Your session is about to expire
← Back to Search
Physical Activity Program for Endometrial Cancer Survivors
N/A
Waitlist Available
Led By Karen Basen-Engquist, PHD, BA, MPH
Research Sponsored by M.D. Anderson Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months
Awards & highlights
Study Summary
This trial is testing whether a home-based physical activity program helps endometrial cancer survivors lose weight.
Who is the study for?
This trial is for Stage I-II endometrial cancer survivors with a BMI of 30-<45, who are 6-36 months post-treatment, over 18 years old, and have access to a phone and internet. Participants must be able to visit the campus twice, speak English, consent to the study, and not be doing much exercise or in another weight loss program.Check my eligibility
What is being tested?
The study tests if a home-based physical activity program can help these survivors lose weight. It includes using an accelerometer (like Fitbit), answering questionnaires, resistance training through video chats, fitness testing, and receiving telephone coaching.See study design
What are the potential side effects?
Potential side effects may include muscle soreness from resistance training or aerobic exercises. There might also be fatigue due to increased physical activity levels compared to what participants are used to.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors
Secondary outcome measures
Changes in Lean Body Mass
Trial Design
3Treatment groups
Experimental Treatment
Active Control
Group I: NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)Experimental Treatment6 Interventions
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.
Group II: NEXT-Steps- Aerobic Exercise (NS-A)Experimental Treatment5 Interventions
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.
Group III: Standard Care Control Group (CG)Active Control4 Interventions
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.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Questionnaires
2013
Completed Phase 2
~3330
Resistance Training
2019
Completed Phase 2
~1190
Accelerometer
2020
Completed Phase 2
~460
Aerobic Exercise
2013
Completed Early Phase 1
~1310
Find a Location
Who is running the clinical trial?
M.D. Anderson Cancer CenterLead Sponsor
2,966 Previous Clinical Trials
1,804,766 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,138 Total Patients Enrolled
Karen Basen-Engquist, PHD, BA, MPHPrincipal InvestigatorM.D. Anderson Cancer Center
4 Previous Clinical Trials
588 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have medical conditions that make it unsafe for you to do exercise at home or follow a low-fat, high fruit and vegetable diet.Your body mass index (BMI) is between 30 and less than 45 kg/m2.You participate in strength training exercises for at least 30 minutes, on 2 or more days every week.You have lymphedema that is not being treated or managed.Your disease has come back or returned after previous treatment.
Research Study Groups:
This trial has the following groups:- Group 1: NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)
- Group 2: NEXT-Steps- Aerobic Exercise (NS-A)
- Group 3: Standard Care Control Group (CG)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial recruiting participants at present?
"Clinicaltrials.gov indicates that the recruitment phase for this trial has concluded, as it was first posted on 17th October 2016 and most recently updated on 10th February 2022. However, there are presently 2860 other trials searching for participants to join their clinical studies."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger