Promoting a Healthier Lifestyle Among Breast Cancer Survivors
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
|Official Title:||Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors|
- Number of Participants Who Increased Activity After Motivational Interviewing [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: No ]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.
- Number of Participants With Desired Impact on Symptoms After Motivational Interviewing [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: Yes ]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 [ Time Frame: 24 Weeks Per Participant ] [ Designated as safety issue: No ](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.
|Study Start Date:||August 2010|
|Study Completion Date:||May 2015|
|Primary Completion Date:||May 2015 (Final data collection date for primary outcome measure)|
|Experimental: Motivational Interviewing||
Behavioral: Motivational Interviewing
Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
|Active Comparator: Physical Activity Counseling||
The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419613
|United States, Florida|
|H. Lee Moffitt Cancer Center and Research Institute|
|Tampa, Florida, United States, 33612|
|Principal Investigator:||Paul B. Jacobsen, Ph.D.||H. Lee Moffitt Cancer Center and Research Institute|