Grant Number:	7R01CA080625-04 Interpret this number
Primary Investigator:	Cohen, Susan
Organization:	University Of Pittsburgh At Pittsburgh
Project Title:	Menopausal Symptom Relief for Women with Breast Cancer
Fiscal Year:	2002

The proposed randomized, placebo-controlled clinical study will examine the use of acupuncture for menopausal symptom management for women who experience menopause following treatment for breast cancer. The study is designed to: 1) Test the anticipated treatment benefits for menopausal symptom relief using changes in frequency and severity of hot flashes as outcome measures; 2) Explore the anticipated treatment benefits of acupuncture for menopausal symptom relief using changes in severity of mood changes, sleep disturbances and loss of concentration, and quality of life; 3) Determine the feasibility of the treatment strategy and develop realistic protocols for women previously diagnosed and treated for breast cancer by examining recruitment and retention rates and through exit interviews regarding the potential burden associated with symptom frequency/severity ratings and acupuncture sessions. A three-group design (site specific needling, control needling, usual care) will be used. Twelve acupuncture treatments will take the form of wither menopausal specific acupuncture sites or control needling at acupuncture points identified in the literature as irrelevant to the menopausal symptoms. The non-acupuncture control group will receive usual care with standardized educational sessions of information drawn from published menopausal literature concerning non-hormonal menopausal symptom management strategies. The study variables are Menopausal Symptoms with hot flashes (primary marker), mood changes, sleep disturbances and loss of concentration as measured by the daily Symptom Diary and the modified Kupperman Index; Physiological Measures of menopausal status (serum LH and FSH) and of stress response (Cortisol); Quality of Life as measured by the Menopause Specific Quality of Life Questionnaire; and Protocol Design as measured by recruitment and retention rates and exit interviews. A convenience sample of 81 women who experience menopausal symptoms with one year following treatment for Stage I or II breast cancer will be recruited. Data analysis includes descriptive statistics, repeated measures ANOVA, time series analysis, and content analysis. Results from the study will test the effectiveness of acupuncture as a treatment for menopausal hot flashes and inform the design of a larger, randomized, placebo-controlled clinical trial of acupuncture for menopausal symptom relief.




The Menopause-specific Quality Of Life Questionnaire: Psychometric Evaluation Among Breast Cancer Survivors
Authors: Radtke J.V. , Terhorst L. , Cohen S.M. .
Source: Menopause (new York, N.y.), 2011 Mar; 18(3), p. 289-95.
PMID: 20881889
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Symptom Clusters In Breast Cancer Across 3 Phases Of The Disease
Authors: Bender C.M. , Ergÿn F.S. , Rosenzweig M.Q. , Cohen S.M. , Sereika S.M. .
Source: Cancer Nursing, 2005 May-Jun; 28(3), p. 219-25.
PMID: 15915067
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