Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
18 Years
70 Years
Female
Breast Cancer
Trial Information
Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
Physical activity may improve quality of life, the control of comorbid conditions, and
weight management while reducing breast cancer recurrence and mortality among breast cancer
survivors. Unfortunately, most breast cancer survivors do not engage in regular physical
activity. In fact, breast cancer survivors are often less active after a diagnosis and may
not return to pre-diagnosis activity levels. Therefore, we conducted a pilot study, "BEAT
Cancer", to test a specifically defined physical activity behavior change intervention to
increase physical activity for breast cancer survivors. The pilot study showed significant
improvement in both physical activity and health outcomes for the study participants after
the intervention. Importantly, the pilot intervention resulted in changes in physical
activity and social cognitive theory constructs, such as the participants feeling more
confident in their ability to exercise. The positive results enhance our potential for
testing mechanisms that encourage physical activity behavior change in breast cancer
survivors. The current study is a follow-up to confirm program effectiveness at 3 months and
to test sustainability of results at 3-12 months. We propose a multi-center, randomized
controlled trial enrolling 256 breast cancer survivors with the following study aims:
1. To compare the effects of the 3-month BEAT Cancer physical activity behavior change
intervention to usual care on short and longer term physical activity adherence among
breast cancer survivors. We hypothesize that, compared with usual care, the
intervention will result in a significant increase in physical activity after the
intervention that will be maintained up to 12 months after baseline.
2. To better understand the reasons why breast cancer patients change their physical
activity behavior, we will compare the effects of the BEAT Cancer physical activity
behavior change intervention to usual care on social cognitive factors to see if such
changes contribute to physical activity behavior change. We hypothesize that, compared
with usual care, the intervention will result in significant improvements in social
cognitive factors which lead to changes in physical activity behavior.
3. We also aim to compare the short and longer term health effects of the BEAT Cancer
physical activity behavior change intervention when compared with usual care. We
hypothesize that, compared with usual care, the intervention will result in significant
improvements in fitness, muscle strength, waist-to-hip ratio, quality of life, fatigue,
and sleep quality, while reducing joint dysfunction.
Inclusion Criteria:
- Female breast cancer patients between the ages of 18 and 70 years of age with a
diagnosis of ductal carcinoma in situ (DCIS) or Stage I, II, or IIIA breast cancer
and who are not currently receiving (and do not plan to receive during the duration
of the study) chemotherapy or radiation therapy. The participant may be taking longer
term therapies such as aromatase inhibitors, estrogen receptor modulators, etc. The
upper age limit of 70 years was chosen to reduce the likelihood of adverse events or
study drop-out due to increasing comorbidities (e.g., cardiovascular disease) that
occur with age.
- If the patient has undergone a surgical procedure, enrollment will be delayed until ≥
8 weeks post-procedure.
- English speaking.
- Medical clearance for participation provided by primary care physician or oncologist.
- Participating, on average, in no more than 60 minutes of moderate physical activity
or no more than 30 minutes of vigorous activity per week during the past six months.
Exclusion Criteria:
- Diagnosis of dementia or organic brain syndrome.
- Medical, psychological, or social characteristic that would interfere with ability to
fully participate in program activities and assessments (e.g., psychosis,
schizophrenia, etc.).
- Contraindication to participation in a regular physical activity program.
- Metastatic or recurrent disease.
- Inability to ambulate.
- Anticipates undergoing elective surgery during the duration of the intervention which
would interfere with intervention participation (e.g., breast reconstructive
surgery).
- Planned travel that would interfere with scheduled study sessions (no travel in the
1st 4 months and no travel ≥ 1 week in the last 8 weeks of the intervention).
Type of Study:
Interventional
Study Design:
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
change in physical activity
Outcome Description:
Physical activity will be measured with accelerometers and self-report questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
Outcome Time Frame:
baseline to 3 months
Safety Issue:
No
Principal Investigator
Laura Q. Rogers, MD, MPH
Investigator Role:
Principal Investigator
Investigator Affiliation:
University of Alabama at Birmingham
Authority:
United States: Institutional Review Board
Study ID:
ROG-SCCI 09-003-2
NCT ID:
NCT00929617
Start Date:
June 2010
Completion Date:
May 2015
Related Keywords:
- Breast Cancer
- breast cancer
- physical activity
- exercise
- quality of life
- Breast Neoplasms
Name | Location |
|---|---|
| Southern Illinois University School of Medicine | Springfield, Illinois 62794-9658 |
| University of Alabama at Birmingham | Birmingham, Alabama 35294-3300 |
| University of Illinois | Chicago, Illinois 60612 |
