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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00872677
Other study ID # CDR0000612147
Secondary ID 013003B3E
Status Completed
Phase N/A
First received March 28, 2009
Last updated April 25, 2013
Start date May 2004
Est. completion date November 2008

Study information

Verified date April 2013
Source Barbara Ann Karmanos Cancer Institute
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

RATIONALE: A culturally sensitive weight loss program for obese African American breast cancer survivors may be more effective than a standard weight loss program in helping women lose weight.

PURPOSE: This randomized clinical trial is studying personalized weight loss counseling to see how well it works in African American women who are breast cancer survivors.


Description:

OBJECTIVES:

- To develop a weight loss intervention for obese African American women who are breast cancer survivors.

OUTLINE: This is a randomized study. Participants are randomized to 1 of 2 intervention groups.

- Group 1: Participants receive traditional individual dietary and exercise counseling in combination with the Weight Watchers weight loss program for 18 months.

- Group 2: Participants receive individual dietary and exercise counseling in combination with the Weight Watchers weight loss program as in group 1. They also receive spiritual counseling that incorporates meditation, readings, and the recording of thoughts into a long-term weight management program. The program addresses coping with stress, setting priorities, dealing with emotional issues that trigger old behavior patterns, and developing accountability for following desired diet and exercise patterns.


Other known NCT identifiers
  • NCT00082056

Recruitment information / eligibility

Status Completed
Enrollment 31
Est. completion date November 2008
Est. primary completion date October 2006
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility DISEASE CHARACTERISTICS:

- Diagnosis of breast cancer within the past 5 years

- Stage I-IIIA disease

- No recurrence of cancer

- Identified as African American

- Body Mass Index 30-40

- Hormone receptor status not specified

PATIENT CHARACTERISTICS:

- Menopausal status not specified

- Stable body weight

- Not currently following a special diet

- No uncontrolled congestive heart failure, untreated hypertension, disabling osteoarthritis, drug or alcohol abuse, or psychiatric conditions that may interfere with counseling

PRIOR CONCURRENT THERAPY:

- More than 3 months since prior chemotherapy or radiotherapy

Study Design

Observational Model: Case Control, Time Perspective: Prospective


Intervention

Behavioral:
Diet
Talk to study dietitian (eight in person or by phone) weekly for the first 3 months, every other week for the next 3 months and monthly thereafter.
Other:
Spiritual counseling
Spiritual counselor weekly in months 6-9, every other week in months 9-12 and monthly thereafter.

Locations

Country Name City State
United States Barbara Ann Karmanos Cancer Institute Detroit Michigan

Sponsors (3)

Lead Sponsor Collaborator
Barbara Ann Karmanos Cancer Institute National Cancer Institute (NCI), National Center for Complementary and Integrative Health (NCCIH)

Country where clinical trial is conducted

United States, 

References & Publications (1)

Djuric Z, Mirasolo J, Kimbrough L, Brown DR, Heilbrun LK, Canar L, Venkatranamamoorthy R, Simon MS. A pilot trial of spirituality counseling for weight loss maintenance in African American breast cancer survivors. J Natl Med Assoc. 2009 Jun;101(6):552-64. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Weight change 18 months No
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