NCT00583726

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable breast-cancer

Timeline
Completed

Started Dec 2007

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2007

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

December 20, 2007

Completed
11 days until next milestone

First Posted

Study publicly available on registry

December 31, 2007

Completed
2.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2011

Completed
Last Updated

December 2, 2015

Status Verified

December 1, 2012

Enrollment Period

2.7 years

First QC Date

December 20, 2007

Last Update Submit

November 30, 2015

Conditions

Breast Cancer

Keywords

chemotherapyexercisedietfruitvegetableslow-fat

Outcome Measures

Primary Outcomes (1)

  • Change in body weight

    12 months

Secondary Outcomes (1)

  • Change in body fat

    12 months

Study Arms (2)

1

ACTIVE COMPARATOR

The control arm receives written information and pedometers

Behavioral: written materials only

2

EXPERIMENTAL

This arm also receives telephone counseling.

Behavioral: motivational interviewing

Interventions

motivational interviewingBEHAVIORAL

telephone counseling

2
written materials onlyBEHAVIORAL

dietary guidance materials and pedometers

1

Eligibility Criteria

Age18 Years - 99 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Related Publications (2)

  • 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.

    PMID: 22238561RESULT

  • 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.

    PMID: 22377591RESULT

MeSH Terms

Conditions

Breast NeoplasmsMotor Activity

Interventions

Motivational Interviewing

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesBehavior

Intervention Hierarchy (Ancestors)

Directive CounselingCounselingMental Health ServicesBehavioral Disciplines and ActivitiesHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Zora Djuric, PhD

    University of Michigan

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Research Professor

Study Record Dates

First Submitted

December 20, 2007

First Posted

December 31, 2007

Study Start

December 1, 2007

Primary Completion

August 1, 2010

Study Completion

November 1, 2011

Last Updated

December 2, 2015

Record last verified: 2012-12

Locations

US(1)