E-PROOF: E-Intervention for Protein Intake and Resistance Training to Optimize Function
Phase: NA
Conditions: Anatomic Stage I Breast Cancer AJCC v8, Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage III Breast Cancer AJCC v8, Stage I Colorectal Cancer AJCC v8, Stage I Prostate Cancer AJCC v8, Stage II Colorectal Cancer AJCC v8, Stage II Prostate Cancer AJCC v8, Stage III Colorectal Cancer AJCC v8, Stage III Prostate Cancer AJCC v8
Sponsor: Ohio State University Comprehensive Cancer Center

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TITLE: E-PROOF: E-intervention for Protein Intake and Resistance Training to Optimize Function 
NCT number: NCT06016725 
Date of document: January 30, 2024 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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PROTOCOL  
TITLE: E-PROOF: E-intervention for Protein Intake and Resistance Training to Optimize Function 
PI: Jessica Krok-Schoen, PhD, Assistant Professor, School of Health and Rehabilitation Sciences, College of 
Medicine, The Ohio State University 
CONTACT: 228A Atwell Hall, 453 W. 10th Avenue, Columbus, OH 43210; Phone: 614-366-9203; Email: 
jessica.krok@osumc.edu 
TYPE OF STUDY: Behavioral Intervention 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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BACKGROUND 
The 12 million older (age ≥65) cancer survivors (OCS) are at heightened risk of physical function impairment, 
one of the most pervasive health challenges at the intersection of aging and cancer.1 Impairments in physical 
function are more prevalent among older adults with a history of cancer (24-58%) compared to the general older 
adult population (20-32%), with increased incidence with age.2-6 Compared to non-cancer peers, older adults 
with a history of cancer are also more likely to become fatigued faster and have comorbidities, including higher 
rates of heart and lung disease, arthritis, pain, and obesity.2,5,7-10 This information underscores the need to design 
effective interventions to prevent or reduce physical function impairment,2,11 which has multiple deleterious health 
effects, including poor health-related quality of life (HRQoL) and higher all-cause mortality.12-14 OCS are at 
particular risk of physical function impairment compared to both younger cancer patients and the general older 
adult population.5,6,15 Despite the clinical importance and rising prevalence of physical function impairment, 
physical function has not always been thoroughly examined among OCS. Thus, there is a critical knowledge gap 
about how physical function can be improved among OCS. Consequences of not addressing this serious need 
will be reduced HRQoL, and increased healthcare costs among the growing OCS population.16,17  
Declines in adequate protein and calorie intake results in accelerated loss of muscle mass and physical 
functioning in older adults.18-20 Prior randomized trials demonstrate that increased protein intake coupled with 
resistance training, is the most effective strategy to improve physical function.19,21,8,22-25 Despite substantial 
evidence, there is a paucity of research on protein consumption and resistance training among OCS, a population 
at high risk for functional limitations. Given the ongoing COVID-19 pandemic and the positive impact of online 
behavior change interventions for cancer survivors,26-34 online-based interventions to improve physical function 
should be tested among OCS. A novel approach to improving physical function in OCS is to utilize online, tailored 
education and counseling from registered dietitians and exercise scientists, to improve dietary intake (protein 
intake, diet quality) and participation in resistance exercise. The proposed study will be the first synchronous, 
online protein-focused diet and resistance training intervention among OCS. 
 
SPECIFIC AIMS 
Our objective is to improve physical function through online, tailored nutritional and resistance training 
counseling to increase protein intake, improve diet quality, increase resistance training, and improve health 
outcomes (muscle strength, dietary quality, HRQoL, self-efficacy, weight management). This online delivery 
mechanism also decreases participant exposure to COVID-19 among susceptible OCS. We will utilize 
established strategies to improve physical function in an innovative way through a 12-week synchronous, online 
counseling and education intervention for OCS at high risk for physical function impairment. Recruitment will 
take place at The Ohio State University Comprehensive Cancer Center. Our rationale is that understanding the 
influence of nutritional and resistance training counseling and education among OCS is likely to advance the 
science of geriatrics and cancer survivorship. This study, the E-PROOF (E-intervention for Protein Intake and 
Resistance Training to Optimize Function) study, builds on our team’s expertise in geriatrics, cancer survivorship, 
diet, exercise, and physical function and our preliminary data on the dietary, exercise, and physical function 
deficits among OCS. To attain the overall objective, two aims will be pursued: 
 
Aim 1: Determine the feasibility and acceptability of implementing a 12-week online dietary and resistance 
training randomized trial with 70 older cancer survivors. This aim will be accomplished by collecting detailed 
process data, which allows the assessment of accrual, retention, and adherence. Our hypothesis is that we will 
recruit (within 9 months) 70 OCS, retain ≥80% of the sample, and maintain ≥80% adherence to the intervention. 
 
Aim 2: Examine the preliminary efficacy of this 12-week online dietary and resistance training intervention with 
the intervention participants. Registered dietitians and exercise scientists will provide these participants with 
tailored dietary and resistance training recommendations, counseling, and educational materials. Our hypothesis 
is that intervention participants will experience statistically significant, clinically meaningful improvements in 
physical function and associated health outcomes (i.e., muscle strength, dietary quality, HRQoL, self-efficacy, 

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weight management) after the 12-week dietary and resistance training intervention and at a 3-month post-
intervention follow-up.  
METHODS 
I. STUDY DESIGN 
We will examine the feasibility and preliminary efficacy of a 12-week online dietary and resistance training 
intervention to improve the physical function of OCS through increased protein consumption, healthy eating, and 
resistance training. In this pilot randomized controlled trial, participants (n=70) will be randomized to one of the 
two groups: experimental (online counseling, menus, educational materials) and enhanced control (passive 
educational materials). We will examine the intervention effects on physical function and associated health 
outcomes during the 12-week period between the experimental and control group. 
 
II. PARTICIPANT SELECTION 
1. ELIGIBILITY CRITERIA  
Eligibility criteria are: ≥65 years of age, a primary diagnosis of stage I-III breast, colorectal, and prostate cancer, 
completion of primary curative treatment, reported at least 1 physical function limitation on the PFSS (“limited a 
little”, “limited a lot”), no evidence of progressive disease or second cancers, community-dwelling, and able to 
provide consent. The 3 cancer types are chosen because they are the most common cancer types35 with high 
5-year survival rates.36 Additionally, most of the evidence of the benefits of exercise and diet has occurred in 
survivors diagnosed with breast, prostate, or colorectal cancer.24,37-39 Individuals are excluded if they currently 
receive cancer treatment (e.g., chemotherapy, radiation), have liver and/or renal disease limiting their protein 
intake, are under the care of a RD/nutritionist, participating in other diet/exercise interventions, consume protein 
supplements, and have contraindications to unsupervised exercise (e.g., walker/wheelchair use). 
 
2. RECRUITMENT  
Five methods will be employed to recruit potential participants: 
1. Flyers distributed at the JamesCare for Life programs (wellness programs offered through the Ohio State 
University Comprehensive Cancer Center (OSUCCC)) as well as through their email list of cancer survivors. 
Flyers will also be distributed at the OSUCCC’s Cancer and Aging Resiliency (CARE) clinics, multidisciplinary 
clinics designed to address the unique needs of older cancer survivors, and the OSUCCC GI Medical Oncology 
Clinic The study will be advertised on the flyer and eligible women and men will be requested to contact the 
research assistant if they are interested in study participation.  
 
2. In-person during follow-up visits at the Survivorship Clinic and CARE clinics within OSUCCC by study team 
member (Dr. Rosko). When prospective patients are identified, the provider will provide the prospective 
participant with the recruitment flyer that has the PI and research assistant’s names and contact information. In 
addition, the research assistant will be in the clinics screening eligible participants by appointment date and 
meeting the potential participants in person to recruit them. 
  
3. Previously consented older cancer survivors in the OSUCCC Total Cancer Care (TCC) registry. The TCC 
registry, a personalized cancer care initiative designed to collect clinical data and tumor specimens throughout 
a patient's lifetime, will be utilized to capture a larger cancer populations. TCC’s consent rate is 94% of all patients 
evaluated at the OSUCCC. Based on the eligibility criteria, TCC will contact potential participants, identified 
across all OSUCCC clinics, through phone calls, to introduce the proposed study and see if they agree to be 
contacted by the study staff. If permission is given, the study staff member will contact the potential participant 
and determine eligibility. The study staff member will administer the 10-question RAND-36 Physical Function 
Subscale (PFSS) to determine physical function limitations. If the participant has at least 1 limitation on the 
PFSS, the participant will be invited to participate in the study, consented, and invited to the baseline in-person 
visit. These recruitment procedures will continue for 9 months until 70 older cancer survivors have agreed to 
participate in the study. Previous efforts by the PI, co-Is, and consultants to recruit older cancer survivors have 
shown these strategies to be effective. 
 
4. Facebook and Research Match Recruitment Messages. OSU Center for Clinical and Translational Science 
(CCTS) services will be used to generate advertisements for Facebook and Research Match that align with The 
Ohio State University’s College of Medicine institutional branding standards. Facebook advertisements will use 

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the following criteria as the target audience: ≥65 years old, geographic location within a 90-minute driving radius 
of Columbus, Ohio. The Facebook advertisement will direct the user to the E-PROOF Study Search page. These 
advertisements will be live for a two-week period during recruitment.  
Research Match will also be used to recruit potential participants. ResearchMatch is a free and secure online 
tool created by academic institutions across the country to share study and PI contact information to potentially 
eligible participants. Potentially eligible participants will receive an email introduction to the study and, if they are 
interested, permit ResearchMatch to release their contact information to the study team. The research assistant 
will then contact potential participants, via email or phone, to explain study requirements, and confirm eligibility 
(≥65 years of age, history of stage 1-3 breast, colorectal, and prostate cancer, completed primary cancer 
treatment, and have an email address). 
 
5. OSUCCC-James Cancer Program Analytics services will be used to generate a list of OSUCCC patients 
meeting the study criteria.  
 
Email: Potential participants with email addresses will be emailed an invitation letter, signed by OSUCCC 
providers, to participate in the study. An informational overview of the study and time commitment will also be 
provided in the invitation. Potential participants interested in the study will be instructed to contact the Clinical 
Research Coordinator to discuss any questions and complete the screening questionnaire to confirm eligibility. 
 
B. Recruitment Locations  
Recruitment will occur at the Survivorship Clinic and CARE clinics within OSUCCC. Recruitment will occur in the 
clinic exam rooms and/or the waiting room at these clinics. As noted in the facilities page, OSUCCC is the third 
largest cancer hospital in the nation. The hospital includes a 36-bed blood and marrow transplant unit, inpatient 
units in which sub-specialists focus on just one type of cancer, a cancer clinical trials unit, 14 state-of-the-art 
operating rooms, six interventional radiology suites, special isolation rooms, chemotherapy and transfusion 
areas, and seven linear accelerators for radiation therapy. The Survivorship Clinic at OSUCCC is one of the 
country’s largest cancer supportive care programs, with about 40 team members. The Cancer and Aging 
Resiliency (CARE) clinics at OSUCCC provides each older adult with cancer with a comprehensive, 
multidisciplinary treatment plan. Study team member, Dr. Rosko, is the director of the CARE clinics located at 
the OSUCCC.  
 
C. Recruitment Follow-up  
The research assistant will send out a reminder mailing to all identified participants two weeks after the initial 
study contact. The research assistant will make at three attempts by phone to reach the non-responders. If no 
response is given after the third attempt, the potential participant will be considered a “non-responder.” 
 
3. INFORMED CONSENT PROCESS 
For in-person informed consent, it will take place in a quiet setting and in a manner such that the participant does 
not feel rushed or pressured. If telephone/video-based informed consent is received, the potential participants 
will be mailed two paper copies of the informed consent (one to send back to study team and one to keep for 
their records) and asked to review them prior to the telephone call with study staff.  
In both in-person and telephone/video-based informed consent procedures, subjects will be informed 
about all aspects of the study and asked to read the consent form. The form will be written in simple, easy-to-
understand language. We require study staff to review all key aspects of the study verbally. Staff will be provided 
with a structured checklist for this purpose. As the participant reads each page, they are asked to initial the page 
and encouraged to ask questions. Prior to signing the document, they will be asked basic questions about the 
study to ascertain as best as possible if they have understood the requirements of the study, the potential risks, 
and the potential benefits. A copy of the informed consent will be given to the participant, and the original signed 
copies will be kept in the participant’s file. 
 
4. RISKS AND BENEFITS 
All data obtained from participants is considered confidential. Precautions will be taken to protect computerized 
or electronic data from unauthorized disclosure, tampering, or damage by controlling access to the computers 
and files that hold this information. Access to computer files will only be obtained through passwords and will 

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Figure 1. Study schema 
only be accessed by IRB-authorized research study personnel. Only authorized research study personnel will 
have permission to examine computer records to identify which patients are eligible to approach. Analysis of 
data will be performed at The Ohio State University by the study PI and with assistance from Dr. Xu (OSU College 
of Medicine). Whereas no assurance can be made to an individual participant that he or she will personally 
benefit from such research, the experience should be beneficial. The risks compared to the potential benefits 
are minimal to the individual research participant and virtually nonexistent to others or society in general. More 
information about the risks and benefits are on pages 8-10.  
 
III. STUDY PROCEDURES 
1. WHAT WILL BE DONE 
The study’s overall goal is to recruit 70 older cancer survivors to examine the feasibility and preliminary efficacy 
of a 12-week online dietary and resistance training intervention to improve their physical function through 
increased protein consumption, healthy eating, and resistance training. 
 
2. HOW IT WILL BE DONE 
The E-PROOF intervention core content is from publicly available, pre-existing educational content provided by 
the NIA, NCI, American Cancer Society, American College of Sports Medicine (ACSM), and OSUCCC. The 
dietary core content includes: 1) recommended amount and sources of protein intake; 2) healthy eating as an 
OCS; 3) protein intake benefits; and 4) importance of maintaining physical function through diet. The resistance 
training intervention core content includes: 1) recommended frequency and resistance training exercises; 2) 
resistance training benefits; 3) different muscle groups; and 4) the importance of maintaining physical function 
through resistance training. Intervention participants will also have the option of attending Zoom®-based social 
hours (held at 7-8pm EST, 1 day/week, weeks 3, 6, 9) to share their thoughts and experiences with each other. 
Informed design was used for intervention development by reviewing relevant evidence; replicating prior 
successful intervention elements from the PI and co-Is and; incorporating feedback from the Cancer and Aging 
Research Group’s patient advocacy group (see Letter of Support).  
 
Randomization and Baseline Assessment: Subjects will be block randomized by the number of physical function 
limitations measured by the PFSS.40 At the in-person visits at baseline and end-of-study, study staff will measure 
the physical function (SPPB), muscle strength (handgrip, SPPB), height, weight, and waist circumference of all 
participants (intervention and control). The Research Electronic Data Capture (REDCap) secure platform41,42 will 
be used for baseline questionnaire data collection, which will assess dietary quality (DHQIII), self-reported 
exercise, HRQoL, self-efficacy, and demographic and clinical information. After data collection, the research 
assistant will show intervention participants how to access the REDCap-based logs and enter their weekly dietary 
intake and exercise adherence. At the end of the baseline visit, intervention participants will receive a binder with 
printed educational materials on increasing dietary protein, healthy eating, and resistance training to preserve or 
rebuild lean body mass as a reference tool. Resistance bands (three levels of Thera-bands®), and resistance 
band exercise guidelines (exercises by muscle group, proper form, how to rate difficulty) will be distributed to 
intervention participants.         
 
Intervention Participants. Participants randomized to the intervention group (n=35) will be paired after the 
baseline assessment with a RD and ES for the duration of the 12-week intervention (Figure 1). The diet and 
resistance training intervention will be tailored to each participant in the intervention group based on the 
information collected during their baseline visit. 
 
 

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Nutritional counseling:  Within 1 week of the baseline visit, a RD will review the DHQIII results and create a 
tailored dietary plan focusing on protein intake and healthy eating for each intervention participant. At weeks 1, 
3, 5, 7, 9, and 11, the RD will provide one-on-one, online (Zoom®, FaceTime®) nutritional counseling to the 
intervention participants. During the biweekly online 30-minute visits, the RD, guided by elements in behavior 
change theories, will review and check on their progress toward increased protein intake and healthy eating, use 
motivational interviewing strategies to support the participants’ progress, provide reinforcement, explore 
strategies to overcome barriers, field questions, and establish tailored goals. Counseling will consist of education 
to stimulate sufficient protein- and energy intake using regular food, based on the current American Cancer 
Society nutrition guidelines for cancer survivors43 and DGAs for protein and energy for adults aged ≥60 (5-6.5 
oz. eq/day based on 1,600-2,600 calories/day).44 Counseling of these protein targets will account for variability 
in body weight.45-47 Due to physiological limit of protein synthetic capacity, spread feeding of proteins over the 
day is preferred and participants will be advised to consume 25-30 grams of proteins per meal.18 After the 
counseling session for weeks 1, 5, and 9, the RD will email/mail participants menus, snack ideas, and recipes 
focused on protein and healthy eating. Participants will be encouraged to record their weekly dietary intake in 
their REDCap-based log to practice self-monitoring, provide motivation, and facilitate recall and reflection during 
nutritional counseling sessions. RDs will access these online entries to review participants’ protein and overall 
dietary intake and provide recommendations during counseling. 
 
Resistance training counseling: For the first 6 weeks, the ES will host weekly, one-on-one, 30-minute, online 
resistance training sessions for the intervention group, using a progression model.48 After week 6, the resistance 
training sessions will taper, and be held biweekly at weeks 8, 10, and 12. Based on behavior change models, at 
the beginning of all sessions, the ES will review progress toward increased resistance training, and support 
progress and strategies to overcome barriers through motivational interviewing. In each training session, the ES 
will provide education, then lead participants through a 5-minute warm-up, followed by a series of whole-body 
exercises (each major muscle group) performed at each session, and a 5-minute cool-down. The training is 
based on a co-I’s (Focht) expertise in exercise interventions,49-51 the ACSM exercise guidelines for cancer 
survivors,52 and ACSM recommendations for progressive resistance training for older adults53 consisting of 1-3 
sets of 8-10 exercises with 8-12 repetitions with a 1-2 min rest between sets. Participants will be encouraged to 
complete these exercises two more times/week, totaling three sessions/week, and record their weekly resistance 
trainings in the REDCap platform (same weekly log as dietary intake). The diary will ask participants if they 
exercised (yes/no), type of exercise (i.e., resistance training, walking), intensity (mild/moderate/strenuous) and 
the time spent exercising for each day of the week. Diaries will be used by the ES to assess exercise adherence 
and to progress the exercise program during training sessions. Participants will be encouraged to refer to their 
educational materials for guidance between synchronous resistance training sessions. 
 
Enhanced Control Participants. Participants randomized to the enhanced control group (n=35) will not receive 
online nutritional or resistance training education or counseling. Control participants will take part in three in-

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person assessments (baseline, end-of-study, 3-month follow-up) with study staff and receive printed materials 
(NCI’s “Facing Forward: Life After Cancer Treatment”) pertaining to general cancer survivorship. 
Follow-up. Three months after the 12-week intervention, all participants will return for an in-person assessment 
by study staff of physical function, muscle strength, and HRQoL. This information is essential to understanding 
the sustained impact of this intervention and trajectories of physical function among OCS.  
 
3. TIMELINE 
We will work with cancer clinic leadership, clinicians, and clinic staff to coordinate recruitment to ensure that 
clinic flow is not disrupted. The Clinical Research Coordinator, TBN, will serve as a central point of contact and 
will assist with these activities. Throughout the course of the study period, Dr. Krok-Schoen will hold regular staff 
meetings to discuss recruitment, and to address any issues that occur on a case-by-case and clinic-by-clinic 
basis. The Clinical Research Coordinator will directly supervise the day-to-day progress of all study activities. 
We estimate a large number (n~150) of potentially eligible patients on an average weekday at the OSUCCC, 
with a limiting factors being workforce, clinic flow, and participation rates. We anticipate that we can feasibly 
enroll an average of 2 patients per day over 9 months of recruitment and reach our recruitment goal of 70 
participants.  
 
Figure 2. Timeline and Work Plan 
 
Year 1 
Year 2 
Study Quarters (over 2 years) 
1 
2 
3 
4 
1 
2 
3 
4 
Participant Recruitment 
Recruitment of 70 older cancer survivors  
 
 
 
 
 
 
 
 
Aim 1: Determine Feasibility and Acceptability of Intervention 
Implementation of a 12-week online, tailored nutritional and 
resistance training counseling intervention 
 
 
 
 
 
 
 
 
Measurement of accrual, retention, and adherence rates 
 
 
 
 
 
 
 
 
Analysis of participant intervention evaluation 
 
 
 
 
 
 
 
 
Aim 2: Examine Efficacy of Intervention 
Measurement of physical function, muscle strength, and height, 
weight, and waist circumference at baseline and 12 weeks 
 
 
 
 
 
 
 
 
Measurement of diet quality, exercise, health-related quality of 
life, self-efficacy, and demographic and clinical information 
through REDCap-based questionnaires at baseline and 12 
weeks 
 
 
 
 
 
 
 
 
Analysis of change in physical function, muscle strength, and 
height, weight, and waist circumference from baseline to 12 
weeks 
 
 
 
 
 
 
 
 
Analysis of change in diet quality, exercise, health-related 
quality of life, self-efficacy, and demographic and clinical 
information from baseline to 12 weeks 
 
 
 
 
 
 
 
 
Examine Maintenance of Intervention 
Measurement of physical function, muscle strength, and 
health-related quality of life at 3-month follow-up 
 
 
 
 
 
 
 
 
Analysis of change baseline and end-of-study (6 months) in 
physical function, muscle strength, and health-related quality of 
life 
 
 
 
 
 
 
 
 
Integration and Dissemination Activities 
Project meetings, monitoring, and fidelity checks 
 
 
 
 
 
 
 
 
Prepare abstracts, manuscripts, and presentations 
 
 
 
 
 
 
 
 
Preparation and submission of next-step grant application 
 
 
 
 
 
 
 
 
 
DATA COLLECTION AND MANAGEMENT PROCESS 

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4. DATA TO BE COLLECTED 
We are collecting data using all validated measures. Our main outcome is physical function which will be 
measured by The physical performance assessment, Short Physical Performance Battery (SPPB)54, will 
measure physical function at baseline, end-of-study, and follow-up. The SPPB includes three lower extremity 
physical performance measures (standing balance, five consecutive chair rises, 4-meter gait walk at usual pace) 
to assess lower extremity strength. 
Secondary outcomes will be:  
• 
Acceptability. At end-of-study, intervention group participants will complete a 5-item, Likert-scale 
questionnaire, with written comments, regarding their preferences for receiving education and counseling, 
successes and challenges, program satisfaction, and suggestions for improvement.  
• 
Feasibility. Intervention feasibility will be measured by rates of accrual, retention, and adherence at baseline, 
end-of-study, and 3-month follow-up. Recruitment rate is based on Consolidated Standards of Reporting 
Trials criteria55 that includes eligible consented individuals and eligible non-consented individuals with non-
recruitment reasons documented. Process information (number/duration of video visits) will be recorded. 
• 
Muscle Strength. Handgrip strength will be measured at baseline, end-of-study, and follow-up in both hands 
using a hydraulic grip strength dynamometer (Jamar Model 7498).  
• 
Dietary Quality. Protein intake and dietary quality will be assessed at baseline and end-of-study by the 
National Cancer Institute’s DHQIII.56  
• 
Resistance exercise. Self-reported resistance exercise will be assessed using the revised version of 
The Godin-Shephard Leisure-Time Exercise Questionnaire (LTEQ) modified to specifically capture self-
reported resistance exercise participation. 
• 
HRQoL. RAND-36 Health Status Measure57 is comprised of 8 subscales assessing multiple aspects of 
HRQoL. Physical and mental component summaries are created. All scores range from 0-100, with 100 as 
the highest. 
• 
Self-efficacy. Baseline and end-of-study self-efficacy for diet and resistance training will be measured by: 
“How sure are you that you could do exercises to make your body stronger for 15 minutes, 3 days a week?” 
and “How sure are you that you could improve your diet?”  
• 
Self-regulation. Baseline and end-of-study self-regulation for diet and exercise will be measured by the 12-
item Dietary Self-Regulation Scale58 and the 12-item Exercise Self-Regulation Scale59.  
• 
Technology competency. The 8-item eHealth Literacy Scale (eHEALS)60 will measure knowledge, comfort, 
and perceived skills of engaging in eHealth at baseline and end-of-study. A 5-point Likert scale will be used. 
• 
Anthropometry. Body weight, height, and waist circumference will be collected at baseline and end-of-study. 
• 
Demographic and Clinical Information. Participants’ age, race, ethnicity, gender, education, income, marital 
status, insurance status, cancer diagnosis, stage at diagnosis, time since diagnosis, treatments received 
(e.g., chemotherapy, radiation) and comorbidities will be collected at baseline and updated at end-of-study. 
 
5. HOW THE DATA WILL BE COLLECTED OR ACCESSED 
Research materials will come from the following sources: Total Cancer Care registry data from the study site, 
and the Cancer Supportive Care Clinic, part of OSUCCC will be used for recruitment purposes. . Participants’ 
physical function (as measured by the SPPB), muscle strength (handgrip, SPPB), weight, height, and waist 
circumference will be collected at the in-person meetings (baseline and after the 12-week intervention). Online 
Research Electronic Data Capture (REDCap)-based questionnaires at baseline and end-of-study will collect 
assessing dietary quality (DHQIII), self-reported exercise (frequency/duration/intensity), health-related quality of 
life (RAND-36), and self-efficacy. Basic demographic (e.g., age, race, education) and health characteristics (e.g., 
comorbidities, stage of cancer at diagnosis, treatments received) will be collected through REDCap 
questionnaires. These questionnaires will be self-administered and a research assistant will be available to 
address any technological difficulties. Three months after the 12-week intervention, all participants will return for 
an in-person assessment of physical function (SPPB), muscle strength (handgrip, SPPB), and health-related 
quality of life (via REDCap questionnaire). 
 
6. DATA COLLECTION TIMELINE 

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This is a two-year study. Figure 2, on pages 6 and 7, illustrates the data collection timeline. Briefly, we will recruit 
70 participants in 9 months. After recruitment and consent, participants will begin their 12- week intervention. 
Data will be collected at baseline, end-of-study (12 weeks), and follow-up (3 months after the end of study). 
 
7. HOW THE DATA ARE STORED AND PROTECTED 
The proposed intervention utilizes an individualized approach and does not operate in group settings, therefore 
ensuring participants’ privacy. Confidentiality will be protected in several ways. All data points will be collated 
and stored on a REDCap database, a secure web application. Data will be used only in aggregate and no 
identifying characteristics of individuals will be published or presented. Confidentiality of data will be maintained 
by using research identification numbers that uniquely identify each individual. Safeguards will be established to 
ensure the security and privacy of participants' study records. The information collected from participants in this 
study has a low potential for abuse, since the data do not address sensitive issues. Nevertheless, appropriate 
measures will be taken to prevent unauthorized use of study information. All computer systems will be password-
protected against intrusion. All network-based communications of confidential information will be encrypted. Data 
other than demographic information do not use names as an identifier. The research number will be used. 
All paper files and computer files with the de-identified data will be stored under lock and key at all times. 
The files matching participants' names and demographic information with research numbers will be kept in a 
separate room and will be stored in a locked file that uses a different key from that of all other files. Only study 
personnel will have access to these files, and they will be asked to sign a document that they agree to maintain 
the confidentiality of the information. After the study is completed, local data will be stored with other completed 
research studies in a secured storage vault. 
 
8. WILL DATA BE SENT OUTSIDE OF OSU FOR ANALYSIS? 
No. 
 
IV. HUMAN SUBJECTS INFORMATION 
1. POTENTIAL RISKS 
An adverse event or experience is defined as any health-related unfavorable or unintended medical occurrence 
that happens during the process of screening or after randomization. Non-serious adverse events are defined 
as conditions that may be unpleasant and bothersome to the participant, such as sore muscles, that do not 
require discontinuing the study intervention or terminating components of the intervention. These do not require 
reporting. Finally, serious adverse events are defined as events that may be harmful to the participant and/or 
may be serious enough to warrant either temporary or permanent discontinuation of the study intervention, either 
because they are intolerable or because they are judged to be potentially harmful. All serious adverse events 
require immediate reporting and an assessment of the implications for the continuation of the study and/or 
modification of the consent form.  
Unexpected adverse events are defined as events that are not listed above potential events and are not 
listed in the consent form. Monitoring for unexpected serious adverse events attributable to the intervention is 
the responsibility of the study project manager who is trained and has experience in monitoring and reporting 
events. The project manager will inform the PI of any events. Specific reporting and review requirements are 
defined for unexpected events, so that, if an unexpected event is found to be related to the intervention, the 
protocol and consent can be modified. 
On-site adverse events are defined as events that occur at a research study site. Events that require 
immediate notification of the study PI (Dr. Krok-Schoen) and senior medical oncologist (Dr. Rosko) and 24-hour 
notification of the IRB include: (1) deaths, and (2) health events at that result in immediate hospitalization or 
medical care. These events are also immediately reported to the rest of the study team, the Data and Safety 
Monitoring Board, and the NIH. 
We anticipate that this study will entail minimal physical and psychological risks for study participants.  
There is a small risk to participants of sustaining an injury while participating in the intervention. However, 
physical injury is not anticipated and the trained, certified exercise scientist will provide guidance on how to 
participate in resistance training, safely and effectively. Participant risk may also include, but not anticipated, 
psychological distress associated with completion of the online questionnaires. If this occurs, study staff will 
speak to the participant about the difficulties that the questionnaires have caused and will offer a referral to a 

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mental health professional if necessary. Lastly, we are proposing a synchronous online intervention design to 
reduce psychological distress and assist with the maintenance of health behaviors among participants. 
Potential risks for the registered dietitian and exercise scientist will be minimal. Minor risk, but not 
anticipated, may include psychological distress associated with potentially negative experiences and feedback 
from participants (i.e., hard to motivate individuals, reported distressing symptoms). These professionals are 
from an established programs, experienced in providing guidance and counseling online, and will receive training 
prior to interacting with the study population.  
 
2. PROTECTIONS AGAINST RISK 
Lifestyle interventions that are personalized to individual functional capacity and activity tolerance have 
been well-established to be safe for older cancer survivors. As a research group, we have the experience and 
expertise to ensure the safety of participants and minimize aforementioned risk. There will be an educational 
session for the registered dietitian and exercise scientist on the unique needs and challenges of older cancer 
survivors prior to the intervention. The content will be taught by members of the research team, gerontologist 
(Dr. Krok-Schoen), registered dietitian (Dr. Spees), and an exercise scientist (Dr. Focht), will host a 
comprehensive training session for the registered dietitian and exercise scientist about the unique needs, goals, 
and contextual factors of older cancer survivors. This training will detail their duties within this intervention 
including: discussing the core educational elements (provided within the study binders), ensuring the 
appropriateness of the registered dietitians and exercise scientist’s guidance and counseling, recommendations, 
informing them of potential reported barriers to improving dietary quality and resistance training, encourage 
tailored messaging for older cancer survivors, recording process data (e.g., number of visits, adherence to 
protocol) within the REDCap platform, accessing the REDCap-based exercise/dietary logs of the intervention 
participants, and ensuring the safety of participants. In addition, Dr. Spees and Dr. Focht, will be the primary 
contacts for the registered dietitian and exercise scientist, respectively, if any concerns arise about the safety of 
participants. The registered dietitian and exercise scientist will also be encouraged to communicate any 
challenges or difficulties to the PI and/or during the regular meetings with the study team. 
As in similar prior lifestyle intervention trials conducted by the study team members, we will obtain a 
release form from each participant’s primary care physician for involvement in the study. We will ask the primary 
care physicians to complete a form related to the inclusion and exclusion health conditions—yes/no. If an activity-
related injury or illness does occur, the PI (Dr. Krok-Schoen), the co-I (Dr. Focht), who is an exercise scientist, 
and study member (Dr. Rosko), who is a senior oncologist, will be consulted according to the type of symptom 
reported. In some instances, it may be appropriate to reduce the participant’s resistance training goals. If the 
injury or symptoms do not resolve after an appropriate period of time, the participant will be referred to her 
primary care provider for further evaluation. The participant will be encouraged to follow the primary care 
provider’s instructions. 
After the baseline assessment, participants will be provided (on paper and via email) a weblink to access 
their REDCap-based weekly logs. The research assistant will provide a demonstration on how to access the 
REDCap-based logs and enter their weekly dietary intake and exercise adherence. Intervention participants will 
be advised to contact the research assistant in the event of technical difficulties. Weekly REDCap-based logs of 
the intervention participant’s dietary intake and exercise adherence will offer the registered dietitian and exercise 
scientist as well as study team insight into their goal progression. These logs will provide an additional method 
to monitor potential participant difficulties, which the study team will address, therefore, reducing participant risk. 
All study members are trained in methods to reduce risks. All study materials and information will be kept on 
the OSU Medical Centers’ secure computer network that is behind a firewall and password-protected. 
Specifically, the data will be housed within The Center for Biostatistics at OSU. At the dissemination phase, the 
data will be shared and housed within OSUWMC Information Technology Department, Biomedical Informatics 
program, an extensive research-oriented virtual server and storage area network facility. The Biomedical 
Informatics program also aligns with and leverages the enterprise support model offered by OSUWMC IT 
including a support desk and a dedicated security and risk assessment team. Any transfer of the data will be 
behind an internal, password-protected firewall. All applications and processes that use patient information are 
governed by HIPAA in the course of daily operations. The study will follow all existing procedures for protecting 
confidentiality and anonymity. 
 
3. BENEFITS 

12 
 
For the older cancer survivors participating the intervention, they may receive benefit from their 
participation in terms of improving their physical function (primary study outcome), learning new resistance 
training techniques, trying new healthy foods and recipes, deepening their personal health and nutrition 
knowledge, and improving their physical and mental health outcomes. Participation may result in increased 
knowledge of personal health risks, ways to improve physical function, how to be active safely and effectively as 
an older cancer survivor, how to overcome barriers to improve dietary quality and resistance training, and 
increased self-efficacy to work toward their health goals. This knowledge can motivate them to continue these 
healthy behaviors to support their life as an older adult with a history of cancer. Participants may also gain a 
better understanding of technology used in this study including Zoom®, FaceTime®, and REDCap. In addition, 
participants may feel a sense of rapport and support with the registered dietitian and exercise scientist. The 
participants, registered dietitian, and exercise scientist may experience pride in knowing that they are 
contributing to research to improve the health and well-being of cancer survivors. The low level of risk associated 
with this study is overshadowed by the potential benefits. We believe that the aforementioned risks of this study 
are minimal and reasonable, when compared to: 1) the scientific knowledge to be gained by performing these 
studies and; 2) the potential benefits to study subjects. 
For others outside this research study, results from this study will provide vital information about 
improving physical function and associated health outcomes among OCS. It will significantly contribute to the 
understanding of retention, adherence, and efficacy of diet and resistance training interventions among OCS as 
well as older adults. This study also will provide information about the acceptability and feasibility of technology-
based intervention among older cancer survivors, a population who are often excluded from technology-based 
interventions. Thus, the multiple anticipated benefits to the subjects and others outweigh the minimal risks for 
participants.  
 
4. STUDY TERMINATION PROCEDURES 
Participants will be informed that they can stop participating at any time with no penalties to them. If participants 
decide to stop being in the study, their surveys will be deleted from the REDCap system. However, if participants 
only choose to answer certain questions without explicitly stating a desire to no longer participate, survey data 
for those answered questions will be stored.  
 
V. STATISTICAL METHODS 
1. SAMPLE SIZE AND JUSTIFICATION 
A pilot randomized controlled trial with 70 OCS (n=35 for intervention arm; n=35 for control arm) is the most 
efficient design to accomplish the aims of this pilot study.61-63 For this study, the minimum sample size is 
calculated using G*Power. Specifying alpha level to be 0.05 (one-sided), expected power to be 0.80, and an 
expected effect size of 0.50 for the primary outcome (physical function measured by SPPB), the sample size 
required is 27 per group. Effect size estimates are based on recommendations for clinically meaningful 
differences for the SPPB64,65 and previous pilot randomized controlled trials utilizing the SPBB reporting effect 
sizes of similar magnitude.66,67 Similar designed pilot randomized controlled trials38,68-70 used comparable sample 
sizes to demonstrate acceptability and feasibility.   
 
 
 
2. DATA ANALYSIS PLAN 
Aim 1: The feasibility of implementing a 12-week online diet and resistance training intervention with OCS will 
be determined by the study accrual rate, retention rate, and adherence rate. The study accrual rate will be 
calculated by dividing the number of potential participants that passed screening by the total number of 
participants started in the study after appropriate informed consent procedures. The recruitment goal is set at 70 
participants recruited over a 9-month period. Retention rate will be calculated by dividing the total number of 
participants initiated by total number of participants in the study at baseline and 12 weeks (end-of-study). 
Retention goal for this trial is 80%. If 80% (56/70) of participants are retained at end-of-study, the retention goal 
for this trial will be achieved. Previous studies by the study team had similar recruitment and retention rates of 
older participants.71-73 We are confident in our ability to recruit and retain the study participants necessary to 
conduct the proposed study. Participants will be determined to be adherent if they attend ≥80% of the intervention 
sessions (in-person meetings with study staff and online intervention sessions).71,74,75 Overall adherence and 

13 
 
retention rates and associated 95% confidence intervals will be reported at baseline, end-of-study, and 3-month 
follow-up. 
 
Aim 2: The primary outcome of the SPPB will be assessed at three time points: baseline, end-of-study, and 3-
month follow-up. Efficacy will be based on 12 weeks. The SPPB score is a continuous variable, collected as 
the total score ranging from 0-12. Group differences in SPPB scores over the time will be tested using repeated 
measures ANOVA (SAS PROC MIXED). Using the planned contrasts command, we will investigate the 
changes in SPPB scores within each group, and between the intervention and control groups at end-of-study. 
Descriptive statistics and frequency distributions will be used to characterize the sample. To examine the effect 
of the intervention on the changes in physical function, a linear mixed effect model will be adopted using SAS 
PROC MIXED procedure. The intervention group (intervention vs. control) and time points (baseline, end-of-
study, 3-month follow-up) serve as the categorical predictors, together with the intervention*time interaction term. 
A significant intervention*time interaction effect would indicate a differential change pattern over the time 
between the groups. Using post-hoc contrasts, we will compare group differences in all collected variables at 
each time point. Using planned contrasts command, we will investigate for each group the change from baseline 
to end-of-study, from end-of-study to 3-month follow-up, and from baseline to 3-month follow-up to capture the 
change patterns over the phases and Bonferroni correction will be applied. Preliminary effect sizes will be 
generated to inform future trials. A Shapiro-Wilk test, skewness, kurtosis, and Q-Q plots will be used to assess 
normality of survivor baseline and end-of-study outcomes. Based on normality tests, change in participant 
outcome measures from baseline to end-of-study will be assessed using paired t-tests or Wilcoxon’s signed rank 
tests.76 Analysis will be carried out using intent-to-treat (all participants) and modified intent-to-treat (adherent 
participants only). All quantitative analyses will be performed using SAS version 9.4.  
 
 

14 
 
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