Menopause and Meditation for Breast Cancer Survivors

The recruitment status of this study is unknown because the information has not been verified recently.
Verified October 2008 by University of Pittsburgh.
Recruitment status was  Recruiting
Sponsor:
Collaborator:
Information provided by:
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT00156416
First received: September 7, 2005
Last updated: October 13, 2008
Last verified: October 2008
  Purpose

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 Intervention Phase
Menopause
Behavioral: Mindfulness Meditation
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Treatment
Official Title: Menopause and Meditation for Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • hot flushes [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Sleep [ Time Frame: 21 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 60
Study Start Date: February 2005
Estimated Study Completion Date: December 2008
Estimated Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Intervention Details:
    Behavioral: Mindfulness Meditation
    8 weeks of meditation training
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.

  Eligibility

Ages Eligible for Study:   30 Years to 70 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00156416

Contacts
Contact: Susan M Cohen, DSN 412.624.5345 cohensu@pitt.edu
Contact: Sue A Cunningham, BA 412.624.4597 scunning@pitt.edu

Locations
United States, Pennsylvania
University of Pittsburgh Recruiting
Pittsburgh, Pennsylvania, United States, 15261
Contact: Sue A Cunningham, BA    412-624-4597    scunning@pitt.edu   
Contact: Susan M Cohen, DSN    412.624.5345    cohensu@pitt.edu   
Principal Investigator: Susan M Cohen, DSN         
Sponsors and Collaborators
University of Pittsburgh
Investigators
Principal Investigator: Susan M Cohen University of Pittsburgh
  More Information

No publications provided

Responsible Party: Susan M Cohen, University of Pittsburgh
ClinicalTrials.gov Identifier: NCT00156416     History of Changes
Other Study ID Numbers: 1R21CA106336-01A1
Study First Received: September 7, 2005
Last Updated: October 13, 2008
Health Authority: United States: Institutional Review Board

Keywords provided by 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

ClinicalTrials.gov processed this record on October 19, 2014