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Clinical Trials/NCT01419613
NCT01419613
Completed
Not Applicable

Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors

H. Lee Moffitt Cancer Center and Research Institute1 site in 1 country68 target enrollmentAugust 2010
ConditionsBreast Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Breast Cancer
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Enrollment
68
Locations
1
Primary Endpoint
Number of Participants Who Increased Activity After Motivational Interviewing
Status
Completed
Last Updated
10 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
August 2010
End Date
May 2015
Last Updated
10 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

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).

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Number of Participants Who Increased Activity After Motivational Interviewing

Time Frame: 24 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 Outcomes

  • 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 Sites (1)

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