Duijts, S.F., van Beurden, M., Oldenburg, H.S., Hunter, M.S., Kieffer, J.M., Stuiver, M.M., . . . Aaronson, N.K. (2012). Efficacy of cognitive behavioral therapy and physical exercise in alleviating treatment-induced menopausal symptoms in patients with breast cancer: Results of a randomized, controlled, multicenter trial. Journal of Clinical Oncology, 30, 4124–4133.  

To evaluate the effects of cognitive behavioral therapy (CBT) and physical exercise (PE) for management of menopausal symptoms

Patients were randomized into four groups: wait list control, CBT alone, PE alone, or combined CBT and PE. The CBT interventions consisted of six weekly group sessions focusing on hot flashes and night sweats as well as other symptoms, with a booster session six weeks after completion of the program. The PE intervention was a 12-week individually tailored program of 2.5–3 weeks exercise of a type selected by the patient with assistance of a physiotherapist. Women were provided with heart rate monitors and instructed to achieve target hear rates. In weeks 4 and 8, women were contacted by phone for any need to adjust the program. Women in the combined group received both interventions concurrently. Study data were obtained at baseline, at 12 weeks, and six months later.

• N = 352 at 12 weeks and 340 at six months  
• MEAN AGE = 48.2 years (SD = 5.6 years)
• FEMALES: 100%
• KEY DISEASE CHARACTERISTICS: All had breast cancer; 85.5% were on hormonal therapy; 81.3% were more than one year since completion of chemotherapy.
• OTHER KEY SAMPLE CHARACTERISTICS: 76% were employed full-time or part-time; 52.6% had high school education, and 38.2% had some college education. Subjects had an average of six hot flash episodes per day.

• SITE: Multi-site
• SETTING TYPE: Outpatient
• LOCATION: Netherlands

• PHASE OF CARE: Transition phase after active treatment

Randomized controlled trial

• Functional Assessment of Cancer Therapy-Endocrine Symptoms (FACT-ES)
• Hot flush rating scale
• European Organization for Research and Treatment of Cancer-Breast Cancer Questionnaire (EORTC-Breast)
• Breast cancer quality-of-life scale
• Short Form Health Survey (36-Item)
• Hospital anxiety and depression scale

Overall effects showed group differences in hot flash symptoms (p < .001) and perceived burden of hot flashes and night sweats (p < .001), but not for the frequency of these symptoms. Effect sizes for study groups were 0.4 for CBT (p < 0.001), 0.31 for PE (p = .007), and 0.36 for the combined intervention (p = .001). Perceived problem rating was only seen in the CBT groups compared to controls at both 12 weeks and six months (p < 0.001). These effect sizes ranged from 0.39 to 0.56. Fifty eight percent of the CBT group were deemed noncompliant, as were 64% of the PE group and 70% of the combined intervention group. To be deemed compliant, subjects had to attend at least four of six CBT sessions and have a minimum of 25 PE training sessions with a specified level of caloric expenditure.

Both physical exercise and CBT interventions were associated with reduced hot flash symptoms, though not the frequency of those symptoms. CBT was helpful to reduce the degree to which patients perceived hot flashes as a problem. Adherence to these programs was low.

• Risk of bias from no blinding
• Risk of bias from no appropriate attentional control condition
• Key sample group differences that could influence results
• Measurement/methods not well described 
• Other limitations/explanation: High rate of lack of adherence to the programs evaluated suggests that final analysis was underpowered and that the programs examined here may not be practical for many patients. Method of determining compliance with exercise is not described. Method of intention-to-treat analysis was not described, so it is not clear if this could have resulted in over or under estimation of effects. There was no subgroup analysis between those who were and were not compliant. Final sample analyzed was underpowered by author analysis.

Findings suggest that both CBT and PE can be helpful in managing hot flash symptoms in women with breast cancer. CBT appears to be more helpful in assisting women to reduce the perceived level of problem created by the symptom. Participation in scheduled group sessions appeared to be difficult for subjects in this study, and many were currently employed, suggesting that this approach may not be practical for many patients. Alternative methods of delivery to achieve results that are practical for patients need to be explored.