Feasibility of the NEXT Steps Weight Loss Intervention +/- Resistance Training for Endometrial Cancer Survivors: Effect on Lean Mass & Biomarkers

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.

Conditions

• Malignant Neoplasms of Female Genital Organs

Interventions

DEVICE

Accelerometer

Participant wears an accelerometer for 7 days before baseline visit to record activity levels, and again before their 6 month visit.

BEHAVIORAL

Questionnaires

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.

BEHAVIORAL

Fitness Test

Fitness test given covering various physical activities at baseline and at 6 month visit.

BEHAVIORAL

Resistance Training

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.

BEHAVIORAL

Aerobic Exercise

Participants placed into an exercise plan focused on physical activity only. Physical activity guidelines workbook distributed along with activity monitor.

BEHAVIORAL

Telephone Coaching/Phone Calls

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.

BEHAVIORAL

Video Chat Sessions

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.

Sponsors & Collaborators

• National Cancer Institute (NCI)

  collaborator NIH

• M.D. Anderson Cancer Center

  lead OTHER

Principal Investigators

• Karen Basen-Engquist, PHD, BA, MPH · M.D. Anderson Cancer Center

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-10-17

Primary Completion

2026-12-31

Completion

2026-12-31

Countries

• United States

Study Locations