Ignite Creation Date:
2024-05-05 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 9:15 AM
Study NCT ID:
NCT00156416
Status:
COMPLETED
Last Update Posted:
2014-12-03
First Post:
2005-09-07
Brief Title:
Menopause and Meditation for Breast Cancer Survivors
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Menopause and Meditation for Breast Cancer Survivors
Status:
COMPLETED
Status Verified Date:
2014-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 eg 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
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 Womens Health Initiative reuse 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 eg 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None