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Lifestyle Intervention for High Risk Cancer Survivors

Primary Purpose

Breast Cancer

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Exercise Program
Website
Exercise DVD
Survey
Self-Report Assessments
Sponsored by
M.D. Anderson Cancer Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Breast Cancer focused on measuring 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

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria:

  1. 18-80 years old at diagnosis
  2. diagnosed with operable invasive cancer
  3. have access to high speed internet
  4. Phase 2 only: be currently sedentary (i.e., engage in < or = 60 minutes of purposeful moderate-intensity PA/week)
  5. Phase 2 only: be overweight or obese (i.e., have a body mass index (BMI) > or = 25 kg/m^2)
  6. speak English

Exclusion Criteria:

  1. watch less than 3 hours of television per day
  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.

Sites / Locations

  • The University of North Texas Health Science Center
  • Memorial Herman Health Care System
  • University of Texas MD Anderson Cancer Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Other

Experimental

Arm Label

Exercise Intervention Program Group

Sedentary Behavior and Dietary Intervention Group

Chair-based Study Group

Arm Description

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.

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.

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.

Outcomes

Primary Outcome Measures

Health Behaviors of Breast Cancer Survivors
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
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.

Full Information

First Posted
January 9, 2012
Last Updated
December 1, 2016
Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
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1. Study Identification

Unique Protocol Identification Number
NCT01508273
Brief Title
Lifestyle Intervention for High Risk Cancer Survivors
Official Title
Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors
Study Type
Interventional

2. Study Status

Record Verification Date
December 2016
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
December 2015 (Actual)
Study Completion Date
December 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
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

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Exercise Intervention Program Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Sedentary Behavior and Dietary Intervention Group
Arm Type
Other
Arm Description
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.
Arm Title
Chair-based Study Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Exercise Program
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Website
Intervention Description
Website access given that allows participant to track exercise behavior and help to set goals.
Intervention Type
Behavioral
Intervention Name(s)
Exercise DVD
Intervention Description
Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.
Intervention Type
Behavioral
Intervention Name(s)
Survey
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Self-Report Assessments
Intervention Description
Self-report assessments given about quality of life and physical assessments of balance and coordination.
Primary Outcome Measure Information:
Title
Health Behaviors of Breast Cancer Survivors
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Home-Based Exercise Feasibility
Description
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.
Time Frame
6 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 18-80 years old at diagnosis diagnosed with operable invasive cancer have access to high speed internet Phase 2 only: be currently sedentary (i.e., engage in < or = 60 minutes of purposeful moderate-intensity PA/week) Phase 2 only: be overweight or obese (i.e., have a body mass index (BMI) > or = 25 kg/m^2) speak English Exclusion Criteria: watch less than 3 hours of television per day be currently enrolled in another intervention study or recently completed a study promoting healthy lifestyle behaviors (diet and/or exercise) 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Richard A. Hajek, PHD, MS, BA
Organizational Affiliation
M.D. Anderson Cancer Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
The University of North Texas Health Science Center
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76107
Country
United States
Facility Name
Memorial Herman Health Care System
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Texas MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Links:
URL
http://www.mdanderson.org
Description
University of Texas MD Anderson Cancer Center Website

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Lifestyle Intervention for High Risk Cancer Survivors

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