Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Motivational Interviewing
Counseling
Sponsored by
About this trial
This is an interventional supportive care trial for Breast Cancer focused on measuring healthy lifestyle, physical activity, behavior, motivational, interview, breast cancer survivor
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).
Sites / Locations
- H. Lee Moffitt Cancer Center and Research Institute
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Motivational Interviewing
Physical Activity Counseling
Arm Description
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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
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.
Full Information
NCT ID
NCT01419613
First Posted
August 17, 2011
Last Updated
June 22, 2015
Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT01419613
Brief Title
Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Official Title
Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors
Study Type
Interventional
2. Study Status
Record Verification Date
June 2015
Overall Recruitment Status
Completed
Study Start Date
August 2010 (undefined)
Primary Completion Date
May 2015 (Actual)
Study Completion Date
May 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
H. Lee Moffitt Cancer Center and Research Institute
Collaborators
United States Department of Defense
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
healthy lifestyle, physical activity, behavior, motivational, interview, breast cancer survivor
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
68 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Motivational Interviewing
Arm Type
Experimental
Arm Title
Physical Activity Counseling
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Motivational Interviewing
Intervention Description
Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
Intervention Type
Behavioral
Intervention Name(s)
Counseling
Intervention Description
The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
Primary Outcome Measure Information:
Title
Number of Participants Who Increased Activity After Motivational Interviewing
Description
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.
Time Frame
24 Weeks Per Participant
Secondary Outcome Measure Information:
Title
Number of Participants With Desired Impact on Symptoms After Motivational Interviewing
Description
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
Time Frame
24 Weeks Per Participant
Title
Number of Participants With Desired Effects From Increased Physical Activity
Description
(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.
Time Frame
24 Weeks Per Participant
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul B. Jacobsen, Ph.D.
Organizational Affiliation
H. Lee Moffitt Cancer Center and Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
H. Lee Moffitt Cancer Center and Research Institute
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
12. IPD Sharing Statement
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Promoting a Healthier Lifestyle Among Breast Cancer Survivors
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