light therapy, Insomnia, randomized controlled trial, chemotherapy, breast cancer

Suggested Citation

Maccora, Jordan and Garland, Sheila and Ftanou, Maria and Day, Daphne and White, Michelle and Lopez, Veronica Aedo and Mortimer, Duncan and Diggens, Justine and Phillips, Andrew J. K. and Wallace, Rebecca and Alexander, Marliese and Boyle, Frances and Stafford, Lesley and Francis, Prudence A. and Bei, Bei and Wiley, Joshua F., The Sleep, Cancer and Rest (SleepCaRe) Trial: Rationale and Design of a Randomized, Controlled Trial of Four Interventions for Insomnia and Fatigue in Women with Breast Cancer Receiving Chemotherapy. Available at SSRN: https://ssrn.com/abstract=4111228 or http://dx.doi.org/10.2139/ssrn.4111228

Jordan Maccora

Monash University - Turner Institute for Brain and Mental Health ( email )

Sheila Garland

Memorial University of Newfoundland (MNU) ( email )

Maria Ftanou

Peter MacCallum Cancer Centre ( email )

Daphne Day

Monash Health ( email )

Australia

Michelle White

Monash Health ( email )

Australia

Veronica Aedo Lopez

Monash Health ( email )

Australia

Duncan Mortimer

Monash University - Centre for Health Economics ( email )

Justine Diggens

Peter MacCallum Cancer Centre ( email )

Andrew J. K. Phillips

Monash University - Turner Institute for Brain and Mental Health ( email )

Rebecca Wallace

Monash University - Turner Institute for Brain and Mental Health ( email )

Marliese Alexander

Peter MacCallum Cancer Centre ( email )

Frances Boyle

Mater Hospital North Sydney ( email )

Lesley Stafford

University of Melbourne - School of Psychological Sciences ( email )

Prudence A. Francis

Peter MacCallum Cancer Centre ( email )

Bei Bei

Monash University - Turner Institute for Brain and Mental Health ( email )

18 Innovation Walk
Clayton Campus
Victoria
Australia

Joshua F. Wiley (Contact Author)

Monash University - Turner Institute for Brain and Mental Health ( email )

18 Innovation Walk
Clayton Campus
Victoria
Australia

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