Menopause and Meditation for Breast Cancer Survivors
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ClinicalTrials.gov Identifier: NCT00156416 |
Recruitment Status
:
Completed
First Posted
: September 12, 2005
Last Update Posted
: December 3, 2014
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Menopause | Behavioral: Mindfulness Meditation | Phase 1 Phase 2 |
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 |

Arm | Intervention/treatment |
---|---|
Experimental: Meditation group
Participants received 8 weeks of mindfulness meditation instruction and support
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Behavioral: Mindfulness Meditation
8 weeks of meditation training
|
Active Comparator: Education group
Participants received 8 weeks of healthy living instruction
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Behavioral: Mindfulness Meditation
8 weeks of meditation training
|
- hot flushes [ Time Frame: 21 weeks ]
- Sleep [ Time Frame: 21 weeks ]

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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00156416
United States, Pennsylvania | |
University of Pittsburgh | |
Pittsburgh, Pennsylvania, United States, 15261 |
Principal Investigator: | Susan M Cohen | University of Pittsburgh |
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 Key Record Dates |
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 |