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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

No Placebo-Only Group

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of Two Home-Based Weight Loss Interventions for Endometrial Cancer Survivors

Secondary study objectives

Changes in Lean Body Mass

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Accelerometer

2022

Completed Phase 2

~590

Questionnaires

2013

Completed Phase 2

~4280