Breast CancerNCT01508273
Lifestyle Intervention for High Risk Cancer Survivors
A study testing Exercise Program, Website and Exercise DVD in people with Breast Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Exercise Program, Website and Exercise DVD
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,150 participants
- Where
- 3 sitesUnited States
- Study dates
- May 2012to Dec 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
The University of North Texas Health Science Center
Fort Worth, Texas, 76107
Memorial Herman Health Care System
Houston, Texas, 77030
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors
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.
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Exercise Program, Website, Exercise DVD, Survey, Self-Report Assessments
- 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
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise ProgramBehavioural
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.
WebsiteBehavioural
Website access given that allows participant to track exercise behavior and help to set goals.
Exercise DVDBehavioural
Participants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks.
SurveyBehavioural
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 AssessmentsBehavioural
Self-report assessments given about quality of life and physical assessments of balance and coordination.
| Study group | Role | What they receive |
|---|---|---|
| Exercise Intervention Program Group | Experimental | 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. Receives: Behavioral: Exercise Program; Behavioral: Website; Behavioral: Survey |
| Sedentary Behavior and Dietary Intervention Group | Other | 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. Receives: Behavioral: Website; Behavioral: Survey |
| Chair-based Study Group | Experimental | 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. Receives: Behavioral: Exercise DVD; Behavioral: Self-Report Assessments |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 6 months
Secondary outcomes (1)
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jan 2012 (estimated)
- Study startMay 2012
- Primary completionDec 2015
- Study completionDec 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by M.D. Anderson Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,150 participants (actual)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Responsible party
- Sponsor
- Investigators
- Richard A. Hajek, PHD, MS, BA, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508273
- Sponsor's protocol ID
- 2011-0743
- Other IDs
- K01CA158000, NCI-2014-02453
- Status last verified
- Dec 2016
- First submitted
- 9 Jan 2012
- Last updated
- 2 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Development of an Aerobic and Resistance Training Feasibility Study for a Racially and Ethnically Diverse Sample of Breast Cancer Survivors
- ClinicalTrials.gov ID
- NCT01508273
- Acronym / sponsor ID
- 2011-0743
- Conditions
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,150 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- May 2012
- Primary completion
- Dec 2015 (actual)
- Study completion
- Dec 2015 (actual)
- First posted
- 11 Jan 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Exercise Intervention Program Group | Experimental | Behavioral: Exercise Program, Behavioral: Website, Behavioral: SurveyAt 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. |
| Sedentary Behavior and Dietary Intervention Group | Other | Behavioral: Website, Behavioral: SurveyAccess 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. |
| Chair-based Study Group | Experimental | Behavioral: Exercise DVD, Behavioral: Self-Report AssessmentsPatients 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (3 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise ProgramResistance 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. | Behavioural | Exercise Intervention Program Group |
| WebsiteWebsite access given that allows participant to track exercise behavior and help to set goals. | Behavioural | Exercise Intervention Program Group, Sedentary Behavior and Dietary Intervention Group |
| Exercise DVDParticipants receive chair-based exercise DVD. Participants in this chair-based exercise program for a total of 8 weeks. | Behavioural | Chair-based Study Group |
| SurveyExercise 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. | Behavioural | Exercise Intervention Program Group, Sedentary Behavior and Dietary Intervention Group |
| Self-Report AssessmentsSelf-report assessments given about quality of life and physical assessments of balance and coordination. | Behavioural | Chair-based Study Group |
Primary outcome
Health Behaviors of Breast Cancer Survivors
Time frame: 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).
1 secondary outcome
Home-Based Exercise Feasibility
Time frame: 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Dec 2016.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Richard A. Hajek, PHD, MS, BA principal investigator
M.D. Anderson Cancer Center
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise Program, Website and Exercise DVD in people with Breast Cancer, run by M.D. Anderson Cancer Center at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health Behaviors of Breast Cancer Survivors (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Dec 2016.