Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-05

Study Completion Date

2020-03-14

Brief Summary

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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.

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Detailed Description

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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

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Endometrial Cancer

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Strength-Training Intervention

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.

Group Type EXPERIMENTAL

Baseline Measures

Intervention Type 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 Type BEHAVIORAL

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

Mid-point Measures

Intervention Type OTHER

Accelerometer (steps)

Post-Study Measures

Intervention Type 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.

Waitlist Control

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

Group Type PLACEBO_COMPARATOR

Baseline Measures

Intervention Type 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.

Mid-point Measures

Intervention Type OTHER

Accelerometer (steps)

Post-Study Measures

Intervention Type 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.

Interventions

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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.

Intervention Type OTHER

Strength-Training

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

Intervention Type BEHAVIORAL

Mid-point Measures

Accelerometer (steps)

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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

Minimum Eligible Age

18 Years

Maximum Eligible Age

74 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No