Marshall-McKenna, R., Morrison, A., Stirling, L., Hutchison, C., Rice, A.M., Hewitt, C., . . . McCartney, E. (2015). A randomised trial of the cool pad pillow topper versus standard care for sleep disturbance and hot flushes in women on endocrine therapy for breast cancer. Supportive Care in Cancer, 24, 1821–1829. 

DOI Link

Study Purpose

To identify if the cool pad pillow topper (CPPT) decreases sleep disturbance, minimizing the effects of hot flashes. The CPPT is a commercial product promoted to improve quality of sleep disrupted by hot flashes.

Intervention Characteristics/Basic Study Process

The intervention arm of pre- and postmenopausal women received during four weeks standard care consisting in booklets with advice on exercise, physical activity, diet, and the reduction of caffeine and alcohol plus the CPPT. The CPPT is an approved commercial product that removes heat from the body and can be placed on top, outside, or inside the pillowcase.

Sample Characteristics

  • N = 75  
  • MEAN AGE: 49.5 years (intervention group mean = 51 years, and control group mean = 51.2 years)
  • FEMALES: 100%
  • KEY DISEASE CHARACTERISTICS: Breast cancer in endocrine therapy, pre- or postmenopausal, night hot flashes
  • OTHER KEY SAMPLE CHARACTERISTICS: Insomnia symptoms, anxiety, depression, exercise, alcohol intake, smoking status

Setting

  • SITE: Not stated/unknown    
  • SETTING TYPE: Outpatient    
  • LOCATION: The Beatson West of Scotland Cancer Centre, Glasgow

Phase of Care and Clinical Applications

  • PHASE OF CARE: Transition phase after active treatment
  • APPLICATIONS: Elder care, palliative care

Study Design

  • Randomized phase II clinical trial, control with routine information and intervention group information plus the CPPT

Measurement Instruments/Methods

The instruments for the intervention group were the sleep diaries to evaluate amount of time asleep and changes in sleep disturbance. The number of hot flashes and the severity at night were evaluated with the hot flash score (HFS), both completed daily for four weeks from the point of randomization; they also record number of alcohol units consumed, if any sleeping pills were taken, and the frequency nightwear changed. The Functional Assessment of Cancer Therapy-Breast (FACT-B) and Hospital Anxiety and Depression Scale (HADS) were used at two points—at randomization and at the end of the study.

Results

Endocrine therapies included tamoxifen (93.2%). Median SES at weeks two to four improved in both arms, but the increase on the intervention arm was almost twice that on the control arm (p = 0.024). There were significantly greater reductions in hot flashes and HADS depression in the intervention arm (p = 0.09 and p = 0.036, respectively). There were no significant differences in FACT-B or HADS anxiety.

Conclusions

CPPT is effective as a self-management strategy to reduce sleep disturbance and the severity/frequency of hot flashes. CPPT did not impact quality of life (QOL) or anxiety but reduction in depression was observed. The CPPT appears to be an effective intervention in conjunction with current standard care.

Limitations

  • Small sample (less than 100)
  • Risk of bias (no blinding)
  • No main limitations are founded in the well-designed study

Nursing Implications

Nurses could recommend the use of the CPPT as no risk or harm is expected and it helps control hot flashes and sleep disturbances associated with endocrine therapies. This is a pilot only; would recommend additional research to note if results are reproducible.