Breast Cancer
Conditions
Keywords
healthy lifestyle, physical activity, behavior, motivational, interview, breast cancer survivor
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.
Interventions
BEHAVIORALMotivational Interviewing
Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors.
BEHAVIORALCounseling
The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
Sponsors
United States Department of Defense
H. Lee Moffitt Cancer Center and Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Who Increased Activity After Motivational Interviewing | 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
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Desired Impact on Symptoms After Motivational Interviewing | 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 |
| Number of Participants With Desired Effects From Increased Physical Activity | 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. |
Countries
United States
Outcome results
None listed