Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Condition: Endometrial Cancer
MeSH terms: Endometrial Neoplasms
Study type: Interventional

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.
    

Intervention name(s): Baseline Measures; Strength-Training; Mid-point Measures; Post-Study Measures
Intervention type(s): Other; Behavioral; Other; Other
Intervention description(s): 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.; 2 sessions per week (20-40 min), home-based resistance training; Accelerometer (steps); 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.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group
Masking: None (Open Label)
Primary purpose: Supportive Care
Keywords: Strength Training; Resistance Training; Obesity; Sedentary