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NCT00156416 · ClinicalTrials.gov registry record · Phase 1
Menopause and Meditation for Breast Cancer Survivors
A Phase 1 study, sponsored by University of Pittsburgh.
- Completed
- Registry status
- Phase 1
- Development phase
- 51
- Enrollment target
NCT00156416 is a Phase 1 study that has completed, run by University of Pittsburgh. The registered enrollment target is 51 participants.
The verdict
NCT00156416, a Phase 1 study, has completed, sponsored by University of Pittsburgh.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 51 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Mindfulness Meditation
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2005-02 |
| Est. Completion | 2010-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT00156416
The ClinicalTrials.gov registry entry for NCT00156416 describes a study currently listed as completed, categorized as Phase 1. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Pittsburgh, which has 1,238 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mindfulness Meditation is the first listed.
NCT00156416 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT00156416 about?
NCT00156416 is a clinical study titled "Menopause and Meditation for Breast Cancer Survivors". 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 mindfu...
What is the current status of trial NCT00156416?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 51 participants. The study started on 2005-02. Estimated completion is 2010-12.
What interventions are being tested in trial NCT00156416?
The interventions under investigation include: Mindfulness Meditation (BEHAVIORAL).
Who is sponsoring clinical trial NCT00156416?
This trial is sponsored by University of Pittsburgh, which has 1,238 total clinical trials registered on ClinicalTrials.gov.
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