TY - JOUR
T1 - The sleep, cancer and rest (SleepCaRe) trial
T2 - Rationale and design of a randomized, controlled trial of cognitive behavioral and bright light therapy for insomnia and fatigue in women with breast cancer receiving chemotherapy
AU - Maccora, Jordan
AU - Garland, Sheila N.
AU - Ftanou, Maria
AU - Day, Daphne
AU - White, Michelle
AU - Lopez, Veronica Aedo
AU - Mortimer, Duncan
AU - Diggens, Justine
AU - Phillips, Andrew J.K.
AU - Wallace, Rebecca
AU - Alexander, Marliese
AU - Boyle, Frances
AU - Stafford, Lesley
AU - Francis, Prudence A.
AU - Bei, Bei
AU - Wiley, Joshua F.
N1 - 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. The funders had no role in the study design, data collection, analysis, interpretation, or presentation of results.
Publisher Copyright:
© 2022 Elsevier Inc.
PY - 2022/9
Y1 - 2022/9
N2 - 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 × 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 and fatigue intervention during chemotherapy for breast cancer. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.
AB - 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 × 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 and fatigue intervention during chemotherapy for breast cancer. Clinical trial information Registered with the Australian New Zealand Clinical Trials Registry (http://anzctr.org.au/), Registration Number: ACTRN12620001133921.
KW - Breast cancer
KW - Chemotherapy
KW - Cognitive behavioral therapy
KW - Insomnia
KW - Light therapy
KW - Randomized controlled trial
UR - http://www.scopus.com/inward/record.url?scp=85136255015&partnerID=8YFLogxK
U2 - 10.1016/j.cct.2022.106877
DO - 10.1016/j.cct.2022.106877
M3 - Article
C2 - 35961468
AN - SCOPUS:85136255015
SN - 1551-7144
VL - 120
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
M1 - 106877
ER -
