Clinical trial NCT00721565: An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial; Pilot Study)
Official title: An Exercise Intervention for Breast Cancer Patients: Feasibility and Effectiveness (BEAT Cancer Trial)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Breast Cancer
Keywords: Breast Cancer
Exercise
Social Cognitive Theory
Adherence
Symptoms
Body Composition
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2008-07-24
Enrollment: 49
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: TREATMENT

Brief summary: "Translation" of the current "basic science" information related to physical activity into patient intervention programs is needed. This translation is critical to providing benefit to the maximum number of patients. Little is known about the determinants of physical activity among breast cancer patients undergoing hormonal therapy and few studies have attempted to evaluate an exercise behavior change program aimed to improve exercise adherence among such patients. The proposed project will evaluate use of an innovative behavioral and psychosocial intervention to increase physical activity among breast cancer patients.


Eligibility criteria: Inclusion Criteria:

* Female breast cancer patients between the ages of 18 and 70 years of age with a diagnosis of Stage I, II, or IIIA breast cancer who are currently taking aromatase inhibitors or selective estrogen receptor modulators for the next 8 months.
* English speaking
* Medical clearance for participation provided by primary care physicians
* If the patient has undergone a surgical procedure, must be at least 6 weeks post-procedure

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
* Engaged in \>/= 60 minutes of vigorous physical activity or \>/= 150 minutes of moderate plus vigorous physical activity per week during the past month.

Primary outcomes:
measure: change in physical activity
timeFrame: 6 months
Secondary outcomes:
measure: social cognitive and biopsychosocial outcomes
timeFrame: 3 months
measure: social cognitive and biopsychosocial outcomes
timeFrame: 6 months
Other outcomes:
Locations:
city: Springfield
country: United States
facility: Southern Illinois University School of Medicine
state: Illinois
Study officials:
affiliation: Southern Illinois University School of Medicine
name: Laura Q. Rogers, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
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, Vicari S, Courneya KS. Lessons learned in the trenches: facilitating exercise adherence among breast cancer survivors in a group setting. Cancer Nurs. 2010 Nov-Dec;33(6):E10-7. doi: 10.1097/NCC.0b013e3181db699d.
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: Ehlers DK, Rogers LQ, Courneya KS, Robbs RS, McAuley E. Effects of BEAT Cancer randomized physical activity trial on subjective memory impairments in breast cancer survivors. Psychooncology. 2018 Feb;27(2):687-690. doi: 10.1002/pon.4438. Epub 2017 May 11. No abstract available.