Trial Outcomes & Findings for Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors (NCT NCT03722030)

NCT ID: NCT03722030

Last Updated: 2021-08-13

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 40 participants
• Primary outcome timeframe: up to 2 years
• Results posted on: 2021-08-13

Participant Flow

Participant milestones

Measure	Strength-Training Intervention 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 5 week follow up period. Baseline Measures: 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-Training: 2 sessions per week (20-40 min), home-based resistance training Mid-point Measures: Accelerometer (steps) Post-Study Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy x-ray absorptiometry)	Waitlist Control Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention. Baseline Measures: 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. Mid-point Measures: Accelerometer (steps) Post-Study Measures: 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.
Overall Study STARTED	20	20
Overall Study COMPLETED	19	20
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Measure	Strength-Training Intervention 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 5 week follow up period. Baseline Measures: 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-Training: 2 sessions per week (20-40 min), home-based resistance training Mid-point Measures: Accelerometer (steps) Post-Study Measures: Accelerometer (steps), Biomarkers (finger prick for hemoglobin A1c and c-reactive protein), Anthropometrics (height, weight, waist and hip circumference), Body composition (dual-energy x-ray absorptiometry)	Waitlist Control Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention. Baseline Measures: 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. Mid-point Measures: Accelerometer (steps) Post-Study Measures: 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.
Overall Study Withdrawal by Subject	1	0

Baseline Characteristics

Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

Baseline characteristics by cohort

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.	Total n=40 Participants Total of all reporting groups
Tumor Stage At Diagnosis Stage 1	15 Participants n=5 Participants	18 Participants n=7 Participants	33 Participants n=5 Participants
Tumor Stage At Diagnosis Stage 2	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Age, Continuous	60.9 years STANDARD_DEVIATION 9.6 • n=5 Participants	60.9 years STANDARD_DEVIATION 8.0 • n=7 Participants	60.9 years STANDARD_DEVIATION 8.7 • n=5 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	20 Participants n=5 Participants	20 Participants n=7 Participants	40 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) White	20 Participants n=5 Participants	19 Participants n=7 Participants	39 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment United States	20 participants n=5 Participants	20 participants n=7 Participants	40 participants n=5 Participants
Body Mass Index (BMI)	42.2 kg/m2 STANDARD_DEVIATION 19.5 • n=5 Participants	37.9 kg/m2 STANDARD_DEVIATION 8.6 • n=7 Participants	39.9 kg/m2 STANDARD_DEVIATION 15.2 • n=5 Participants
Married or Partnered	15 Participants n=5 Participants	13 Participants n=7 Participants	28 Participants n=5 Participants
Education High school graduate or less	1 Participants n=5 Participants	2 Participants n=7 Participants	3 Participants n=5 Participants
Education Trade school / some college	7 Participants n=5 Participants	6 Participants n=7 Participants	13 Participants n=5 Participants
Education College graduate	6 Participants n=5 Participants	8 Participants n=7 Participants	14 Participants n=5 Participants
Education Post-graduate degree	6 Participants n=5 Participants	4 Participants n=7 Participants	10 Participants n=5 Participants
Percentage Total Body Fat	51.6 percent body fat STANDARD_DEVIATION 5.0 • n=5 Participants	50.4 percent body fat STANDARD_DEVIATION 6.8 • n=7 Participants	51.2 percent body fat STANDARD_DEVIATION 6.0 • n=5 Participants
Waist Circumference	107.9 centimeters STANDARD_DEVIATION 16.9 • n=5 Participants	105.5 centimeters STANDARD_DEVIATION 15.2 • n=7 Participants	106.8 centimeters STANDARD_DEVIATION 16.0 • n=5 Participants
Hip Circumference	130.2 centimeters STANDARD_DEVIATION 18.4 • n=5 Participants	129.2 centimeters STANDARD_DEVIATION 19.4 • n=7 Participants	129.7 centimeters STANDARD_DEVIATION 18.7 • n=5 Participants
Waist-to-Hip Ratio	0.82 waist-to-hip circumference ratio STANDARD_DEVIATION 0.04 • n=5 Participants	0.83 waist-to-hip circumference ratio STANDARD_DEVIATION 0.07 • n=7 Participants	0.83 waist-to-hip circumference ratio STANDARD_DEVIATION 0.06 • n=5 Participants
Tumor Stage At Diagnosis Stage 3	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Treatment No treatment beyond surgery	14 Participants n=5 Participants	16 Participants n=7 Participants	30 Participants n=5 Participants
Treatment Radiation alone	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Treatment Chemotherapy alone	0 Participants n=5 Participants	3 Participants n=7 Participants	3 Participants n=5 Participants
Treatment Chemotherapy and Radiation	4 Participants n=5 Participants	0 Participants n=7 Participants	4 Participants n=5 Participants
Time since diagnosis	2.8 years STANDARD_DEVIATION 1.2 • n=5 Participants	3.0 years STANDARD_DEVIATION 1.3 • n=7 Participants	2.9 years STANDARD_DEVIATION 1.2 • n=5 Participants
Time since surgery	2.7 years STANDARD_DEVIATION 1.4 • n=5 Participants	3.0 years STANDARD_DEVIATION 1.3 • n=7 Participants	2.8 years STANDARD_DEVIATION 1.3 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Feasibility - Number of Participants Recruited	20 Participants	20 Participants

PRIMARY outcome

Timeframe: up to 20 weeks from beginning of intervention

Population: Waitlist control group was not included in adherence measures as they did not receive exercises until final measures were completed.

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.

Outcome measures

Measure	Strength-Training Intervention n=19 Participants 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 5 week follow up period.	Waitlist Control Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Number of Participants Who Completed 100% of the Prescribed Exercises	17 Participants	0 Participants

PRIMARY outcome

Timeframe: up to 20 weeks

The primary safety endpoint will be total number of adverse events over the duration of the intervention.

Outcome measures

Measure	Strength-Training Intervention n=19 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Number of Participants With Adverse Events	0 Participants	0 Participants

SECONDARY outcome

Timeframe: At final visit - up to 20 weeks

Population: Satisfaction was only collected for the strength training intervention. Sixteen participants completed the end of study satisfaction survey upon which this metric was based.

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.

Outcome measures

Measure	Strength-Training Intervention n=16 Participants 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 5 week follow up period.	Waitlist Control Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention	16 Participants	—

SECONDARY outcome

Timeframe: baseline and 10 weeks

Baseline and post-study blood biomarkers to assess Hemoglobin A1c will be collected and reported in a table as a change from baseline.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Hemoglobin A1c From Baseline	4.7 ng/mL Standard Deviation 8.4	3.2 ng/mL Standard Deviation 5.9

SECONDARY outcome

Timeframe: baseline and 10 weeks

Baseline and post-study blood biomarkers to assess c-reactive protein will be collected and reported in a table as a change from baseline.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in C-Reactive Protein From Baseline	222.1 ng/mL Standard Deviation 538.3	108.6 ng/mL Standard Deviation 400.9

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Lean Muscle Mass From Baseline	1.0 pounds muscle Standard Deviation 2.6	-0.7 pounds muscle Standard Deviation 3.3

SECONDARY outcome

Timeframe: baseline and 10 weeks

Population: Absolution change in fat mass was not reported, instead percent fat change was reported to standardize for total body mass allowing for easier interpretation across individuals.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: up to 20 weeks

Population: Visceral fat mass was not measured for all scans on each participant, therefore due to the amount of missing data, the change in visceral fat mass could not be measured.

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.

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Total Percent Body Fat From Baseline	-0.6 body fat percent Standard Deviation 0.9	-0.3 body fat percent Standard Deviation 1.5

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Number of Arm Curls Performed From Baseline	4.9 repetitions Standard Deviation 3.7	2.2 repetitions Standard Deviation 2.0

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Number of Sit to Stand Repetitions Performed From Baseline	3.3 repetitions Standard Deviation 3.5	0.3 repetitions Standard Deviation 2.4

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

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Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Handgrip Weight From Baseline	0.7 kilograms Standard Deviation 2.2	-0.4 kilograms Standard Deviation 2.1

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Sit and Reach Distance From Baseline	0.9 inches Standard Deviation 2.3	-0.5 inches Standard Deviation 3.7

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Back Scratch Distance From Baseline	1.1 inches Standard Deviation 1.7	0.1 inches Standard Deviation 4.1

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in 6-minute Walk Distance From Baseline	70.0 feet Standard Deviation 89.3	34.9 feet Standard Deviation 114

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in 8 Foot Up and Go Time From Baseline	-0.7 seconds Standard Deviation 0.9	-0.1 seconds Standard Deviation 1.0

SECONDARY outcome

Timeframe: baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT Scores baseline	146 score on a scale Standard Deviation 11.9	141 score on a scale Standard Deviation 21.7
FACT Scores Week 5	146 score on a scale Standard Deviation 13.2	142 score on a scale Standard Deviation 21.7
FACT Scores Week 10	146 score on a scale Standard Deviation 15.0	140 score on a scale Standard Deviation 26.1

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in FACT From Baseline	-0.3 score on a scale Standard Deviation 14.0	0.6 score on a scale Standard Deviation 13.0

SECONDARY outcome

Timeframe: baseline, 5 Weeks,10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT-En Scores Baseline	55.0 score on a scale Standard Deviation 7.1	54.5 score on a scale Standard Deviation 7.1
FACT-En Scores Week 5	54.6 score on a scale Standard Deviation 7.2	54.7 score on a scale Standard Deviation 5.0
FACT-En Scores Week 10	55.0 score on a scale Standard Deviation 7.5	55.0 score on a scale Standard Deviation 7.0

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in FACT-En From Baseline	-0.0 score on a scale Standard Deviation 5.1	0.4 score on a scale Standard Deviation 5.8

SECONDARY outcome

Timeframe: baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT Physical Subscale Scores Baseline	24.4 score on a scale Standard Deviation 2.3	24.0 score on a scale Standard Deviation 3.4
FACT Physical Subscale Scores Week 5	24.5 score on a scale Standard Deviation 2.9	23.9 score on a scale Standard Deviation 4.3
FACT Physical Subscale Scores Week 10	24.8 score on a scale Standard Deviation 2.9	24.5 score on a scale Standard Deviation 4.5

SECONDARY outcome

Timeframe: baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT Social Subscale Scores Baseline	22.3 score on a scale Standard Deviation 3.2	20.6 score on a scale Standard Deviation 6.5
FACT Social Subscale Scores Week 5	22.4 score on a scale Standard Deviation 5.0	20.8 score on a scale Standard Deviation 6.0
FACT Social Subscale Scores Week 10	22.3 score on a scale Standard Deviation 4.8	19.7 score on a scale Standard Deviation 7.6

SECONDARY outcome

Timeframe: baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT Emotional Subscale Scores Baseline	21.1 score on a scale Standard Deviation 2.7	20.4 score on a scale Standard Deviation 3.3
FACT Emotional Subscale Scores Week 5	21.4 score on a scale Standard Deviation 2.4	20.7 score on a scale Standard Deviation 3.3
FACT Emotional Subscale Scores Week 10	20.8 score on a scale Standard Deviation 3.8	20.2 score on a scale Standard Deviation 3.4

SECONDARY outcome

Timeframe: baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
FACT Functional Subscale Scores Baseline	23.0 score on a scale Standard Deviation 2.6	21.6 score on a scale Standard Deviation 5.0
FACT Functional Subscale Scores Week 5	22.9 score on a scale Standard Deviation 3.2	21.7 score on a scale Standard Deviation 5.3
FACT Functional Subscale Scores Week 10	23.3 score on a scale Standard Deviation 3.5	21.0 score on a scale Standard Deviation 6.3

SECONDARY outcome

Timeframe: baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in FACT Subscales From Baseline Physical	0.4 score on a scale Standard Deviation 2.7	0.5 score on a scale Standard Deviation 2.5
Changes in FACT Subscales From Baseline Social	-0.0 score on a scale Standard Deviation 3.6	-0.7 score on a scale Standard Deviation 3.8
Changes in FACT Subscales From Baseline Emotional	-0.4 score on a scale Standard Deviation 3.3	-0.1 score on a scale Standard Deviation 3.0
Changes in FACT Subscales From Baseline Functional	0.3 score on a scale Standard Deviation 2.8	-0.5 score on a scale Standard Deviation 3.3

SECONDARY outcome

Timeframe: baseline and Week 10

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in Mental Well-being From Baseline Anxiety	-0.3 T-score Standard Deviation 6.7	1.5 T-score Standard Deviation 6.6
Changes in Mental Well-being From Baseline Fatigue	-2.5 T-score Standard Deviation 7.9	-2.0 T-score Standard Deviation 9.3
Changes in Mental Well-being From Baseline Depression	-1.8 T-score Standard Deviation 5.0	-0.8 T-score Standard Deviation 5.4

SECONDARY outcome

Timeframe: Baseline and 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in Self-Efficacy From Baseline	-3.4 score on a scale Standard Deviation 19.0	-6.0 score on a scale Standard Deviation 14.7

SECONDARY outcome

Timeframe: Baseline, 5 weeks, 10 weeks

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Self-Efficacy Scores baseline	63.4 score on a scale Standard Deviation 20.4	63.7 score on a scale Standard Deviation 19.7
Self-Efficacy Scores week 5	57.3 score on a scale Standard Deviation 19.0	58.3 score on a scale Standard Deviation 20.3
Self-Efficacy Scores week 10	60.0 score on a scale Standard Deviation 21.3	57.7 score on a scale Standard Deviation 22.9

SECONDARY outcome

Timeframe: baseline and Week 10

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

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Changes in Accelerometer-Measured Physical Activity From Baseline Light Activity	-77 minutes per week Standard Deviation 200	5 minutes per week Standard Deviation 306
Changes in Accelerometer-Measured Physical Activity From Baseline Moderate Activity	-41 minutes per week Standard Deviation 72	5 minutes per week Standard Deviation 69
Changes in Accelerometer-Measured Physical Activity From Baseline Vigorous Activity	0 minutes per week Standard Deviation 3	-2 minutes per week Standard Deviation 9
Changes in Accelerometer-Measured Physical Activity From Baseline Moderate Vigorous Physical Activity (continuous minutes)	-41 minutes per week Standard Deviation 72	3 minutes per week Standard Deviation 73
Changes in Accelerometer-Measured Physical Activity From Baseline Moderate Vigorous Physical Activity in bouts greater than 10 minutes	-30 minutes per week Standard Deviation 49	-8 minutes per week Standard Deviation 41

SECONDARY outcome

Timeframe: baseline and Week 10

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.

Outcome measures

Measure	Strength-Training Intervention n=20 Participants 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 5 week follow up period.	Waitlist Control n=20 Participants Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.
Change in Steps Per Day From Baseline	-1038 steps per day Standard Deviation 1190	-92 steps per day Standard Deviation 2046

Adverse Events

Strength-Training Intervention

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Waitlist Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Lisa Cadmus-Bertram

University of Wisconsin - Madison

Phone: 608-262-1167

Email: lisa.bertram@wisc.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place