Clinical trial NCT02774759: Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
Official title: Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Malignant Neoplasms of Female Genital Organs
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
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2016-05-17
Enrollment: 15
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. Diagnosed with Stage I-II endometrial cancer
2. Six to 36 months post treatment
3. Body mass index (BMI) 30-\<45 kg/m2
4. Age of at least 18 years
5. Access to a telephone for coaching sessions and access to a computer, smartphone, or tablet for syncing Fitbit devices
6. Can speak and read English
7. Can provide informed consent
8. Willing to travel to MD Anderson's main campus for 2 visits (baseline and 6 months post-baseline)

Exclusion Criteria:

1. Unmanaged lymphedema
2. Medical contraindications to home-based exercise or low-fat, high fruit and vegetable diet
3. Functional limitations requiring a walker/scooter/wheelchair for daily activities
4. Recurrent disease
5. 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.
6. Resistance training on \> or = 2 days/week accounting for more than 30 minutes of strength training per week
7. Enrollment in a structured weight loss program in the past 6 months

Primary outcomes:
measure: Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
timeFrame: 6 months
measure: Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
timeFrame: 6 Months
measure: Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
timeFrame: 6 months
measure: Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
timeFrame: 6 months
Secondary outcomes:
measure: Changes in Lean Body Mass
timeFrame: 6 months
Other outcomes:
Locations:
city: Houston
country: United States
facility: University of Texas MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Karen Basen-Engquist, PHD, BA, MPH
role: PRINCIPAL_INVESTIGATOR
References: