NCT00006346

Brief Summary

RATIONALE: Transcendental meditation may be an effective way to decrease the amount of stress in older women with breast cancer. It is not yet known if transcendental meditation is more effective than basic breast cancer education in improving quality of life. PURPOSE: This randomized clinical trialstudies stress reduction in improvingquality of life in older women with stage II, stage III, or stage IV breast cancer.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Aug 2000

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

3 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2000

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 4, 2000

Completed
2.9 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2003

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 4, 2003

Completed
Last Updated

July 10, 2013

Status Verified

March 1, 2010

First QC Date

October 4, 2000

Last Update Submit

July 9, 2013

Conditions

Breast CancerPsychosocial Effects of Cancer and Its Treatment

Keywords

stage II breast cancerstage IV breast cancerstage IIIA breast cancerstage IIIB breast cancerpsychosocial effects of cancer and its treatment

Interventions

psychosocial assessment and carePROCEDURE
quality-of-life assessmentPROCEDURE

Eligibility Criteria

Age55 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Diagnosis of stage II, III, or IV breast cancer * No brain or CNS metastases * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: Age: * 55 and over Sex: * Female Menopausal status: * Not specified Performance status: * ECOG 0-2 Life expectancy: * More than 3 months Hematopoietic: * Not specified Hepatic: * Not specified Renal: * Not specified Other: * No non-cancer life-threatening illness * No history of major psychiatric disorders * No drug abuse dependency disorder PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Not specified Endocrine therapy: * Not specified Radiotherapy: * Not specified Surgery: * Not specified

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Study Sites (3)

St. Joseph Hospital

Chicago, Illinois, 60657, United States

Location

Hope Center

Terre Haute, Indiana, 47809, United States

Location

Maharishi International University

Fairfield, Iowa, 52557, United States

Location

Related Publications (1)

  • Nidich SI, Fields JZ, Rainforth MV, Pomerantz R, Cella D, Kristeller J, Salerno JW, Schneider RH. A randomized controlled trial of the effects of transcendental meditation on quality of life in older breast cancer patients. Integr Cancer Ther. 2009 Sep;8(3):228-34. doi: 10.1177/1534735409343000.

    PMID: 19815592RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Psychiatric Rehabilitation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

RehabilitationTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Rhoda S. Pomerantz, MD, MPH

    Unity Health Toronto

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 4, 2000

First Posted

September 4, 2003

Study Start

August 1, 2000

Study Completion

September 1, 2003

Last Updated

July 10, 2013

Record last verified: 2010-03

Locations

US(3)