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Completed

NCT Number: NCT01419613

Promoting a Healthier Lifestyle Among Breast Cancer Survivors

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

H. Lee Moffitt Cancer Center and Research Institute

Tampa, Florida, 33612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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).

Treatment and study plan

Motivational Interviewing

Behavioral

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

Counseling

Behavioral

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

Primary outcomes

  1. 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

  1. Number of Participants With Desired Impact on Symptoms After Motivational Interviewing

    Time frame: 24 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

  2. Number of Participants With Desired Effects From Increased Physical Activity

    Time frame: 24 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.

Sponsors and collaborators

Lead sponsor

H. Lee Moffitt Cancer Center and Research Institute

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors

Important dates

Study start
2010
Primary completion
2015
Study completion
2015
First posted
Aug 18, 2011
Registry last updated
Jun 23, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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