Clinical trial · Interventional
Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers
NCT02774759CI-TRIAL-00104939active not recruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 19, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260919-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Malignant Neoplasms of Female Genital Organs | — | UNRESOLVED | — |
Interventions
Interventions (7)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Accelerometer | Device | — | UNRESOLVED |
| Aerobic Exercise | Behavioral | — | UNRESOLVED |
| Fitness Test | Behavioral | — | UNRESOLVED |
| Questionnaires | Behavioral | — | UNRESOLVED |
| Resistance Training | Behavioral | — | UNRESOLVED |
| Telephone Coaching/Phone Calls | Behavioral | — | UNRESOLVED |
| Video Chat Sessions | Behavioral | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- EXPERIMENTAL
- label
- NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
- description
- 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.
- interventionNames
- Device: Accelerometer
- Behavioral: Questionnaires
- Behavioral: Fitness Test
- Behavioral: Resistance Training
- Behavioral: Telephone Coaching/Phone Calls
- Behavioral: Video Chat Sessions
- type
- EXPERIMENTAL
- label
- NEXT-Steps- Aerobic Exercise (NS-A)
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.