Endometrial CancerNCT03722030
Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
A study testing Baseline Measures, Strength-Training and Mid-point Measures in people with Endometrial Cancer, run by University of Wisconsin, Madison at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Endometrial Cancer
- What is being tested?
- Baseline Measures, Strength-Training and Mid-point Measures
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Dec 2018to 14 Mar 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country.
United States1 site
University of Wisconsin Carbone Cancer Center
Madison, Wisconsin, 53706
About this study
Official title: Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
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.
Read the 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.
- Conditions
- Endometrial Cancer
- Being tested
- Baseline Measures, Strength-Training, Mid-point Measures, Post-Study Measures
- Keywords
- Strength Training, Resistance Training, Obesity, Sedentary
- Medical subject headings
- Endometrial Neoplasms, Obesity, Sedentary Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Baseline MeasuresOther
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-TrainingBehavioural
2 sessions per week (20-40 min), home-based resistance training
Mid-point MeasuresOther
Accelerometer (steps)
Post-Study MeasuresOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Strength-Training Intervention | Experimental | 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. Receives: Other: Baseline Measures; Behavioral: Strength-Training; Other: Mid-point Measures; Other: Post-Study Measures |
| Waitlist Control | Placebo comparator | Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention. Receives: Other: Baseline Measures; Other: Mid-point Measures; Other: Post-Study Measures |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility - Number of Participants Recruited
The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants.
Measured: up to 2 years
Number of Participants Who Completed 100% of the Prescribed Exercises
Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session.
Measured: up to 20 weeks from beginning of intervention
Number of Participants With Adverse Events
The primary safety endpoint will be total number of adverse events over the duration of the intervention.
Measured: up to 20 weeks
Secondary outcomes (28)
Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention
Participants will complete semi-structured qualitative interviews with the study coordinator. Interviews will be recorded, transcribed and coded to identify content themes. These interviews will be used to collect qualitative information and overall satisfaction with the intervention, as well as areas to improve with future interventions and barriers to participation.
Measured: At final visit - up to 20 weeks
Change in Hemoglobin A1c From Baseline
Baseline and post-study blood biomarkers to assess Hemoglobin A1c will be collected and reported in a table as a change from baseline.
Measured: baseline and 10 weeks
Change in C-Reactive Protein From Baseline
Baseline and post-study blood biomarkers to assess c-reactive protein will be collected and reported in a table as a change from baseline.
Measured: baseline and 10 weeks
Change in Lean Muscle Mass From Baseline
Baseline and post-study lean muscle mass will be assessed using dual-energy absorptiometry (DXA) using the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Measured: baseline and 10 weeks
Change in Fat Mass From Baseline
Baseline and post-study fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Measured: baseline and 10 weeks
Change in Visceral Fat Mass From Baseline
Baseline and post-study visceral fat mass will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Measured: up to 20 weeks
Change in Total Percent Body Fat From Baseline
Baseline and post-study % body fat will be assessed using dual-energy absorptiometry (DXA) utilizing the enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). Data will be reported in a table as change from baseline.
Measured: baseline and 10 weeks
Change in Number of Arm Curls Performed From Baseline
Arm curls are part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. These tests will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The 30 second arm curl assesses the strength of the upper body, where participants hold a 5 pound dumbbell in a seated position, and they will have 30 seconds to curl their arm and extend it as many times as possible within the time frame.
Measured: baseline and 10 weeks
Change in Number of Sit to Stand Repetitions Performed From Baseline
The 30 second chair stand is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The 30 second chair stand assesses the strength of the lower body. Each person will have 30 seconds to stand up and sit down from a chair as many times as possible within the time frame.
Measured: baseline and 10 weeks
Change in Handgrip Weight From Baseline
Handgrip is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
[can you describe this test? I do not see it in the protocol]
Measured: baseline and 10 weeks
Change in Sit and Reach Distance From Baseline
The chair sit and reach test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The chair sit and reach assesses lower body flexibility where the participant will sit in a chair, extend one leg in front of them and flex at the waist, reaching toward their toes, the measure is the distance between their toes and fingers.
Measured: baseline and 10 weeks
Change in Back Scratch Distance From Baseline
The back scratch test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The back scratch test assesses the upper body flexibility, where the person is seated and one arm will be flexed behind the head, and the other arm will be extended behind the shoulder. The assessment measures the distance between the finger tips of both hands.
Measured: baseline and 10 weeks
Change in 6-minute Walk Distance From Baseline
The 6-minute walk test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The 6 minute walk test measures the total distance that a person can quickly walk on a flat hard surface within a period of 6 minutes, using a 100ft length of distance.
Measured: baseline and 10 weeks
Change in 8 Foot Up and Go Time From Baseline
The 8-foot-up and go test is part of the functional fitness test (FFT); a battery of tests measuring strength, flexibility, fitness, body composition, and agility. This test will be performed at baseline and post-study time points. Data will be reported in a table as change from baseline.
The 8-foot-up and go is an assessment of speed agility and balance. The participant begins in a seated position and will be timed for the duration it takes to rise from the chair, walk as quickly as possible around a cone 8 feet away from the chair, and return to a seated position.
Measured: baseline and 10 weeks
FACT Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such.
Measured: baseline, 5 weeks, 10 weeks
Changes in FACT From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The FACT assessment measures physical, social/family, and functional well-being, each on a scale of 0-28, and emotional well being on a scale of 0-24. The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64. Each of these sections will be scored for sub-scale scores and then the entire instrument will have a total composite score (0-172; the higher the score, the more quality of life improvements) and will be reported as such.
Measured: baseline and 10 weeks
FACT-En Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements.
Measured: baseline, 5 Weeks,10 weeks
Changes in FACT-En From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En). The Endometrial component contains concerns specific to endometrial cancer such as hot/flashes, cramps, and swelling; measured on a scale of 0-64, the higher the score, the more quality of life improvements.
Measured: baseline and 10 weeks
FACT Physical Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Measured: baseline, 5 weeks, 10 weeks
FACT Social Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Measured: baseline, 5 weeks, 10 weeks
FACT Emotional Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Measured: baseline, 5 weeks, 10 weeks
FACT Functional Subscale Scores
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Measured: baseline, 5 weeks, 10 weeks
Changes in FACT Subscales From Baseline
Functional Assessment of Cancer Therapies (FACT) changes from baseline, mid-point, to post-study will be captured using the Functional Assessment of Cancer Therapies (FACT). The FACT assessment measures physical, social/family, emotional, and functional well-being, each on a scale of 0-28. Each of these sections will be scored for sub-scale scores; the higher the score, the more quality of life improvements.
Measured: baseline and 10 weeks
Changes in Mental Well-being From Baseline
Changes in mental well-being from baseline, mid-point, and post-study (including anxiety, depression, and fatigue) will be assessed using standardized NIH-provided Patient-Reported Outcome Measurement Information System (PROMIS) measures.
The fatigue assessment asks about self-reported systems of fatigue and tiredness, all the way up to exhaustion overall, and ask about fatigue over the past seven days. The depression assessment asks about depressive symptoms over the past seven days. The anxiety assessment asks about symptoms adjacent-to and including anxiety over the past seven days. For each of these three instruments (which comprise the mental well-being assessments) the data will be reported as change over time, specifically using the T-score (standardized mean) and the standard error.
Each is standardized to a mean of 50 and a range of 0-100; a higher scores indicate a higher "level" of that construct, whether it's higher levels of depression, fatigue or anxiety.
Measured: baseline and Week 10
Changes in Self-Efficacy From Baseline
Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training.
This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time.
Measured: Baseline and 10 weeks
Self-Efficacy Scores
Self-efficacy will be assessed at baseline, mid-point, and post-study using the validated self-efficacy for exercise scale, modified for specificity to strength training.
This instrument has 9 items, each of which is scored from 0-10, with a maximum score of 90. Higher scores indicate higher self-efficacy for exercise. These scores will be reported descriptively at each time point (baseline, mid-point, final), and will also be reported in a table as change over time.
Measured: Baseline, 5 weeks, 10 weeks
Changes in Accelerometer-Measured Physical Activity From Baseline
Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period.
Light intensity is Moderate intensity is Vigorous intensity is
Measured: baseline and Week 10
Change in Steps Per Day From Baseline
Although aerobic and lifestyle physical activity (PA) are not a focus of the intervention, they will be assessed to determine baseline PA level and identify whether uptake of resistance training is associated with changes in other PA types. Participants will wear the ActiGraph wGT3X-BT accelerometer (ActiGraph, Pensacola, FL) for 7 days during all waking hours, at baseline, mid-point, and post-study visit. The ActiGraph is a gold standard method of objective activity assessment. Accelerometer data will be measured in total minutes of moderate to vigorous physical activity over a 7-day period.
Measured: baseline and Week 10
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2018
- Study start5 Dec 2018
- Primary completion14 Mar 2020
- Study completion14 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Endometrial CancerStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group
- Masking
- None (open label)
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Responsible party
- Sponsor
- Investigators
- Lisa Cadmus-Bertram, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03722030
- Sponsor's protocol ID
- UW18013
- Other IDs
- P30CA014520, NCI-2018-02257, 2018-0953, 1R03CA230965-01A1, A176000, EDUC/KINESIOLOGY
- Status last verified
- Jun 2021
- First submitted
- 16 Oct 2018
- Last updated
- 13 Aug 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
- ClinicalTrials.gov ID
- NCT03722030
- Acronym / sponsor ID
- UW18013
- Conditions
- Endometrial Cancer
- Keywords
- Strength Training, Resistance Training, Obesity, Sedentary
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Collaborators
- National Cancer Institute (NCI), American Cancer Society, Inc.
- Study start
- 5 Dec 2018 (actual)
- Primary completion
- 14 Mar 2020 (actual)
- Study completion
- 14 Mar 2020 (actual)
- First posted
- 26 Oct 2018 (actual)
- Results
- Posted 11 Aug 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group
| Arm | Type | Receives |
|---|---|---|
| Strength-Training Intervention | Experimental | Other: Baseline Measures, Behavioral: Strength-Training, Other: Mid-point Measures, Other: Post-Study MeasuresFollowing 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. |
| Waitlist Control | Placebo comparator | Other: Baseline Measures, Other: Mid-point Measures, Other: Post-Study MeasuresFollowing baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Baseline MeasuresAccelerometer (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. | Other | Strength-Training Intervention, Waitlist Control |
| Strength-Training2 sessions per week (20-40 min), home-based resistance training | Behavioural | Strength-Training Intervention |
| Mid-point MeasuresAccelerometer (steps) | Other | Strength-Training Intervention, Waitlist Control |
| Post-Study MeasuresAccelerometer (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. | Other | Strength-Training Intervention, Waitlist Control |
Primary outcome
Feasibility - Number of Participants Recruited
Time frame: up to 2 years
The feasibility of recruiting endometrial cancer survivors to a home-based resistance training; 2 sessions per week of 20-40 minutes of exercise. This will be measured by the number of participants recruited. The goal is 40 participants.
Number of Participants Who Completed 100% of the Prescribed Exercises
Time frame: up to 20 weeks from beginning of intervention
Compliance/adherence will be measured via detailed exercise logs. A participant needs to complete at least 50% of the prescribed exercises in a session to be considered adherent to the session.
Number of Participants With Adverse Events
Time frame: up to 20 weeks
The primary safety endpoint will be total number of adverse events over the duration of the intervention.
28 secondary outcomes
Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention
Time frame: At final visit - up to 20 weeks
Change in Hemoglobin A1c From Baseline
Time frame: baseline and 10 weeks
Change in C-Reactive Protein From Baseline
Time frame: baseline and 10 weeks
Change in Lean Muscle Mass From Baseline
Time frame: baseline and 10 weeks
Change in Fat Mass From Baseline
Time frame: baseline and 10 weeks
Change in Visceral Fat Mass From Baseline
Time frame: up to 20 weeks
Change in Total Percent Body Fat From Baseline
Time frame: baseline and 10 weeks
Change in Number of Arm Curls Performed From Baseline
Time frame: baseline and 10 weeks
Change in Number of Sit to Stand Repetitions Performed From Baseline
Time frame: baseline and 10 weeks
Change in Handgrip Weight From Baseline
Time frame: baseline and 10 weeks
Change in Sit and Reach Distance From Baseline
Time frame: baseline and 10 weeks
Change in Back Scratch Distance From Baseline
Time frame: baseline and 10 weeks
Change in 6-minute Walk Distance From Baseline
Time frame: baseline and 10 weeks
Change in 8 Foot Up and Go Time From Baseline
Time frame: baseline and 10 weeks
FACT Scores
Time frame: baseline, 5 weeks, 10 weeks
Changes in FACT From Baseline
Time frame: baseline and 10 weeks
FACT-En Scores
Time frame: baseline, 5 Weeks,10 weeks
Changes in FACT-En From Baseline
Time frame: baseline and 10 weeks
FACT Physical Subscale Scores
Time frame: baseline, 5 weeks, 10 weeks
FACT Social Subscale Scores
Time frame: baseline, 5 weeks, 10 weeks
FACT Emotional Subscale Scores
Time frame: baseline, 5 weeks, 10 weeks
FACT Functional Subscale Scores
Time frame: baseline, 5 weeks, 10 weeks
Changes in FACT Subscales From Baseline
Time frame: baseline and 10 weeks
Changes in Mental Well-being From Baseline
Time frame: baseline and Week 10
Changes in Self-Efficacy From Baseline
Time frame: Baseline and 10 weeks
Self-Efficacy Scores
Time frame: Baseline, 5 weeks, 10 weeks
Changes in Accelerometer-Measured Physical Activity From Baseline
Time frame: baseline and Week 10
Change in Steps Per Day From Baseline
Time frame: baseline and Week 10
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- University of Wisconsin Carbone Cancer CenterLink provided by the sponsor.
Related trials for Endometrial Cancer
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
Active, not recruitingPhase 3
Endometrial Cancer Patientes MMR Deficient Comparing Chemotherapy vs Dostarlimab in First Line
Endometrial Cancer
RecruitingPhase 3
Testing the Addition of an Antiangiogenic Drug (Bevacizumab) to Chemotherapy (Carboplatin and Paclitaxel) Combined With Immunotherapy (Pembrolizumab) for pMMR, TP53 Mutated Endometrial Cancer
Advanced Endometrial Carcinoma, Recurrent Endometrial Carcinoma
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
RecruitingPhase 3
Impact of Sentinel Lymph Node Mapping on Patient Reported Lower Extremity Limb Dysfunction in Stage I Endometrial Cancer
Stage I Uterine Corpus Carcinoma or Carcinosarcoma AJCC v8
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Cadmus-Bertram principal investigator
University of Wisconsin, Madison
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Baseline Measures, Strength-Training and Mid-point Measures in people with Endometrial Cancer, run by University of Wisconsin, Madison at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 13 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 11 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility - Number of Participants Recruited (time frame: up to 2 years). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Aug 2021.