Fenlon, D.R., Corner, J.L., & Haviland, J.S. (2008). A randomized controlled trial of relaxation training to reduce hot flashes in women with primary breast cancer. Journal of Pain and Symptom Management, 35, 397–405.

DOI Link

Study Purpose

The study sought to assess the efficacy of relaxation training in reducing the incidence of hot flashes in women with primary breast cancer.

Intervention Characteristics/Basic Study Process

The intervention group received a single relaxation training session and was instructed to use practice tapes on a daily basis at home for one month; the control group received no intervention.

Sample Characteristics

The study enrolled150 women from three breast cancer centers in England.

  • Inclusion criteria: Postmenopausal women diagnosed with primary breast cancer and suffering from menopausal hot flashes. Any level of severity was accepted for inclusion in the trial as long as the women found the flashes to be troublesome. Postmenopausal was defined as six months without menstruation.

Study Design

The study was a randomized controlled trial.

Measurement Instruments/Methods

The incidence of flashes was measured using a diary, kept by the women, of every flash as it occurred over the period of one week. The women also gave a measure of the severity of each flash using four predefined categories: (a) length of flash, (b) physical manifestation, (c) emotional response, and (d) behavioral response. For each of these domains, four levels of severity (graded 1–4) were assigned, using the Hunter Menopause Scale.

Results

Of 150 women recruited to the trial, 104 women completed it to the primary endpoint at one month, and 97 completed all three months. The incidence and severity of hot flashes, as recorded by diaries, significantly declined over one month (p < 0.001 and p < 0.01, respectively), compared with the control group. Distress caused by flashes also significantly declined in the treatment group over one month (p < 0.01), compared with the contro.l No significant differences between the treatment group and the control group at three months and no changes in anxiety or QOL were reported.

Limitations

A large amount of attrition marred the trial.