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Promoting a Healthier Lifestyle Among Breast Cancer Survivors

Not Applicable
Completed
Conditions
Breast Cancer
Interventions
Behavioral: Motivational Interviewing
Behavioral: Counseling
Registration Number
NCT01419613
Lead Sponsor
H. Lee Moffitt Cancer Center and Research Institute
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.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
68
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).
Exclusion Criteria

Not provided

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Motivational InterviewingMotivational Interviewing-
Physical Activity CounselingCounseling-
Primary Outcome Measures
NameTimeMethod
Number of Participants Who Increased Activity After Motivational Interviewing24 Weeks Per Participant

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.

Secondary Outcome Measures
NameTimeMethod
Number of Participants With Desired Impact on Symptoms After Motivational Interviewing24 Weeks Per Participant

The secondary objectives of this study are (1) to examine the impact of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness; and

Number of Participants With Desired Effects From Increased Physical Activity24 Weeks Per Participant

(2) to explore whether the degree of change in physical activity acts as a mediator of the expected benefits of the MI intervention on depressive symptoms, fatigue, vigor, and aerobic fitness.

Trial Locations

Locations (1)

H. Lee Moffitt Cancer Center and Research Institute

🇺🇸

Tampa, Florida, United States

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