Menopause and Meditation for Breast Cancer Survivors

NCT00156416 | Completed Phase 1 DMC

• 1 other identifier: 1R21CA106336-01A1
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

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 (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.

Conditions

Menopause

Keywords

menopause; hot flash; night sweat; meditation; breast cancer

Outcome Measures

Primary Outcomes (1)

• hot flushes

  21 weeks

Secondary Outcomes (1)

• Sleep

  21 weeks

Study Arms (2)

Meditation group

EXPERIMENTAL

Participants received 8 weeks of mindfulness meditation instruction and support

Behavioral: Mindfulness Meditation

Education group

ACTIVE COMPARATOR

Participants received 8 weeks of healthy living instruction

Behavioral: Mindfulness Meditation

Interventions

Mindfulness Meditation BEHAVIORAL

8 weeks of meditation training

Education group; Meditation group

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• University of Pittsburgh: lead
• National Institutes of Health (NIH): collaborator

Study Sites (1)

University of Pittsburgh

Pittsburgh, Pennsylvania, 15261, United States

Location

MeSH Terms

Conditions

Hot Flashes; Breast Neoplasms

Interventions

Mindfulness

Condition Hierarchy (Ancestors)

Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Cognitive Behavioral Therapy; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Susan M Cohen

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: September 7, 2005
• First Posted: September 12, 2005
• Study Start: February 1, 2005
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: December 3, 2014

Record last verified: 2014-12

Locations

US (1)