Clinical trial NCT00929617: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)
Official title: Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: breast cancer
physical activity
exercise
quality of life
doubly labeled water
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: National Institutes of Health (NIH)
name: University of Illinois at Urbana-Champaign
name: Southern Illinois University
First posted: 2009-06-29
Enrollment: 374
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of the study is to compare the effects of one exercise/counseling protocol with usual care on long term exercise adherence and on changes in health related outcomes after breast cancer diagnosis.

Detailed description: 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 356 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.

Eligibility criteria: 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).

Primary outcomes:
measure: change in physical activity
timeFrame: baseline to 3 months
measure: change in physical activity
timeFrame: 3 mos to 6 months
measure: change in physical activity
timeFrame: 6 months to 12 months
Secondary outcomes:
measure: change in treadmill fitness
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change in waist-to-hip ratio
timeFrame: baseline, 3 months, 6 months, 12 months
measure: change in 3-day dietary intake
timeFrame: baseline, 3 months, 6 months, 12 months
Other outcomes:
measure: Energy expenditure (doubly labeled water)
timeFrame: baseline, 3 months, and 6 months
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
city: Champaign
country: United States
facility: University of Illinois
state: Illinois
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: University of Alabama at Birmingham
name: Laura Q. Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Rogers LQ, Hopkins-Price P, Vicari S, Markwell S, Pamenter R, Courneya KS, Hoelzer K, Naritoku C, Edson B, Jones L, Dunnington G, Verhulst S. Physical activity and health outcomes three months after completing a physical activity behavior change intervention: persistent and delayed effects. Cancer Epidemiol Biomarkers Prev. 2009 May;18(5):1410-8. doi: 10.1158/1055-9965.EPI-08-1045. Epub 2009 Apr 21.
citation: Rogers LQ, Hopkins-Price P, Vicari S, Pamenter R, Courneya KS, Markwell S, Verhulst S, Hoelzer K, Naritoku C, Jones L, Dunnington G, Lanzotti V, Wynstra J, Shah L, Edson B, Graff A, Lowy M. A randomized trial to increase physical activity in breast cancer survivors. Med Sci Sports Exerc. 2009 Apr;41(4):935-46. doi: 10.1249/MSS.0b013e31818e0e1b.
citation: Rogers LQ, Markwell SJ, Verhulst S, McAuley E, Courneya KS. Rural breast cancer survivors: exercise preferences and their determinants. Psychooncology. 2009 Apr;18(4):412-21. doi: 10.1002/pon.1497.
citation: Rogers LQ, Courneya KS, Verhulst S, Markwell SJ, McAuley E. Factors associated with exercise counseling and program preferences among breast cancer survivors. J Phys Act Health. 2008 Sep;5(5):688-705. doi: 10.1123/jpah.5.5.688.
citation: Rogers LQ, McAuley E, Courneya KS, Verhulst SJ. Correlates of physical activity self-efficacy among breast cancer survivors. Am J Health Behav. 2008 Nov-Dec;32(6):594-603. doi: 10.5555/ajhb.2008.32.6.594.
citation: Rogers LQ, Markwell S, Hopkins-Price P, Vicari S, Courneya KS, Hoelzer K, Verhulst S. Reduced barriers mediated physical activity maintenance among breast cancer survivors. J Sport Exerc Psychol. 2011 Apr;33(2):235-54. doi: 10.1123/jsep.33.2.235.
citation: Rogers LQ, McAuley E, Anton PM, Courneya KS, Vicari S, Hopkins-Price P, Verhulst S, Mocharnuk R, Hoelzer K. Better exercise adherence after treatment for cancer (BEAT Cancer) study: rationale, design, and methods. Contemp Clin Trials. 2012 Jan;33(1):124-37. doi: 10.1016/j.cct.2011.09.004. Epub 2011 Sep 29.
citation: Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Vicari SK, Robbs RS, Mocharnuk R, McAuley E. Effects of the BEAT Cancer physical activity behavior change intervention on physical activity, aerobic fitness, and quality of life in breast cancer survivors: a multicenter randomized controlled trial. Breast Cancer Res Treat. 2015 Jan;149(1):109-19. doi: 10.1007/s10549-014-3216-z. Epub 2014 Nov 23.
citation: Ainsworth MC, Pekmezi D, Bowles H, Ehlers D, McAuley E, Courneya KS, Rogers LQ. Acceptability of a Mobile Phone App for Measuring Time Use in Breast Cancer Survivors (Life in a Day): Mixed-Methods Study. JMIR Cancer. 2018 May 14;4(1):e9. doi: 10.2196/cancer.8951.
citation: Rogers LQ, Courneya KS, Anton PM, Hopkins-Price P, Verhulst S, Robbs RS, Vicari SK, McAuley E. Social Cognitive Constructs Did Not Mediate the BEAT Cancer Intervention Effects on Objective Physical Activity Behavior Based on Multivariable Path Analysis. Ann Behav Med. 2017 Apr;51(2):321-326. doi: 10.1007/s12160-016-9840-6.