Avon Foundation Program to Improve Quality of Life in Breast Cancer Survivors

Breast Cancer Clinical Trial

Official title:

Contemplative Self-Healing to Improve Quality of Life in Breast Cancer Survivors: the Avon Foundation Program to Reach Medically Underserved Populations

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00278837
• Other study ID #: 0209005792(RCT)
• Status: Completed
• Phase: N/A
• First received: January 13, 2006
• 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
• Study type: Interventional

Clinical Trial Summary

Women with breast cancer 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 breast cancer decrease their suffering and improve their quality of life.

Description:

The objective of this study in women recently treated for breast 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 cancer who have received treatment within the preceding year will be eligible for inclusion in the study.

Exclusion Criteria:

1. Patients who refuse to participate will be excluded

2. Patients with metastatic (stage IV) cancer are excluded.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

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	The New York Presbyterian Hospital-Weill Medical Center	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.