Menopause and Meditation for Breast Cancer Survivors

Study Description

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Brief 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.

Condition or disease	Intervention/treatment	Phase
Menopause	Behavioral: Mindfulness Meditation	Phase 1; Phase 2

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.

Study Design

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Study Type :	Interventional (Clinical Trial)
Actual Enrollment :	51 participants
Allocation:	Randomized
Intervention Model:	Parallel Assignment
Masking:	Single (Investigator)
Primary Purpose:	Treatment
Official Title:	Menopause and Meditation for Breast Cancer Survivors
Study Start Date :	February 2005
Actual Primary Completion Date :	December 2010
Actual Study Completion Date :	December 2010

Arms and Interventions

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm	Intervention/treatment
Experimental: Meditation group; Participants received 8 weeks of mindfulness meditation instruction and support	Behavioral: Mindfulness Meditation; 8 weeks of meditation training
Active Comparator: Education group; Participants received 8 weeks of healthy living instruction	Behavioral: Mindfulness Meditation; 8 weeks of meditation training

Outcome Measures

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :

1. hot flushes [ Time Frame: 21 weeks ]

Secondary Outcome Measures :

1. Sleep [ Time Frame: 21 weeks ]

Eligibility Criteria

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Ages Eligible for Study:	30 Years to 70 Years (Adult, Senior)
Sexes Eligible for Study:	Female
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Locations

United States, Pennsylvania
University of Pittsburgh
Pittsburgh, Pennsylvania, United States, 15261

Sponsors and Collaborators

University of Pittsburgh

National Institutes of Health (NIH)

Investigators

Principal Investigator:	Susan M Cohen	University of Pittsburgh

More Information

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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party:	Susan Cohen, Associate Professor, University of Pittsburgh
ClinicalTrials.gov Identifier:	NCT00156416 History of Changes
Other Study ID Numbers:	1R21CA106336-01A1 ( U.S. NIH Grant/Contract )
First Posted:	September 12, 2005
Last Update Posted:	December 3, 2014
Last Verified:	December 2014

Keywords provided by Susan Cohen, University of Pittsburgh:

menopause; hot flash; night sweat; meditation; breast cancer

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases