Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

NCT03722030 | Completed Results DMC

• 7 other identifiers: UW18013P30CA014520NCI-2018-022572018-09531R03CA230965-01A1A176000EDUC/KINESIOLOGY
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

This 2-arm pilot trial will enroll 40 participants to test the feasibility, adherence, and benefits of a home-based strength training intervention for endometrial cancer survivors relative to a wait-listed control group.

Conditions

Endometrial Cancer

Keywords

Strength Training; Resistance Training; Obesity; Sedentary

Outcome Measures

Primary Outcomes (3)

• Feasibility - Number of Participants Recruited

  The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants.

  up to 2 years

• Number of Participants Who Completed 100% of the Prescribed Exercises

  Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session.

  up to 20 weeks from beginning of intervention

• Number of Participants With Adverse Events

  The primary safety endpoint will be total number of adverse events over the duration of the intervention.

  up to 20 weeks

Secondary Outcomes (28)

• Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention

  At final visit - up to 20 weeks

• Change in Hemoglobin A1c From Baseline

  baseline and 10 weeks

• Change in C-Reactive Protein From Baseline

  baseline and 10 weeks

• Change in Lean Muscle Mass From Baseline

  baseline and 10 weeks

• Change in Fat Mass From Baseline

  baseline and 10 weeks

Study Arms (2)

Strength-Training Intervention

EXPERIMENTAL

Following baseline measures, participants will receive an initial in-person instructional session, instructional material and resistance training equipment, support and feedback via video coaching, mid-point assessment, and an in-person study visit to collect post study measures. Intervention will be 10 weeks, with a 5 week follow up period.

Other: Baseline Measures; Behavioral: Strength-Training; Other: Mid-point Measures; Other: Post-Study Measures

Waitlist Control

PLACEBO COMPARATOR

Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.

Other: Baseline Measures; Other: Mid-point Measures; Other: Post-Study Measures

Interventions

Baseline Measures OTHER

Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.

Strength-Training Intervention; Waitlist Control

Strength-Training BEHAVIORAL

2 sessions per week (20-40 min), home-based resistance training

Strength-Training Intervention

Mid-point Measures OTHER

Accelerometer (steps)

Strength-Training Intervention; Waitlist Control

Post-Study Measures OTHER

Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy absorptiometry for measuring fat mass, lean mass, % body fat, visceral fat), Functional fitness test.

Strength-Training Intervention; Waitlist Control

Eligibility Criteria

• Age: 18 Years - 74 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willing to provide written informed consent
• Willing to comply with all study procedures and be available for the duration of the study
• Fluent in spoken and written English
• Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years
• Completion of current treatment for endometrial cancer, period of time of ≥10 weeks from treatment completion to study enrollment is required

You may not qualify if:

• Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or musculoskeletal limitations
• Have evidence of recurrent or metastatic disease
• Are currently performing resistance training ≥2 days per week
• Report of chest pain, shortness of breath, fainting, or angina pectoris
• Have physical disability that would limit range of motion through exercises such as sitting, standing and inability to walk one block
• Plans to move from the area
• Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices within 30 days prior to randomization
• Women who are pregnant or breast-feeding
• Not suitable for study participation due to other reasons at the discretion of the investigator

Sponsors & Collaborators

• University of Wisconsin, Madison: lead
• National Cancer Institute (NCI): collaborator
• American Cancer Society, Inc.: collaborator

Study Sites (1)

University of Wisconsin Carbone Cancer Center

Madison, Wisconsin, 53706, United States

Location

Related Links

• University of Wisconsin Carbone Cancer Center

MeSH Terms

Conditions

Endometrial Neoplasms; Obesity; Sedentary Behavior

Interventions

Resistance Training

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Exercise Therapy; Rehabilitation; Aftercare; Continuity of Patient Care; Patient Care; Therapeutics; Physical Therapy Modalities; Physical Conditioning, Human; Exercise; Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Results Point of Contact

• Title: Dr. Lisa Cadmus-Bertram
• Organization: University of Wisconsin - Madison

lisa.bertram@wisc.edu

608-262-1167

Study Officials

• Lisa Cadmus-Bertram

  University of Wisconsin, Madison

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

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

Model Details: Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group

Study Record Dates

• First Submitted: October 16, 2018
• First Posted: October 26, 2018
• Study Start: December 5, 2018
• Primary Completion: March 14, 2020
• Study Completion: March 14, 2020
• Last Updated: August 13, 2021
• Results First Posted: August 11, 2020

Record last verified: 2021-06

Locations

US (1)