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Menopause and Meditation for Breast Cancer Survivors

Phase 1/Phase 2
30 Years
70 Years
Open (Enrolling)

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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.

Inclusion Criteria:

- . Subjects will be selected based on their self-identification of menopausal hot
flushes. Subjects may identify other menopausal symptoms but must have hot flushes.
Inclusion criteria will include English speaking, self-identification of the
menopausal symptom of hot flushes following treatment for breast cancer (stage I or
II) and amenorrhea secondary to breast cancer treatment or for women with naturally
occurring menopause amenorrhea of greater that one year but less than three years.

Exclusion Criteria:

- Exclusion criteria are, for women with breast cancer, amenorrhea of greater that one
year prior to their diagnosis of breast cancer. Also, excluded is concurrent
treatment of menopausal symptoms with hormonal supplementation, herbal remedies,
acupuncture, acupressure or non-hormonal pharmacologic agents prescribed at doses
specifically for hot flush relief (beta blockers, SSRIs). However, women taking
either serotonin reuptake inhibitors for depression or beta-blockers for hypertension
who exhibit hot flushes sufficient to meet inclusion criteria will be accepted into
the study. Previous treatment of menopausal symptoms with hormones, herbs or
acupuncture, structured meditation and/or regular yoga practice must have ceased at
least three months prior to enrollment in the study to allow for a sufficient wash
out period. Women who are presently in chemotherapy treatment for breast cancer are
excluded due to the potential confounding effect of mindfulness meditation on quality
of life due to chemotherapy symptom relief. Women with a moderate to severe level of
depression (>27), or suicidal thoughts or wishes, as measured by the Beck Depression
Index, 2nd Ed (BDI-II), will be excluded and referred for treatment. However,
following treatment for depression, they may enroll in the study assuming
continuation of hot flushes at inclusion criteria levels.

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Investigator), Primary Purpose: Treatment

Outcome Measure:

hot flushes

Outcome Time Frame:

21 weeks

Safety Issue:


Principal Investigator

Susan M Cohen

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Pittsburgh


United States: Institutional Review Board

Study ID:




Start Date:

February 2005

Completion Date:

December 2008

Related Keywords:

  • Menopause
  • menopause
  • hot flash
  • night sweat
  • meditation
  • breast cancer
  • Breast Neoplasms



University of Pittsburgh Pittsburgh, Pennsylvania  15261