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The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers

Primary Purpose

Breast Cancers, Gynecologic Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Mindfulness based meditation program

About this trial

This is an interventional supportive care trial for Breast Cancers focused on measuring Breast cancer, Gynecologic cancers, Meditation, Stress-reduction, Cognitive-affective behavioral learning

Eligibility Criteria

18 Years - 101 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria: All women with stage I-III breast or other gynecologic cancer who have received treatment within the preceding year will be eligible for inclusion in the study. Exclusion Criteria: Patients who refuse to participate will be excluded Patients with Metastatic cancer are excluded.

Sites / Locations

Weill Cornell Medical College-New York Hospital

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mindfulness based meditation program

Arm Description

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00248911

First Posted

November 3, 2005

Last Updated

February 17, 2017

Sponsor

Weill Medical College of Cornell University

Collaborators

Avon Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00248911

Brief Title

The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers

Official Title

The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers:Avon Program for Meditation and Healing

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

May 2003 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Weill Medical College of Cornell University

Collaborators

Avon Foundation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

Detailed Description

The objective of this project in women recently treated for breast or other gynecologic cancer is to determine whether an intervention program consisting of group and individual instruction in a meditation-based practice of stress-reduction and cognitive-affective-behavioral learning has the potential for reducing disabling distress and improving quality of life in a population vulnerable to the progression or recurrence of disease. Quality of life will be assessed at 12 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancers, Gynecologic Cancer

Keywords

Breast cancer, Gynecologic cancers, Meditation, Stress-reduction, Cognitive-affective behavioral learning

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

94 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mindfulness based meditation program

Arm Type

Experimental

Arm Description

Intervention Type

Behavioral

Intervention Name(s)

Mindfulness based meditation program

Other Intervention Name(s)

Meditation and Breast Cancer

Intervention Description

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.

Primary Outcome Measure Information:

Title

Time Frame

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

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

101 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Mary E Charlson, MD

Organizational Affiliation

Weill Medical College of Cornell University

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Joseph Loizzo, MD,PhD

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Weill Cornell Medical College-New York Hospital

City

New York

State/Province

New York

ZIP/Postal Code

10065

Country

United States

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

No Plan to Share IPD

Learn more about this trial

The Effect Of Meditation On Quality Of Life In Women With Breast Cancer And Other Gynecological Cancers

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