Promoting a Healthier Lifestyle Among Breast Cancer Survivors

NCT ID: NCT01419613

Last Updated: 2015-06-23

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 68 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2015-05-31

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.

Detailed Description

Participants will be randomly assigned to one of two groups. One group of breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. The other group of breast cancer survivors will receive counseling on how to increase their level of physical activity.

Participants will have three consultations with a health counselor. The first two consultations will take place in-person and the third consultation will take place via telephone. Participants will also be asked to complete questionnaires assessing their physical and mental well-being, their dietary habits, and their physical activity habits at four time-points: in-person during their first study visit, via mail or through an online survey 6 weeks later, in-person 12 weeks later, and via mail or through an online survey 24 weeks later. Additionally, during their first study visit and 12 weeks later, their level of aerobic fitness will be tested by having participants walk a long hallway for six minutes.

Conditions

Breast Cancer

Study Design

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

Study Groups

Motivational Interviewing

Group Type: EXPERIMENTAL

Motivational Interviewing

Intervention Type: BEHAVIORAL

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

Physical Activity Counseling

Group Type: ACTIVE_COMPARATOR

Counseling

Intervention Type: BEHAVIORAL

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

Interventions

Motivational Interviewing

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

Intervention Type: BEHAVIORAL

Counseling

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

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• ≥ 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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

United States Department of Defense

FED

Sponsor Role: collaborator

H. Lee Moffitt Cancer Center and Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Paul B. Jacobsen, Ph.D.

Role: PRINCIPAL_INVESTIGATOR

H. Lee Moffitt Cancer Center and Research Institute

Locations

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, United States

Countries

United States

Other Identifiers

MCC-16265

Identifier Type: -

Identifier Source: org_study_id