Promoting a Healthier Lifestyle Among Breast Cancer Survivors
This study is ongoing, but not recruiting participants.
Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborator:
Information provided by (Responsible Party):
H. Lee Moffitt Cancer Center and Research Institute
ClinicalTrials.gov Identifier:
NCT01419613
First received: August 17, 2011
Last updated: May 9, 2013
Last verified: May 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Breast Cancer |
Behavioral: Motivational Interviewing Behavioral: Counseling |
| Study Type: | Interventional |
| 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 |
Resource links provided by NLM:
Further study details as provided by H. Lee Moffitt Cancer Center and Research Institute:
Primary Outcome Measures:
- 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.
Secondary Outcome Measures:
- 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.
| Enrollment: | 68 |
| Study Start Date: | August 2010 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | December 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
| 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 |
Behavioral: Counseling
The control group of breast cancer survivors will receive counseling on how to increase their level of physical activity.
|
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| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
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).
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419613
Locations
| United States, Florida | |
| H. Lee Moffitt Cancer Center and Research Institute | |
| Tampa, Florida, United States, 33612 | |
Sponsors and Collaborators
H. Lee Moffitt Cancer Center and Research Institute
Investigators
| Principal Investigator: | Paul B. Jacobsen, Ph.D. | H. Lee Moffitt Cancer Center and Research Institute |
More Information
Additional Information:
No publications provided
| Responsible Party: | H. Lee Moffitt Cancer Center and Research Institute |
| ClinicalTrials.gov Identifier: | NCT01419613 History of Changes |
| Other Study ID Numbers: | MCC-16265 |
| Study First Received: | August 17, 2011 |
| Last Updated: | May 9, 2013 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by H. Lee Moffitt Cancer Center and Research Institute:
|
healthy lifestyle physical activity behavior |
motivational interview breast cancer survivor |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 16, 2013