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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.
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 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 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:
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:
If you are assigned to the Phone Group:
Both groups will receive the following:
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 bring the accelerometer, daily diary, and completed questionnaires with you to your second visit to the BRTC.
During your second visit to the BRTC:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Standard Arm (mail/telephone) |
| ||
| Internet Arm |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard Arm (mail/telephone) | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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Participants recruited from UT MD Anderson Cancer Center clinics in Houston, Texas
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| Name | Affiliation | Role |
|---|---|---|
| Karen Basen-Engquist, PHD, BA, MPH | M.D. Anderson Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas MD Anderson Cancer Center | Houston | Texas | 77030 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 28954716 | Derived | 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. |
| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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|
| Internet Arm | Behavioral | 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 Questionnaires | Behavioral | 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 Diet | Behavioral | 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. |
|
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D015179 | Colorectal Neoplasms |
| D011471 | Prostatic Neoplasms |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007414 | Intestinal Neoplasms |
| D005770 | Gastrointestinal Neoplasms |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D005767 | Gastrointestinal Diseases |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D012002 | Rectal Diseases |
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D005832 | Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D001519 | Behavior |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D015444 | Exercise |
| D004032 | Diet |
| ID | Term |
|---|---|
| D003625 | Data Collection |
| D004812 | Epidemiologic Methods |
| D008919 | Investigative Techniques |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
| D009747 | Nutritional Physiological Phenomena |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
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