Malignant Neoplasms of Female Genital OrgansNCT02774759
Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
A study testing Accelerometer, Questionnaires and Fitness Test in people with Malignant Neoplasms of Female Genital Organs, run by M.D. Anderson Cancer Center at 1 site in United States.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Malignant Neoplasms of Female Genital Organs
- What is being tested?
- Accelerometer, Questionnaires and Fitness Test
- Type of treatment
- Medical device, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteUnited States
- Study dates
- 17 Oct 2016to 31 Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosed with Stage I-II endometrial cancer
- Six to 36 months post treatment
- Body mass index (BMI) 30-<45 kg/m2
- Age of at least 18 years
- Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices
- Can speak and read English
- Can provide informed consent
- Willing to travel to MD Anderson's main campus for 2 visits (baseline and 6 months post-baseline)
Who cannot join
- Unmanaged lymphedema
- Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet
- Functional limitations requiring a walker/scooter/wheelchair for daily activities
- Recurrent disease
- Vigorous exercise > or = 60 min/week or moderate exercise > or = 150 min/week. If a combination of moderate and vigorous exercise are preformed, the minutes of moderate exercise/week plus 2 x minutes of vigorous exercise/week > or = 150 min/week.
- Resistance training on > or = 2 days/week accounting for more than 30 minutes of strength training per week
- Enrollment in a structured weight loss program in the past 6 months
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
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.
Read the detailed description
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:
- Participant's height, weight, blood pressure, and waist and hip circumferences will be measured.
- Blood (about 1½ tablespoons) will be drawn after participant fasts (has nothing to eat or drink but water) for 8 hours. These samples will be stored for future biomarker testing. Biomarkers will give information about inflammation, the breakdown of food into energy, and molecules released by fat cells. This information will help to see the changes in participant's metabolism and inflammation levels throughout the study.
- Participant will have a dual energy x-ray absorptiometry (DEXA) scan to check the amount of muscle in their body.
- Participant's fitness will be checked using a 6-minute walk test to see how far they can walk in 6 minutes. Participant will also see how many arm curls they can do in 30-seconds, how many times they can stand from a sitting position in 30-seconds, and how fast they can get out of a chair and walk 8 feet.
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.
- If participant is in Group 1, they will have an exercise plan focused on physical activity and resistance training.
- If participant is in Group 2, they will have an exercise plan focused on physical activity only.
- If participant is in Group 3, they will receive the standard of care, which is phone calls asking about their health and self-help materials.
Study Procedures:
Both Groups 1 and 2:
- Participant will receive a portion control plate that they should use at least 1 time day to plan a meal.
- Participant will receive a personalized workbook with physical activity guidelines.
- Participant will be given a Fitbit (which measures their activity levels) and a wireless scale. The information from the scale and Fitbit will be sent to the Fitbit website so participant can monitor their activity levels. Participant can keep the Fitbit after the study is over, but they must return the scale.
- Participant will also be loaned an iPad mini if they do not own one. This can be used to video chat using FaceTime with the research team.
- Participant will be called 4 times during the first month, 2 times during the second month, and 1 time per month for the rest of the study. Participant will also receive a follow-up call at the end of the study. These calls can occur using the telephone or through video chat by using FaceTime on an iPad. The calls should take about 15-30 minutes. Participant will be asked for feedback on reaching goals, given tips for success, and helped to make plans that remove barriers to physical activity.
- Participant will receive around 7 text messages per week. Text messages will include feedback, support, and information about diet and exercise. Text messages will also ask participant to report how often they use their portion plate and how many servings of fruit and vegetables they ate during the day.
- Participant will be told to aerobic exercise (such as walking or swimming) for 30-60 minutes at least 5 days a week. The amount of exercise will slowly increase over the 6 months.
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:
- Participant will complete 9 online questionnaires about their physical activity, diet, quality of life, satisfaction, safety, sexual function, fatigue, body image and ability to function physically. It will take about 3 hours to complete.
- Participant's height, weight, blood pressure and waist circumference will be measured.
- Blood (about 1½ tablespoons) will be drawn after participant fasts for 8 hours. These samples will be stored for biomarker testing as listed above.
- Participant will have a DEXA scan.
- Participant will repeat the fitness tests they did at their baseline visit which include a 6-minute walk test, 30-second arm curl, 30-second sit-to-stand test, and a test to see how fast they can get up from a chair and walk 8 feet.
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.
- Being tested
- Accelerometer, Questionnaires, Fitness Test, Resistance Training, Aerobic Exercise
- Keywords
- Malignant neoplasms of female genital organs, Endometrial cancer survivors, Obese, Weight loss intervention, Resistance training, Aerobic exercise, Questionnaires, Surveys, Accelerometer, Fitness Test, Telephone Coaching, Video Chat Sessions
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AccelerometerDevice
Participant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit.
QuestionnairesBehavioural
Also called Surveys
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 TestBehavioural
Fitness test given covering various physical activities at baseline and at 6 month visit.
Resistance TrainingBehavioural
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 ExerciseBehavioural
Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor.
Telephone Coaching/Phone CallsBehavioural
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 SessionsBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Resistance Training; Behavioral: Telephone Coaching/Phone Calls; Behavioral: Video Chat Sessions |
| 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. Receives: Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Aerobic Exercise; Behavioral: Telephone Coaching/Phone Calls |
| Standard Care Control Group (CG) | Active comparator | 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. Receives: Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Telephone Coaching/Phone Calls |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Study considered feasible if consent rate is larger than 40%.
Measured: 6 months
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Study considered feasible if retention rate is larger than 70%.
Measured: 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%.
Measured: 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.
Measured: 6 months
Secondary outcomes (1)
Changes in Lean Body Mass
Changes in lean body mass measured by dual-energy x-ray absorptiometry (DXA).
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 posted17 May 2016 (estimated)
- Study start17 Oct 2016
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant Neoplasms of Female Genital OrgansStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 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
- Karen Basen-Engquist, PHD, BA, MPH, Principal investigator, M.D. Anderson Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02774759
- Sponsor's protocol ID
- 2015-1076
- Other IDs
- NCI-2016-00904, 5T32CA101642
- Status last verified
- Sep 2026
- First submitted
- 11 May 2016
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
- ClinicalTrials.gov ID
- NCT02774759
- Acronym / sponsor ID
- 2015-1076
- Keywords
- Malignant neoplasms of female genital organs, Endometrial cancer survivors, Obese, Weight loss intervention, Resistance training, Aerobic exercise, Questionnaires, Surveys
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 15 participants (actual)
- Lead sponsor
- M.D. Anderson Cancer CenterUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI)
- Study start
- 17 Oct 2016 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 17 May 2016 (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 research study is to learn if a home-based physical activity program is feasible and can help endometrial cancer survivors lose weight.
Detailed description
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:
- Participant's height, weight, blood pressure, and waist and hip circumferences will be measured.
- Blood (about 1½ tablespoons) will be drawn after participant fasts (has nothing to eat or drink but water) for 8 hours. These samples will be stored for future biomarker testing. Biomarkers will give information about inflammation, the breakdown of food into energy, and molecules released by fat cells. This information will help to see the changes in participant's metabolism and inflammation levels throughout the study.
- Participant will have a dual energy x-ray absorptiometry (DEXA) scan to check the amount of muscle in their body.
- Participant's fitness will be checked using a 6-minute walk test to see how far they can walk in 6 minutes. Participant will also see how many arm curls they can do in 30-seconds, how many times they can stand from a sitting position in 30-seconds, and how fast they can get out of a chair and walk 8 feet.
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.
- If participant is in Group 1, they will have an exercise plan focused on physical activity and resistance training.
- If participant is in Group 2, they will have an exercise plan focused on physical activity only.
- If participant is in Group 3, they will receive the standard of care, which is phone calls asking about their health and self-help materials.
Study Procedures:
Both Groups 1 and 2:
- Participant will receive a portion control plate that they should use at least 1 time day to plan a meal.
- Participant will receive a personalized workbook with physical activity guidelines.
- Participant will be given a Fitbit (which measures their activity levels) and a wireless scale. The information from the scale and Fitbit will be sent to the Fitbit website so participant can monitor their activity levels. Participant can keep the Fitbit after the study is over, but they must return the scale.
- Participant will also be loaned an iPad mini if they do not own one. This can be used to video chat using FaceTime with the research team.
- Participant will be called 4 times during the first month, 2 times during the second month, and 1 time per month for the rest of the study. Participant will also receive a follow-up call at the end of the study. These calls can occur using the telephone or through video chat by using FaceTime on an iPad. The calls should take about 15-30 minutes. Participant will be asked for feedback on reaching goals, given tips for success, and helped to make plans that remove barriers to physical activity.
- Participant will receive around 7 text messages per week. Text messages will include feedback, support, and information about diet and exercise. Text messages will also ask participant to report how often they use their portion plate and how many servings of fruit and vegetables they ate during the day.
- Participant will be told to aerobic exercise (such as walking or swimming) for 30-60 minutes at least 5 days a week. The amount of exercise will slowly increase over the 6 months.
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:
- Participant will complete 9 online questionnaires about their physical activity, diet, quality of life, satisfaction, safety, sexual function, fatigue, body image and ability to function physically. It will take about 3 hours to complete.
- Participant's height, weight, blood pressure and waist circumference will be measured.
- Blood (about 1½ tablespoons) will be drawn after participant fasts for 8 hours. These samples will be stored for biomarker testing as listed above.
- Participant will have a DEXA scan.
- Participant will repeat the fitness tests they did at their baseline visit which include a 6-minute walk test, 30-second arm curl, 30-second sit-to-stand test, and a test to see how fast they can get up from a chair and walk 8 feet.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) | Experimental | Device: Accelerometer, Behavioral: Questionnaires, Behavioral: Fitness Test, Behavioral: Resistance Training, Behavioral: Telephone Coaching/Phone Calls, Behavioral: Video Chat SessionsParticipant 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 | Device: Accelerometer, Behavioral: Questionnaires, Behavioral: Fitness Test, Behavioral: Aerobic Exercise, Behavioral: Telephone Coaching/Phone CallsParticipant 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) | Active comparator | Device: Accelerometer, Behavioral: Questionnaires, Behavioral: Fitness Test, Behavioral: Telephone Coaching/Phone CallsParticipant 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Diagnosed with Stage I-II endometrial cancer
- Six to 36 months post treatment
- Body mass index (BMI) 30-<45 kg/m2
- Age of at least 18 years
- Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices
Key exclusion criteria (7 listed)
- Unmanaged lymphedema
- Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet
- Functional limitations requiring a walker/scooter/wheelchair for daily activities
- Recurrent disease
- Vigorous exercise > or = 60 min/week or moderate exercise > or = 150 min/week. If a combination of moderate and vigorous exercise are preformed, the minutes of moderate exercise/week plus 2 x minutes of vigorous exercise/week > or = 150 min/week.
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 |
|---|---|---|
| AccelerometerParticipant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit. | Device | NEXT-Steps- Aerobic Exercise (NS-A), NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART), Standard Care Control Group (CG) |
| QuestionnairesAlso: SurveysQuestionnaires completed at baseline regarding quality of life and diet. Questionnaires completed at 3 and 6 months regarding quality of life, diet, physical activity, etc. | Behavioural | NEXT-Steps- Aerobic Exercise (NS-A), NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART), Standard Care Control Group (CG) |
| Fitness TestFitness test given covering various physical activities at baseline and at 6 month visit. | Behavioural | NEXT-Steps- Aerobic Exercise (NS-A), NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART), Standard Care Control Group (CG) |
| Resistance TrainingPhysical 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. | Behavioural | NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) |
| Aerobic ExerciseParticipants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor. | Behavioural | NEXT-Steps- Aerobic Exercise (NS-A) |
| Telephone Coaching/Phone CallsParticipants 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. | Behavioural | NEXT-Steps- Aerobic Exercise (NS-A), NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART), Standard Care Control Group (CG) |
| Video Chat SessionsVideo 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. | Behavioural | NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART) |
Primary outcome
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Time frame: 6 months
Study considered feasible if consent rate is larger than 40%.
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Time frame: 6 Months
Study considered feasible if retention rate is larger than 70%.
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Time frame: 6 months
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%.
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Time frame: 6 months
Study considered feasible if the mean overall satisfaction with the program is larger than 3.5 in a 5-level scale.
1 secondary outcome
Changes in Lean Body Mass
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2026.
- 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.
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?
A study testing Accelerometer, Questionnaires and Fitness Test in people with Malignant Neoplasms of Female Genital Organs, 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 8 inclusion and 7 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: under way, not looking for participants, as of the sponsor's last update on 18 Sep 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors (time frame: 6 months). The study lists 4 primary outcomes in all. 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 18 Sep 2026.