Lifestyle Intervention for High Risk Cancer Survivors
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Study type: Interventional

Summary: 
      The goal of this behavioral research study is to find out more about the health behaviors of
      cancer survivors. Researchers want to understand the cultural, social, and environmental
      factors related to physical activity and personal diet. Researchers also want to learn if
      cancer survivors who take part in lifestyle interventions have better overall health and
      quality of life than those who do not take part in these interventions.
    

Detailed description: 
      If you agree to take part in this study, you will have a baseline study visit. This visit
      will include a physical exam, including measurements of your height and weight. Your hips,
      wrist, mid-arm, and waist will also be measured. You will also fill out questionnaires that
      contain items about your diet and exercise habits as well as questions about your quality of
      life.

      Study Groups:

      You will be randomly assigned (as in the flip of a coin) to 1 of 2 groups.

        -  Group 1 will take part in an exercise intervention program.

        -  Group 2 will take part in a sedentary behavior and dietary intervention group.

      Group 1--Exercise Intervention:

      At the baseline study visit, the study staff will show you how to complete the physical
      exercises you will perform while you are on study.

      You will receive a pedometer that you can wear on your waistband to track your physical
      activity. The pedometer is the size of a deck of cards and will be worn throughout the study
      to track your progress.

      You will be given resistance training bands to use as part of the home-based exercise
      program. At the baseline study visit, you will receive a directions on how to use the study
      website. In addition, the study coordinator will walk you through each of these exercises.
      After the study is complete, you will be allowed to keep the resistance training bands and
      pedometer.

      Participants in Groups 1 will receive access to a website that will allow you to track your
      exercise behavior and help you set goals. This data will be recorded for you, and your
      progress will be graphed throughout the course of the study.

      You will be given access to an internet-based curriculum that will help teach you about
      goal-setting, overcoming barriers to physical activity, self-management strategies, and
      time-management skills. You are being asked to visit the website every week to read that
      week's lesson materials and to set weekly goals. In addition to this weekly visits, you will
      need to record your activity and the number of steps you take every day on the website. Each
      month, you will be asked to fill our a survey about your attitudes and beliefs about physical
      activity.

      Group 2--Parallel-Study Group:

      Participants who are assigned to this group will received access to the same website as Group
      1. You will also be asked to read information about improving the quality of your diet and
      cutting back on sedentary behavior ( for example, television viewing and overall sitting).
      The website will allow you to track your sitting and dietary behaviors and help you set
      goals. This data will be recorded for you, and your progress will be graphed throughout the
      course of the study.

      Participants in Group 2 will be given access to curriculum that will help teach you about
      goal-setting, overcoming barriers to improving your diet and cutting back on sedentary
      behavior, as well as learn self-management strategies and time-management skills. You are
      being asked to visit the website once a week to read that week's lesson materials and to set
      weekly goals. In addition to this weekly visit, you will need to record on the website how
      much television you watch and how many fruits and vegetables you eat every day. Each month,
      you will be asked to fill our a survey about your attitude and beliefs about sedentary
      behavior and dietary intake.

      6-Month Follow-up Visit: For both groups (Groups 1 & 2), at the 6-month follow-up visit, your
      weight and waist, hip, and arm measurements will be recorded and compared to your
      measurements from the baseline visit.

      Length of Study:

      For both groups, you will be taken off study if you experience side effects from taking part
      in the intervention, you are hospitalized for any reason, or you are diagnosed with a
      condition that needs a treatment not allowed while on this study.

      Your participation on the study will be over once you have completed the 6-month visit.

      This is an investigational study.

      Up to 200 cancer survivors will take part in this study. Up to 150 will be enrolled at MD
      Anderson.
    

Intervention name(s): Exercise Program; Website; Exercise DVD; Survey; Self-Report Assessments
Intervention type(s): Behavioral; Behavioral; Behavioral; Behavioral; Behavioral
Intervention description(s): Resistance training bands, guidebook, and pedometer given at baseline visit. Internet-based curriculum access given to teach goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Access given website that will allow participant to track exercise behavior and help set goals.; Website access given that allows participant to track exercise behavior and help to set goals.; Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.; Exercise Intervention Program Group : Survey completion monthly about attitudes and beliefs about physical activity.
Sedentary Behavior and Dietary Intervention Group: Survey completion monthly attitudes and beliefs about sedentary behavior and dietary intake.; Self-report assessments given about quality of life and physical assessments of balance and coordination.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Breast Cancer; Breast Cancer Survivors; High risk cancer survivors; Stage II to IIIC breast cancer; African American; AA; Hispanic; Non-Hispanic White; Operable invasive breast carcinoma; Aerobic and resistance training; Pedometer; Telephone Counseling Calls; Physical activity report; PAR; Functional Assessment of Cancer Therapy-Breast; FACT-B; Health related quality of life; HRQOL