Lifestyle Intervention for High Risk Cancer Survivors

This study is currently recruiting participants.
Verified March 2014 by M.D. Anderson Cancer Center
Sponsor:
Collaborator:
Information provided by (Responsible Party):
M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier:
NCT01508273
First received: January 9, 2012
Last updated: March 11, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Breast Cancer
Behavioral: Exercise Program
Behavioral: Website
Behavioral: Exercise DVD
Behavioral: Survey
Behavioral: Self-Report Assessments

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors

Resource links provided by NLM:


Further study details as provided by M.D. Anderson Cancer Center:

Primary Outcome Measures:
  • Health Behaviors of Breast Cancer Survivors [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Home-Based Exercise Feasibility [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Rates of recruitment (% recruited out of the total number invited), retention (% completing the 6-month intervention), adherence (% completing 100% of study requirements), satisfaction, adverse events, and barriers to a home-based aerobic and resistance-training program.


Estimated Enrollment: 600
Study Start Date: May 2012
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Exercise Intervention Program Group
At baseline study visit, participant shown how to complete the physical exercises performed while on study. Pedometer received to track physical activity. Resistance training bands given to use as part of the home-based exercise program. At the baseline study visit, directions received on how to use the study website. Access given to website that will allow tracking of exercise behavior and help set goals. Access given to an internet-based curriculum that will help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participant asked to visit website every week. Participant records activity and the number of steps taken every day on the website. Survey completed monthly about attitudes and beliefs about physical activity.
Behavioral: Exercise Program
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.
Behavioral: Website
Website access given that allows participant to track exercise behavior and help to set goals.
Behavioral: Survey

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.

Sedentary Behavior and Dietary Intervention Group
Access given to internet-based curriculum to help teach about goal-setting, overcoming barriers to physical activity, self-management strategies, and time-management skills. Participants read information about improving the quality of their diet and cutting back on sedentary behavior. Participants record on the website how much television watched and how many fruits and vegetables eaten every day. Survey completed monthly about attitudes and beliefs about sedentary behavior and dietary intake.
Behavioral: Website
Website access given that allows participant to track exercise behavior and help to set goals.
Behavioral: Survey

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.

Experimental: Chair-based Study Group
Patients participate in chair-based exercise study. Participants receive chair-based exercise DVD. Chair-based exercise program participation for a total of 8 weeks. Participants receive self-report assessments about quality of life and asked to participate in physical assessments of their balance and coordination.
Behavioral: Exercise DVD
Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.
Behavioral: Self-Report Assessments
Self-report assessments given about quality of life and physical assessments of balance and coordination.

  Hide Detailed Description

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 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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01508273

Contacts
Contact: Richard A. Hajek, PHD, MS, BA 713-563-2735

Locations
United States, Texas
UT MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Memorial Herman Health Care System Not yet recruiting
Houston, Texas, United States, 77030
Sponsors and Collaborators
M.D. Anderson Cancer Center
Investigators
Principal Investigator: Richard A. Hajek, PHD, MS, BA UT MD Anderson Cancer Center
  More Information

Additional Information:
No publications provided

Responsible Party: M.D. Anderson Cancer Center
ClinicalTrials.gov Identifier: NCT01508273     History of Changes
Other Study ID Numbers: 2011-0743, K01CA158000
Study First Received: January 9, 2012
Last Updated: March 11, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by M.D. Anderson Cancer Center:
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

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on April 15, 2014