Life ImproVed by Exercise (LIVE Trial)
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      This is a prospective randomized controlled trial in which patients with previous breast
      cancer will be randomized into two treatment arms:

        1. Control Group of Usual Physical Activity

        2. Intervention Group of Increased Physical Activity

      No specific intervention will be performed In the patients randomized in the control group.

      Patients randomized in the Intervention group will receive a program of increased physical
      activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time
      patients of this group will receive an 8-week recreational program of brisk walking/running
      (3 times a week).

      All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able
      to count the number of steps, determine a daily goal of steps, determine the covered distance
      (in Km), determine daily caloric consumption, and determine the movements during sleep.
    

Detailed description: 
      In this prospective randomized controlled trial patients with previous breast cancer will be
      randomized into two treatment arms:

        1. Control Group of Usual Physical Activity

        2. Intervention Group of Increased Physical Activity

      No specific intervention will be performed In the patients randomized in the control group.

      Patients randomized in the Intervention Group will receive a program of increased physical
      activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks. At the same time
      patients of this group will receive an 8-week recreational program of brisk walking/running
      (3 times a week).

      All the patients enrolled in this trial will receive a pedometer device (Garmin Vìvofit) able
      to count the number of steps, determine a daily goal of steps, determine the covered distance
      (in Km), determine daily caloric consumption, and determine the movements during sleep.

      Data will be downloaded in a specific application available online (Garmin Connect).

      All the patients will receive written information on the potential benefits of physical
      exercise and better lifestyle.

      At baseline, at the end of the study period (8 weeks) and after 1 year patients will be asked
      to fill out the following questionnaires:

        -  Funcional Assessment of Cancer Therapy- Breast (FACT-B, 37 items)

        -  Patient reported symptoms (PRS like International Breast Cancer Study Group form, 19
           items)

        -  Funcional Assessment of Cancer Therapy- Fatigue (FACT-Fatigue, 13 items)

        -  Functional Assessment of Cancer Therapy-Cognitive Function (FACT-Cog; 37 items)

        -  Impact of Event Scale (IES; 22 items)

      At baseline, at the end of the study period (8 weeks) patients will be asked to undergo blood
      draw for serum analysis of insulin, IGF-1, leptin, PCR, cholesterol, triglycerides leucocyte
      count, T lymphocyte subpopulations (T regulatory and TH17).

      The hypothesis of the study is that even a short course of increased physical activity may
      improve quality of life of non-regular exercisers women with a personal history of breast
      cancer who completed treatment (endocrine treatment excluded).
    

Intervention name(s): Increased Physical Activity
Intervention type(s): Behavioral
Intervention description(s): Patients will receive a program of increased physical activity starting from 5000 steps/day up to 12000 steps/day after 8 weeks and an 8-week recreational program of brisk walking/running (3 times a week).
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Breast Cancer; Physical Activity; Quality of life