Lifestyle Intervention for High Risk Cancer Survivors

Sponsor

M.D. Anderson Cancer Center (Other)

Overall Status

Completed

CT.gov ID

NCT01508273

Collaborator

National Cancer Institute (NCI) (NIH)

1,150

Enrollment

Locations

Arms

Duration (Months)

383.3

Patients Per Site

8.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Behavioral: Exercise Program Behavioral: Website Behavioral: Exercise DVD Behavioral: Survey Behavioral: Self-Report Assessments	N/A

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

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

1150 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

May 1, 2012

Actual Primary Completion Date :

Dec 1, 2015

Actual Study Completion Date :

Dec 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
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.
Other: 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.

Arm

Intervention/Treatment

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.

Other: 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

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.

Outcome Measures

Primary Outcome Measures

Health Behaviors of Breast Cancer Survivors [6 months]
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 [6 months]
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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	The University of North Texas Health Science Center	Fort Worth	Texas	United States	76107
2	Memorial Herman Health Care System	Houston	Texas	United States	77030
3	University of Texas MD Anderson Cancer Center	Houston	Texas	United States	77030