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Clinical Trials (PDQ®)

Menopause and Meditation for Breast Cancer Survivors

Basic Trial Information
Trial Description
     Summary
     Further Trial Information
     Eligibility Criteria
Trial Contact Information

Basic Trial Information

PhaseTypeStatusAgeSponsorProtocol IDs
Phase II, Phase ISupportive careActive30 to 70NCI, Other1R21CA106336-01A1
NCT00156416

Trial Description

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.

Further Study Information

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.

Eligibility 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.

Trial Contact Information

Trial Lead Organizations/Sponsors

UPMC Cancer Centers

National Cancer Institute

Susan M CohenPrincipal Investigator

Susan M Cohen, DSNPh: 412.624.5345
  Email: cohensu@pitt.edu

Trial Sites

U.S.A.
Pennsylvania
  Pittsburgh
 UPMC Cancer Centers
 Sue A Cunningham, BA Ph: 412-624-4597
  Email: scunning@pitt.edu
 Susan M Cohen, DSN Ph: 412.624.5345
  Email: cohensu@pitt.edu
 Susan M Cohen, DSNPrincipal Investigator

Link to the current ClinicalTrials.gov record.
NLM Identifer NCT00156416
ClinicalTrials.gov processed this data on October 17, 2013

Note: Information about this trial is from the ClinicalTrials.gov database. The versions designated for health professionals and patients contain the same text. Minor changes may be made to the ClinicalTrials.gov record to standardize the names of study sponsors, sites, and contacts. Cancer.gov only lists sites that are recruiting patients for active trials, whereas ClinicalTrials.gov lists all sites for all trials. Questions and comments regarding the presented information should be directed to ClinicalTrials.gov.

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