Mann, E., Smith, M. J., Hellier, J., Balabanovic, J. A., Hamed, H., Grunfeld, E. A., & Hunter, M. S. (2012). Cognitive behavioural treatment for women who have menopausal symptoms after breast cancer treatment (MENOS 1): a randomised controlled trial. Lancet Oncology, 13, 309–318.

DOI Link

Study Purpose

To investigate whether cognitive-behavioral therapy (CBT) can help survivors of breast cancer in effectively managing menopausal symptoms.

Intervention Characteristics/Basic Study Process

The intervention consisted of six 90-minute weekly sessions with group discussions, handouts, weekly homework, and paced breathing and relaxation practice—along with an audio CD to practice paced breathing and relaxation at home daily—in addition to usual care. The control group received usual care and follow-up by an oncologist or clinical nurse specialist every six months. Assessments took place at baseline, nine weeks after randomization (typically two weeks after treatment), and 26 weeks after randomization. All sessions were audio recorded, and a 10% random sample of the tapes was reviewed to evaluate the intervention.

Sample Characteristics

  • The study enrolled 88 English-speaking women with breast cancer who were randomized into blocks, stratified by age (younger than 50 years and 50 years or older).
  • Patients reported a minimum of 10 problematic episodes of hot flashes per week for a duration of two months or more.

Setting

  • Mutlisite
  • Outpatient
  • Breast clinics in London, England

Phase of Care and Clinical Applications

  • Patients were undergoing the transition phase of care after initial treatment.
  • The study has clinical applicability for palliative and end-of-life care.

Study Design

This was a triple-blinded, randomized, controlled trial.

Measurement Instruments/Methods

  • Sternal Skin Conductance (SSC) for physiological symptoms from hot flashes  
  • SF-36® health-related quality-of-life ratings
  • Women’s Health Questionnaire (WHQ)
  • Adherence was measured by the number of sessions attended and the number of times that a patient practiced relaxation or paced breathing each week.

Results

Night sweats problem rating scores at 9 and 26 weeks were lower in the CBT group than they were in the usual care group, with a mean difference between groups of –1.67 (95% confidence interval [CI] [–2.43, –0.91]; p < .0001). These scores also declined over time in the control group. There were no differences between groups in hot flush frequency, night sweats frequency, or SSC measures. Those receiving the CBT intervention reported less sleep problems (adjusted mean difference (AMD) = –0.16; 95% CI [–0.29, –0.02]), anxiety (AMD = –0.16; 95% CI [–0.29, –0.02]), and better memory and concentration (AMD = –0.14; 95% CI [–0.26, –0.02]).

Conclusions

The findings suggest that group CBT improved patients’ perceptions of the degree to which hot flashes were a problem but did not appear to affect the actual frequency or objective measures of hot flashes. Group CBT appeared to have a small size of effect on sleep problems, anxiety, and other self-reported outcomes.

Limitations

  • The study had a small sample size, with less than 100 patients.
  • No attentional control was used.
  • Specific AMD calculation was not described, so it is not clear how well this represents an effect size. 
  • Measures for anxiety and other outcomes were limited.

Nursing Implications

This study provides some supportive evidence for the benefit of cognitive-behavioral approaches. Group CBT may have a benefit in managing hot flashes and other symptoms through altered perceptions of the degree to which these symptoms are seen as problematic. Health professionals, such as breast cancer nurses or clinical nurse specialists trained in CBT, can improve long-term health outcomes for patients with breast cancer, and CBT could be incorporated into breast cancer survivorship programs.