Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Status: | Recruiting |
---|---|
Conditions: | Cervical Cancer, Cancer, Endometrial Cancer |
Therapuetic Areas: | Oncology |
Healthy: | No |
Age Range: | 18 - 74 |
Updated: | 10/28/2018 |
Start Date: | September 27, 2018 |
End Date: | October 1, 2019 |
Contact: | Cancer Connect |
Email: | cancerconnect@uwcarbone.wisc.edu |
Phone: | 800-622-8922 |
Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
This 2-arm pilot trial will enroll 20 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.
benefits of a home-based strength training intervention for endometrial cancer survivors
relative to a wait-listed control group.
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 20 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.
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 20 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.
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
We found this trial at
1
site
600 Highland Ave.
Madison, Wisconsin 53792
Madison, Wisconsin 53792
(608) 263-6400
Phone: 608-262-1167
University of Wisconsin Carbone Cancer Center UW Carbone Cancer Center holds the unique distinction of...
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