Promoting a Healthier Lifestyle Among Breast Cancer Survivors

Study Overview
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Brief Summary
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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
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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.

Official Title
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Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors

Conditions
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Breast Cancer

Intervention / Treatment
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* Behavioral: Motivational Interviewing
* Behavioral: Counseling


Participation Criteria
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Eligibility Criteria
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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).

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Motivational Interviewing<br> | Behavioral: Motivational Interviewing<br>* Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.<br>|
| Active Comparator: Physical Activity Counseling<br> | Behavioral: Counseling<br>* The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Desired Impact on Symptoms After Motivational Interviewing | 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 | 24 Weeks Per Participant | 
| Number of Participants With Desired Effects From Increased Physical Activity | (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. | 24 Weeks Per Participant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy lifestyle, physical activity, behavior, motivational, interview, breast cancer survivor