Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

University of Wisconsin (UW)

Status: Completed

Conditions: Endometrial Cancer

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

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03722030

1R03CA230965-01A1 (U.S. NIH Grant/Contract)

P30CA014520 (U.S. NIH Grant/Contract)

UW18013

A176000 (Other Identifier)

2018-0953 (Other Identifier)

NCI-2018-02257 (Registry Identifier)

EDUC/KINESIOLOGY (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 patients

Sex: Female

Ages: 18 to 74 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups, including a placebo group

Strength-Training Intervention

Experimental group

Description:

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.

Treatment:

Other: Mid-point Measures

Behavioral: Strength-Training

Other: Post-Study Measures

Other: Baseline Measures

Waitlist Control

Placebo Comparator group

Description:

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

Treatment:

Other: Mid-point Measures

Other: Post-Study Measures

Other: Baseline Measures