Trial Information

Menopause and Meditation for Breast Cancer Survivors

One of the consequences of breast cancer treatment for younger women is the abrupt onset of
menopause and its related symptoms. Menopausal symptoms disrupt usual activities, alter
sleep patterns and decrease quality of life. In light of the recent findings from the
Women's Health Initiative (re:use of exogenous estrogen), the need to investigate
non-hormonal approaches (meditation) for short-term menopausal symptom discomfort is high.
The purpose of this randomized feasibility pilot study is to examine mindfulness meditation
for menopausal symptom management for women who are breast cancer survivors and for women
with naturally occurring menopause. The study is designed to: 1. establish the feasibility
of a mindfulness meditation program for women who experience menopausal symptoms (e.g. hot
flushes). 2. explore the treatment benefit of a mindfulness meditation program for
menopausal symptom relief using changes in frequency and severity of hot flushes; frequency
of sleep disruption, various aspects of quality of life and physiologic stress response
(cortisol) as outcome measures. 3. evaluate whether the treatment benefits of mindfulness
meditation differ in menopausal women with naturally occurring menopause versus women with
menopause secondary to chemotherapy for breast cancer. A 2x2 factorial repeated design will
be used. The four randomized groups will consist of 1) naturally occurring menopause
meditation; 2) naturally occurring menopause attention control; 3) breast cancer survivors
meditation; 4) breast cancer survivors attention. Participants randomized to the attention
control group will be offered meditation training after completion of the intervention and
follow up phases. Participants will attend 8 meditation sessions or 8 attention control
sessions. Study variables are Menopausal Hot Flushes (self report & skin conductance
monitoring), Sleep Disruption (Pgh Sleep Quality Index), Physiologic Stress Response
(cortisol), Quality of Life (Menopausal Quality of Life); and Protocol Design (recruitment &
retention rates, exit interviews). A convenience sample of 60 women who experience
menopausal symptoms will be recruited. Data analysis includes descriptive statistics,
repeated measures content analysis. Results from this feasibility pilot study will inform
the design of a larger randomized clinical trial to test the effectiveness of mindfulness
meditation as a self care intervention for menopausal symptom management and improvement in
quality of life.