The Women's Healthy Lifestyle Study

NCT ID: NCT00583726

Last Updated: 2015-12-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2007-12-31
• Study Completion Date: 2011-11-30

Brief Summary

This study aims to determine if a motivational interviewing counseling style can help women eat a healthy diet and exercise during breast cancer treatment and beyond.

Detailed Description

Women receiving chemotherapy for early stage breast cancer often gain weight and body fat, and this contributes to the health burden that cancer survivors face. Weight gain is a concern not only for overall health status, but also as a possible factor for risk of cancer recurrence. Unfortunately achieving weight loss, after a gain has occurred, is difficult, and there are no satisfactory methods for maintenance of weight loss. This study proposes to design and test a novel telephone-based intervention for preventing weight gain during treatment for breast cancer in a pilot, randomized study. The 12-month intervention will target maintenance of current weight and prevention of body fat gain using counseling for moderate exercise and a low-fat, high fruit-vegetable diet. The counseling approach will be based on motivational interviewing techniques and will be delivered through telephone appointments. Motivational interviewing is a client-centered type of counseling that elicits active participation of the patient. By taking a more active role, patients may be more likely to follow through with the recommended lifestyle changes. Study endpoints will include blood markers of dietary compliance, pedometer steps, self-monitoring logs, questionnaires (including quality of life) and anthropometric measures (including body fat by DEXA). An important goal of the study is to establish recruitment methods and demonstrate recruitment rates in newly diagnosed stage I-IIIA breast cancer patients. The study data also will demonstrate implementation of the counseling approach and provide a basis for sample size estimates for a larger trial. This type of intervention, namely a combination of exercise and diet, has been indicated to have good potential for prevention of recurrence. It is therefore necessary to develop effective methods for eliciting these behaviors.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

1

The control arm receives written information and pedometers

Group Type: ACTIVE_COMPARATOR

written materials only

Intervention Type: BEHAVIORAL

dietary guidance materials and pedometers

2

This arm also receives telephone counseling.

Group Type: EXPERIMENTAL

motivational interviewing

Intervention Type: BEHAVIORAL

telephone counseling

Interventions

motivational interviewing

telephone counseling

Intervention Type: BEHAVIORAL

written materials only

dietary guidance materials and pedometers

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• Adult female, age 18 and older
• Stage I, II, or IIIA breast cancer
• Scheduled for chemotherapy and completed no more than two weeks of chemotherapy
• Body mass index 25-45 kg/m2
• Stable body weight within 5 pounds in the past 2 months
• Physician approval for participating in a weight control program
• Willing and able to follow advice for exercise and diet quality

Exclusion Criteria

• Previous invasive cancers, excluding basal cell carcinoma, in the past 10 years
• Following a medically-prescribed diet
• Currently participating in a formal weight loss program
• Medical conditions that preclude safe exercise

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 99 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

University of Michigan

OTHER

Sponsor Role: lead

Responsible Party

Zora Djuric

Research Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Zora Djuric, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Michigan

Locations

University of Michigan

Ann Arbor, Michigan, United States

Countries

United States

References

Djuric Z, Ellsworth JS, Weldon AL, Ren J, Richardson CR, Resnicow K, Newman LA, Hayes DF, Sen A. A Diet and Exercise Intervention during Chemotherapy for Breast Cancer. Open Obes J. 2011;3:87-97. doi: 10.2174/1876823701103010087.

Reference Type: RESULT

PMID: 22238561 (View on PubMed)

Djuric Z, Ren J, Brown PR, Ellsworth JS, Sen A. Lifestyle factors associated with serum N-3 fatty acid levels in breast cancer patients. Breast. 2012 Aug;21(4):608-11. doi: 10.1016/j.breast.2012.02.003. Epub 2012 Feb 28.

Reference Type: RESULT

PMID: 22377591 (View on PubMed)

Other Identifiers

HUM00012524

Identifier Type: -

Identifier Source: org_study_id