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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00248911
Other study ID # 0209005792
Secondary ID
Status Completed
Phase N/A
First received November 3, 2005
Last updated February 17, 2017
Start date May 2003
Est. completion date March 2010

Study information

Verified date February 2017
Source Weill Medical College of Cornell University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 94
Est. completion date March 2010
Est. primary completion date March 2010
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 101 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Mindfulness based meditation program
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.

Locations

Country Name City State
United States Weill Cornell Medical College-New York Hospital New York New York

Sponsors (2)

Lead Sponsor Collaborator
Weill Medical College of Cornell University Avon Foundation

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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.
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