Clinical trial NCT01419613: Promoting a Healthier Lifestyle Among Breast Cancer Survivors
Official title: Motivational Interviewing to Promote Physical Activity in Breast Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: healthy lifestyle
physical activity
behavior
motivational
interview
breast cancer survivor
Lead sponsor: H. Lee Moffitt Cancer Center and Research Institute
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2011-08-18
Enrollment: 68
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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).

Primary outcomes:
measure: Number of Participants Who Increased Activity After Motivational Interviewing
timeFrame: 24 Weeks Per Participant
Secondary outcomes:
measure: Number of Participants With Desired Impact on Symptoms After Motivational Interviewing
timeFrame: 24 Weeks Per Participant
measure: Number of Participants With Desired Effects From Increased Physical Activity
timeFrame: 24 Weeks Per Participant
Other outcomes:
Locations:
city: Tampa
country: United States
facility: H. Lee Moffitt Cancer Center and Research Institute
state: Florida
Study officials:
affiliation: H. Lee Moffitt Cancer Center and Research Institute
name: Paul B. Jacobsen, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References: