Menopause and Meditation for Breast Cancer Survivors
Condition: Menopause
Study type: Interventional
Phase: Phase 1/Phase 2

Summary: 
      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. 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.
      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.
    

Detailed description: 
      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.
    

Intervention name(s): Mindfulness Meditation
Intervention type(s): Behavioral
Intervention description(s): 8 weeks of meditation training
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Treatment
Keywords: menopause; hot flash; night sweat; meditation; breast cancer