Feasibility and Acceptability of a Telehealth-Based Resistance Training Intervention for Endometrial Cancer Survivors
Phase: NA
Conditions: Endometrial Cancer
Sponsor: University of Wisconsin, Madison

1 
 
HOME-BASED RESISTANCE TRAINING IN ENDOMETRIAL CANCER 
SURVIVORS 
Feasibility and acceptability of a telehealth-based resistance training intervention for endometrial cancer survivors 
 
 
Principal Investigator:  
Lisa Cadmus-Bertram, Ph.D.  
University of Wisconsin - Madison 
 
 
This document is confidential. 
No part of it may be transmitted, reproduced, published, or used by other persons without prior 
written authorization from the Sponsor or Principal Investigator. 
 
 
PROTOCOL VERSION and AMENDMENTS 
 
Protocol 
Version 
Date 
Change 
Initiated 
(Initials) 
Brief description of protocol modification/actions requested, if 
any 
Version 
1.0 
2/5/2018 
JSG 
Preliminary draft 
Version 
1.1 
2/7/2018 
JSG 
Updated for review by PRMC at UWCCC 
Version 
1.2 
2/13/2018 
JSG 
Updated post meeting Ryan Spencer 
Version 
1.3 
3/9/2018 
JSG 
Updated again for review by PRMC 
Version 
1.4 
4/2/2018 
JSG 
Updated post-review of PRMC 
Version 
1.5 
4/19/2018 
JSG 
Update: mental health questions, repeated measures and qualitative 
measures added 
Version 
1.6 
7/5/2018 
JSG 
Updated informed consent as separate document 
Version 
1.7 
7/14/2018 
JSG 
Updated a new, streamlined checklist in the appendix 
Version 
1.8 
08/24/2018 JSG 
Revised after IRB pre-review 
Version 
1.9 
08/30/2018 JSG 
Revised after second IRB pre-review 
Version 
1.10 
09/26/2018 JSG 
Updated post PRMC re-review 
Version 
1.11 
10/04/2018 JSG 
Updated after PRMC, QA and Compliance manager review at the 
UWCCC.  
Version 
1.12 
11/24/2018 JSG 
Updated the participant compensation information due to oversight in 
previous versions. 
Version 
2.1 
3/19/2019 
JSG 
R03 awarded: updating accrual goals, length of intervention, 
recruitment strategies 

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1 Study Summary 
 
Title 
Feasibility and acceptability of a telehealth-based resistance training 
intervention for endometrial cancer survivors 
Short Title and Precise 
Home-based resistance training in ECS 
Protocol Number 
UW18013 
Methodology 
Randomized, two arms including a wait list control 
Study Duration 
One year 
Study Center(s) 
UW-Madison 
Objectives 
Determine adherence rates to prescribed exercises, quantify changes in lean 
body tissue and blood biomarkers, and functional changes in performance 
Number of Subjects 
40 
Diagnosis 
Endometrial cancer 
Main Inclusion Criteria 
Diagnosis of Type I, stage I-IIIc endometrial cancer, with completion of primary 
treatment 
Main Exclusion Criteria 
Absolute contraindications to exercise, failure on pre-MVPA screening 
Study Product, Dose, 
Route, Regimen 
Home-based, full-body resistance training exercises of 2-3 sets of 8-10 reps 
two days a week for 10 weeks, with a five week follow up period  
Statistical 
Methodology 
Paired comparisons to assess pre-post differences within groups, as well as 
between groups pre and post 

3 
 
Schematic of Study Design 
Flow diagram or study calendar (e.g., randomized controlled trial) 
 
 
 
 

4 
 
Contents 
HOME-BASED RESISTANCE TRAINING IN ENDOMETRIAL CANCER SURVIVORS ........................................................ 1 
1 Study Summary ................................................................................................................................................. 2 
2  Key Roles ......................................................................................................................................................... 5 
2.1 
Background and Rationale ........................................................................................................................ 5 
2.2 
Aims and Hypotheses ............................................................................................................................... 6 
2.3 
Potential Risk and Benefits to Subjects ..................................................................................................... 7 
3 
Study Aims ...................................................................................................................................................................... 8 
4 
Study Design and Endpoints .......................................................................................................................................... 8 
5 
Study Infrastructure ......................................................................................................................................................... 8 
6 
Study Subjects – Enrollment and Withdrawal ................................................................................................................. 8 
6.1 
Subject Population .................................................................................................................................... 9 
6.4 
Subject Screening for Recruitment ............................................................................................................ 9 
7.5 
Vulnerable Populations ........................................................................................................................... 10 
7.5.1 
Subject Capacity .................................................................................................................................. 10 
7.6 
Informed Consent .................................................................................................................................... 10 
7.7 
Early Withdrawal of Subjects ................................................................................................................... 11 
8 
Study Procedures ......................................................................................................................................................... 12 
8.1 
Measures ................................................................................................................................................. 13 
8.2 
Video calls ............................................................................................................................................... 14 
8.3 
Labs ......................................................................................................................................................... 15 
8.4 
Established Standard of Care: ................................................................................................................ 15 
8.5 
Study Visits .............................................................................................................................................. 15 
9 
Study Analysis .............................................................................................................................................................. 16 
9.1 
Sample Size Determination ..................................................................................................................... 16 
9.2 
Statistical Methods .................................................................................................................................. 16 
9.3 
Subject Population(s) for Analysis ........................................................................................................... 16 
9.4 Planned Interim Analysis: ............................................................................................................................. 17 
10 Data Collection, Handling and Record Keeping ........................................................................................................... 17 
10.1 
Data Confidentiality ................................................................................................................................. 17 
10.2 
Data Capture ........................................................................................................................................... 17 
10.3 
Records Retention ................................................................................................................................... 18 
10.4 
Data and Safety Monitoring ..................................................................................................................... 18 
11 Assessment of Safety ................................................................................................................................................... 19 
12 Study Finances ............................................................................................................................................................. 19 
12.30 
Funding Source ................................................................................................................................... 19 
12.31 
Conflict of Interest ................................................................................................................................ 19 
12.32 
Subject Stipends or Payments ............................................................................................................. 19 
13 Publication Plan ............................................................................................................................................................ 19 
14 Protocol implementation timeline and contingency plans ............................................................................................. 19 
 

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2 Key Roles 
Following is a list of all personnel in key roles: 
 
Principal Investigator: PI 
Lisa Cadmus-Bertram, PhD, Assistant Professor of Kinesiology 
University of Wisconsin-Madison 
2000 Observatory Drive 
Madison, WI 53706 
(608) 265-5946 
Lisa.bertram@wisc.edu 
 
Co-Investigator / Medical monitor 
Ryan Spencer, MD, Assistant Professor 
University of Wisconsin-Madison 
600 Highland Ave 
H4/6, 6188 Clinical Science Center 
Madison, WI 53792 
(608) 265-1700 
 
Biostatistician 
Ron Gangnon, PhD, Professor of Population Health Sciences/Biostatistics 
University of Wisconsin-Madison 
610 Walnut St 
603 Warf Office Building 
Madison, WI 53726 
 
Project Coordinator 
Jessica Gorzelitz, MS, Research Fellow 
University of Wisconsin-Madison 
2000 Observatory Drive 
Madison, WI 53706 
(608) 262-1167 
gorzelitz@wisc.edu 
 
 
 
 
Introduction 
This document is a protocol for a human research study. This study is to be conducted according to 
applicable government regulations and Institutional research policies and procedures, and State Law. 
 
2.1 Background and Rationale 
 
Endometrial cancer survivors have an extremely high prevalence of inactivity and obesity. The US 
has a large and rapidly growing population of 760,000 endometrial cancer survivors, which will increase 
55% by 2030.1, 2 Despite a generally favorable 81% 5-year survival rate, patients remain at increased risk 
for cardiovascular disease, diabetes, and other cancers.3 A key risk factor for endometrial cancer is 
unopposed estrogen, which is linked to inactivity and obesity.4, 5 Indeed, up to 90% of Type 1 endometrial 
cancer patients are obese.6 Inactivity and obesity are associated with poorer outcomes among survivors. 
In the NIH-AARP Diet and Health Study, endometrial cancer survivors who were physically active had a 
lower all-cause 5-year mortality rate and lower BMI was associated with lower risk of both overall and 
disease-specific mortality.7 

6 
 
There is a critical need for data about the feasibility and benefits of strength training in this 
population. Other interventions have demonstrated that walking and aerobic exercise are safe and feasible 
in endometrial cancer patients.8-11 However few published studies have examined strength training in 
endometrial cancer survivors, and these have done so only in combination with aerobic PA intervention 
(and often also dietary change) in the context of a larger multi-component intervention.12, 13 Therefore the 
specific contribution of strength training remains unknown. This is important because aerobic exercise leads 
to improvements in the cardiovascular system, whereas resistance training has specific effects at the 
musculoskeletal level in addition to systematic cardiovascular benefits.14 Strength training increases muscle 
mass, which is critically important given the high prevalence of sarcopenic obesity among middle- aged 
and older women.15 It is also highly effective for functional improvements such as increased strength and 
balance.16, 17 Indeed, in other cancer survivor groups, strength training is more effective than aerobic 
exercise for improving functional status.14 Another benefit of strength training is that it is a realistic health 
promotion option given poor long-term efficacy of weight loss interventions.18 Unfortunately, without 
intervention, strength training has a relatively high barrier to participation among women, due to factors 
such as lack of knowledge and difficulty finding time to travel to a gym.19 
 
Previous strength training interventions not optimized for rural populations. Rural areas are often 
underserved in terms of medical access/use and educational and economic opportunities.20, 21 
Consequently, rural populations are diagnosed at later stages of cancer22 and have higher rates of cancer 
mortality.23 Unfortunately, previous strength training research in cancer populations have mainly used 
supervised sessions with a personal trainer at a gym, an approach that is not feasible in many rural settings. 
 
Overview of proposed research. To address these gaps, we 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.24 With small samples, the true 
effect size is more likely to be under or overestimated, therefore hypothesis testing is not valid.25 Our aims 
are designed accordingly. 
 
 
2.2 Aims and Hypotheses 
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. We hypothesize that we will 
meet the accrual goal and maintain >90% retention. 
• 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. We hypothesize that the 
participants will adhere to 90% of the prescribed exercise sessions and that overall satisfaction will be 
high. 
• 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. We hypothesize that these 
assessments will be well tolerated, as measured by the percent of participants who complete all measures 
and data from participant feedback questionnaires. 

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2.3 Potential Risk and Benefits to Subjects 
 
2.3.1 Known Potential Risks 
Potential risks of participating in this study include musculoskeletal soreness and a possible loss of 
confidentiality, either through the breach of non-identifiable data collected online, or through the breach of 
secure study databases or physical files. 
Potential Benefits of the Proposed Research to Human Subjects and Others: Findings from the 
proposed study will contribute to the scientific knowledge of the feasibility of resistance training 
interventions in endometrial cancer survivors. Additionally, the knowledge gained will contribute to the 
scientific knowledge aimed at understanding the potential therapeutic benefits of resistance training 
exercise for endometrial cancer survivors. The risks of our study procedures are low and therefore are 
seen as justifiable in regards to the knowledge to be gained. 
Importance of Knowledge to be gained: Increasing physical activity after a cancer diagnosis is an 
important area of researching, and finding feasibly interventions for endometrial cancer survivors are 
key to sustainable lifestyle changes. This research will take the first step that will provide valuable 
information and serve as a scaffolding for the continued design and development of future interventions. 
 
2.3.2 Protection against Risks 
Study procedures will be reviewed and approved annually by the University of Wisconsin Health 
Sciences Institutional Review Board. Participants will be completing this intervention in their own home, 
and will be directed to stop exercising immediately if they experience any chest pains or abnormal 
symptoms such as dizziness, faintness, nausea etc. Additionally, in order to maximize participant safety 
and well-being, several strategies will be implemented to protect against and minimize any potential 
risks and to protect the privacy of all participants. Including: 
• 
All participants will be screened with a telephone interview to determine their health status, 
eligibility, and ability to participate in aerobic exercise (Physical Activity Readiness 
Questionnaire; PAR-Q) 
• 
Although the exercises will be completed at home, participants will be instructed to 
discontinue exercise if they experience any dizziness or light-headedness or pain in their 
chest. We will recommend that participants with continued issue to seek out their primary care 
physician. 
• 
To minimize risks to confidentiality, participants will be assigned a study ID number to be 
used in place of their name. The only document linking study ID number and the participant’s 
name will be kept separate from the data used for data processing and analysis. Only 
authorized study personnel will have access to the data. Electronic data will be coded and 
entered into a secured file on the Physical Activity Epidemiology lab server which is located in 
a password protected area with firewall protection and backed up daily. Moreover, the 
screening data for eligible participants will be kept and secured in a locked file cabinet in the 
Physical Activity Epidemiology lab until the participants has either completed the study, 
removed themselves from participation, or is excluded from participation. All screening data for 
eligible participants will be shredded upon participant completion, dropout, or exclusion from 
the study. Phone screening data from any interested potential participants not meeting 
inclusion criteria will be shredded immediately. 
• 
If used, web-based surveys and their accompanying database will reside on a secure 
survey server. No private health information will reside on the survey server, only randomly 
generated ID numbers. Survey information will then be pulled into the secure database. 
 
2.3.3 Potential Benefits to the Subjects 
There are no anticipated benefits to the participants in this research study. 

8 
 
2.3.4 Risk Minimization: 
No drug, biologic, or dietary supplement will be used in this study. To minimize risk, participants will 
undergo distal finger pricks to collect blood samples as opposed to traditional venipuncture for 
collection of blood biomarkers. No other laboratory tests will be conducted. 
 
3 Study Aims 
• 
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. 
 
4 Study Design and Endpoints 
4.1 General Design 
• 
A phase III, randomized, two-arm trial with a wait-list control group 
• 
The intervention itself is 10 weeks, with an additional five week follow up assessment for 
those in the exercise arm to determine adoption of the program. Overall, the  anticipated total 
duration should be 20 weeks for participants 
• 
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; and (d) a final in-person study visit to collect 
post-study measures for both groups 
 
4.1.1 Primary Study Endpoints 
The primary endpoint is adherence to prescribed exercise sessions as measured using exercise 
logging and video sessions of exercises. 
 
4.1.2 Secondary Study Endpoints 
Secondary endpoints to be measured include qualitative satisfaction with intervention, blood 
biomarkers, lean muscle mass, body composition, functional fitness performance, self-efficacy, 
quality of life measures, and accelerometer-measured physical activity. 
 
4.1.3 Primary Safety Endpoints 
The primary safety endpoint will be total number of adverse events over the duration of the 
intervention. 
 
5 Study Infrastructure 
The general infrastructure for this study will include an overall PI (Dr. Lisa Cadmus-Bertram). There will be 
additionally one primary biostatistician for the study, and one main study coordinator who will be responsible 
for managing daily study operations. 
 
6 Study Subjects – Enrollment and Withdrawal 
• 
Accrual Goal: The study aims to enroll 40 participants over a one-year period. Subjects will 
be identified through their clinician/oncologist to determine interest in the study before being 
screened over the telephone by study staff. 
• 
Participants will be screened over the phone to determine eligibility, and enrollment in the 
study will occur after screening by both the clinician/oncologist and research staff. The screening 
procedures will be performed under a separate screening consent form. 

9 
 
6.1 Subject Population 
Age range of participants include ages 18-74 which is the range where diagnosis of endometrial cancer 
is most common. Because we intend to study adults, and not geriatric populations, the upper cap on 
the age for this study is 74 as to not dilute or modify the effect of resistance training in adults compared 
to elderly populations. 
 
Women are the only participants in this study as endometrial cancer doesn’t afflict men. No minorities 
or ethnic groups will be excluded from this study. We will recruit subjects without regard for minority 
status and ethnic status will be coded according to the Office of Management and Budget (OMG) 
Directive No. 15. The estimated ethnic/racial composition is presented in the Targeted/Planned 
Enrollment table and is representative of women in the geographic area of the proposed study (2010 
Census Data for Madison, WI: 79% white, non-Hispanic; 7% African American; 7% Hispanic or Latino; 
7% other ethnic/racial identities). 
 
6.2 Inclusion Criteria 
 
Inclusion Criteria 
1 
Willing to provide written informed consent 
2 
Willing to comply with all study procedures and be available for the duration of the study 
3 
Fluent in spoken and written English 
4 
Women 18-74 years of age 
5 
Documented diagnosis of Type I, stage I-IIIc endometrial cancer within the past 5 years 
6 
Completion of current treatment for endometrial cancer, period of time of ≥10 weeks from 
treatment completion to study enrollment is required 
 
6.3 Exclusion Criteria 
 
Exclusion Criteria 
1. Absolute contraindications to exercise (i.e., acute myocardial infarction, severe orthopedic or 
musculoskeletal limitations 
2. Have evidence of recurrent or metastatic disease 
3. Are currently performing resistance training ≥2 days per week 
4. Report of chest pain, shortness of breath, fainting, or angina pectoris 
5. Have physical disability that would limit range of motion through exercises such as sitting, 
standing and inability to walk one block 
6. Plans to move from the area 
7. Enrolled in another clinical trial or has used of any investigational drugs, biologics, or devices 
within 30 days prior to randomization 
8. Women who are pregnant or breast-feeding 
9. Not suitable for study participation due to other reasons at the discretion of the investigator 
 
6.4 Subject Screening for Recruitment 
 
6.4.1 Subject Identification 
Participants will be recruited primarily through referrals at the research site. At the primary site, it 
will be UW-Madison’s gynecologic oncology clinic, assisted by the UW Carbone Cancer Center’s 
Gynecology Disease Oriented Team (DOT), a group that supports accrual to both collaborative and 
investigator-initiated clinical trials. Potentially eligible patients will be identified by the clinician after 
primary treatment has been completed and initial contact will be made by a member of the study 
team with endorsement of the medical care team. If needed, recruitment will be augmented via 
outreach through local cancer support organizations. Patients referred by their physician will be 

10 
 
contacted by study staff and screened for eligibility over the telephone. Self-referred participants 
will undergo telephone screening first, then eligibility will then be confirmed with the woman’s 
physician. Recruitment methods will be the same between potential subject groups, i.e. same in 
treatment and wait-list control groups. 
Additionally, members of the clinical care team may identify eligible cancer survivors from the 
electronic health record (EHR) and provide contact information for potentially eligible individuals to 
members of the study team. The study team will mail a letter to these individuals inviting them to 
participate, and providing them with information on how to contact the study team to enroll or to opt 
out. 
 
Should we encounter difficulties with recruitment, we may accrue participants through community- 
based strategies including posting fliers at partnership organizations (such as Gilda’s Club, for 
example). The primary mechanism of subject identification will be through referrals at the research 
site, but if necessary we may deploy community, word of mouth and flier-based recruitment. 
 
 
6.4.2 Permission to Contact Form 
Participants will be identified and recruited primarily through referrals at the research site, and 
prospective participants who are interested in the study will be asked to sign a Permission to Contact 
Form (Appendix 7) which allows members of the research team to contact them. Those who would 
like to be contacted to learn more about the study will sign the permission to contact from at the 
clinical site, and then those forms will be delivered to members of the research team to contact and 
screen for eligibility for the study. Once the permission to contact form is signed, the research team 
will take over to confirm eligibility, screen over the phone and enroll in the study. 
 
6.4.3 Recruitment and Retention Strategies 
Participants will be recruited primarily through referrals at the research site. If necessary, 
participants may be recruited through community partnerships through fliers and word of mouth 
recruiting. 
 
Because the intervention is only 10 weeks in duration with a five week follow up, we do not anticipate 
major issues with participant retention. We have experience conducting several previous PA trials in 
cancer survivors and typically observe only ~5% loss to follow-up in a short-term study. To 
encourage retention, participants will receive $50 compensation at the baseline visit and again at 
the 10-week follow-up visit. 
 
7.5 Vulnerable Populations 
No vulnerable populations will be included in this study design. 
 
TABLE 1: Vulnerable populations included and excluded from this study 
 
Include 
Exclude 
Vulnerable Population Type 
X 
Adults unable to consent 
X 
Individuals who are not yet adults (e.g. infants, children, teenagers) 
X 
Wards of the State (e.g. foster children) 
X 
Pregnant women 
X 
Prisoners 
 
7.5.1 Subject Capacity 
All subjects will have the capacity to give informed consent, else they will be excluded from this 
study. 
 
7.6 
Informed Consent 

11 
 
The PI will be responsible for ensuring that valid consent is obtained and documented for all 
subjects unless the IRB waives the requirement for documentation of informed consent for all or 
part of the study. Verbal consent will be given for the telephone screening questionnaire; however 
for the intervention, informed consent will be obtained during an in-person visit. 
7.6.1 Process of Consent 
 
• 
Consent will be obtained by either the PI, or by the Study Coordinator. 
• 
Consent will be documented by having the participant sign the form, with a member of the study 
team signing to affirm the witnessing of the signing. One copy will be made and given to the 
participant, with another kept by the study team. Documentation will be stored in each 
participant’s individual research file at the site’s pre-determined storage location. 
• 
Informed consent will be structured to be conducive to rational and thoughtful decision making 
by asking the prospective participant several questions about the intervention, including how to 
withdraw, how the groups will be allocated, what participation consists of, as well as what are 
the alternatives to participation. 
 
7.6.2 Consent Form 
The informed consent document for this study is maintained as a separate 
document. 
7.6.3 HIPAA 
Information about study subjects will be kept confidential and managed according to the 
requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA). 
Attached/submitted as part of our application is a signed subject authorization form that includes 
information collected during this study as well as from medical record data will be used by the 
researchers and research staff as a part of this investigation. A HIPPA authorization form is attached 
to this protocol as an Appendix. 
 
7.6.4 Revoking Consent 
In the event that a subject revokes authorization to collect or use PHI, the investigator, by regulation, 
retains the ability to use all information collected prior to the revocation of subject authorization. For 
subjects that have revoked authorization to collect or use PHI, attempts should be made to obtain 
permission to collect at least vital status (i.e. that the subject is alive) at the end of their scheduled 
study period. 
 
7.6.5 Costs to the Subject 
There will be no costs to the participants for this study, any costs occurred during this research 
study will be covered by the grant funding mechanism. 
 
7.6.6 Payment for Participation 
Participants will be paid $50 in cash at the baseline visit as well as another $50 cash at the final 
(post-intervention) visit. Those who complete the intervention will receive a total of $100 cash. 
At the instructional visit, participants will be provided with exercise equipment (towel, band, duffle 
bag, resistance bands, and dumbbells) that they will use for the intervention and will be allowed to 
keep after the intervention has completed. Any parking costs required for the in-person visits will be 
covered as a part of the study. 
 
7.7 Early Withdrawal of Subjects 
 
7.7.1 When and How to Withdraw Subjects 
Participants may withdraw from the study prior to expected completion due to safety reason, losses 
to follow up, failure of subject to adhere to protocol requirements, subject consent withdrawal, etc. 

12 
 
 
7.7.2 Data Collection and Follow-up for Withdrawn Subjects 
Data will be attempted to be gathered from participants who have withdrawn from the study to collect 
their data prior to their withdrawal, including emails from the research staff and telephone calls. 
Withdrawn subjects will be analyzed using an intent to treat analysis, therefore maximizing the amount 
of data is paramount to success. However, if participants cannot be contacted after 3 attempts from the 
study team (both telephone calls and emails) then the participants will be considered lost to follow-up. 
 
8 Study Procedures 
Wait list interventions 
After being randomized to the wait-list group, participants will be scheduled for their 10 week follow up visit. The 
wait list arm will not have the additional five week follow up that the exercise arm receives. Participants will be 
reminded that at that final visit, participants will complete the same study measures (body composition, functional 
fitness testing, blood sample collection, and anthropometrics) and will also receive study materials at the end of 
their wait list period. Participants in the wait list group will also complete accelerometer (Actigraph) assessments at 
three study points: Early in the intervention near the instructional visit, at the mid-way (5-week) mark, and before 
the final visit. These accelerometers will be sent and received via mail and participants will receive instructions on 
how to wear, use and send to us during the instructional visit.  
 
 
Exercise interventions 
After being randomized to the exercise (intervention) arm, participants will be scheduled for an instructional visit 
with the study coordinator within a week of randomization. At that visit, participants will be instructed to wear 
comfortable clothes and shoes for learning the exercises. The instructional visit includes going through each 
exercise of the intervention (see Table below) to learn the movement, learn the muscle groups involved, and to 
learn how to monitor themselves by tracking their progress via logs. This instructional visit should take 60-90 
minutes, and each participant will receive a summary sheet of her starting point at each exercise with respect to 
intensity and progressions/regressions. For example, a participant may be starting on a blue resistance band for 
biceps curls, but the squats may simply be body weight at this time. Table below outlines the exercises for the 
intervention.  
 
 
During the study period, participants in the intervention arm will be instructed to complete the exercise routine twice 
a week for 10 weeks during the intervention, and also continued throughout the five week follow up period. There 
are eight video calls with the study coordinator to check in, to identify any issues or concerns with the exercises, 
and to finally monitor progress in the form of assessing volume/intensity/difficulty of each of the exercises. These 
calls are done over video so that the coordinator can build rapport with participants, and that participants can show 

13 
 
or demonstrate issues with exercises or their form. At the mid-point of the study, participants will receive an email 
with the questionnaires, so that the questionnaires will be done at baseline, at the study mid-point, and at the final 
visit.  
Participants in the intervention group will also complete accelerometer (Actigraph) assessments at three study 
points: Early in the intervention near the instructional visit, at the mid-way (5-week) mark, and before the final visit. 
These accelerometers will be sent and received via mail and participants will receive instructions on how to wear, 
use and send to us during the instructional visit.  
At the end of the 10 week period, participants will return to the UW campus for a final visit to repeat baseline study 
measures. At this time, intervention arm participants will also complete an exit-style interview with the study 
coordinator to help improve the intervention for future participants. This will be recorded, but anonymized upon 
transcription.  
While the formal intervention period will be 10 weeks in duration, we will continue to follow those in the exercise 
arm for five weeks post-final assessment. This follow up period will consist of surveys to the participants assessing 
the frequency of the home-based resistance exercise, to determine if the behavior of exercise persists in the short-
term following intervention conclusion. 
8.1 Measures 
Below are the study measures that will be collected over the course of the intervention: 
• 
Demographics and other participant characteristics: Participants will self-report age, 
race/ethnicity, marital status, education, and cancer characteristics (tumor type and stage, dates 
of diagnosis and treatment completion, treatment received). Clinical information will be 
confirmed with the medical record. 
• 
When collected: Baseline 
• 
Accelerometer. Although aerobic and lifestyle PA (e.g., MVPA, steps) 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. The ActiGraph is a gold standard method of objective activity assessment.26, 27  
• 
When collected: Baseline, mid-point (~5 weeks), final visit (~10 weeks) 
• 
Biomarkers. Using a standardized protocol, participants will undergo a fingerpick to collect a 
peripheral blood sample to assess glycosylated hemoglobin (A1c) and c-Reactive Protein28 via 
dried blood spots. The values for both A1c and CRP are highly correlated between dried blood 
spots and venipuncture.29 
• 
When collected: Baseline, final visit (~10 weeks) 
• 
Anthropometrics. Height, weight, waist and hip circumferences will be measured according to 
standard protocols. 
• 
When collected: Baseline, final visit (~10 weeks) 
• 
Body composition. Resistance training can improve body composition even without weight loss. 
Body composition will therefore be assessed using dual-energy absorptiometry (DXA) using the 
enCORE Lunar iDXA software suite (GE Healthcare, Little Chalfont, UK). DXA provides a 
precise measure of fat mass, lean mass, total % body fat, and visceral fat and is sensitive to 
small changes from pre- to post-intervention.30  
• 
When collected: Baseline, final visit (~10 weeks) 
• 
Functional fitness. The functional fitness test (FFT) is a battery of six tests measuring strength, 
flexibility, fitness, body composition, and agility. It has high test-retest reliability and is suitable 
for tracking within-person changes.31 The functional fitness test battery includes the following 6 
assessments: 1.) The 30 second chair stand, which 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. 2.) The 30 second arm curl assesses the strength of the upper 
body, where women will hold a 5 pound dumbbell in a seated position, and they will have 30 

14 
 
seconds to curl their arm and extend it as many times as possible within the time frame. 3.) 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. 4.) The chair sit and 
reach assesses the 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, and we will measure the 
distance between their toes and fingers. 5.) The 8-foot-up and go is an assessment of speed 
agility and balance. With this assessment, 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. 6.) The back scratch test is 
an assessment of the flexibility of the upper body, where the person will be 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. 
• 
When collected: Baseline, final visit (~10 weeks) 
• 
Quality of life (QOL). QOL changes will be captured using the Functional Assessment of Cancer 
Therapies (FACT) questionnaire including the Endometrial subscale (FACT-En).32 These 
measures will be repeated at the study mid-point (5 weeks) to assess changes over time. 
• 
When collected: Baseline, mid-point (~5 weeks), final visit (~10 weeks) 
• 
Mental well-being. Changes in mental well-being (including anxiety, depression, and fatigue) will 
be assessed using standardized PROMIS measures.33 These measures will be repeated at the 
study mid-point (5 weeks) to assess changes over time. 
• 
When collected: Baseline, mid-point (~5 weeks), final visit (~10 weeks) 
• 
Self-efficacy. This will be assessed using the validated self-efficacy for exercise scale, modified 
for specificity to strength training.34 These measures will be repeated at the study mid-point (5 
weeks) to assess changes over time. 
• 
When collected: Baseline, mid-point (~5 weeks), final visit (~10 weeks) 
• 
Adherence. Compliance and 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. 
• 
When collected: ongoing, logs will be completed throughout the intervention and 
submitted at the final visit 
• 
Additionally, for those in the intervention arm, we will ask that they continue to 
conduct the prescribed exercises for an additional five weeks after study 
completion. Participants will still submit paper logs, and this adherence measure 
will allow for study of adherence without prescribed check-ins from the study 
coordinator over the five week period.  
• 
Acceptability. Participants will participate in a 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. 
• 
When collected: Final visit (~10 weeks) 
8.2 Video calls  
 
Participants will receive a tablet for the duration of the intervention for video conferencing with research team. 
Phone call conferencing will be available, however the tablets allow for video applications so that participants can 
visually interface with members of the research team. Additionally, using video conferencing allows participants to 
receive feedback and form recommendations from her home if she has questions or would like feedback on her 
performance for specific exercises. However, because this is a pilot intervention, we aim to determine if the video 

15 
 
conferencing component is useful. By providing each participant with a tablet, we are inclusive for individuals who 
may not have access to these resources on her own. Each participant will receive a check-in at eight points during 
the 10 week study: two calls in the first week, one during weeks three four and five, one during week six , and 
finally one during week eight consistent with their preferred contact method to provide feedback on their progress 
and resistance training. The study coordinator will ask about overall qualitative satisfaction, and issues the 
participant is having, and any questions that the study coordinator could potentially address. Participants are 
welcome to reach out to the lab or study coordinator at any point during the study, however these pre-planned 
check in visits will hopefully facilitate discussion if any issues remain unaddressed.  
 
8.3 Labs 
Blood spots: In a non-clinical setting, dried blood spots collected using finger pricks are a low-cost way 
to establish the feasibility of biomarker data collection. Using a standardized protocol, participants will 
undergo a fingerpick to collect a peripheral blood sample to assess glycosylated hemoglobin (A1c) and 
c-Reactive Protein50 via dried blood spots. Dried blood spots can be collected by non-phlebotomists in 
non-clinical settings, and the values for both A1c and CRP are highly correlated between dried blood 
spots and venipuncture.51 
 
8.4 Established Standard of Care: 
 
There are currently no established standards of care in terms of prescribing exercise (especially 
resistance training exercise) in endometrial cancer survivors. 
 
Table 3. Study Calendar of scheduled measures 
 
 
 
8.5 Study Visits 
 
8.4.1 
Screening/Baseline: 
Baseline. At this visit, the study coordinator will explain 
the study and obtain written informed consent. Physical 
measurements (anthropometrics, blood sample, DXA 
scan, functional fitness testing) will be completed. The 
study coordinator will instruct the participant on how to 
properly wear the accelerometer (to be returned via 
pre-paid mailer), complete a 7-day PA log, and 
complete the online questionnaires. 
Randomization. After all baseline measures have been 
completed and checked, the participant will be 
randomized with 1:1 probability to the intervention or 
wait-list control group. A blocked randomization 
scheme will ensure equal allocation of participants to 
each group. Participants will be notified of their group 
assignment by phone; those in the intervention group 
will be scheduled for the intervention introductory session. (Those in the wait-list control group will 
receive this session at the same time as the final measures are collected.) 
Instructional. Participants randomized to the intervention group will meet with study coordinator to 
learn how to conduct the exercises, how to use the materials, how to complete the exercise log and 
general instructions on the normal symptoms of resistance training. This visit should take 1-2 hours, 
ensuring the participant is confident. 
8.4.2 Follow up: 
 

16 
 
Table 4. Acceptable Window for Study Visits (including weekends) 
 
Visit 
Window 
Activities 
Randomization 
+/- 5 days 
Allocate to group 
Instructional visit 
+/- 2 weeks 
Teach exercises, learn how to interface with 
software, how to log exercises 
Final visit 
+ /- 2 weeks 
Collect final measures 
 
 
8.4.3 Unscheduled: 
• 
Pain or concerns that need to be addressed in person 
• 
Adverse event follow ups with PCP 
8.4.4 Final Study Visit 
 
Final Visit. All participants will return for follow-up assessments at 10 weeks. In advance, the participant 
will be mailed an accelerometer and 7-day PA log and will receive a link to complete the online 
questionnaires. Physical measures (anthropometrics, blood sample, DXA scan, functional fitness 
testing) will be completed. Those women in the wait-list control group will receive their introductory 
intervention session at this visit. 
 
9 Study Analysis 
9.1 Sample Size Determination 
Sample Size and Power. The purpose of this trial is not to conduct hypothesis testing, but rather to field- 
test the intervention to identify adherence rates to exercise prescription across a group of participants. 
At this time, the anticipated effect size is unknown and the sample size of 40 has been selected to 
maximize feasibility in the anticipated time frame for this project. 
 
9.2 Statistical Methods 
As this is the first investigation in this population to look at this resistance training, both in terms of 
adherence rates as well as objective and functional changes in performance, there are no published 
effect sizes to anticipate at this time; therefore, we have a feasibility/descriptive focus as opposed to a 
hypothesis-testing focus. In addition to quantitative analysis, we plan to conduct qualitative analyses 
from participant feedback surveys to assess barriers to participation and to improve future interventions 
and to increase adherence rates. 
 
9.3 Subject Population(s) for Analysis 
The populations for this investigation include: 
• 
All-randomized population: Any subject randomized into the study, regardless of whether they received 
study agent 
• 
All-treated population: Any subject randomized into the study that received at least the instructional 
visit of the intervention 
• 
Protocol-compliant population: Any subject who was randomized, was allocated to the exercise group 
and provided at least one set of data elements required by the protocol. 
 
9.3.1 Describe the types of analysis: 
• 
Primary Analysis: The primary objective includes measuring the percentage of completed 
sessions compared to prescribed, and a one-sample t-test will be conducted to determine if that 
proportion, across participants, is >90%. A one-sample t-test will be done to determine if retention 
is >90%. 

17 
 
• 
Secondary Analyses: The secondary analyses includes measuring the objective and functional 
changes from pre to post intervention as well as differences between groups. Paired ANOVAs and 
descriptive statistics will be used to analyze functional and objective data, as well as participant 
feedback data, including satisfaction with each component of the intervention. 
• 
Exploratory, longitudinal analyses: Content analysis will be done on the qualitative interviews to 
examine barriers to physical activity, as well as satisfaction with the intervention, and identification 
of themes to improve the intervention. Although formal hypothesis testing is not part of our specific 
aims, we will conduct longitudinal analyses of the data we collect to estimate potential magnitude 
of expected changes, as well as longitudinal analysis of the repeated measures. 
• 
Safety Analysis: The safety analysis includes simple descriptive analysis about the number of 
adverse events over the course of the intervention between groups and across sites. 
 
9.4 Planned Interim Analysis: 
There are no planned interim analyses for this investigation. 
 
10 Data Collection, Handling and Record Keeping 
10.1 Data Confidentiality 
• 
We will take extensive measures to ensure data safety and security. A dedicated study database will 
be constructed on a secure server using the REDCap study management system.56 To ensure quality 
control and appropriate completion of self-report measures, questionnaires will be collected online. 
Data quality will be checked by examining descriptive statistics and checking ranges of missing 
values. 
 
10.1.1 Confidentiality of Subject Records 
By signing the protocol, the Investigator agrees that IRB and NCI representative may consult and/or copy 
study documents in order to verify CRF data. By signing the consent form, the subject agrees to this 
process. If study documents will be photocopied during the process of verifying CRF information, the 
subject will be identified by unique code only and full names and similar identifying information (such as 
medical record number or social security number) will be masked. 
 
The Clinical Site Investigators will ensure that the identity of subjects will be protected. All study records 
will be maintained in a secure fashion with access limited to essential study personnel only. All study 
documents submitted to the Coordinating Center will have identifiers removed other than dates of birth and 
service and subjects will be identified with a study-specific identification number only. The Clinical Site 
Investigators will maintain, in a secure location, an enrollment log that includes subject identifying 
information and links subjects to their study-specific identification number. 
 
10.2 Data Capture 
 
10.2.1 Missing Data 
Strategies for handling missing data will be chosen based on the type and extent of the problem under 
advisement from biostatistician Dr. Gangnon. It is anticipated that sensitivity analyses or model-based 
approaches will be assessed for appropriateness for this investigation. 
 
10.2.2 Data Collection Tools 
UW-ICTR provides REDCap that will be used for data collection for this investigation. This tool is self- 
service, secure, and can be easily used across all study sites to ensure appropriate data collection. 
Additionally, this tool is buildable for the unique needs of this investigation, and we plan to use the 
participant as the unit of measure for this study, and not the time point as the unit of measure. 

18 
 
 
 
10.3 Records Retention 
To ensure the integrity of the data collected from study participants, several procedures will be 
implemented. All personnel involved in data collection will be thoroughly trained in all assessment 
methods, thus ensuring consistent applications of procedures and measurement consistency across 
participants. All questionnaire data will be automatically saved in the secured, password protected 
Qualtrics or REDCap systems and will be downloaded to a password protected network folder on a 
secure server (i.e., password protected) which is backed up daily ensuring access only by the 
investigators. All other data will be saved to a computer hard drive in real time and then stored on a 
secure server (i.e., password protected) which is backed up daily. All raw data are kept in locked 
cabinets in the site-PI’s laboratory. All hardcopies of raw data will be de-identified (with the exception 
of the study ID number) and copied for mailing to the coordinating center for data management. 
Although all packages with data will be mailed by certified mail so that tracking the location is possible, 
maintaining copies of the data at the collaborating centers in locked cabinets in the site investigator’s 
laboratory will be done in the unlikely event that data is lost in the mail. Informed consent forms will be 
kept in a separate locked file cabinet with restricted access. Issues related to data integrity will be 
discussed on a weekly basis as a recurring agenda item in the weekly project meeting. Finally, 
continuing review of all procedures will be obtained by all appropriate institutional review boards. 
 
Study data will be labeled with a study ID number. Data linking the study ID numbers with subject identities 
will be stored in hard copy format only. This and other paper files will be kept in a locked file cabinet in 
the Physical Activity Laboratory in the UW Department of Kinesiology (2000 Observatory Drive, Madison 
WI 53706, Room 2057). The laboratory door is kept locked at all times. Only study personnel will have 
access to participant data. Electronic data, including accelerometer data files, will be kept on a server at 
the Department of Kinesiology, in a drive accessible only by the PI and study staff. Data will be retained 
for an indefinite amount of time, and all study data will be banked in a coded format. Data may be used in 
the future for a secondary data analysis looking at relationships between collected study data and other 
variables. Study data may only be used by the study team, and all future investigations using any banked 
data from this study must undergo a separate IRB application. Use of study data is limited to the research 
team for this protocol, unless a separate IRB application is submitted for use of this banked data for 
future investigations.  
 
10.4 Data and Safety Monitoring 
The Site Investigator (Dr. Cadmus-Bertram) will be responsible for reviewing and monitoring all study 
data and any adverse events for this study.  The Investigator will meet with study personnel at least 
weekly to evaluate study progress, including periodic assessment of data quality and timeliness, 
participant recruitment, accrual and retention, participant risk versus benefit, and other factors that can 
affect study outcomes. All unanticipated problems regardless of where they occur, will be reported to 
the University of Wisconsin IRB.   
 
This protocol is considered to have a minimal risk to participants, as it prescribes physical activity that 
is consistent with national recommendations and guidelines for cancer survivors.  We attempt to reduce 
the risk of injury or muscular soreness by excluding individuals who report difficulty transitioning from 
sitting to standing, walking 1 block (as a proxy measure of basic physical functioning), or report that they 
are otherwise unable to work towards the intervention goals. As with any exercise intervention, there is 
also a minor risk of cardiovascular events.  Participants in both intervention groups will receive regular 
check-in calls to assess progress and address any potential problems regarding physical issues or 
emotional stress. 
 

19 
 
11 Assessment of Safety 
 
 
This protocol is considered to have a minimal risk to participants, as it prescribes physical activity that is 
consistent with national recommendations and guidelines for cancer survivors. We attempt to reduce the 
risk of injury or muscular soreness by excluding individuals who report difficulty transitioning from sitting 
to standing, walking 1 block (as a proxy measure of basic physical functioning), or report that they are 
otherwise unable to work towards the intervention goals. As with any exercise intervention, there is also 
a minor risk of cardiovascular events. Participants in both intervention groups will receive regular check-
in calls to assess progress and address any potential problems regarding physical issues or emotional 
stress.  
 
 
 
12 Study Finances 
12.30 
Funding Source 
This study is financed through an institutional pilot grant from the American Cancer Society and funds 
from the UWCCC. 
 
12.31 
Conflict of Interest 
Any investigator who has a conflict of interest with this study (patent ownership, royalties, or financial 
gain greater than the minimum allowable by their institution, etc.) must have the conflict reviewed by 
a properly constituted Conflict of Interest Committee with a Committee-sanctioned conflict 
management plan that has been reviewed and approved by the study sponsor prior to participation 
in this study. All UW investigators will follow the UW conflict of interest policy. 
 
12.32 
Subject Stipends or Payments 
Participants will be paid $50 in cash at the baseline visit as well as another $50 cash at the final (post- 
intervention) visit. Those who complete the intervention will receive a total of $100 cash. 
 
13 Publication Plan 
 
The primary responsibility for publication of the results of this study are the investigators at UW Madison 
(Dr. Cadmus-Bertram). Neither the complete nor any part of the results of the study carried out under 
this protocol, nor any of the information provided by the sponsor for the purposes of performing the 
study, will be published or passed on to any third party without the consent of the study sponsor. Any 
investigator involved with this study is obligated to provide the sponsor with complete test results and 
all data derived from the study. 
 
14 Protocol implementation timeline and contingency plans 
There are three primary concerns for this research design and there are listed preliminary contingency 
plans if these concerns come to fruition: 
• The primary concern is a lack of subjects or low accrual to study participant goals for site numbers. 
o If there is insufficient or slow recruitment through a clinical route, we plan to reach out to 
community support groups such as Gilda’s Club to bolster recruitment numbers. This 
strategy will not replace the clinical route, but may increase participant enrollment. 
• The secondary concern is high attrition in the treatment group and potential losses to follow up over 
the course of the 10-week intervention. Although this is a lower probability event, we will utilize the 
following contingency plans: 
o Deploy follow ups using a sufpport person for the participant that we can contact if the 
participant is not contacting study staff or seems to be lost to follow up 
o At the start of the study, we will collect multiple email addresses and phone numbers from 

20 
 
each participant to avoid this problem a priori. 
• Finally, we may have poor adherence and compliance to the protocol. 
o We have pre-scheduled check-ins during the course of the intervention to avoid this issue 
o However, we will deploy additional health coaching if necessary where participants are really 
struggling with adherence 
o Participant satisfaction surveys will be used at the end of the intervention to evaluate the 
quality of the study to learn and improve for the future if adherence is very high 
Table 5: Protocol implementation timeline for the home-based resistance training protocol in endometrial 
cancer survivors 
 
Pre-award 
Year 1 
Year 2 
Protocol 
development 
PRMC/IRB 
Approval 
Recruitment 
Data collection 
Data analysis 
Manuscript 
preparation 
Data closeout 
protocols 
Manuscript 
publication 

21 
 
Appendix 1: Participant tracking form: Checklist of Study Activities 
Activity 
Date completed 
Staff initials 
Screening call 
  
/ 
/ 
 
  
 
Baseline Assessments (all participants) 
Confirmation Letter sent 
  
/ 
/ 
 
  
 
Demographics and cancer characteristics 
  
/ 
/ 
 
  
 
Physical Measures (FFT and Anthropometrics) 
  
/ 
/ 
 
  
 
DXA Scan 
  
/ 
/ 
 
  
 
Blood biomarkers collected 
  
/ 
/ 
 
  
 
Questionnaire links emailed (5 questionnaires) 
  
/ 
/ 
 
  
 
Actigraph/instructions given 
  
/ 
/ 
 
  
 
Randomized to: Intervention Wait-list 
  
/ 
/ 
 
  
 
If intervention: Instructional visit scheduled 
  
/ 
/ 
 
  
 
Baseline Questionnaires verified 
  
/ 
/ 
 
  
 
Baseline incentive provided 
  
/ 
/ 
 
  
 
Instructional Visit (Intervention group) 
Date of visit – all exercises taught 
  
/ 
/ 
 
  
 
Participant exercise materials delivered 
  
/ 
/ 
 
  
 
ActiGraph data downloaded/checked 
  
/ 
/ 
 
  
 
Intervention materials provided (Both groups) 
  
/ 
/ 
 
  
 
Intervention Period (Intervention group) 
Date of first coaching call (1A) 
  
/ 
/ 
 
  
 
Date of second coaching call (1B) 
  
/ 
/ 
 
  
 
Date of week 2 coaching call (2) 
  
/ 
/ 
 
  
 
Date of week 3 coaching call (3) 
  
/ 
/ 
 
  
 
Date of week 4 coaching call (4) 
  
/ 
/ 
 
  
 
Actigraph mailed out 
  
/ 
/ 
 
  
 
Mid-point (5 week) Questionnaires Sent (5) 
Mid-point Questionnaires Verified 
  
/ 
/ 
 
  
/ 
/ 
 
  
 
  
 
Date of week 6 coaching call (6) 
  
/ 
/ 
 
  
 
Date of week 8 coaching call (8) 
  
/ 
/ 
 
  
 
Actigraph data downloaded/checked 
  
/ 
/ 
 
  
 

22 
 
Final Assessments (all participants) 
Final visit scheduled 
  
/ 
/ 
 
  
 
ActiGraph mailed 
  
/ 
/ 
 
  
 
Questionnaire links emailed (5 questionnaires) 
  
/ 
/ 
 
  
 
Questionnaires verified 
  
/ 
/ 
 
  
 
Physical Measures (FFT and Anthropometrics) 
  
/ 
/ 
 
  
 
DXA Scan 
  
/ 
/ 
 
  
 
Blood biomarkers collected 
  
/ 
/ 
 
  
 
Accelerometer downloaded/checked 
  
/ 
/ 
 
  
 
Incentive delivered 
  
/ 
/ 
 
  
 
Qualitative interview with study coordinator 
  
/ 
/ 
 
  
 

23 
 
Appendix 2: Demographic form 
 
 
 
HEALTH HISTORY AND 
DEMOGRAPHIC 
QUESTIONNAIRE 
 
Name: 
 
Address:    
 
 
City: 
ZipCode:    
 
 
Phone: 
Date of Birth: 
Current Age:    
 
 
 
Are you currently employed? (circle one): Yes 
No 
 
What is your current job status? (Check all that apply). 
 
Employed full time (including self employed) 
 
Employed part time (including self employed) Hours/week:   
 
 
Volunteering full-time 
 
Volunteering part-time Hours/week:   
 
 
On leave of absence 
 
Retired (not due to health) 
 
Disabled and/or retired because of health 
 
Unemployed 
 
Student 
 
Homemaker- full time 
 
Occupation:   
 
 
Marital Status (circle one):  Single 
Living with a partner/married 
 
Education (circle highest level completed): 
 
Elementary / High School / College / Some College / Graduate School 
 
 
(PAGE 1 OF 2) 
STUDY ID 
CURRENT DATE 

24 
 
 
 
 
(PAGE 2 OF 2) 
Have you been hospitalized in the last year? 
(circle one)  Yes 
No 
If YES, how many days were you in hospital?  
 
Back Pain 
Diabetes 
Heart Attack 
Joint problems 
Coughing of blood 
Dizzy spells 
Frequent headaches 
Shortness of breath 
Heart palpitations 
Skipped heart beats 
YOUR PRESENT HEALTH 
Chest pain / discomfort Cough on exertion 
Stroke 
Blood Clots 
Cancer 
Liver or Kidney Disease 
Any breathing problems 
High blood pressure 
Any heart problems 
Arthritis 
Diabetes 
Recurring leg pain 
Ankle swelling 
Low back or joint problems 
YOUR PAST HEALTH HISTORY 
Circle any of the following medical conditions you have either been 
diagnosed with or have experienced. 

25 
 
Appendix 3: Exercise tracking log (example) for week 1 of 10 weeks 
 
 
Week 1: Date 
Circle one: Day 1 OR Day 2 
Exercise 
Set 1 
Set 2 
Set 3 (Optional) 
# 
Repetitions 
RPE 
# 
Repetitions 
RPE 
# 
Repetitions 
RPE 
Chair squats 
Dumbbell 
chest 
press 
Dumbbell single arm 
row 
Dumbbell shoulder 
press 
Standing heel raises 
Seated 
triceps 
extension 
Seated biceps curl 
Supported 
floor 
crunches 
 
Comments:  
 
 
Concerns:  
 
 
Week 1: Date 
Circle one: Day 1 OR Day 2 
Exercise 
Set 1 
Set 2 
Set 3 (Optional) 
# 
Repetitions 
RPE 
# 
Repetitions 
RPE 
# 
Repetitions 
RPE 
Chair squats 
Dumbbell 
chest 
press 
Dumbbell single arm 
row 
Dumbbell shoulder 
press 
Standing heel raises 
Seated 
triceps 
extension 
Seated biceps curl 
Supported 
floor 
crunches 
 
 
Comments:  
 
 
Concerns:  
 

26 
Version #: 1H 
 
Appendix 5: Permission to Contact for Resistance Training Trial 
 
You may be eligible for a study using a resistance training intervention in endometrial cancer survivors. Can 
research staff talk to you about their exercise study in endometrial cancer survivors? 
 
The HIPAA Privacy Rule requires University of Wisconsin - Madison to obtain your written permission to release 
your name and phone number to Dr. Lisa Cadmus-Bertram and her research team at the University of Wisconsin- 
Madison so that they can contact you about taking part in this study. If you agree that we can share your name 
and telephone number, this information will only be used to contact you to provide more information about this 
study. Your name and telephone number will not be shared with anyone other than the UW research team. This 
permission for the researchers ends after the release of your health information to the researchers. 
 
 
If you decide that you do not wish to take part in the research study after giving permission to provide the 
researchers with your name and telephone number, the UW researchers will destroy this information. 
Whenever possible, your health information will be kept confidential. However, if you have given permission to 
share your information with recipients who are not covered by federal health information privacy laws, the 
health information they receive may no longer be protected under those federal laws and the recipients may be 
permitted to further share your information without your permission. As noted before, there are no plans to 
share your name and contact information with anyone other than the UW researchers. 
 
 
You do not have to give your name and contact information if you don’t want to. If you don’t want to provide your 
name and contact information, it will not affect your health care at this clinic. 
 
By printing your name below and signing this form, you are giving permission for this clinic to give your name 
and telephone number to Dr. Lisa Cadmus-Bertram’s research team to contact you about taking part in her study. 
 
Your name:   
 
 
Your signature:  
 
Date:   
 
 
Phone number:    
 
 
Best time to call:   
 

27 
Version #: 1H 
 
7 References 
 
1. 
DeSantis CE, Lin CC, Mariotto AB, Siegel RL, Stein KD, Kramer JL, et al. Cancer treatment and survivorship 
statistics, 2014. CA Cancer J Clin. 2014;64(4):252-71. doi: 10.3322/caac.21235. PubMed PMID: 24890451. 
2. 
Sheikh MA, Althouse AD, Freese KE, Soisson S, Edwards RP, Welburn S, et al. USA Endometrial Cancer 
Projections to 2030: should we be concerned? Future Oncology. 2014;10(16):2561-8. doi: 10.2217/fon.14.192. 
3. 
Fader AN, Arriba LN, Frasure HE, von Gruenigen VE. Endometrial cancer and obesity: epidemiology, biomarkers, 
prevention and survivorship. Gynecol Oncol. 2009;114(1):121-7. Epub 2009/05/02. doi: 10.1016/j.ygyno.2009.03.039. 
PubMed PMID: 19406460. 
4. 
Schouten LJ, Goldbohm RA, Van Den Brandt PA. Anthropometry, physical activity, and endometrial cancer risk: 
results from the Netherlands Cohort Study. Journal of the National Cancer Institute. 2004;96(21):1635-8. 
5. 
Mastellos N, Gunn LH, Felix LM, Car J, Majeed A. Transtheoretical model stages of change for dietary and 
physical exercise modification in weight loss management for overweight and obese adults. Cochrane Database Syst 
Rev. 2014(2):Cd008066. Epub 2014/02/07. doi: 10.1002/14651858.CD008066.pub3. PubMed PMID: 24500864. 
6. 
von Gruenigen VE, Gil KM, Frasure HE, Jenison EL, Hopkins MP. The impact of obesity and age on quality of life 
in gynecologic surgery. American journal of obstetrics and gynecology. 2005;193(4):1369-75. 
7. 
Arem H, Park Y, Pelser C, Ballard-Barbash R, Irwin ML, Hollenbeck A, et al. Prediagnosis body mass index, 
physical activity, and mortality in endometrial cancer patients. J Natl Cancer Inst. 2013;105(5):342-9. Epub 2013/01/09. 
doi: 10.1093/jnci/djs530. PubMed PMID: 23297041; PubMed Central PMCID: PMCPMC3589256. 
8. 
Zaleta AK, Neff R, McCann GA, O'Malley DM, Carpenter KM. Perceptions of weight management counseling 
among gynecologic cancer survivors: opportunities for enhancing survivorship care. Support Care Cancer. 
2017;25(5):1537-45. Epub 2017/01/05. doi: 10.1007/s00520-016-3552-0. PubMed PMID: 28050708. 
9. 
Nock NL, Dimitropoulos A, Rao SM, Flask CA, Schluchter M, Zanotti KM, et al. Rationale and design of REWARD 
(revving-up exercise for sustained weight loss by altering neurological reward and drive): a randomized trial in obese 
endometrial cancer survivors. Contemp Clin Trials. 2014;39(2):236-45. Epub 2014/08/21. doi: 10.1016/j.cct.2014.08.008. 
PubMed PMID: 25139726; PubMed Central PMCID: PMCPMC4294324. 
10. 
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