App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic Toxicity in Cancer Patients
Conditions: Cancer
Sponsor: Masonic Cancer Center, University of Minnesota

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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ANCILLARY REVIEWS 
DO NOT DELETE.  Submit the completed checklist below with your protocol. 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
X No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
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☐ No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☐ Yes 
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Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
See 
https://policy.umn.edu/research/indide  
      
Require Scientific Review? Not 
sure? See guidance in the 
Investigator Manual (HRP-
103).      
 
ONLY REQUIRED      BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
  
X Yes 
☐ No 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
☐ Yes 
X No 
Include the use of radiation? 
(x-ray imaging, 
radiopharmaceuticals, external 
beam or brachytherapy) 
 
Complete the AURPC Human Use 
Application and follow instructions on 
Approval 
from these 
committees 
must be 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
received 
prior to IRB 
approval;  
 
These 
groups 
each have 
their own 
application 
process.  
☐ Yes 
X No 
Use the Center for Magnetic 
Resonance Research (CMRR) 
or MR at Masonic Institute for 
the Developing Brain (MIDB) 
as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  
☐ Yes 
X No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☐ Yes 
X No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
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☐ No 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of this 
protocol. 
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X No 
Use data from CTSI Best 
Practices Integrated 
Informatics Core (BPIC) 
Formerly the AHC Information 
Exchange (AHC-IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: bpic@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
☐ Yes 
X No 
Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
STOP – Complete the Medical Template 
Protocol (HRP-590)  
 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: Jenny Pham 
Pham0435@umn.edu 
X Yes 
☐ No 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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X Yes 
☐ No 
Need to be registered on 
clinicaltrials.gov? 
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: fencl003@umn.edu  
may be 
required. 
 
X Yes 
☐ No 
Require registration in 
OnCore? 
If you select “No” or “I Don’t Know” in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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PROTOCOL COVER PAGE 
Protocol Title 
App-Assisted Day Reconstruction to Reduce Treatment Burden and 
Logistic Toxicity in Cancer Patients – Aim 1 
Principal 
Investigator/Faculty 
Advisor 
Name: Rachel I. Vogel 
Department: Obstetrics, Gynecology, and Women’s Health 
Telephone Number: 612-624-6928 
Email Address: isak0023@umn.edu 
Student Investigator 
Name: 
Current Academic Status (Student, Fellow, Resident): 
  
Department: 
Telephone Number: 
Institutional Email Address: 
Scientific Assessment 
Nationally-based, federal funding organizations 
Version 
Number/Date: 
4.0, 01/05/2023 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 
07/27/2022 
Clarify that study team may screen 
participants in the clinic and that 
participants may complete consent in-
person as well (in addition to 
electronic consent). 
N 
2 
08/09/2022 
Remove Aims 2 and 3 from this 
protocol as those will be submitted to 
a commercial IRB separately due to 
conflict of interest concerns for those 
aims; this will be led by Daynamica 
N 
3 
09/06/2022 
Increase number to be consented 
from 20 to 30, goal remains the same 
to obtain interviews from 20 
participants.  
N 
4 
01/05/2023 
Allow for follow-up survey to be 
completed online (original plan) or 
paper (new) 
N 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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Table of Contents 
1.0 
Objectives ......................................................................................................................................... 8 
2.0 
Background ....................................................................................................................................... 8 
3.0 
Study Endpoints/Events/Outcomes .......................................................................................... 10 
4.0 
Study Intervention(s)/Interaction(s) ......................................................................................... 10 
5.0 
Procedures Involved ..................................................................................................................... 10 
6.0 
Data Banking ................................................................................................................................. 11 
7.0 
Sharing of Results with Participants ......................................................................................... 11 
8.0 
Study Duration .............................................................................................................................. 11 
9.0 
Study Population .......................................................................................................................... 11 
10.0 
Vulnerable Populations ............................................................................................................... 12 
11.0 
Number of Participants ............................................................................................................... 14 
12.0 
Recruitment Methods .................................................................................................................. 14 
13.0 
Withdrawal of Participants ........................................................................................................ 14 
14.0 
Risks to Participants ..................................................................................................................... 15 
15.0 
Incomplete Disclosure or Deception .......................................................................................... 15 
16.0 
Potential Benefits to Participants .............................................................................................. 15 
17.0 
Statistical Considerations ............................................................................................................ 15 
18.0 
Health Information and Privacy Compliance ........................................................................... 16 
19.0 
Confidentiality ............................................................................................................................... 19 
20.0 
Provisions to Monitor the Data to Ensure the Safety of Participants ................................. 20 
21.0 
Compensation for Research-Related Injury ............................................................................. 20 
22.0 
Consent Process ............................................................................................................................ 20 
23.0 
Setting ............................................................................................................................................ 21 
24.0 
Multi-Site Research ...................................................................................................................... 21 
25.0 
Coordinating Center Research.................................................................................................... 21 
26.0 
Resources Available ..................................................................................................................... 21 
27.0 
References ..................................................................................................................................... 26 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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ABBREVIATIONS/DEFINITIONS 
AUC 
Area under the curve 
EHR 
Electronic Health Record 
CAB 
Community Advisory Board 
MARS Mobility App Rating Scale 
PETS 
Patient Experience with Treatment and Self-Management 
POI 
Point of interest 
TBQ 
Treatment Burden Questionnaire 
 
 
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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1.0 
Objectives 
1.1 Purpose: The number of new cases of cancer diagnosed in the U.S. was 1.7 million in 
2017 and is expected to increase by 35% to 2.3 million in 2030[1]. Cancer treatments 
often create numerous logistic challenges in prioritizing and managing treatment 
and everyday life priorities and how these challenges affect their everyday lives and 
well-being (hence “logistic toxicity”). However, there are no established reliable 
tools to monitor patients’ logistic challenges and the associated impacts; and logistic 
toxicity has been largely unaddressed in cancer care delivery. Our objective is to 
develop the first digital health app for cancer patients to continuously monitor 
logistic toxicity in their daily lives. The app will combine objective data from mobile 
sensing with subjective self-reported data to form an app-assisted day 
reconstruction system that captures activity engagement and well-being information 
associated with cancer treatment-related activities and trips throughout the day.  
The proposed patient monitoring app that captures logistic toxicity information on 
an ongoing basis will empower patients to advocate for care that better fits their 
life, give providers new insights into potential reasons for treatment non-adherence 
and nonresponse, and allow health systems to design more patient-centered care 
regimens. 
We will use a participatory design approach to inform the design of our system, 
engaging an 8-member community advisory board (CAB; including 2 patients, 2 
oncologists, 1 nurse, 1 patient advocate, 1 payer, and 1 hospital administrator), and 
performing in-depth interviews and follow-up surveys with 20 diverse patients 
undergoing treatment for cancer. Patients will supply examples of logistic toxicity 
and how they would like to measure and communicate logistic toxicity across 
scenarios. Follow-up surveys will ask participants to provide satisfaction ratings 
towards user interface sketches and app function narratives.  
2.0 
Background 
2.1 Significance of Research Question/Purpose: Symptom burden and financial toxicity 
have been widely acknowledged side-effects of cancer, but logistic toxicity—the 
toxic effects of the logistic burden of carrying out cancer treatment tasks on patient 
well-being  - has only recently received any attention.[2-7] Sources of logistic toxicity 
include scheduling and attending appointments, engagement with different care 
providers, pharmacy visits, consultations, insurance paperwork, managing drugs, 
transportation, and wait times. The well-being effects of these burdens can be 
biographical (loss of freedom, independence, and time availability to engage in 
meaningful activities), relational (strained family and social relations), and emotional 
(feelings of anger, anxiety, frustration, worry, and guilt).[8] 
Logistical challenges in treatment burden can lead to poor treatment adherence, 
low quality of life, and worsening of disease; and it negatively affects family and 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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friends, employers, and healthcare payers and providers.[9-15] Further, burdens of 
cancer and cancer treatments disproportionately affect disadvantaged patients such 
as racial and ethnic minorities, and hence logistic toxicity is likely to reinforce 
persistent inequities in cancer care and outcomes.[16-19]  
The cancer care landscape has rapidly evolved to accommodate COVID-19 
precautions, transitioning toward telehealth, greater emphasis on patient self-
management, and opportunities for providers to tailor treatment plans. Oncology 
clinical practices can potentially adopt interventions such as minimally disruptive 
medicine, care coordination, and telemedicine that could reduce logistic toxicity in 
cancer care delivery.[20, 21] However, implementing these interventions requires 
tools that can reliably track patients’ behavior and well-being in navigating the day-
to-day logistic burden of undertaking cancer treatment tasks. 
2.2 Preliminary Data: The concept of logistic toxicity in cancer care is similar to the 
concepts described in treatment burden in chronic disease management, Burden of 
Treatment Theory, and the Cumulative Complexity Model.[22, 23] Within these 
frameworks, instruments such as the Treatment Burden Questionnaire (TBQ) and 
the Patient Experience with Treatment and Self-management (PETS) have been 
developed to collect self-reported, recall-based data on treatment burden.[24, 25] 
Building upon this prior research, effective monitoring of logistic toxicity needs to 
capture the objective treatment workload (i.e., activities and trips carried out by 
the patient for treatment purposes) as well as the subjective effects of that 
workload on well-being (i.e., including biographical, relational, and emotional 
effects).[3-7] Objective measures of logistic toxicity to date have relied on electronic 
health records (EHR) and claims data, which cover medical and pharmacy visits only 
and offer limited information on other important sources of logistic toxicity such as 
scheduling time, transportation, and wait time. Subjective measures to date are 
research-oriented retrospective measurements that are not timely enough to inform 
or help the patient. 
(1) Our app will offer a remote patient monitoring platform to capture logistic 
toxicity information on a timely and ongoing basis; 2) it will apply machine learning 
techniques to automatically infer cancer treatment-related activities and trips as a 
way to minimize the need for manual input, and 3) it will integrate objective mobile 
sensing with subjective patient input to generate more accurate and complete 
summaries of logistic toxicity.  
On this project, we will collaborate with Daynamica Inc. In 2013-2015, Daynamica 
developed an app-assisted day reconstruction system that integrates smartphone 
sensing and surveying capabilities capturing spatiotemporal and other details of 
daily activities and trips, leading to a US Patent titled “Travel and Activity 
Capturing”.[26-27] The system was later augmented with experience sampling 
capabilities to capture well-being during the day. Since then, the Daynamica app has 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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been deployed in a wide range of research studies across the U.S. to collect daily 
activity engagement and well-being data, and Daynamica developed a HIPAA-
compliant version of the app that is currently being trialed in two medical research 
studies at the University of Minnesota, including “Using smartphone sensor 
technology to characterize ambulatory patterns of patients with peripheral artery 
disease receiving supervised exercise training”, and “Implementing Personalized 
Exercise Prescriptions through Mobile Health in Rural Elderly Cancer Survivors”.[27-
30]  
2.3 Existing Literature:  The relevant literature is cited in sections 2.1 and 2.2 above. 
There is an urgent need for a tool that generates accurate, comprehensive, and 
timely measures of logistic toxicity.  
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: 
Interviews: Identify themes to develop 1) a cancer-specific, multi-tiered activity/trip 
classification system to organize cancer treatment-related activities and trips in the 
app; and 2) user stories to describe what the users want to do with the proposed 
app. 
Follow-up survey: Overall satisfaction with proposed system design will be measured 
using a 5-point Likert scale from not at all satisfied to very satisfied. The primary 
endpoint will be the proportion of participants who report an overall satisfaction 
score of 4.0 or above. 
4.0 
Study Intervention(s)/Interaction(s) 
4.1 Description: 20 individuals with cancer will be asked to complete 45-minute 
interviews for input on features that the app should include. 
5.0 
Procedures Involved 
5.1 Study Design:  Qualitative interviews with follow-up surveys.  
5.2 Study Procedures:  
CAB: All aspects of the proposed work will be conducted with input from a CAB to be 
led by Drs. Vogel and Blaes. In quarterly and ad hoc virtual meetings, the CAB will 
assist in finalizing strategies for major project tasks. CAB engagement will focus on 
determining the preliminary format and contents of the app-generated logistic 
toxicity summary reports. To enable patients to solicit help from the cancer care 
system, the summary reports need to be meaningful and digestible to all CAB 
members.  
Patient interviews: We will perform 45-minute interviews via phone or Zoom 
among 20 English-speaking individuals >18 years old who are currently receiving 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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treatment for cancer. After recruitment and obtaining informed consent, an 
interviewer trained by Drs. Vogel and Fan will use a semi-structured guide including 
open-ended questions. Following review by the research team and CAB, the 
interview guide will be assessed after the first five interviews for any necessary 
changes. If significant edits are made, those interviews will be treated as pilot data 
and left out of the analysis. Interviews will be digitally recorded and transcribed 
verbatim.  
After the system design, the 20 interview participants will be sent a follow-up survey 
(approximately 15 minutes) online via REDCap or paper via mail to review the user 
interface sketches and app function narratives. Participants will be asked to provide 
open-ended feedback as well as their satisfaction ratings with each user interface 
sketch and app function narrative using a 5-point Likert scale from not at all satisfied 
to very satisfied. For each participant, the satisfaction ratings will be averaged to 
derive an overall satisfaction score.  
5.3 Follow-Up: Survey data will be collected.  
5.4 
Individually Identifiable Health Information: We will obtain written HIPAA 
agreement from participants and authorization to communicate via email if that is 
the participant’s preference.  
6.0 
Data Banking  N/A 
7.0 
Sharing of Results with Participants 
7.1 We will not share results with participants.  
8.0 
Study Duration 
8.1 Individual participants will participate for approximately 2 hours over a 5 month 
time frame.  
We will enroll all participants within 6 months and anticipate all study procedures 
and data analysis will be completed within 24 months.  
9.0 
Study Population 
9.1 
Inclusion Criteria:  
≥18 years of age, currently receiving treatment for cancer, able to 
read/write/speak in English, and able to provide voluntary informed consent. 
9.2 Exclusion criteria: Those who are currently incarcerated or have opted out of 
research contact within M Health Fairview system. 
9.3 Screening: Participants will confirm their eligibility criteria via screening in-person, 
online (REDCap) or phone call with study coordinator.  
 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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10.0 Vulnerable Populations 
10.1 
Vulnerable Populations:  
 
Population / Group 
Identify whether any of the 
following populations will be 
primary focus of the research 
(targeted), included but not the 
focus of the research or excluded 
from participation in the study.  
Children 
Excluded 
Pregnant women/fetuses/neonates 
included but not the focus 
Prisoners 
Excluded 
Adults lacking capacity to consent 
and/or adults with diminished 
capacity to consent, including, but 
not limited to, those with acute 
medical conditions, psychiatric 
disorders, neurologic disorders, 
developmental disorders, and 
behavioral disorders 
Excluded 
Non-English speakers 
Excluded 
Those unable to read (illiterate) 
Excluded 
Employees of the researcher 
Excluded 
Students of the researcher 
Excluded 
Undervalued or disenfranchised 
social group 
included but not the focus 

SOCIAL PROTOCOL (HRP-580) 
PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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Active members of the military 
(service members), DoD personnel 
(including civilian employees) 
included but not the focus 
Individual or group that is 
approached for participation in 
research during a stressful situation 
such as emergency room setting, 
childbirth (labor), etc. 
Excluded 
Individual or group that is 
disadvantaged in the distribution of 
social goods and services such as 
income, housing, or healthcare. 
included but not the focus 
Individual or group with a serious 
health condition for which there are 
no satisfactory standard treatments. 
included but not the focus 
Individual or group with a fear of 
negative consequences for not 
participating in the research (e.g. 
institutionalization, deportation, 
disclosure of stigmatizing behavior). 
included but not the focus 
Any other circumstance/dynamic 
that could increase vulnerability to 
coercion or exploitation that might 
influence consent to research or 
decision to continue in research. 
Excluded 
 
10.2 
Additional Safeguards:  
All participants will have had a cancer diagnosis, which is a serious health 
condition. This study specifically aims to understand the time burdens of cancer 
care.  
The proposed research will not specifically seek military members or DOD 
personnel, disadvantaged individuals or members of undervalued or 
disenfranchised social groups, however, if volunteers meets the inclusion criteria 

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PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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and also happen to be from one of the groups checked above, they will be eligible 
to participate in the study.  
11.0 Number of Participants 
11.1 Number of Participants to be Consented: up to 30, 20 participants to complete 
interviews 
12.0 Recruitment Methods 
12.1 Recruitment Process: 
CAB: CAB members will be recruited by study team members directly via phone calls 
and emails. This will not involve recruitment of MHealth Fairview patients. 
Cancer Patients: Dr. Blaes and study staff will identify potentially eligible participants 
in the clinic and/or through BPIC, who will review the electronic medical records of 
patients at MHealth Fairview using inclusion criteria. Patients who have opted out of 
research, including being approached for new studies, will not be contacted or 
approached. Potential participants will be approached in the clinic before or after a 
scheduled appointment and/or via MyChart using Fairview Research Services. 
Research activities will not impact or interfere with patient’s appointment times or 
clinical care. They will be given time to whether they would like to participate and 
provided information to contacting the study coordinator at a later time/date if they 
want to consider further.  
12.2 Source of Participants: MHealth Fairview cancer clinics  
12.3 Identification of Potential Participants: M Health Fairview medical records will be 
queried by BPIC to identify eligible individuals who have been diagnosed and treated 
for cancer within the past two years and who have not opted out of research. 
12.4 Recruitment Materials:  Mail recruitment documents for Aims 1 are provided. 
12.5 
Payment:  
Each CAB member will be compensated $500 for their 12-month project 
participation. 
Interview participants will receive a $50 gift card upon completion of the 
interview.  Participants will receive an additional $20 gift card for survey 
completion after evaluating the initial app design draft. 
13.0 Withdrawal of Participants 
13.1 Withdrawal Circumstances: No participant will be withdrawn from the study against 
their will. Participants will only be withdrawn from the study if they ask to withdraw 
or become too ill or die prior to completing the study.  If participants become too ill, 

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Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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they will not be withdrawn from the study until they have given their voluntary 
consent for study withdrawal. 
13.2 Withdrawal Procedures: If a participant chooses to withdraw at any point, their 
decisions will be respected without repercussions. Data collected until the point of 
withdrawal will be used unless the participant specifies otherwise.  
13.3 Termination Procedures: Participants will not be terminated for any reason.  
14.0 Risks to Participants 
14.1 Foreseeable Risks: This study carries minimal risk and will comply with the University 
of Minnesota IRB reporting requirements.  We identified the following 2 possible 
risks to subjects:  
Risk to confidentiality:  Inadvertent breaches of confidentiality by investigators or 
their staff are unlikely but may occur.  Identifying information will be kept private 
and all identifiers will be removed prior to any data being given to researchers. The 
records will be identified only with a unique ID number on an encrypted database. 
Data transfer will only occur with de-identified data with encrypted transfer of all 
information containing protected health information between participants and 
study databases.  
Discomfort while answering interview or survey questions: There is a possibility that 
some participants may feel uncomfortable answering interview or survey questions 
which may remind them of their cancer diagnosis. They will be reminded that they 
can skip any questions or discontinue at any time.  
14.2 Reproduction Risks: N/A 
14.3 Risks to Others: N/A 
15.0 Incomplete Disclosure or Deception  
15.1 Incomplete Disclosure or Deception: N/A  
16.0 Potential Benefits to Participants 
16.1 Potential Benefits: There are likely no direct benefits to individual participants.   
17.0 Statistical Considerations 
17.1 Data Analysis Plan:  
Evaluating the interviews: Two coders will read the patient interview transcripts and 
identify themes grounded in the transcripts by using a computer-assisted qualitative 
data analysis system (NVivo) and applying the grounded theory approach and 
constant comparative method. Major categories in the classification system will be 
broad enough to remain relevant across contextual examples of logistic toxicity. 
Each major category will include subcategories to cluster specific activity examples. 

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PROTOCOL TITLE: App-Assisted Day Reconstruction to Reduce Treatment Burden and Logistic 
Toxicity in Cancer Patients – Aim 1 
VERSION DATE: 01/05/2023 
 
 
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The patient interview data will also be used to develop user stories, an approach 
that is widely used in agile software development to identify key app requirements 
and provide good business cases for these requirements.  Based on the interview 
findings, we will develop user interface sketches and app function narratives using 
established usability guidelines to illustrate functionality and appearance of the app. 
Surveys will be scored using standard methods. Mean scores and score distributions 
will be evaluated. 
17.2 Power Analysis:  
A sample size of 20 participants will allow us to estimate the overall satisfaction rate 
with a margin of error of ±18%. 
17.3 Statistical Analysis: N/A 
17.4 Data Integrity: Data integrity and completeness will be monitored on an ongoing 
basis by the study coordinator and statistician, using both the reporting tools 
provided by REDCap and the study/data management dashboard provided by 
Daynamica.  
18.0 Health Information and Privacy Compliance 
18.1 Select which of the following is applicable to your research: 
☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
X I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 
 
18.2 Identify the source of Private Health Information you will be using for your research 
(Check all that apply)   

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X I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
X I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
☐ Other.  Describe:  
18.3 Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed.  
We will obtain information about potentially eligible patients through BPIC which  
will filter out patients who do not agree to have their records used for research.  
18.4 
Approximate number of records required for review: 3000 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 
☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
X Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants.  
Communication with participants will occur through phone calls and email 
based on participant preference for scheduling appointments and by email 
through REDCap or mail for survey completion. We will ask participants to 
complete an authorization to receive unsecured emails from study staff if they 
prefer that mode of contact.  

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18.6 
Access to participants 
Participants will complete consent and HIPAA forms prior to any data collection. 
After they agree to participate, all data will be provided by the participants.  
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
X In the data shelter of the Information Exchange (IE)  
 X Store 
X Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
X In REDCap (recap.ahc.umn.edu)  
 X Store 
☐ Analyze 
X Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
X In the University’s Box Secure Storage (box.umn.edu) 
 ☐ Store 
☐ Analyze 
X Share 
X In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact: 
\\cancer.ahc.umn.edu\cancer\CancerCenter\Biostat\CCSG\Vogel, RI\ 
Daynamica_STTR\data 
 X Store 
X Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 
 ☐ Store 
☐ Analyze 
☐ Share 

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☐  Other.  
Indicate if data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartphone (iPhone or Android devices) that you have not 
already identified in the preceding questions 
☐  I will use a server not previously listed to collect/download research data:  
 
     ☐ I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as a tablet or smartphone not previously listed 
18.8 Consultants. Vendors. Third Parties. N/A 
18.9 Links to identifiable data: When patients agreed to participate, they will be given a 
study ID which will be used for the remainder of the study. The identifying 
information will be stored in REDCap (survey data collection) with the study ID and 
all other data will be stored using this ID alone.     
18.10 Sharing of Data with Research Team Members. Data will be shared using Box and 
REDCap.  
18.11 Storage of Documents: Paper consent forms may be collected during in-person 
recruitment. Paper documents will be stored in a locked cabinet in the PI’s locked 
office. They will be stored up to 10 years. 
18.12 Disposal of Documents: Following publication and dissemination (up to 10 years 
post study initiation), all paper documents will be shredded and all identifying 
information in REDCap will be removed.  
19.0 Confidentiality 
19.1 Data Security: All study investigators and staff will be fully trained on data safety and 
participant confidentiality using appropriate CITI and University of Minnesota 
courses. An electronic copy of the signed consent form will be stored on an AHC-IS 
supported server.  The consent form and other research information will NOT be 
placed in the participants’ medical record. 
Electronic data will be entered by the study coordinator and will be stored on the 
secure REDCap database. Study data will be de-identified before data analysis. Only 
the researchers directly involved with the study will have access to the data. 
Identifying data will be stored until completion of the study and manuscript 
submission.   

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20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
20.1 Data Integrity Monitoring. The PI will review all signed consent forms for 
completeness at the time of participant entry into the study.   
Data collection will occur primarily using REDCap, which will be set up to ensure 
data are clean and ready for analysis.  Reports within REDCap will be used to identify 
missing data.  
20.2 Data Safety Monitoring. This study carries minimal risk and therefore the PI will 
assume responsibility for monitoring and reporting safety concerns/events to the 
University of Minnesota IRB.  Events requiring prompt reporting include any adverse 
event that requires a change to the protocol or consent form, any unauthorized 
disclosure of confidential information, any unresolved subject complaint or any 
protocol deviation that resulting in harm or the unanticipated death of an enrolled 
subject.    
21.0 Compensation for Research-Related Injury 
21.1 Compensation for Research-Related Injury: N/A 
21.2 Contract Language: N/A 
22.0 Consent Process 
22.1 Consent Process (when consent will be obtained): In-person paper or electronic 
consent will be obtained for participants. Individuals who consent in-person will be 
provided with a copy of the signed documents. Online consents and HIPAA forms 
will obtain signatures captured electronically via the e-consent functionality in 
REDCap. At the bottom of the e-consent participants are asked whether they wish to 
receive signed copies or opt out of receiving them. Those wishing to receive them 
will provide their mailing address to receive paper copies through the USPS mail. 
Additionally, participants will also have the option to download signed copies of 
these documents to their own computer or electronic device directly from REDCap.  
Paper consent forms will be stored in a locked cabinet in a locked office. Electronic 
signatures will be stored within REDCap as well as a copy on the Academic Health 
Center (AHC) secure servers. Access to these records will be limited to the study 
team as needed or required. 
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception): N/A 
22.3 Waiver of Written/Signed Documentation of Consent (when written/signed consent 
will not be obtained): N/A  
22.4 Non-English Speaking Participants: N/A 

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22.5 Participants Who Are Not Yet Adults (infants, children, teenagers under 18 years of 
age): N/A 
22.6 Cognitively Impaired Adults, or adults with fluctuating or diminished capacity to 
consent: N/A 
22.7 Adults Unable to Consent: N/A 
 
23.0 Setting 
23.1 Research Sites: All study procedures will be conducted remotely or on the University 
of Minnesota campus. Participants will be recruited through the MHealth Fairview 
network.  
23.2 International Research: N/A  
● 
Community Based Participatory Research: N/A 
24.0 Multi-Site Research N/A 
25.0 Coordinating Center Research N/A 
26.0 Resources Available 
26.1 Resources Available: 
Research team and Funding 
All investigators are committed to this project and will provide appropriate effort as 
needed. This study will be supported by an NIH STTR grant to Daynamica, with Dr. Vogel 
as a subcontract PI for the University of Minnesota. Dr. Vogel will have appropriate 
dedicated time to oversee and conduct the research described.   
All members of the study team have reviewed and approved the protocol and study 
procedures. They have understood their duties and study roles, and provide the skills 
needed to conduct the study and study analyses. All members of the research team have 
relevant publication records. They have also completed appropriate trainings and these 
trainings will be revisited as appropriate, particularly for those involved directly with 
participants in the consent process and/or data collection 
Facilities 
The University of Minnesota is one of the state’s greatest assets. It is one of the most 
comprehensive universities in the United States and ranks among the most prestigious. 
The University, with more than 370 fields of study, offers more choices and unique 
opportunities for its 60,000 students. It is both the state land-grant university and 
Minnesota’s only research university, where new knowledge, new products, and new 
services improve the quality of life for all Minnesotans. Another major resource is the 

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University of Minnesota’s research activities. The University is one of the leading 
recipients of federal research awards. The University received more than $520 million in 
grant and contract awards from federal, state, and private sources in fiscal year 2010 and 
ranks in the top 10 of all public and private research universities. The University conducts 
98% of all sponsored academic research in Minnesota. Some of the many major resources 
at the University of Minnesota include an extensive library system. The University of 
Minnesota Libraries is one of the University's and the state's greatest intellectual and 
capital assets. Housed in 14 facilities on the three Twin Cities campuses, the University 
Libraries' collections contain 6.2 million print volumes, nearly 37,000 serial subscriptions, 
6.3 million microforms, 2.65 million government documents, and 423,000 maps, making it 
the 16th largest research library in North America. Finally, the University of Minnesota has 
taken an aggressive, proactive stance in creating an atmosphere that is compliant with the 
Health Insurance Portability and Accountability Act (HIPAA). All personnel with any access 
whatsoever to human subject data, including custodians, are required to take a 3-part 
HIPAA training session. In addition, all individuals who work directly with human subjects 
data are required to take a course in protection of human subjects and all key personnel 
are required to take a 2-part course on the responsible conduct of research. The Medical 
School provides assistance in technical writing and an extensive biomedical library is 
readily available.  
Clinical and Translational Science Institute 
The University of Minnesota is also one of approximately 60 Clinical and Translational 
Science Award Institutions (TL1R002493 and UL1TR002494). The Clinical and Translational 
Science Institute (CTSI) is part of the University’s Academic Health Center. The CTSI and its 
Clinical Translational Research Services (CTRS) team will provide access to technologies, 
services and scientific consultation that facilitate interaction and enhance scientific 
productivity. The shared resources provide stability, reliability, cost-effectiveness, and 
quality control that would be difficult to achieve otherwise. Clinical support services 
provide support at all levels of research:  
 
• Planning  
o Review background and rationale 
o Identify endpoints and covariates 
o Design experiments and surveys 
o Estimate sample size and calculate power 
o Develop databases 
o Write statistical component of grant/research protocols 
• Monitoring  

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o Registration with ClinicalTrials.gov 
o IRB submission and ongoing IRB completion 
o Regular monitoring visits 
o Data query resolution 
o Process, store and retrieve data 
o Monitor accrual 
o Provide quality control 
o Adverse event (AE) /serious adverse event (SAE) reviews 
o Compliance consultation services 
o Assist with continuation/stopping decisions 
o Review of subject specific documents, including but not limited to: 
o Signed informed consent/HIPAA documents 
o Case report forms (CRFs) 
o Medical records (for AEs/SAEs) 
o Regulatory binders 
o Communication with FDA/IRB 
• Analysis  
o Conduct statistical analyses  
o Assist with interpretation of results  
o Recommend presentation methods  
o Author statistical analysis components of manuscripts  
Masonic Cancer Center 
The Masonic Cancer Center serves to advance knowledge by creating a collaborative 
research environment focused on the causes, prevention, detection, and treatment of 
cancer; applying that knowledge to improve quality of life for patients and survivors; and 
sharing its discoveries with other scientists, students, professionals, and the community. It 
was founded in 1991, and is part of the University's Academic Health Center, which also 
includes the Medical School, Dental School, College of Pharmacy, and Schools of Public 
Health and Veterinary Medicine. The Masonic Cancer Center includes more than 500 
faculty and staff members. It is home to some of the world's top cancer researchers in 
bone marrow transplantation, breast cancer, bone cancer, cancer genetics, tobacco 
research, immunology, new therapies development, pediatric oncology, 

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chemoprevention, and epidemiology. The National Cancer Institute (NCI) designated the 
Masonic Cancer Center, University of Minnesota a comprehensive cancer center in 1998, 
and in 2003, 2009, 2013, and 2018 NCI renewed this designation. The Masonic Cancer 
Center is one of only 71 institutions in the United States to hold this designation. It is 
awarded only to institutions that make ongoing, significant advances in cancer research, 
treatment, and education.  
The Department of Obstetrics, Gynecology and Women’s Health (Vogel):  
The department is a nationally recognized entity that maintains several highly productive 
established programs while regularly adding new initiatives. Today the department hosts 
four active academic divisions: Gynecology Oncology, Maternal-Fetal Medicine, 
Obstetrics, Gynecology, Midwifery and Family Planning and Female Pelvic Medicine and 
Reconstructive Surgery. On an annual basis, The Department of Obstetrics and 
Gynecology successfully compete for significant Federal and private funding. These 
endeavors regularly involve partnerships with other units within the Academic Health 
Center. 
The Division of Gynecologic Oncology is heavily engaged in funded laboratory and clinical 
research. All faculty members are members of the Masonic Cancer Center and receive 
additional support from an NCI Cancer Center Support Grant. Support for the Division’s 
extensive research activities including funding from the National Institutes of Health, 
Department of Defense Ovarian Cancer Research Program and American Cancer Society.  
Department of Medicine at the University of Minnesota (Blaes) 
The department is a nationally recognized entity that maintains several highly productive, 
established programs while regularly adding new initiatives. The collective mission of the 
Department of Medicine is to improve the health and well-being of people, now and in 
the future, by providing exemplary medical care, discovering and applying new 
knowledge, and training the next generation of physicians in the science and practice of 
medicine. 
 
While the department has an expanding primary care practice, its core expertise is in 
areas of tertiary and quaternary care such as advanced lung disease, oncology, 
hematology, bone marrow transplant, critical care, electrophysiology, all cardiovascular 
services, complex hematologic abnormalities and solid organ transplantation. The 
department has extremely talented physicians who devote the majority of their efforts 
toward these programs. 
The Department is an innovative leader in medical education and has developed new, 
exciting curricula for medical student and resident education. We provide developmental 
opportunities for students or residents interested in primary care, global health, hospital 
medicine, medical education, clinical research, or basic science. The Department is a 

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national leader in training subspecialty physicians and has NIH-funded training grants in 
six divisions. 
The Department of Medicine is one of the top research departments in the United States 
and represents the largest research faculty group at the University of Minnesota. Core 
areas of excellence in research include cardiovascular medicine, diabetes, infectious 
diseases, stem cell biology, vascular disease, hemostasis, auto immunology, fibrotic lung 
disease, medical genetics and cancer.  
The Department of Medicine at the University of Minnesota is here to serve local, national 
and international communities with all aspects of its mission. The Division of adult 
Hematology/Oncology/Transplantation is the top producing, and grant funded division 
within the department.  
Offices 
All investigators has private offices on the University of Minnesota campus. Dr. Vogel has 
a private office in the Division of Gynecologic Oncology on the 12th floor of Moos Tower 
(Room 12-262) at the University of Minnesota. The 12th floor also provides space for 
research staff to work. Each desk includes a desktop computer and/or a network 
connection for a laptop. Two conference rooms are available on the same floor for group 
meetings.  
Computers 
All communication and data collection for this study will be completed online. Each 
member of the research team at the University of Minnesota has a personal computer 
which is linked via the internet and connected to the University of Minnesota’s central 
servers and the Academic Health Center Information Services (AHC-IS) protected health 
information (PHI)-compliant environment. All have local or network printers, as well as 
support for standard software through AHC-IS. The University of Minnesota has a high-
end server, and network equipment. Multiple software packages are available for 
qualitative and quantitative analysis (SAS, NVivo), word processing (Microsoft Word), 
creation of tables and figures (Microsoft office, Microsoft Excel), and for citation 
management (EndNote). Information Technology (IT) staff are available to maintain the 
hardware, local area network (LAN), wireless area network (WAN), and the software used. 
A dedicated server is housed off-site and backs-up all of the data nightly. Appropriate 
network security is present via firewalls. Virus protection and encryption software for all 
computers and servers is supplied and managed centrally using the most up-to-date 
versions of antivirus detection and cleaning software.  
Support Services 
The Department of OB/GYN works with the Department of Pediatrics to employ full-time 
staff of professional administrators to ensure that sponsored research projects, including 
research budgets, are appropriately managed and receive oversight to ensure responsible 

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use of funds from sponsored research. These staff include an executive administrator, an 
office manager, a team of accountants, pre- and post-award grants managers and 
administrative assistants. These local services are supported by centralized university 
services including the Sponsored Projects Administration and the Institutional Review 
Board, which are housed within the Office of the Vice-President for Research (OVPR). The 
University has numerous policies established for the protection of research subjects and 
the responsible management and oversight of the research conducted by University 
employees. These policies are available through the OVPR website. 
27.0 References 
 
1. Smith, B.D., et al., Future of cancer incidence in the United States: burdens upon an 
aging, changing nation. Journal of clinical oncology, 2009. 27(17): p. 2758-2765. 
2. Nasso, S. F. (2015) Logistic Toxicity and Administrative Burdens for Cancer Survivors 
and Caregivers. 
Cancer News, Cancer Policy Blog, NCCS News.  December 1, 2021]; Available from: 
https://canceradvocacy.org/logistic-toxicity-and-administrative-burdens-for-cancer-
survivors-and-caregivers/. 
3. Yabroff, K.R., et al., Annual patient time costs associated with medical care among 
cancer survivors in the United States. Medical care, 2014. 52(7): p. 594. 
4. Cheng, A.C. and M.A. Levy, Measures of treatment workload for patients with breast 
cancer. JCO clinical cancer informatics, 2019. 2: p. 1-10. 
5. Presley, C.J., et al., Treatment burden of Medicare beneficiaries with stage I non–
small-cell lung cancer. Journal of oncology practice, 2017. 13(2): p. e98-e107. 
6. Henry, D.H., et al., Symptoms and treatment burden associated with cancer treatment: 
results from a cross-sectional national survey in the US. Supportive care in cancer, 
2008. 16(7): p. 791-801. 
7. Crane, S., et al., Understanding treatment burden and quality of life impact of 
participating in an early-phase pediatric oncology clinical trial: a pilot study. Journal 
of Pediatric Oncology Nursing, 2018. 35(1): p. 25-35. 
8. Demain, S., et al., Living with, managing and minimising treatment burden in long term 
conditions: a systematic review of qualitative research. PloS one, 2015. 10(5): p. 
e0125457. 
9. Sav, A., et al., Burden of treatment for chronic illness: a concept analysis and review of 
the literature. Health Expectations, 2015. 18(3): p. 312-324. 
10. Schreiner, N., et al., Treatment burden as a predictor of self-management adherence 
within the primary care population. Applied Nursing Research, 2020. 54: p. 151301. 
11. Heckman, B.W., A.R. Mathew, and M.J. Carpenter, Treatment burden and treatment 
fatigue as barriers to health. Current opinion in psychology, 2015. 5: p. 31-36. 
12. Eton, D.T., et al., Risk factors for poor health-related quality of life in cancer survivors 
with multiple chronic conditions: exploring the role of treatment burden as a mediator. 
Patient related outcome measures, 2019. 10: p. 89. 
13. Yabroff, K.R. and Y. Kim, Time costs associated with informal caregiving for cancer 
survivors. Cancer, 2009. 115(S18): p. 4362-4373. 

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14. Kamal, K.M., et al., A systematic review of the effect of cancer treatment on work 
productivity of patients and caregivers. Journal of managed care & specialty pharmacy, 
2017. 23(2): p. 136-162. 
15. Lawless, G.D., The working patient with cancer: implications for payers and 
employers. American health & drug benefits, 2009. 2(4): p. 168. 
16. Alcaraz, K.I., et al., Understanding and addressing social determinants to advance 
cancer health equity in the United States: a blueprint for practice, research, and policy. 
CA: a cancer journal for clinicians, 2020. 70(1): p. 31-46. 
17. Emerson, M.A., et al., Breast cancer treatment delays by socioeconomic and health 
care access latent classes in Black and White women. Cancer, 2020. 126(22): p. 4957-
4966. 
18. Nwadiuko, J. and L.D. Sander, Simplifying care: when is the treatment burden too 
much for patients living in poverty? BMJ quality & safety, 2018. 27(6): p. 484-487. 
19. Smith, J.L. and I.J. Hall, Advancing health equity in cancer survivorship: opportunities 
for public health. American journal of preventive medicine, 2015. 49(6): p. S477-S482. 
20. May, C., V.M. Montori, and F.S. Mair, We need minimally disruptive medicine. Bmj, 
2009. 339. 
21. Penedo, F.J., et al., The increasing value of eHealth in the delivery of patient-centred 
cancer care. The Lancet Oncology, 2020. 21(5): p. e240-e251. 
22. Eton, D.T., et al., Building a measurement framework of burden of treatment in 
complex patients with chronic conditions: a qualitative study. Patient related outcome 
measures, 2012. 3: p. 39. 
23. Sheehan, O.C., et al., A systematic literature review of the assessment of treatment 
burden experienced by patients and their caregivers. BMC geriatrics, 2019. 19(1): p. 1-
11. 
24. Tran, V.-T., et al., Development and description of measurement properties of an 
instrument to assess treatment burden among patients with multiple chronic conditions. 
BMC medicine, 2012. 10(1): p. 1-10. 
25. Eton, D.T., et al., Development and validation of the Patient Experience with Treatment 
and Self-management (PETS): a patient-reported measure of treatment burden. Quality 
of Life Research, 2017. 26(2): p. 489-503. 
26. Fan, Y., et al., SmarTrAC: A smartphone solution for context-aware travel and activity 
capturing. 2015. 
27.Fan, Y., Wolfson, J., & Adomavicius, G. (2017). Travel and Activity Capturing. U.S. 
Patent No. 9,763,055. Washington, DC: U.S. Patent and Trademark Office.