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Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II) (BEAT)

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ClinicalTrials.gov Identifier: NCT00929617
Recruitment Status : Active, not recruiting
First Posted : June 29, 2009
Last Update Posted : February 21, 2019
Sponsor:
Collaborators:
National Cancer Institute (NCI)
National Institutes of Health (NIH)
University of Illinois at Urbana-Champaign
Southern Illinois University
Information provided by (Responsible Party):
Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham

Tracking Information
First Submitted Date  ICMJE June 26, 2009
First Posted Date  ICMJE June 29, 2009
Last Update Posted Date February 21, 2019
Study Start Date  ICMJE June 2009
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 23, 2010)
  • change in physical activity [ Time Frame: baseline to 3 months ]
    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).
  • change in physical activity [ Time Frame: 3 mos to 6 months ]
    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).
  • change in physical activity [ Time Frame: 6 months to 12 months ]
    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).
Original Primary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
physical activity assessment [ Time Frame: 14 months ]
Change History Complete list of historical versions of study NCT00929617 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2015)
  • change in treadmill fitness [ Time Frame: baseline, 3 months, 6 months, 12 months ]
    Treadmill fitness will be measured by sub-maximal fitness test. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
  • change in waist-to-hip ratio [ Time Frame: baseline, 3 months, 6 months, 12 months ]
    Waist-to-hip ratio will be measured with a tape measure. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
  • change in 3-day dietary intake [ Time Frame: baseline, 3 months, 6 months, 12 months ]
    3-day dietary intake will be measured by questionnaire. Change will be calculated as difference between baseline and 3 endpoints (3, 6 and 12 months).
Original Secondary Outcome Measures  ICMJE
 (submitted: June 26, 2009)
  • treadmill [ Time Frame: 12 months ]
  • muscle strength test [ Time Frame: 12 months ]
  • waist-to-hip ratio [ Time Frame: 12 months ]
  • 3-day dietary intake [ Time Frame: 12 months ]
Current Other Pre-specified Outcome Measures
 (submitted: August 19, 2014)
Energy expenditure (doubly labeled water) [ Time Frame: baseline, 3 months, and 6 months ]
Doubly labeled water results will be used to determine reliability of accelerometer measures as part of an NCI funded supplement.
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)
Official Title  ICMJE Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer Study II)
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Breast Cancer
Intervention  ICMJE
  • Behavioral: Experimental 1: exercise with 2 counseling types
    Patients will participate in 12 individual exercise sessions with an exercise specialist which will include stretching exercises and aerobic treadmill walking; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
  • Other: Usual Care - written materials
    Patients will receive written materials about exercise for cancer survivors
Study Arms  ICMJE
  • Experimental: 1: exercise with 2 counseling types
    Patients will participate in 12 individual exercise sessions with an exercise specialist; plus attend 6 discussion group sessions with a trained facilitator; plus 3 face-to-face, individual counseling sessions with an exercise specialist
    Intervention: Behavioral: Experimental 1: exercise with 2 counseling types
  • 2. Usual Care - written materials
    Patients will receive written materials about exercise for cancer survivors
    Intervention: Other: Usual Care - written materials
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 19, 2014)
356
Original Estimated Enrollment  ICMJE
 (submitted: June 26, 2009)
256
Estimated Study Completion Date  ICMJE December 2019
Actual Primary Completion Date March 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 70 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00929617
Other Study ID Numbers  ICMJE ROG-SCCI 09-003-2
3R01CA136859-02S1 ( U.S. NIH Grant/Contract )
U01CA136859 ( U.S. NIH Grant/Contract )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Laura Q. Rogers, MD, MPH, University of Alabama at Birmingham
Study Sponsor  ICMJE University of Alabama at Birmingham
Collaborators  ICMJE
  • National Cancer Institute (NCI)
  • National Institutes of Health (NIH)
  • University of Illinois at Urbana-Champaign
  • Southern Illinois University
Investigators  ICMJE
Principal Investigator: Laura Q. Rogers, MD, MPH University of Alabama at Birmingham
PRS Account University of Alabama at Birmingham
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP