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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2016-00904 | Registry Identifier | NCI CTRP | |
| 5T32CA101642 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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The goal of this research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight.
Baseline Visit:
If participant is found to be eligible to take part in this study, an accelerometer will be mailed to them. An accelerometer is a small device that records participant's activity levels that participant wears on their waist during the day. Participant will wear this accelerometer for 7 days before their baseline visit. Participant will bring the accelerometer with them to the baseline visit.
Participant will also complete 8 questionnaires about their demographic information (such as their age, race, sex, and so on) / health and treatment history, current physical activity, quality of life, how well they function physically, sexual function, fatigue, body image, and safety as well as a brief survey about their exercise and nutrition preferences. It should take about 2 hours to complete the questionnaires and brief survey.
Participant will also complete 3 questionnaires online about what they ate in the last 24 hours. Two (2) will be completed during weekdays and the other on a weekend day. They should take about 45 minutes to complete. The link to the questionnaires will be emailed to participant.
At the baseline visit at MD Anderson:
Study Groups:
After baseline, participant will be randomly assigned (as in the roll of the dice) to 1 of 3 study groups. Participant will have an equal chance of being in each group.
Study Procedures:
Both Groups 1 and 2:
Group 1 only:
If participant is in Group 1, they will also use resistance exercise for 15-30 minutes at least 2 times a week. Participant will be given resistance bands, exercise handouts, and access to a video PDF containing training videos. Participant will use an iPad mini to video chat with a research team member twice during month 1 and once during month 3. Sessions will take between 30 and 60 minutes and will make sure participant is doing the exercises correctly and their questions are answered. Participant will need to return the loaned iPad mini after the study is over. Participant will be able to use their own iPad or iPad minis if they would like and will have electronic access to the necessary programs and videos.
Group 3:
If participant is in Group 3, they will be called 4 times during the first month, 2 times during the second month, and then 1 time a month for the remaining 4 months. Additionally, participant will receive a follow-up call at the end of the study. Participant will also receive self-help materials at 4 time points. Participants in this group will not receive a Fitbit, wifi scale, portion plate, or iPad mini.
Study Visits:
At 3 months, participant will be sent a link to 8 questionnaires about their physical activity, safety, satisfaction, quality of life, physical functioning, sexual function, body image and fatigue as well as brief survey. Participant will complete these online and it should take about 1½ hours to complete.
At 6 months participant will return to MD Anderson:
The accelerometer will be mailed back to participant before their 6 month visit. Participant will be instructed to wear it again for 7 days, following the same instructions they were given for their first 7 days.
Length of Study:
Study participation will be over after participant completes the 6 month visit. Participant's study participation may be stopped early if they become injured, if they become ineligible (for example, if they need to have treatment), or if the research staff thinks it is in their best interest.
This is an investigational study.
Up to 75 participants will take part in the study. All will be enrolled at MD Anderson.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) | Experimental | Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity and resistance training. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc. |
|
| NEXT-Steps- Aerobic Exercise (NS-A) | Experimental | Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. Participants receive phone calls and text messages for support in reaching exercise and diet goals. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc. |
|
| Standard Care Control Group (CG) |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Accelerometer | Device | Participant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors | Study considered feasible if consent rate is larger than 40%. | 6 months |
| Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors | Study considered feasible if retention rate is larger than 70%. | 6 Months |
| Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors | Study considered feasible if adherence in NEXT Steps- Aerobic exercise and Resistance Training (NS-ART) and NEXT Steps- Aerobic exercise (NS-A) is larger than 65%. | 6 months |
| Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors | Study considered feasible if the mean overall satisfaction with the program is larger than 3.5 in a 5-level scale. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Lean Body Mass | Changes in lean body mass measured by dual-energy x-ray absorptiometry (DXA). | 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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 |
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| Label | URL |
|---|---|
| University of Texas MD Anderson Cancer Center Website | View source |
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Participant wears an accelerometer for 7 days before baseline visit. Six questionnaires completed regarding quality of life and diet. Fitness test given covering various physical activities at baseline and at 6 month visit. Participants receive standard of care consisting of phone calls asking about their health and self-help materials. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc. |
|
| Questionnaires | Behavioral | Questionnaires completed at baseline regarding quality of life and diet. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc. |
|
|
| Fitness Test | Behavioral | Fitness test given covering various physical activities at baseline and at 6 month visit. |
|
| Resistance Training | Behavioral | Physical activity guidelines workbook distributed along with activity monitor. Participants receive resistance bands to perform resistance exercises. Exercise handouts and an iPad mini with training videos used to video chat with a research team member. Information from wireless scale and Fitbit sent to Fitbit website to monitor levels. |
|
| Aerobic Exercise | Behavioral | Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. |
|
| Telephone Coaching/Phone Calls | Behavioral | Participants called 4 times during the first month, 2 times during the second month, and 1 time per month for the rest of the study. Participants also receive a follow-up call at the end of the study. |
|
| Video Chat Sessions | Behavioral | Video chatting between the research team and participants occurs 2 times per month during the first and third months, when new exercises are introduced. Video chatting offered monthly as needed by participants during months 2, 4, 5, and 6. |
|
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D011795 | Surveys and Questionnaires |
| D005080 | Exercise Test |
| D055070 | Resistance Training |
| D015444 | Exercise |
| 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 |
| D006334 | Heart Function Tests |
| D003935 | Diagnostic Techniques, Cardiovascular |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D012129 | Respiratory Function Tests |
| D003948 | Diagnostic Techniques, Respiratory System |
| D016552 | Ergometry |
| D005081 | Exercise Therapy |
| D012046 | Rehabilitation |
| D000359 | Aftercare |
| D003266 | Continuity of Patient Care |
| D005791 | Patient Care |
| D013812 | Therapeutics |
| D026741 | Physical Therapy Modalities |
| D064797 | Physical Conditioning, Human |
| D009043 | Motor Activity |
| D009068 | Movement |
| D009142 | Musculoskeletal Physiological Phenomena |
| D055687 | Musculoskeletal and Neural Physiological Phenomena |
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