NCT00556218

Brief Summary

The goal of this behavioral research study is to learn if participating in a Tibetan meditation program helps to improve quality of life for women after chemotherapy and during recovery from breast cancer. Whether the meditation program helps to improve brain function and sleep quality will also be studied.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
47

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Oct 2007

Longer than P75 for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

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

October 24, 2007

Completed
14 days until next milestone

First Submitted

Initial submission to the registry

November 7, 2007

Completed
2 days until next milestone

First Posted

Study publicly available on registry

November 9, 2007

Completed
14.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 10, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 10, 2022

Completed
Last Updated

August 30, 2022

Status Verified

August 1, 2022

Enrollment Period

14.8 years

First QC Date

November 7, 2007

Last Update Submit

August 26, 2022

Conditions

Keywords

Breast CancerTibetan MeditationQuality of LifeCognitive FunctionQOL

Outcome Measures

Primary Outcomes (2)

  • Number of Eligible Women Approached Who Consented to be in Trial (Feasibility)

    2 Years

  • Women's Reported Satisfaction with Tibetan Meditation intervention

    2 Years

Study Arms (2)

Tibetan Meditation

OTHER
Behavioral: Tibetan Meditation Program

No Meditation

OTHER
Behavioral: No Meditation

Interventions

12 sessions of Tibetan meditation (2 times a week), over a 6-week period. Each class will last about 60 minutes.

Tibetan Meditation
No MeditationBEHAVIORAL

No meditation; usual care.

No Meditation

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women with stage I - III breast cancer who have undergone chemotherapy (either neoadjuvant or adjuvant) 6 - 60 months prior to recruitment.
  • Women who report cognitive impairment since starting chemotherapy as assessed by four questions from the FACT-Cog.
  • Women must be 18 years or older.
  • Women must be able to read, write and speak English.
  • Women must be currently undergoing hormone therapy (e.g., Tamoxifen or AIs)
  • Willing to come to MDACC for the meditation sessions and assessment sessions.
  • Women must be within 2 hours driving distance of MDACC.

You may not qualify if:

  • Women who have a documented diagnosis of a formal thought disorder (e.g., schizophrenia) will be excluded from the study.
  • Women with metastatic disease to the brain or any past neurologic injury.
  • Women with a Mini-Mental State Examination score of 23 or below.
  • Women with recurrent cancer

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Lorenzo Cohen, PhD

    M.D. Anderson Cancer Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2007

First Posted

November 9, 2007

Study Start

October 24, 2007

Primary Completion

August 10, 2022

Study Completion

August 10, 2022

Last Updated

August 30, 2022

Record last verified: 2022-08

Locations