The Sleepcare Trial

During chemotherapy for breast cancer, many people experience significant disruptions to their sleep and fatigue.

In fact, problems with sleep and fatigue are two of the most common symptoms reported in people with cancer but are often not managed in routine care.

An international team from Monash University, Monash Health, the Peter MacCallum Cancer Center, Memorial University (Canada), and the Patricia Ritchie Centre are conducting the Sleep Cancer and Rest (SleepCaRe) trial.

This multicentre trial uses a randomised controlled trial design to test four conditions: Sleep Hygiene and Education, Cognitive Behavioural Therapy for Insomnia (CBT-I), Bright Light Therapy (BLT), and combined CBT-I + BLT. SleepCaRe builds on the team’s previous trial that showed combined CBT-I + BLT improved sleep and fatigue compared to usual care.

Now the team hopes to determine the efficacy of specific intervention components, which may reduce burden during an already busy time (chemotherapy). Cost and health care use data are also being collected for planned health economic analyses to answer the questions: "How much does each intervention cost?" and "What is each intervention's cost effectiveness?", important if interventions are ever to be added to routine care.

SleepCaRe is open for recruitment now and aims to recruit 210 women with breast cancer. Eligible participants are women receiving cytotoxic chemotherapy with at least 6 weeks of chemotherapy remaining.

Participants are randomised to one of the four conditions. Everyone who participates are offered an approximately one-hour telehealth session covering key strategies to improve sleep and fatigue, followed by weekly emails for six weeks. People randomised to either group involving bright light are also mailed a pair of light glasses to be worn 20 minutes each morning. Halfway through the six week intervention, everyone receives a call to check on progress, answer questions, and support ongoing use of the intervention strategies.

All sessions and halfway calls are delivered by provisional or registered psychologists with specific training in sleep interventions and supervised by experienced clinical psychologists. The Sleep Hygiene and Education arm involves psychoeducation on evidence-based factors that impact sleep.

The Cognitive Behavioural Therapy arm involves behavioural strategies to improve sleep and cognitive strategies to support relaxation and a healthy attitude toward sleep.

Finally the Bright Light Therapy arm draws on an evidence base about how our body clock (internal rhythm responsible for things like jet lag) respond to light to target sleepiness at night and wakefulness/energy in the day.

More information is available on the trial website: https://sleepcarestudy.weebly.com/

Clinicians who are interested in becoming a site of this trial please contact the lead investigator, Dr Joshua Wiley on 03 990 59598 or email: joshua.wiley@monash.edu

Although we can only enrol people from participating hospitals, people with cancer can register interest in our team reaching out to their hospital or about receiving other information and support resources for sleep in cancer by contacting the SleepCaRe team at psych.sleepcare@monash.edu

For other enquiries please contact the lead investigator: joshua.wiley@monash.edu