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Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors


N/A
18 Years
80 Years
Open (Enrolling)
Female
Breast Cancer

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Trial Information

Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors


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 3 will take part in a chair-based exercise study

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.

Group 3--Chair-based Study Group:

Up to 60 men and women who do not have access to high-speed internet or have physical
limitations that would keep them from taking part in a walking or resistance training
program will be given an opportunity to participate in a chair-based exercise study. These
participants will receive a chair-based exercise DVD. Group 3 participants will take part
in this chair-based exercise program for a total of 8 weeks. If you are assigned to this
group, you will receive self-report assessments about your quality of life and will be asked
to participate in physical assessments of your balance and coordination.

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.


Inclusion Criteria:



1. 18-80 years old at diagnosis

2. diagnosed with operable invasive breast carcinoma

3. not currently undergoing chemotherapy or radiation treatment. Women taking hormone
therapy will not be excluded from the study

4. >= 1 year out from diagnosis

5. have no evidence of recurrent disease or new primary disease

6. be accessible by telephone

7. Phase 2 only: have access to high speed internet

8. Phase 2 only: be currently sedentary (i.e., engage in < or = 60 minutes of purposeful
moderate-intensity PA/week)

9. Phase 2 only: be overweight or obese (i.e., have a body mass index (BMI) > or = 25
kg/m^2)

10. speak English or Spanish

Exclusion Criteria:

1. Phase 2 only: have objective evidence of recurrent disease

2. be currently enrolled in another intervention study or recently completed a study
promoting healthy lifestyle behaviors (diet and/or exercise)

3. participants answering 'Yes' to one or more of the questions on the physical activity
readiness questionnaire (PAR-Q) will need to obtain approval from a physician before
they can participate in the intervention.

4. We opted to not include participants over the age of 70 because previous research has
shown that the exercise habits of women breast cancer survivors in this age range are
different from those of younger women. In addition, women over the age of 70 may have
other health challenges that would prevent them from being active at the levels that
we are recommending.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Outcome Measure:

Health Behaviors of Breast Cancer Survivors

Outcome Description:

Data collected from mail-based surveys (n = 1,000) to assess intervention preferences, physical activity (PA), health related quality of life (HRQOL), and mediators of change (e.g., self-efficacy).

Outcome Time Frame:

6 months

Safety Issue:

No

Principal Investigator

Raheem J. Paxton, PHD

Investigator Role:

Principal Investigator

Investigator Affiliation:

UT MD Anderson Cancer Center

Authority:

United States: Institutional Review Board

Study ID:

2011-0743

NCT ID:

NCT01508273

Start Date:

May 2012

Completion Date:

Related Keywords:

  • Breast Cancer
  • 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
  • Breast Neoplasms

Name

Location

UT MD Anderson Cancer CenterHouston, Texas  77030
Memorial Herman Health Care SystemHouston, Texas  77030