Nutritional and Metabolic Diseases

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

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Uterine Neoplasms

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Genital Diseases

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Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Anti-Inflammatory Agents

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Chrysarobin

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.

Following baseline measures, participants will provide mid-point measures, and in-person post-study measures with no 10-week strength training intervention.

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.

Baseline Measures

2 sessions per week (20-40 min), home-based resistance training

Strength-Training

Mid-point Measures

Post-Study Measures

Lisa Cadmus-Bertram

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.

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.

Pilot/Feasibility trial - 2 arms, one strength-training intervention vs. waitlist control group

Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors

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.

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.

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

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

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.

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.

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.

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.

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.

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.

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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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.

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.

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.

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.

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.

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.

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.

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.

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.

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

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.

National Cancer Institute (NCI)

American Cancer Society, Inc.

University of Wisconsin, Madison

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.

Strength-Training Intervention

Waitlist Control

Total

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Body Mass Index (BMI)

Married or Partnered

Education

Measured by Dual-energy X-ray absorptiometry (DXA)

Percentage Total Body Fat

Waist Circumference

Hip Circumference

Waist-to-Hip Ratio

Staging by pathologist per the World Health Organization Classification of Tumours of the Female Genital Tract, published in 2020

Tumor Stage At Diagnosis

Treatment

Time since diagnosis

Time since surgery

Dr. Lisa Cadmus-Bertram

Feasibility - Number of Participants Recruited

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

Number of Participants Who Completed 100% of the Prescribed Exercises

Number of Participants With Adverse Events

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

Number of Participants Reporting "Very" or "Extremely" Satisfied With Intervention

Change in Hemoglobin A1c From Baseline

Change in C-Reactive Protein From Baseline

Change in Lean Muscle Mass From Baseline

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.

Change in Fat Mass From Baseline

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.

Change in Visceral Fat Mass From Baseline

Change in Total Percent Body Fat From Baseline

Change in Number of Arm Curls Performed From Baseline

Change in Number of Sit to Stand Repetitions Performed From Baseline

Change in Handgrip Weight From Baseline

Change in Sit and Reach Distance From Baseline

Change in Back Scratch Distance From Baseline

Change in 6-minute Walk Distance From Baseline

Change in 8 Foot Up and Go Time From Baseline

baseline

Week 5

Week 10

FACT Scores

Changes in FACT From Baseline

Baseline

FACT-En Scores

Changes in FACT-En From Baseline

FACT Physical Subscale Scores

FACT Social Subscale Scores

FACT Emotional Subscale Scores

FACT Functional Subscale Scores

Physical

Social

Emotional

Functional

Changes in FACT Subscales From Baseline

Anxiety

Fatigue

Depression

Changes in Mental Well-being From Baseline

Changes in Self-Efficacy From Baseline

week 5

week 10

Self-Efficacy Scores

Light Activity

Moderate Activity

Vigorous Activity

Moderate Vigorous Physical Activity (continuous minutes)

Moderate Vigorous Physical Activity in bouts greater than 10 minutes

Changes in Accelerometer-Measured Physical Activity From Baseline

Change in Steps Per Day From Baseline

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)

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.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors	NCT03722030	Endometrial Can...	Baseline Measur... Strength-Traini... Mid-point Measu... Post-Study Meas...	18 Years - 74 Years	University of Wisconsin, Madison
Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors	NCT03722030	Endometrial Can...	Baseline Measur... Strength-Traini... Mid-point Measu... Post-Study Meas...	18 Years - 74 Years	University of Wisconsin, Madison

Spots Global Cancer Trial Database for baseline measures