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

NCT02774759 | Active Not Recruiting

• 3 other identifiers: 2015-1076NCI-2016-009045T32CA101642
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (4)

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

  Study considered feasible if consent rate is larger than 40%.

  6 months

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

  Study considered feasible if retention rate is larger than 70%.

  6 Months

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

  Study considered feasible if adherence in NEXT Steps- Aerobic exercise and Resistance Training (NS-ART) and NEXT Steps- Aerobic exercise (NS-A) is larger than 65%.

  6 months

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

  Study considered feasible if the mean overall satisfaction with the program is larger than 3.5 in a 5-level scale.

  6 months

Secondary Outcomes (1)

• Changes in Lean Body Mass

  6 months

Study Arms (3)

NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)

EXPERIMENTAL

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.

Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Resistance Training; Behavioral: Telephone Coaching/Phone Calls; Behavioral: Video Chat Sessions

NEXT-Steps- Aerobic Exercise (NS-A)

EXPERIMENTAL

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.

Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Aerobic Exercise; Behavioral: Telephone Coaching/Phone Calls

Standard Care Control Group (CG)

ACTIVE COMPARATOR

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.

Device: Accelerometer; Behavioral: Questionnaires; Behavioral: Fitness Test; Behavioral: Telephone Coaching/Phone Calls

Interventions

Accelerometer DEVICE

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

NEXT-Steps- Aerobic Exercise (NS-A); NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART); Standard Care Control Group (CG)

Questionnaires BEHAVIORAL

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.

Also known as: Surveys

NEXT-Steps- Aerobic Exercise (NS-A); NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART); Standard Care Control Group (CG)

Fitness Test BEHAVIORAL

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

NEXT-Steps- Aerobic Exercise (NS-A); NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART); Standard Care Control Group (CG)

Resistance Training BEHAVIORAL

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.

NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)

Aerobic Exercise BEHAVIORAL

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

NEXT-Steps- Aerobic Exercise (NS-A)

Telephone Coaching/Phone Calls BEHAVIORAL

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.

NEXT-Steps- Aerobic Exercise (NS-A); NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART); Standard Care Control Group (CG)

Video Chat Sessions BEHAVIORAL

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.

NEXT-Steps- Aerobic Exercise and Resistance Training (NS-ART)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• M.D. Anderson Cancer Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

University of Texas MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• University of Texas MD Anderson Cancer Center Website

MeSH Terms

Conditions

Obesity

Interventions

Surveys and Questionnaires; Exercise Test; Resistance Training; Exercise

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Data Collection; Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Heart Function Tests; Diagnostic Techniques, Cardiovascular; Diagnostic Techniques and Procedures; Diagnosis; Respiratory Function Tests; Diagnostic Techniques, Respiratory System; Ergometry; Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Karen Basen-Engquist, PHD, BA, MPH

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2016
• First Posted: May 17, 2016
• Study Start: October 17, 2016
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2026
• Last Updated: March 9, 2026

Record last verified: 2026-03

Locations

US (1)