Breast CancerNCT01311856
Telephone Counseling-Mailed Materials Versus Internet Interventions in Overweight Cancer Survivors
An observational study of Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
The goal of this behavioral research study is to learn if an internet or phone based exercise and weight management program can help cancer survivors to lose weight and change their eating and exercise behavior. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- What is being tested?
- Standard Arm (mail/telephone), Internet Arm and Surveys and Questionnaires
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2011to Mar 2021
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Participants recruited from UT MD Anderson Cancer Center clinics in Houston, Texas
Who may be able to join
- Diagnosis of either loco-regional breast cancer (Stages 0 - IIIA), colon cancer (Stages I - II), endometrial cancer (Stages I - IIIa) or prostate cancer (Stages I - II);
- No history of other cancers (excluding non-melanoma skin cancer);
- Age 18 years of age or older;
- BMI greater than or equal to 25;
- Has access to a computer with high-speed internet;
- Has access to a telephone for possible multiple counseling sessions;
Show all 12Show fewer
- Living in the Houston area (Harris county or a contiguous county);
- Has agreed in the protocol 2009-0544 survey to be re-contacted about studies (for breast, prostate, and colon cancer survivors), or is an endometrial cancer survivor seen seen by an MD Anderson gynecologic oncologist at MD Anderson or an outreach site;
- Able to come to MD Anderson for assessments at baseline and six-month intervals;
- Has completed primary cancer treatment and is at least 3 months from surgery (if elected);
- Able to read and speak English; and
- Able to provide informed consent.
Who cannot join
- Have pre-existing medical conditions that preclude adherence to an unsupervised exercise program or a low-fat, high fruit and vegetable (F\&V) diet;
- Persons using walker or wheelchair/scooter;
- Women who are pregnant; and
- Patients that are identified as having metastatic disease at the time of recruitment.
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Texas MD Anderson Cancer Center
Houston, Texas, 77030
About this study
Official title: Telephone Counseling-Mailed Materials Versus Internet Weight Management Interventions in Overweight Cancer Survivors
The goal of this behavioral research study is to learn if an internet or phone based exercise and weight management program can help cancer survivors to lose weight and change their eating and exercise behavior.
Read the detailed description
If you agree to take part in this study, you will be asked questions about your physical activity to make sure you are eligible. If you are found to have any pre-existing medical or dietary conditions that may prevent you from participating in this study, you will be asked to have your physician complete a form about your health conditions. You will only be allowed to participate in this study if he or she feels it is safe for you to engage in moderate physical activity. After physician clearance, if applicable, you will be scheduled for study visits at the Behavioral Research and Treatment Center (BRTC) at MD Anderson where you will complete tasks to measure your physical functioning ability. Information about your cancer and treatment history will be collected from your medical records as part of this study.
First Study Visit:
During the week before your first visit to the BRTC, you will complete the following tasks at home:
- You will wear an accelerometer and record your physical activities and exercise in a daily diary. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. The accelerometer and diary will be mailed to you ahead of time, and a study staff member will call you to remind you when to start wearing the accelerometer and recording information in the daily diary.
- You will complete questionnaires that ask about any usual physical activities you may participate in, your health history, your quality of life, your social support, and your confidence for changing your eating and exercise behavior. The questionnaires will be mailed to you with the accelerometer and diary. You will complete the questionnaires at home when you have time. These questionnaires should take you no longer than about 30 minutes total to complete.
- Within a week of your first visit to the BRTC, you will complete 2 online "24-hour diet recalls", 1 during a weekday and the other on a weekend day. One of the diet recalls will be done during your first visit to the BRTC and the other will be done at your home. This involves completing an online questionnaire that asks about what you eat and drink. You will report everything you have consumed in the last 24 hours (from midnight to midnight). A study staff member will call you and tell you when to complete each 24-hour diet recall. Each phone call should last no longer than about 5 minutes, depending on if you have any questions for the study staff member.
You will bring the accelerometer, daily diary, and completed questionnaires with you to your first visit to the BRTC.
During your first visit to the BRTC, the following tests and procedures will be performed:
- You will complete any of the questionnaires that you may not have had time to complete at home.
- Your blood pressure, height, weight, and waist and hip measurements will be recorded.
You will also complete 5 simple performance tests that are designed to measure your aerobic function, lower body strength, upper body strength, agility (ability to move quickly), balance, and endurance:
- To test your aerobic fitness, you will complete a 2 minute step test. You will step in place. You must lift your leg up to midway between the knee and hip bone with each step. Your goal is to complete as many steps as possible within 2 minutes.
- To test your lower body strength, you will complete a 30 second chair-stand test. You will rise to an upright standing position from a fully seated position and then return to a fully seated position. You will repeat this as many times as you can within 30 seconds.
- To test your upper body strength, you will complete a timed arm-curl test. You will hold a dumbbell in each hand and slowly curl your arm up towards your shoulder, then slowly lower it until your arm is extended. You will repeat this with your other arm. You will complete this as many as you can within 30 seconds.
- To test your agility and balance, you will complete the "8 foot up-and-go test." For this test, you will sit in a chair facing a cone that marks exactly 8 feet from the chair. You will start the test sitting in the chair. When instructed to start, you will stand up and walk as fast as you can around the cone (without running or hitting the cone) and return to a fully seated position in the chair. You will repeat this test 2 times.
- Finally, you will complete a 6-minute walk test to measure your endurance. To complete this test, you will walk as fast as you can in an indoor hallway for 6 minutes. The distance you walk will be recorded.
A study staff member will instruct you on how to complete each of these tests correctly and safely. You will be given a chance to practice each test, except for the 6 minute walk test. If you have any physical problem or condition that you think may interfere with completing any of the tests, you should tell the study staff member right away.
Additionally, you will complete a dual energy x-ray absorptiometry (DEXA) scan to evaluate body composition. The DEXA scan exposes your body to radiation. The radiation you will receive is about a 10th of the radiation of a chest x-ray. If you are female, you will be asked if you are pregnant. If you state that you are not pregnant, you will receive the DEXA. If you are not sure if you are pregnant, you will have a urine pregnancy test done. If you are pregnant, you will not be able to take part in this study.
The visit to the BRTC should take approximately 2 1/2 hours to complete.
Internet and Phone Intervention Groups:
After you have completed your first visit to the BRTC, you will be randomly assigned (as in a toss of the dice) to either the internet-based intervention group or the phone-based intervention group. Each intervention program will take 6 months to complete. Two (2) out of 3 participants will be assigned to the internet group, and 1 out of 3 participants will be assigned to the phone group.
If you are assigned to the Internet Group:
- You will be given instructions on how to access the diet and exercise information online (www.WalkingSpree.com) that will help you to monitor the amount of fat grams and calories you eat.
- You will participate in a discussion group online that will be led by the study staff.
- You will be able to email questions directly to the study staff at any time.
- You will also receive personalized reports about your progress in meeting the diet and exercise recommendations every 6 weeks by email from the study staff. This is to help you to stay on track with the exercise and diet recommendations.
If you are assigned to the Phone Group:
- You will be given a fat gram and calorie counter to help you to monitor your eating habits.
- You will be given a binder of printed materials with information to help increase your exercise behavior and eat a more healthy diet.
- You will receive 1 counseling phone call each week for the first 3 weeks, then 1 call every 2 weeks for one month, and then 1 call each month for 4 months after that. Each phone call should last about 15-30 minutes. The calls will be recorded and reviewed by the research staff to make sure that the meetings are covering the program content.
- You will also receive personalized reports about your progress in meeting the diet and exercise recommendations every 6 weeks by mail from the study staff. This is to help you to stay on track with the exercise and diet recommendations.
Both groups will receive the following:
- You will receive a pedometer, which is a small device you wear on your belt that counts the number of steps you take. You will need to wear the pedometer all day (from when you wake up to when you go to sleep). You will need to record your daily steps either online or in the binder, depending on which group you are in.
- You will receive resistance bands, which are long, flexible, rubber bands with handles on each end that are used for resistance training. You will be given instructions with pictures, either online or in the binder, that tell and show you how to use the resistance bands correctly and safely. If you have any questions about using the resistance bands, you should email the study staff or call the study counselor, depending on which group you are assigned to.
- You will receive a portion guidance plate, which you are asked to use while eating to help you learn correct portion sizes.
- You will be provided with recommended goals for your exercise, diet, and weight.
After you have been on study for 14 weeks, questionnaires will be mailed to you to complete at home and mail back to the study staff. The questionnaires will ask about your level of physical activity, quality of life, and personal beliefs related to exercising and eating a healthy diet. The questionnaire should take about 20 minutes to complete.
You will also complete 9 online surveys before your intervention sessions while you are on study. These surveys will ask for information about your exercise and eating habits, as well as your personal beliefs related to changing exercise and dieting behavior. This information will help the study staff to give program related information that is specifically designed for you. The surveys should take about 5 minutes to complete.
Second Study Visit:
You will have a second study visit 6 months after the first visit. During the week before your second visit to the BRTC:
- You will wear an accelerometer for a week, record your physical activities and exercise in a daily diary, and complete the same questionnaires. The accelerometer, daily diary, and questionnaires will be mailed to you ahead of time.
- You will also complete 2 more online "24-hour diet recalls" within a week of your second visit. A study staff member will call you and tell you when to complete each diet recall.
You will bring the accelerometer, daily diary, and completed questionnaires with you to your second visit to the BRTC.
During your second visit to the BRTC:
- You will complete any of the questionnaires that you may not have had time to complete at home.
- Your blood pressure, weight, and waist and hip measurements will be recorded.
- You will complete the 5 simple performance tests and a DEXA scan (after testing negative for pregnancy, if applicable).
Length of Study:
You will remain on study for up to 6 months after your first visit to the BRTC.
This is an investigational study.
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Being tested
- Standard Arm (mail/telephone), Internet Arm, Surveys and Questionnaires, Exercise and Diet
- Keywords
- Behavioral intervention, Exercise, Physical Assessment, Questionnaire, Survey, Telephone counseling, Internet interventions, Overweight cancer survivors, Exercise and weight management program
- Medical subject headings
- Breast Neoplasms, Colorectal Neoplasms, Prostatic Neoplasms, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard Arm (mail/telephone)Behavioural
Participants will receive print materials on diet and exercise, telephone counseling calls (3 weekly calls, 2 semi-weekly calls, 4 monthly calls; 15-30 minutes in length), and customized mailed progress reports every 6 weeks to adhere to diet and exercise recommendations.
Internet ArmBehavioural
Participants will access print information online. Participants will also participate in a discussion forum facilitated by the intervention staff, have the opportunity to email questions directly to the intervention staff, and receive progress reports every 6 weeks by email.
Surveys and QuestionnairesBehavioural
9 online surveys to be completed before intervention sessions. After 14 weeks on study, questionnaires will be mailed for completion at home and mailed back to the study staff.
Exercise and DietBehavioural
15 minutes of strength exercise every other day, >30 minutes of walking or other moderate-intensity exercise on 5 or more days of the week. Diet recommendations for both groups.
| Study group | Role | What they receive |
|---|---|---|
| Standard Arm (mail/telephone) | Not described Receives: Behavioral: Standard Arm (mail/telephone); Behavioral: Surveys and Questionnaires; Behavioral: Exercise and Diet | |
| Internet Arm | Not described Receives: Behavioral: Internet Arm; Behavioral: Surveys and Questionnaires; Behavioral: Exercise and Diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Recruitment Rate
Recruitment and drop-out rates in both treatment groups used to assess internal validity of study by comparison of drop-out between two study conditions, and drop-outs to completers.
Measured: 6 months
Secondary outcomes (1)
Drop-Out Rate
Recruitment and drop-out rates in both treatment groups used to assess internal validity of study by comparison of drop-out between two study conditions, and drop-outs to completers.
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 posted10 Mar 2011 (estimated)
- Study startMar 2011
- Primary completionMar 2020 (estimated)
- Study completionMar 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- M.D. Anderson Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Karen Basen-Engquist, PHD, BA, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01311856
- Sponsor's protocol ID
- 2009-0504
- Status last verified
- May 2019
- First submitted
- 4 Mar 2011
- Last updated
- 20 May 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Cox M, Basen-Engquist K, Carmack CL, Blalock J, Li Y, Murray J, Pisters L, Rodriguez-Bigas M, Song J, Cox-Martin E, Demark-Wahnefried W. Comparison of Internet and Telephone Interventions for Weight Loss Among Cancer Survivors: Randomized Controlled Trial and Feasibility Study. JMIR Cancer. 2017 Sep 27;3(2):e16. doi: 10.2196/cancer.7166.
PubMed 28954716
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Counseling-Mailed Materials Versus Internet Weight Management Interventions in Overweight Cancer Survivors
- ClinicalTrials.gov ID
- NCT01311856
- Acronym / sponsor ID
- 2009-0504
- Conditions
- Breast Cancer, Colorectal Cancer, Prostate Cancer
- Keywords
- Behavioral intervention, Exercise, Physical Assessment, Questionnaire, Survey, Telephone counseling, Internet interventions, Overweight cancer survivors
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Study start
- Mar 2011 (actual)
- Primary completion
- Mar 2020 (estimated)
- Study completion
- Mar 2021 (estimated)
- First posted
- 10 Mar 2011 (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 learn if an internet or phone based exercise and weight management program can help cancer survivors to lose weight and change their eating and exercise behavior.
Detailed description
If you agree to take part in this study, you will be asked questions about your physical activity to make sure you are eligible. If you are found to have any pre-existing medical or dietary conditions that may prevent you from participating in this study, you will be asked to have your physician complete a form about your health conditions. You will only be allowed to participate in this study if he or she feels it is safe for you to engage in moderate physical activity. After physician clearance, if applicable, you will be scheduled for study visits at the Behavioral Research and Treatment Center (BRTC) at MD Anderson where you will complete tasks to measure your physical functioning ability. Information about your cancer and treatment history will be collected from your medical records as part of this study.
First Study Visit:
During the week before your first visit to the BRTC, you will complete the following tasks at home:
- You will wear an accelerometer and record your physical activities and exercise in a daily diary. An accelerometer is a small device that you wear on your waist during the day. It records how active you are. The accelerometer and diary will be mailed to you ahead of time, and a study staff member will call you to remind you when to start wearing the accelerometer and recording information in the daily diary.
- You will complete questionnaires that ask about any usual physical activities you may participate in, your health history, your quality of life, your social support, and your confidence for changing your eating and exercise behavior. The questionnaires will be mailed to you with the accelerometer and diary. You will complete the questionnaires at home when you have time. These questionnaires should take you no longer than about 30 minutes total to complete.
- Within a week of your first visit to the BRTC, you will complete 2 online "24-hour diet recalls", 1 during a weekday and the other on a weekend day. One of the diet recalls will be done during your first visit to the BRTC and the other will be done at your home. This involves completing an online questionnaire that asks about what you eat and drink. You will report everything you have consumed in the last 24 hours (from midnight to midnight). A study staff member will call you and tell you when to complete each 24-hour diet recall. Each phone call should last no longer than about 5 minutes, depending on if you have any questions for the study staff member.
You will bring the accelerometer, daily diary, and completed questionnaires with you to your first visit to the BRTC.
During your first visit to the BRTC, the following tests and procedures will be performed:
- You will complete any of the questionnaires that you may not have had time to complete at home.
- Your blood pressure, height, weight, and waist and hip measurements will be recorded.
You will also complete 5 simple performance tests that are designed to measure your aerobic function, lower body strength, upper body strength, agility (ability to move quickly), balance, and endurance:
- To test your aerobic fitness, you will complete a 2 minute step test. You will step in place. You must lift your leg up to midway between the knee and hip bone with each step. Your goal is to complete as many steps as possible within 2 minutes.
- To test your lower body strength, you will complete a 30 second chair-stand test. You will rise to an upright standing position from a fully seated position and then return to a fully seated position. You will repeat this as many times as you can within 30 seconds.
- To test your upper body strength, you will complete a timed arm-curl test. You will hold a dumbbell in each hand and slowly curl your arm up towards your shoulder, then slowly lower it until your arm is extended. You will repeat this with your other arm. You will complete this as many as you can within 30 seconds.
- To test your agility and balance, you will complete the "8 foot up-and-go test." For this test, you will sit in a chair facing a cone that marks exactly 8 feet from the chair. You will start the test sitting in the chair. When instructed to start, you will stand up and walk as fast as you can around the cone (without running or hitting the cone) and return to a fully seated position in the chair. You will repeat this test 2 times.
- Finally, you will complete a 6-minute walk test to measure your endurance. To complete this test, you will walk as fast as you can in an indoor hallway for 6 minutes. The distance you walk will be recorded.
A study staff member will instruct you on how to complete each of these tests correctly and safely. You will be given a chance to practice each test, except for the 6 minute walk test. If you have any physical problem or condition that you think may interfere with completing any of the tests, you should tell the study staff member right away.
Additionally, you will complete a dual energy x-ray absorptiometry (DEXA) scan to evaluate body composition. The DEXA scan exposes your body to radiation. The radiation you will receive is about a 10th of the radiation of a chest x-ray. If you are female, you will be asked if you are pregnant. If you state that you are not pregnant, you will receive the DEXA. If you are not sure if you are pregnant, you will have a urine pregnancy test done. If you are pregnant, you will not be able to take part in this study.
The visit to the BRTC should take approximately 2 1/2 hours to complete.
Internet and Phone Intervention Groups:
After you have completed your first visit to the BRTC, you will be randomly assigned (as in a toss of the dice) to either the internet-based intervention group or the phone-based intervention group. Each intervention program will take 6 months to complete. Two (2) out of 3 participants will be assigned to the internet group, and 1 out of 3 participants will be assigned to the phone group.
If you are assigned to the Internet Group:
- You will be given instructions on how to access the diet and exercise information online (www.WalkingSpree.com) that will help you to monitor the amount of fat grams and calories you eat.
- You will participate in a discussion group online that will be led by the study staff.
- You will be able to email questions directly to the study staff at any time.
- You will also receive personalized reports about your progress in meeting the diet and exercise recommendations every 6 weeks by email from the study staff. This is to help you to stay on track with the exercise and diet recommendations.
If you are assigned to the Phone Group:
- You will be given a fat gram and calorie counter to help you to monitor your eating habits.
- You will be given a binder of printed materials with information to help increase your exercise behavior and eat a more healthy diet.
- You will receive 1 counseling phone call each week for the first 3 weeks, then 1 call every 2 weeks for one month, and then 1 call each month for 4 months after that. Each phone call should last about 15-30 minutes. The calls will be recorded and reviewed by the research staff to make sure that the meetings are covering the program content.
- You will also receive personalized reports about your progress in meeting the diet and exercise recommendations every 6 weeks by mail from the study staff. This is to help you to stay on track with the exercise and diet recommendations.
Both groups will receive the following:
- You will receive a pedometer, which is a small device you wear on your belt that counts the number of steps you take. You will need to wear the pedometer all day (from when you wake up to when you go to sleep). You will need to record your daily steps either online or in the binder, depending on which group you are in.
- You will receive resistance bands, which are long, flexible, rubber bands with handles on each end that are used for resistance training. You will be given instructions with pictures, either online or in the binder, that tell and show you how to use the resistance bands correctly and safely. If you have any questions about using the resistance bands, you should email the study staff or call the study counselor, depending on which group you are assigned to.
- You will receive a portion guidance plate, which you are asked to use while eating to help you learn correct portion sizes.
- You will be provided with recommended goals for your exercise, diet, and weight.
After you have been on study for 14 weeks, questionnaires will be mailed to you to complete at home and mail back to the study staff. The questionnaires will ask about your level of physical activity, quality of life, and personal beliefs related to exercising and eating a healthy diet. The questionnaire should take about 20 minutes to complete.
You will also complete 9 online surveys before your intervention sessions while you are on study. These surveys will ask for information about your exercise and eating habits, as well as your personal beliefs related to changing exercise and dieting behavior. This information will help the study staff to give program related information that is specifically designed for you. The surveys should take about 5 minutes to complete.
Second Study Visit:
You will have a second study visit 6 months after the first visit. During the week before your second visit to the BRTC:
- You will wear an accelerometer for a week, record your physical activities and exercise in a daily diary, and complete the same questionnaires. The accelerometer, daily diary, and questionnaires will be mailed to you ahead of time.
- You will also complete 2 more online "24-hour diet recalls" within a week of your second visit. A study staff member will call you and tell you when to complete each diet recall.
You will bring the accelerometer, daily diary, and completed questionnaires with you to your second visit to the BRTC.
During your second visit to the BRTC:
- You will complete any of the questionnaires that you may not have had time to complete at home.
- Your blood pressure, weight, and waist and hip measurements will be recorded.
- You will complete the 5 simple performance tests and a DEXA scan (after testing negative for pregnancy, if applicable).
Length of Study:
You will remain on study for up to 6 months after your first visit to the BRTC.
This is an investigational study.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Standard Arm (mail/telephone) | – | Behavioral: Standard Arm (mail/telephone), Behavioral: Surveys and Questionnaires, Behavioral: Exercise and Diet |
| Internet Arm | – | Behavioral: Internet Arm, Behavioral: Surveys and Questionnaires, Behavioral: Exercise and Diet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Participants recruited from UT MD Anderson Cancer Center clinics in Houston, Texas
Key inclusion criteria (12 listed)
- Diagnosis of either loco-regional breast cancer (Stages 0 - IIIA), colon cancer (Stages I - II), endometrial cancer (Stages I - IIIa) or prostate cancer (Stages I - II);
- No history of other cancers (excluding non-melanoma skin cancer);
- Age 18 years of age or older;
- BMI greater than or equal to 25;
- Has access to a computer with high-speed internet;
Key exclusion criteria (4 listed)
- Have pre-existing medical conditions that preclude adherence to an unsupervised exercise program or a low-fat, high fruit and vegetable (F\&V) diet;
- Persons using walker or wheelchair/scooter;
- Women who are pregnant; and
- Patients that are identified as having metastatic disease at the time of recruitment.
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 |
|---|---|---|
| Standard Arm (mail/telephone)Participants will receive print materials on diet and exercise, telephone counseling calls (3 weekly calls, 2 semi-weekly calls, 4 monthly calls; 15-30 minutes in length), and customized mailed progress reports every 6 weeks to adhere to diet and exercise recommendations. | Behavioural | Standard Arm (mail/telephone) |
| Internet ArmParticipants will access print information online. Participants will also participate in a discussion forum facilitated by the intervention staff, have the opportunity to email questions directly to the intervention staff, and receive progress reports every 6 weeks by email. | Behavioural | Internet Arm |
| Surveys and Questionnaires9 online surveys to be completed before intervention sessions. After 14 weeks on study, questionnaires will be mailed for completion at home and mailed back to the study staff. | Behavioural | Internet Arm, Standard Arm (mail/telephone) |
| Exercise and Diet15 minutes of strength exercise every other day, >30 minutes of walking or other moderate-intensity exercise on 5 or more days of the week. Diet recommendations for both groups. | Behavioural | Internet Arm, Standard Arm (mail/telephone) |
Primary outcome
Recruitment Rate
Time frame: 6 months
Recruitment and drop-out rates in both treatment groups used to assess internal validity of study by comparison of drop-out between two study conditions, and drop-outs to completers.
1 secondary outcome
Drop-Out Rate
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2019.
- Derived from this study: PubMed 28954716Cox M, Basen-Engquist K, Carmack CL, Blalock J, Li Y, Murray J, Pisters L, Rodriguez-Bigas M, Song J, Cox-Martin E, Demark-Wahnefried W. Comparison of Internet and Telephone Interventions for Weight Loss Among Cancer Survivors: Randomized Controlled Trial and Feasibility Study. JMIR Cancer. 2017 Sep 27;3(2):e16. doi: 10.2196/cancer.7166.
- University of Texas MD Anderson Cancer Center WebsiteLink provided by the sponsor.
Related trials for Breast Cancer
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Karen Basen-Engquist, PHD, BA, MPH principal investigator
M.D. Anderson Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Colorectal Cancer, run by M.D. Anderson Cancer Center at 1 site 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 12 inclusion and 4 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: status not confirmed, as of the sponsor's last update on 20 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Recruitment Rate (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01311856, which also lists 1 linked publication.
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 20 May 2019.