A Home-Based Study to Enhance Activity in Breast Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      There is a well-documented association between physical activity & risk for breast cancer
      development and recurrence. It is known that exercise interventions have been effective at
      increasing physical activity levels in breast cancer survivors. Knowing that breast cancer
      survivors are less active than non-cancer patients, a less active lifestyle places them at
      risk of obesity and poor overall health, which in turn also increases risk of cancer and
      cancer recurrence. Not all the reasons for the risk reduction are clear, however it is known
      that hormones and other inflammatory markers play a role.

      This study has three goals:

        1. To investigate the feasibility of a home intervention designed to reduce sedentary
           behavior.

        2. Describe the effects of the intervention on levels of sedentary behavior, physical
           activity, and symptoms.

        3. Assess cost of the intervention.
    

Detailed description: 
      There is a well-documented association between physical activity and risk for breast cancer
      development and recurrence. Exercise training interventions have been effective at increasing
      physical activity levels in breast cancer survivors, however they require 1) a large degree
      of patient initiative to achieve positive health outcomes associated with sustained
      behavioral change and 2) facilities and oversight that may be prohibitive in a clinical
      setting. Although most activity-based research to date has focused on increasing levels of
      moderate to vigorous physical activity (MVPA) for breast cancer survivors, large
      epidemiological studies suggest that breast cancer survivors are also more sedentary when
      compared to non-cancer controls. A recent meta-analysis of controlled intervention trials
      designed to promote physical activity among sedentary cancer survivors found that none of the
      trials within the scope of the review succeeded in achieving 75% or better adherence to
      prescribed exercise guidelines, leading the authors to question whether shifting the target
      of intervention from MVPA to reductions in sedentary time might be a more realistic goal.
      Recent research suggests that interventions designed to reduce sedentary time in breast
      cancer survivors have the potential to yield clinically meaningful health benefits,
      especially for individuals at higher risk for sedentary behaviors, however the optimal method
      of intervention is not clear.

      Aim 1: Feasibility of the intervention Assess the feasibility of an intervention designed to
      reduce sedentary behavior in breast cancer survivors. The behavioral intervention will
      involve the review of a 7-day baseline snapshot of sedentary behavior and physical activity
      patterns, combined with tailored activity prompts described over the following 6 weeks.

      Aim 2: Effects of the intervention Aim 2a: Describe a preliminary range of effect sizes of
      the intervention on levels of sedentary behavior, physical activity and symptoms of cancer
      survivorship (e.g. cancer related fatigue).

      Aim 2b: Evaluate the relationship between change in sedentary behavior and change in
      cancer-relevant outcomes, such as fatigue and biomarkers of cancer recurrence (e.g. IGF-1,
      Leptin), following the reduced sedentary time intervention.

      Aim 3: Assessment of intervention components Aim 3a: Quantitatively assess overall cost of
      the intervention and its individual components, dose delivered and dose received by
      intervention participants Aim 3b: Quantitatively describe intervention participants'
      perspectives on the impact of the individual intervention components, including which
      components appeared most useful for reducing sedentary time.
    

Intervention name(s): Reduced Sedentary Time Intervention (RSTI)
Intervention type(s): Behavioral
Intervention description(s): Following 7 days of baseline activity monitoring a study investigator will download the information from the monitor, evaluate the periods of sedentary behavior and create a tailored RSTI for each participant. For example, the investigator may notice a long stretch of sitting in the evening following a meal and identify several exercises that can be done indoors during that time, or if the participant is amiable to walking breaks and a period after work is identified the investigator might suggest the appropriate walking activity at that time. This program has been successful in sedentary overweight office workers and investigators will use similar techniques.
Intervention model: Single Group Assignment
Masking: None (Open Label)
Primary purpose: Treatment