Enhancing Physical Activity Adherence After Breast Cancer Diagnosis (BEAT Cancer II)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Experimental 1: exercise with 2 counseling types; Usual Care - written materials
Intervention type(s): Behavioral; Other
Intervention description(s): 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; Patients will receive written materials about exercise for cancer survivors
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: breast cancer; physical activity; exercise; quality of life; doubly labeled water