Clinical trial NCT03722030: Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Official title: Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Endometrial Cancer
Keywords: Strength Training
Resistance Training
Obesity
Sedentary
Lead sponsor: University of Wisconsin, Madison
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
name: American Cancer Society, Inc.
First posted: 2018-10-26
Enrollment: 40
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Feasibility - Number of Participants Recruited
timeFrame: up to 2 years
measure: Number of Participants Who Completed 100% of the Prescribed Exercises
timeFrame: up to 20 weeks from beginning of intervention
measure: Number of Participants With Adverse Events
timeFrame: up to 20 weeks
Secondary outcomes:
measure: Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention
timeFrame: At final visit - up to 20 weeks
measure: Change in Hemoglobin A1c From Baseline
timeFrame: baseline and 10 weeks
measure: Change in C-Reactive Protein From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Lean Muscle Mass From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Fat Mass From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Visceral Fat Mass From Baseline
timeFrame: up to 20 weeks
measure: Change in Total Percent Body Fat From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Number of Arm Curls Performed From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Number of Sit to Stand Repetitions Performed From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Handgrip Weight From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Sit and Reach Distance From Baseline
timeFrame: baseline and 10 weeks
measure: Change in Back Scratch Distance From Baseline
timeFrame: baseline and 10 weeks
measure: Change in 6-minute Walk Distance From Baseline
timeFrame: baseline and 10 weeks
measure: Change in 8 Foot Up and Go Time From Baseline
timeFrame: baseline and 10 weeks
measure: FACT Scores
timeFrame: baseline, 5 weeks, 10 weeks
measure: Changes in FACT From Baseline
timeFrame: baseline and 10 weeks
measure: FACT-En Scores
timeFrame: baseline, 5 Weeks,10 weeks
measure: Changes in FACT-En From Baseline
timeFrame: baseline and 10 weeks
measure: FACT Physical Subscale Scores
timeFrame: baseline, 5 weeks, 10 weeks
measure: FACT Social Subscale Scores
timeFrame: baseline, 5 weeks, 10 weeks
measure: FACT Emotional Subscale Scores
timeFrame: baseline, 5 weeks, 10 weeks
measure: FACT Functional Subscale Scores
timeFrame: baseline, 5 weeks, 10 weeks
measure: Changes in FACT Subscales From Baseline
timeFrame: baseline and 10 weeks
measure: Changes in Mental Well-being From Baseline
timeFrame: baseline and Week 10
measure: Changes in Self-Efficacy From Baseline
timeFrame: Baseline and 10 weeks
measure: Self-Efficacy Scores
timeFrame: Baseline, 5 weeks, 10 weeks
measure: Changes in Accelerometer-Measured Physical Activity From Baseline
timeFrame: baseline and Week 10
measure: Change in Steps Per Day From Baseline
timeFrame: baseline and Week 10
Other outcomes:
Locations:
city: Madison
country: United States
facility: University of Wisconsin Carbone Cancer Center
state: Wisconsin
Study officials:
affiliation: University of Wisconsin, Madison
name: Lisa Cadmus-Bertram
role: PRINCIPAL_INVESTIGATOR
References: