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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Motivational Interviewing | Experimental |
| |
| Physical Activity Counseling | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Motivational Interviewing | Behavioral | Breast cancer survivors will receive general information on how to adopt healthy lifestyle behaviors. |
|
| 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 |
| 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 |
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Inclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Paul B. Jacobsen, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| H. Lee Moffitt Cancer Center and Research Institute | Tampa | Florida | 33612 | United States |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009043 | Motor Activity |
| D001519 | Behavior |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| D062405 | Motivational Interviewing |
| D003376 | Counseling |
| ID | Term |
|---|---|
| D037001 | Directive Counseling |
| D008605 | Mental Health Services |
| D004191 | Behavioral Disciplines and Activities |
| D006296 | Health Services |
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| Counseling | Behavioral | The control group of breast cancer survivors will receive counseling on how to increase their level of 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 |
| D017437 |
| Skin and Connective Tissue Diseases |
| D005159 | Health Care Facilities Workforce and Services |
| D003153 | Community Health Services |