Promoting a Healthier Lifestyle Among Breast Cancer Survivors

NCT01419613 | Completed DMC

• 1 other identifier: MCC-16265
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to find out if a counseling program the investigators have developed can help breast cancer survivors adopt a healthier lifestyle.

Conditions

Breast Cancer

Keywords

healthy lifestyle; physical activity; behavior; motivational; interview; breast cancer survivor

Outcome Measures

Primary Outcomes (1)

• Number of Participants Who Increased Activity After Motivational Interviewing

  The primary objective of this study is to evaluate the efficacy of a brief Motivational Interviewing (MI) based intervention, relative to a time and attention control intervention (healthy lifestyle counseling), in promoting physical activity among early-stage breast cancer survivors who are physically inactive but are contemplating increasing their level of physical activity.

  24 Weeks Per Participant

Secondary Outcomes (2)

• Number of Participants With Desired Impact on Symptoms After Motivational Interviewing

  24 Weeks Per Participant

• Number of Participants With Desired Effects From Increased Physical Activity

  24 Weeks Per Participant

Study Arms (2)

Motivational Interviewing

EXPERIMENTAL

Behavioral: Motivational Interviewing

Physical Activity Counseling

ACTIVE COMPARATOR

Behavioral: Counseling

Interventions

Motivational Interviewing BEHAVIORAL

Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.

Motivational Interviewing

Counseling BEHAVIORAL

The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Physical Activity Counseling

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥ 18 years of age;
• be capable of speaking and reading English;
• be diagnosed with stage 0-II breast cancer;
• be currently disease free;
• have been treated surgically for breast cancer;
• have completed chemotherapy and/or radiotherapy at least three months but no more than two years prior;
• be physically able to exercise as measured by the Physical Activity Readiness Questionnaire-Revised (Thomas, Reading, \& Shephard, 1992) ;
• be currently physically inactive as measured by the Godin Leisure Time Exercise Questionnaire (Godin \& Shepard, 1985); and
• be contemplating increasing physical activity as measured by the Exercise Stages of Change - Short Form (Marcus, Selby, Niaura, \& Rossi, 1992).

Sponsors & Collaborators

• H. Lee Moffitt Cancer Center and Research Institute: lead
• United States Department of Defense: collaborator

Study Sites (1)

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Motor Activity; Behavior

Interventions

Motivational Interviewing; Counseling

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Directive Counseling; Mental Health Services; Behavioral Disciplines and Activities; Health Services; Health Care Facilities Workforce and Services; Community Health Services

Study Officials

• Paul B. Jacobsen, Ph.D.

  H. Lee Moffitt Cancer Center and Research Institute

  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: SPONSOR

Study Record Dates

• First Submitted: August 17, 2011
• First Posted: August 18, 2011
• Study Start: August 1, 2010
• Primary Completion: May 1, 2015
• Study Completion: May 1, 2015
• Last Updated: June 23, 2015

Record last verified: 2015-06

Locations

US (1)