NCT00248911

Brief Summary

Women with breast cancer and other gynecologic cancers often suffer significant distress and disability from their disease. A practice of meditation-based stress reduction and cognitive-affective-behavioral learning may help women with these conditions decrease their suffering and improve their quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
94

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started May 2003

Longer than P75 for not_applicable

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

November 3, 2005

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 4, 2005

Completed
4.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
Last Updated

February 23, 2017

Status Verified

February 1, 2017

Enrollment Period

6.8 years

First QC Date

November 3, 2005

Last Update Submit

February 17, 2017

Conditions

Keywords

Breast cancerGynecologic cancersMeditationStress-reductionCognitive-affective behavioral learning

Outcome Measures

Primary Outcomes (1)

  • Quality of life will be assessed by within patient differences in the FACT-G (General Functional Assessment of Cancer Treatment Scale), as well as with the disease specific subscales at baseline and at 12 months.

    Subjects will complete questionnaires at baseline and closeout. Patients will participate in the meditation program weekly for 20 weeks.

Study Arms (1)

Mindfulness based meditation program

EXPERIMENTAL

Meditation and Breast Cancer: Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.

Behavioral: Mindfulness based meditation program

Interventions

Subjects will participate in an intervention consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning.

Also known as: Meditation and Breast Cancer
Mindfulness based meditation program

Eligibility Criteria

Age18 Years - 101 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may not qualify if:

  • Patients who refuse to participate will be excluded
  • Patients with Metastatic cancer are excluded.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Weill Cornell Medical College-New York Hospital

New York, New York, 10065, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Meditation

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesRelaxation TherapyBehavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Mary E Charlson, MD

    Weill Medical College of Cornell University

    PRINCIPAL INVESTIGATOR
  • Joseph Loizzo, MD,PhD

    Center for Complementary and Intergrative Medicine, New York Presbyterian Hospital-Weill Cornell Medical College

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

November 3, 2005

First Posted

November 4, 2005

Study Start

May 1, 2003

Primary Completion

March 1, 2010

Study Completion

March 1, 2010

Last Updated

February 23, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

No Plan to Share IPD

Locations