NCT03722030

Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: University of Wisconsin, Madison · Academic / Other
• Sex: Female
• Age: 18 Years – 74 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Endometrial cancer survivors have an extremely high prevalence of inactivity and obesity. Inactivity and obesity are associated with poorer outcomes among survivors. Other interventions have demonstrated that walking and aerobic exercise are safe and feasible in endometrial cancer patients. However few published studies have examined strength training in endometrial cancer survivors, and these have done so only in combination with aerobic intervention (and often also dietary change) in the context of a larger multi-component intervention. There is a critical need for data about the feasibility and benefits of strength training in this population. The investigators propose a 2-arm pilot trial of a home-based strength training intervention (vs. waitlist control) among 40 endometrial cancer survivors. The intervention will consist of (a) an initial in-person instructional session; (b) instructional materials and resistance training equipment (e.g., resistance bands) and (c) support and feedback provided via video coaching sessions. The purpose of a pilot trial is not to conduct hypothesis testing, but rather to field-test the logistical components of the study to incorporate into a larger, future study design. The proposed trial will determine the feasibility of an at-home resistance training protocol and measurements of exercise logging, functional fitness testing, DXA, dried blood spots and questionnaire measures. Participants will be assigned either to the resistance training program (i.e., initial in-person instructional session, telephone coaching, and self-monitoring) or to a comparison arm (wait-list control). * Aim 1: To determine the feasibility of recruiting and retaining endometrial cancer survivors to a home- based resistance training 2 sessions per week of 20-40 minutes of exercise. * Aim 2: To determine participant satisfaction with each component of the intervention and identify opportunities for refinement of the intervention prior to testing in a larger study. * Aim 3: To establish that functional and objective assessments are feasible and well-tolerated in enrolled participants, as assessed using the functional fitness test (FFT) battery, dual-energy x-ray absorptiometry (DXA), finger-pricks for dried blood spots and patient-reported outcomes.

Conditions

• Endometrial Cancer

Interventions

Type	Name	Description
OTHER	Baseline Measures	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.
BEHAVIORAL	Strength-Training	2 sessions per week (20-40 min), home-based resistance training
OTHER	Mid-point Measures	Accelerometer (steps)
OTHER	Post-Study Measures	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.

Timeline

• Start date: 2018-12-05
• Primary completion: 2020-03-14
• Completion: 2020-03-14
• First posted: 2018-10-26
• Last updated: 2021-08-13
• Results posted: 2020-08-11

Locations

1 site across 1 country: United States