An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life Among Hispanic Women Completing Active Treatment for Breast Cancer
Phase: NA
Conditions: Cancer-related Problem/Condition, Quality of Life, Stress, Emotional
Sponsor: Northwestern University

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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PROTOCOL TITLE:
An e-Health Intervention to Improve Symptom Burden and Health-Related Quality of Life among 
Hispanic Women Completing Active Treatment for Breast Cancer
PRINCIPAL INVESTIGATOR:
Betina Yanez, Ph.D.
Assistant Professor
Department of Medical Social Sciences 
633 N. St. Clair Floor 19
312-503- 5341
betina.yanez@northwestern.edu
VERSION DATE:
01/08/2018
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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1.0  Purpose of the Study: 
This study aims to create and evaluate Mi Guia study aims, a culturally informed eHealth educational 
and psychosocial intervention for English or Spanish-speaking Hispanic women completing treatment 
for breast cancer. Mi Guia is grounded in evidence-based paradigms to improve our Primary 
Outcomes: Cancer-Related Symptom Burden and HRQOL and our Secondary Outcomes: cancer-
specific distress, depressive symptoms, and markers of Mi Guia use. We propose a two-phase study to 
develop our Smartphone-based intervention that can be disseminated to survivors at a relatively low 
cost. We will use innovative methodology; MOST framework that will allow us to achieve both 
optimization and evaluation of Mi Guia by determining which single components or combination of 
components in Mi Guia affect our outcomes9,10. Study components (one on breast cancer education, 
two psychosocial evidence-based components relevant to Hispanic women who have been diagnosed 
with breast cancer) will be paired with personal tele-coaching. 
Aim 1 (Phase 1, Year 1): Create Mi Guia, an eHealth intervention designed to improve cancer-related 
symptom burden and HRQOL. Aim 1 is further broken down into four parts. Using a mixed-methods 
approach, we will 1a) collect qualitative data (n= 20) on the study content, 1b) conduct usability testing 
on the Mi Guia Smartphone application, and 1c) conduct feasibility testing (e.g., field trial) to refine 
the content in the components and the design of the Smartphone-delivered intervention for Hispanic 
women. Finally, we will add one more part to Aim 1, aim 1d) to conduct interviews with community 
stakeholders about the Mi Guia/My Guide application. These interviews with community stakeholders 
will not include any questions about participants. The interviews will only include questions about the 
application itself and their ideas on how to improve it. 
Aim 2 (Phase 2, Years 2 & 3): Optimize components for Mi Guia through an 6-week randomized trial 
to evaluate the efficacy of Mi Guia relative to a smartphone application on health education (Mi 
Salud), our control condition. The health promotion application, Mi Salud, includes health education 
content on nutrition, and general advice on lifestyle choices and prevention. Participants will complete 
the same procedures regardless of randomization assignment to help minimize potential confounding 
factors during the intervention or control delivery. Participants will be early-stage women completing 
active treatment (n= 90) We hypothesize that Hispanic BCS will find the smartphone application, Mi 
Guia, an acceptable and feasible way of accessing post-treatment relevant information. Furthermore, 
we expect that, in comparison to the control condition, My Guide will have a measurable, positive 
impact on this population’s HRQOL and cancer-specific distress.
2.0  Background / Literature Review / Rationale for the study:
Ethnic minority and underserved populations are disproportionately burdened by cancer.1 Among 
Hispanics, the largest and fastest growing ethnic minority group in the U.S., cancer is the leading cause 
of death whereas cardiovascular disease is the leading cause of death for African Americans and non-
Hispanic Whites (NHWs). Hispanics also experience substantially lower rates of 5-year cancer-specific 
survival relative to non–Hispanic Whites (NHWs). Relative to NHWs, Hispanics are more likely to be 
diagnosed with advanced stages of breast cancer.2 Furthermore, the average age of breast cancer 
diagnosis for Hispanics is 50 years, which is a decade earlier than for NHW women. Barriers to 
accessing and effectively engaging in health care, limited cancer information, beliefs about cancer are 
some factors that may contribute to these disparities.1-3
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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Hispanic cancer patients in the U.S. also report significantly worse cancer-related symptom burden and 
health-related quality of life (HRQOL) than NHWs, even after adjusting for socioeconomic factors.3,4 
Despite this, very few randomized, intervention studies have specifically targeted cancer-related 
symptom burden and HRQOL outcomes among Hispanic women, especially during the period at the 
end of active treatment which is a critical period to intervene to provide skills and tools to assist with 
the transition to survivorship5. The few, existing studies were too small and underpowered to detect 
differences or yielded null findings6,7. One study did report a positive effect, however which 
components or combination components of psychosocial interventions that may reduce symptom 
burden and improve HRQOL in Hispanic breast cancer survivors (BCS) remains unknown, thus 
creating a critical gap in the literature8. Hispanic women diagnosed with cancer may have difficulty 
gaining access to supportive and psychosocial services that can assist with symptom burden and 
HRQOL and face obstacles such as cost, lack of insurance coverage, time constraints to name a few1,11. 
Therefore innovative approaches to providing interventions such as Smartphone technology are 
especially important for this patient population. Ubiquitous Smartphone use among ethnic minorities in 
the US provide a unique opportunity to implement a pragmatic technology- and evidence-based 
psychosocial intervention that overcomes some access to care barriers as well as time and logistical 
constraints12. Given that Hispanics own Smartphones and seek health information online from a mobile 
device at similar or higher rates than other groups in the U.S., Smartphone interventions offer an 
opportunity to overcome obstacles to accessing resources and services that can be culturally informed 
and provide skills to improve symptom burden and HRQOL12. We have previously shown that cancer-
related knowledge, stress management, coping skills, and communication can negatively affect the 
post-treatment survivorship phase, underscoring the importance addressing these components in a 
psychosocial intervention3,13,14.  
3.0  Inclusion and exclusion criteria:
Eligibility Criteria will remain mostly the same for all the phases of the study. Inclusion criteria: 1) 
Female; 2) Diagnosis of BC, non-metastatic, stage 0-IIIA; for women diagnosed with stage 0, either 
radiation or chemotherapy is required as an additional treatment to surgery 3) Completed active 
treatment for BC (surgery, chemotherapy and/or radiation therapy, current hormonal treatment 
allowed); 4) No current evidence of disease; 5) Within 3 to 15 months post-active treatment [e.g., 
surgery, chemotherapy, radiation, or combination of the two or three]; 6) at least 21 years of age; 7) 
Able to speak and read English or Spanish; 8) Able to provide informed consent; 9) Elevated score on 
breast cancer symptom burden and HRQOL, measured by the Functional Assessment of Cancer 
Therapy-Breast using an established cut-off score for clinically meaningful, compromised symptom 
burden and HRQOL; 10) Self-identified Hispanic/Latina ethnicity; 11) with the exception of 
nonmelanoma skin cancer, no previous diagnosis of cancer. Exclusion criteria: 1) Visual, hearing, 
voice, or motor impairment that would prevent completion of study procedures; 2) diagnosis of an 
unmanaged psychotic or psychiatric disorder (e.g., clinical depression, anxiety, or PTSD), bipolar 
disorder, dissociative disorder, or other diagnosis for which participation in this trial is either 
inappropriate or dangerous – this includes patients who have life-threatening illness (e.g., end-stage 
kidney disease) or diagnosis of a chronic disease that is associated with a major functional impairment 
(e.g., chronic severe pain, fibromyalgia); 3) Illicit substance or alcohol dependence 4) Suicidal 
ideation, plan, intent; 5) Alzheimer’s, dementia or history of stroke. 6) Scheduled reconstruction 
surgery within 1 month of any study procedures or involvement. Also women in presurgery 
preparations such as expanders that would affect quality of life and/or study outcomes. To minimize 
threats to internal validity, we evaluate intervention components among a relatively homogenous 
population with regard to cancer type, stage and treatment. Patients with metastatic disease have a 

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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higher likelihood of dying of breast cancer, more extensive treatment, and may differ in levels of 
HRQOL and therefore will not be included. Previous observational studies indicate that Hispanic 
women are more likely to report symptom burden within 6 months of completing active treatment 
relative to NHWs. 
Additionally during Aim 1c only, we will expand eligibility criteria to include women who are as far 
out as 36 months and who do not have an elevated score on the breast cancer symptom burden and 
HRQOL questionnaire. Our goal is to have at least half of the sample for Aim 1c (10 women) meet all 
eligibility criteria, but if need be use the expanded criteria just described. Since the field trial is mainly 
focused on addressing the functionality of the phone application, we have decided to expand the 
criteria since this is a phase in the project when we can be more lenient with eligibility. It is also very 
possible that women other than those with lower HRQOL or high symptom burden could benefit from 
being part of the project.  
During Aim 2 only, we will expand eligibility criteria to include women who are as far out as 24 
months after completing treatment, and women who have had cancer recurrences as they might also 
benefit from our intervention. We will include participants with cancer recurrences as long as they still 
fit the original breast cancer specific eligibility criteria listed above, and as long as the occurrence of a 
different cancer does not confound our ability to make direct inferences about the source of breast 
cancer related distress, and for whom our breast cancer intervention will be most relevant. We have 
created a flow chart and additional questions that we will use when deciding how to include women in 
the study who have had recurrences (see screening questionnaire).
Additionally, during Aim 2, we will exclude women who only received education until the 4th grade as 
we have observed difficulties among participants with limited education that could cause more 
challenges for the participant rather than benefiting them. We will also be excluding women who will 
be traveling or who have previous scheduled events that could hinder their commitment and 
availability for the study. 
Finally, as we did during Aim 1c, in Aim 2 we will include women who do not meet our originally 
stablished score on the breast cancer symptom burden and HRQOL questionnaire. Based on 
preliminary observations of the data collected from Aim 1c, it appears that all participants can equally 
benefit from using My Guide. However we will ask participants during screening the abridged version 
of the FACT questionnaire (the FACT-G7-See screening questionnaire). Our goal is to have at least 25 
woman meet the elevated FACT-G7 score (-14).
Participants for Aim 1d will be community stakeholders who have worked with Latina/Hispanic breast 
cancer survivors who would like to view the application and provide feedback.
4.0  Procedures Involved:
Specific Aim 1.
1a. We will begin developing our intervention content by interviewing 20 English or Spanish-speaking 
Hispanic/Latina women (women will be stratified by language) who meet the study eligibility criteria. 
Individual interviews with the participants will be conducted by the bilingual PI and 
biculutrally/bilingually trained research staff, using a semi-structured guide based on prior work from 
the PI. The translated final Spanish versions of all participant-facing materials for Aim 1a will be 
submitted prior to recruitment once the final English versions of the documents have been approved by 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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the IRB. This will help minimize back-and-forward resubmission of documents due to any changes 
requested prior to final approval. 
Potential subjects at the Northwestern site will be identified by the electronic data warehouse (EDW) 
and EPIC (all oncologists specializing in breast cancer at NU will be informed of this project via 
email). Study staff will have IRB/HIPAA compliant approval to access electronic medical records 
(EMR) systems. EDW will release up to 100 viable participants for the purpose of recruitment, and the 
research staff will then review and identify participants to be recruited and then pre-screen those 
participants via their EMR in EPIC to determine potential eligibility using a Screening EMR 
Extraction form.  For participants recruited through Judy Guitelman, no EMR extraction is feasible 
during screening, for these patients only the phone screening will be used to determine eligibility.
Once a patient is identified as potentially eligible based on the EMR screening, research staff will 
discuss the case with the attending physician and obtain physician approval prior to making contact 
with the patient to conduct a phone eligibility screening. 
Participants for Aim 1a and 1b will be recruited from the Robert H. Lurie Comprehensive Cancer 
Center (RHLCCC). Once we receive IRB approval to add the University of Illinois as a recruitment 
site for Aim 1c and Aim 2, we will begin recruiting form UIC as well. An IAA will be submitted to the 
Northwestern IRB prior to recruitment at UIC. Patients will be identified either by physicians at 
Northwestern or UIC and at the Northwestern site participants will be screened in EMRs.  Across all 
Aims, participants will also be recruited through Judy Guitelman, the associate director of the Latina 
Association of Breast Cancer, who is a study community consultant and breast cancer advocate. Once 
a patient is identified as potentially eligible based on the EMR screening or physician referral, and 
following physician approval to make contact with the patient, prospective participants will be 
contacted via a mailed pre-recruitment letter. Study staff will send the potential participant this letter, 
which introduces the study. One week later, unless the potential participant contacts the study staff to 
opt out of the study, the study staff will call the potentially eligible participant to provide additional 
information about the study. During this call, if the potential participant expresses interest, bilingual 
and bicultural study staff will proceed with a brief eligibility phone screening to determine further 
eligibility. Potential subjects recruited from the Latina Association of Breast Cancer will be identified 
by Judy Guitelman, the association director. Ms. Guitelman is informed of the study goals, procedures, 
and eligibility. Ms. Guitelman will briefly discuss the study goals and procedures with potentially 
interested women, and provide them with a study brochure. The study staff will call the women that 
express interest and agree to being contacted. During this call, research staff will provide the 
potentially eligible participant with additional information about the study, if the potential participant 
expresses interest, bilingual and bicultural study staff will proceed with a brief eligibility phone 
screening to determine further eligibility.
In order to minimize the possibility of coercion, the UIC PI, Dr. Perez-Tamayo, will be involved in 
identifying potentially eligible participants from her practice, but neither she nor her staff, Yvette 
Castro, will be involved in consenting participants. Any other member of the study staff will be 
involved in consenting patients recruited from UIC. This recruitment and consent structure will 
minimize possibility of coercion for participants recruited by Dr. Perez-Tamayo, the UIC site PI.
The phone screening is a short-answer and multiple choice questionnaire that is estimated to last about 
10 minutes with each participant. The questions address all the items in the inclusion/exclusion criteria 
above (section 3.0) to determine participant eligibility for the study. Most of the phone screening 
questions regarding inclusion criteria items 1-8, 10 and 11 are short-answer questions and will serve to 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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verify the data in the Screening EMR Extraction form, to address missing data or discrepancies if any. 
Certain items such as item 9 in the inclusion criteria, and items in the exclusion criteria are often not 
clearly defined in the EMR. To verify eligibility for item 9 in the inclusion criteria, we will include 
women who score higher than 30 points in the FACT-B questionnaire (version 4). For exclusion 
criteria items 1, 2, 5 and 6 we will ask yes/no questions to participants about the diagnosis or 
impairments mentioned above, and prove with a short-answer question to determine when the specific 
diagnosis or impairment would interfere with participation/eligibility in the study (because it is 
unmanaged, too severe and would make participation inappropriate, or because it would confound 
study outcomes). To further screen for item 2, we will exclude women who have been hospitalized for 
psychotic or psychiatric disorders in the past 12 months. To address item 3 on substance and alcohol 
abuse, we will ask the participant a series of short-answer questions to determine if any drug or alcohol 
use indicate dependence or abuse, in which case the participant would be excluded. Finally to address 
item 4, we will ask if the person has thoughts of harming themselves and determine the nature and 
imminence of the threat. Persons with suicidal ideation, plan or intent will be excluded from the study.     
In the event that a participant expresses suicidal tendencies during the screening process (see question 
3 on phone screening form), we will provide immediate assistance over the phone as appropriate and 
refer them for local treatment. Speaking privately with the participant, we will assess for suicidal 
ideation, plan of action, and likelihood of carrying out the plan. We will help the participant obtain 
immediate assistance in the home (e.g., ask if spouse/friend can be contacted) and will encourage her 
to seek medical attention if she is at high risk. Local resource referrals will be kept on file to be used in 
the event of such an emergency. Dr. Penedo, Northwestern site co-investigator, is a licensed clinical 
health psychologist, experienced in psychotherapy, and counseling of patients and families dealing 
with chronic and acute medical conditions, particularly cancer. Drs. Yanez and Penedo have doctorates 
in clinical psychology and have provided individual therapy for patients through the supportive 
oncology program at Northwestern.
The data collected in the EMR Extraction Screening form will not be retained as participant records. 
However, for eligible subjects that consent to participate in this study, the data collected during the 
eligibility phone screening will be used as study data across both aims. This will clearly be stated in in 
the consent forms. Using the phone screening data as study data will allow us to minimize participant 
burden by not re-asking the same questions post-consent.
If a participant is eligible after verifying the data collected both in the EMR Extraction Screening form 
and during the phone screening, they will be notified right away on the phone that they are eligible, 
and be asked if they would like to participate in the study. For participants recruited through Judy 
Guitelman, no EMR extraction is feasible during screening, for these patients only the phone screening 
will be used to determine eligibility. If a participant is eligible and would like to participate, we will try 
to set up a time to meet in person to conduct the consent procedures and the study interview (see 
interview details below and 7.0 Consent Process). If the eligible participant does not want to 
participate in the study, study staff will not proceed with further screening. They will thank her for her 
time and will not contact her again. The completed screening documents of potential participants who 
are deemed ineligible will be destroyed after the completion of screening.
The purpose of the interview is to further understand Latina women’s experiences with cancer and 
survivorship as well as symptom burden, quality of life and unmet needs during the cancer and 
survivorship experience and assess interest in a technology-assisted intervention. Participants who 
meet all study eligibility criteria and consent to participate will be scheduled for an in-person interview 
that will take approximately 60 minutes (see interview script) and take place at our laboratory space 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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within the Department of Medical Social Sciences at the Feinberg School of Medicine or at a location 
convenient for the respondent (e.g., respondent’s home, local library). Participants will also be asked to 
complete a technology survey to gather information on their general comfort with technology (e.g., cell 
phone, smartphones, computers). During the interview, participants will also be asked complete a brief 
“Knowledge of Breast Cancer Questionnaire, and to review a breast cancer information packet from 
the National Cancer Institute (attached to the IRB application) and be asked to give the interviewer 
their opinion on the usefulness of this information. The demographics questionnaire, interview, 
Knowledge of Breast Cancer Questionnaire and technology survey are attached to the IRB application. 
Upon completion of informed consent and HIPAA authorization participants will be asked to complete 
questions on their demographics (e.g., Hispanic ancestry, age, income, education) so that we may 
characterize the study sample. We are also requesting HIPAA authorization in order to obtain medical 
and treatment-related information from participants’ medical records (e.g., stage of diagnosis, cancer 
treatments and dates of treatment, medical co-morbidities) as these data will be considered covariates 
in our data analyses and will be collected using the Post-Consent EMR Extraction form. We will also 
be obtaining genetic health information, specifically for BRCA susceptibility. Women who are aware 
of an increased risk of recurrence might experience more distress, and it is important to statistically 
control for this type of testing to understand the study results.  For participants recruited through Judy 
Guitelman, the study staff will obtain the necessary information to request the patient’s medical 
records by obtaining the required documentation from their doctor’s office to release the records.  
Following completion of their demographics, women will complete the interview followed by the brief 
technology survey. All interviews will be audio recorded so that they may later be transcribed and 
coded for thematic content. The PI is experienced with qualitative methods and is PI on another grant 
with similar qualitative methods. Participants will be paid $35 for their time and reimbursed for travel 
costs. A mix of inductive and deductive methods will be used to guide analyses for this phase of the 
study. Responses from the interviews will be transcribed and then examined using NVIVO software. 
Two independent raters will generate a list of themes and dimensions of major ideas expressed by 
participants. Findings from these interviews will be used to finalize the application content before 
proceeding to next phase (phase 1b) of our research. We anticipate completion of the interviews by 
June of 2016. 
1b. Following completion of the interviews in 1a and thematic coding of the interviews, participants 
(either those who previously participated who agree to be contacted for future similar studies in their 
consent or newly recruited participants) will participate in usability testing which is 1b. Eligibility 
criteria is the same across all study aims. Recruitment procedures for new participants are the same as 
in Aim 1a. However, we anticipate that most is not all women participating in Aim 1b will be 
participants who previously participated in Aim 1a of the project. Upon completing consent and 
HIPAA authorization to collect protected health information, participants will be asked to completed 
demographic and clinical self-reported information. We are also requesting HIPAA authorization in 
order to obtain medical and treatment-related information from participants’ medical records (e.g., 
stage of diagnosis, cancer treatments and dates of treatment, medical co-morbidities) as these data will 
be considered covariates in our data analyses and will be collected using the same Post-Consent EMR 
Extraction form used during Aim 1a. Participants who already completed demographics and 
information regarding their cancer treatment in Aim 1a will not be asked to completed demographic or 
clinical information again. Any participants who were not enrolled in Aim 1a but are now enrolled in 
Aim 1b as new study participants will be asked to complete their clinical and demographic information 
using the same forms as the IRB approved forms used in Aim 1a. Researchers Rachel Adler and 
Francisco Iacobelli from Northeastern Illinois University (NEIU) will collaborate with the 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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Northwestern team in developing and conducting this phase of the project which will start shortly after 
completion of Aim 1a. The NEIU IRB approval letter is included in this IRB modification.
Patients involved in the qualitative interviews for Aim 1b will be asked to complete a 1 hour 
laboratory-based usability testing session on the Smartphone-based application that will take place 
within Dr. Yanez’s laboratory space in the Department of Medical Social Sciences at Northwestern 
University. If a participant is unable to make it to Northwestern University of usability testing, the 
members of the study staff will conduct a field visit to the participant’s house to conduct the usability 
testing. 
We will employ a task-based usability approach, where participants will complete a series of tasks with 
mockups and prototypes of the application and performance measures related to usability will be 
captured on their ability to complete these tasks such as the USE questionnaire (see attached measures 
and questions that will be asked in Aim 1b). This test will focus on several aspects of usability: 
learnability, memorability, ease of use, and efficiency. Participants will complete the usability testing 
in a controlled laboratory environment while a member of the research team guides them through the 
process. A second member of the research team will observe, audio record the session, and take notes 
during the usability test as well as record the section. The usability observer will capture quantitative 
metrics related to usability performance such as time on task and errors accessing content on the 
application (e.g., unable to find the homescreen bottom or navigate through the application). The 
usability observer will also capture qualitative data from think aloud related to appeal, comprehension 
of words and graphs and appeal of the design of the application (e.g., are the colors appealing, is the 
font size to small or too big). Participants will also be prompted with questions addressing technical 
reliability on the application (e.g. problems with the technology) and functional reliability (e.g. 
problems with application use, integrating the system into daily life). Usability will also be assessed 
with the USE questionnaire to capture quantitative feedback on the prototype of the Smartphone-based 
application. Participants in the usability testing will be paid $35 and reimbursed for travel. The 
translated final Spanish versions of the Aim 1b consent and the Aim 1b interview guide will be 
submitted prior to Aim 1b recruitment once the final English versions of these documents have been 
approved by the IRB. This will help minimize back-and-forward resubmission of documents due to 
changes requested prior to approval.
1c. Following completion of the interviews in 1a and thematic coding of the interviews, as well as 
participating in usability testing for 1b, participants (either those who previously participated who 
agree to be contacted for future similar studies in their consent or newly recruited participants) will 
participate in a 4-week field trial, 1c. We expect to recruit a total of 20 participants for this phase of the 
study. Eligibility criteria is mostly the same across all study aims. However during Aim 1c, we will 
expand eligibility criteria to also include women who are as far out as 36 months and who do not 
necessarily need to have an elevated score on breast cancer symptom burden and HRQOL 
questionnaire. Our goal is to have at least 10 women meet all original eligibility criteria, but if need be 
use the expanded criteria. Since the field trial is mainly focused on addressing the functionality of the 
phone application and study procedures, we have decided to expand the criteria. Additionally, it is 
possible that women other than those with lower HRQOL or high symptom burden could benefit from 
participation. 
All interactions with participants will be conducted by the bilingual PI and biculutrally/bilingually 
trained research staff. The translated final Spanish versions of all participant-facing materials for Aim 
1c will be submitted prior to recruitment once the final English versions of the documents have been 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
Page 9 of 29
approved by the IRB. This will help minimize back-and-forward resubmission of documents due to 
any changes requested prior to final approval.
Recruitment and screening procedures will be the same as in Aim 1a and Aim 1b. We will add the 
University of Illinois at Chicago as a recruitment site during Aim 1c and Aim 2 once we add the UIC 
signed IAA and UIC is approved by NU IRB as a study site. 
Participants that completed Aim 1a or Aim 1b will be invited to participate in Aim 1c. If they are 
interested in being part of the field trial, we will explain all the procedures for Aim 1c, and if they 
choose to participate they will not have to redo any questionnaires, but will be asked instead to let us 
use already collected information in the previous study aims. This will be explained in the consent 
document as well. Additional details about recruitment and screening procedures are described under 
aim 1a above.
For participants that have not participated in previous phases, and all participants in Aim 2 if a 
participant is eligible after both verifying the data revised using the EMR Extraction Screening form 
(the first level of screening to exclude participants) and during the phone screening (the final level of 
eligibility screening to confirm unclear criteria in the EMR), they will be notified right away on the 
phone that they are eligible, and be asked if they would like to participate in the study. If a participant 
is eligible and would like to participate, we will try to set up a time to meet in person to conduct the 
consent procedures and the procedures for the first Aim 1c or Aim 2 in-person meeting (see below). If 
the eligible participant does not want to participate in the study, study staff will not proceed with 
further screening. They will thank her for her time and will not contact her again. The completed 
screening documents of potential participants who are deemed ineligible will be destroyed after the 
completion of screening.
University of Illinois Subject Enrollment: Dr. Perez-Tamayo will be involved in identifying 
potentially eligible participants from her clinic. In order to minimize the possibility of coercion, neither 
she nor her staff, Yvette Castro, will be involved in consenting participants. Both Dr. Tamayo and 
Yvette Castro will be added as research staff, however, other members of the study staff at 
Northwestern will be involved in consenting patients recruited from UIC. This recruitment and consent 
structure will minimize possibility of coercion for participants recruited from Dr. Perez-Tamayo’s 
clinic. Dr. Perez Tamayo and Yvette Castro will introduce the study to potentially eligible patients 
using the study brochure and recruitment scrip, if patients agree to participate they will forward their 
name and phone number to the NU research staff via phone. The NU research staff will continue with 
the phone screening and setting up a time for their first meeting. At UIC, the EMR screening form will 
be used as a guideline only in order to guide the initial participant screening by Yvette Castro and Dr. 
Perez Tamayo. However, no information from the EMR will be recorded on this form by UIC 
personnel, only contact information necessary to call participants will be recorded in order to continue 
with recruitment and phone screening.
For both sites, when participants are eligible and agree to participate, we will ask them to set up a time 
for an in-person consenting process and for an initial meeting. There are 2 in-person meetings for aim 
1c, these meetings will take place at our laboratory space within the Department of Medical Social 
Sciences at the Feinberg School of Medicine or at a location convenient for the respondent (e.g., 
respondent’s home, local library). During the call when we set up a meeting for the initial interview, 
we will also ask participants whether they would like to borrow a study phone or use their own, and if 
they will need the study team to create a temporary email address to log into the phone application. 
These preparatory questions will help the research team have all study materials ready for the first 
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
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meeting. At this point we will also ask participants if they would like to receive a text message to 
remind them of the appointment location and other general reminders for their first visit (see Study’s 
Text Messages and Phone Screening documents). Text messages will be sent only from a secure 
Northwestern’s Outlook account. 
After completing the consent and HIPAA authorization, participants will be asked to complete a 
demographics questionnaire (unless otherwise completed in previous study phases). We are requesting 
HIPAA authorization in order to obtain medical and treatment-related information from participants’ 
medical records (e.g., stage of diagnosis, cancer treatments and dates of treatment, medical co-
morbidities) as these data will be considered covariates in our data analyses. Only the information 
listed in the Post-Consent EMR Extraction form used in previous aims will be collected. Additionally 
as it was requested in previous aims, we will ask participants to let us use the information collected 
during the phone screening as part of the study records. This will be stated in the consent document. 
During the consent process, we will also ask participants if they would like to receive text message 
reminders for their weekly call and final appointment (see Study’s Text Messages document). This is 
an optional element that is not required for participation. 
Participants will then complete a multiple choice baseline assessment  consisting of 6 validated 
questionnaires: the Impact of Event Scale (IES), Knowledge about Breast Cancer (already approved 
and used for previous aims), the Communication and Attitudinal Self-Efficacy scale for cancer (CASE-
cancer), the Unmet Needs Scale, the Breast Cancer Prevention Trial symptom questionnaire, and the 
FACT-B (already used during the phone screening, but re-administered if more than 3 weeks pass 
between screening and baseline assessment). This baseline assessment is estimated to take 15 minutes 
to complete. In order to make it easier for participants to complete this questionnaire, we created a 
page with the response options to use when answering the questions in the assessment. This same 
document would also be used during their follow-up assessment on their last meeting, which consists 
of the same questions as the baseline assessment. 
Once the baseline assessment is completed, participants will go through an orientation of the Mi Guia 
application. Participants will be given the option to either use their own phone to download the 
application, and be reimbursed $40 for data usage at the end of the trial; or they can choose to borrow a 
study phone (an Android Nexus 5X) with the application already downloaded. Participants who would 
do not have their own headset, will be given a headset at no cost. Once the participant downloads the 
application or is provided with a new phone, we will create a unique account with the participant. Only 
an email address and password is required to register. If the participant does not have an email address, 
we will create a temporary email address using pseudonyms, which will be deleted at the end of the 
trial. During the registration we will go over all the features of the application with the respondent, and 
address any questions. At this point we would give participants a copy of the orientation document so 
that they can refer to the images and instructions in the document in the future if they have questions 
during their individual use. 
The baseline assessment, and the protocol to be used during registration/orientation is attached to this 
IRB application. The total estimated time for completing the demographics questionnaire, baseline 
assessment and orientation process is 1 hour. After this initial meeting is completed, participants will 
receive $35, out of a possible $100. The remainder $65 will be received during the second and final 
meeting of Aim 1c.
Participants will then be instructed to access the application for an average of 3-4 hours per week for 
the duration of the trial (4 weeks total). All the information contained in the application has been 
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submitted for review, and we will submit images of the final application design prior starting Aim 1c. 
During the 4 week trial, the application will prompt participants once a week to complete the FACT-B 
(the short, multiple choice questionnaire already used during screening and baseline). The weekly 
completion of the FACT-B questionnaire should take less than 5 minutes. 
We will also schedule a weekly telecoaching 15-minute call to guide participants through application 
content they might not be aware of, and to see if there are any issues accessing the application. 
Coaching participants improves eHealth adherence and outcomes. Dr. Yanez will conduct training for 
the telecoaches and Dr. Yanez will supervise the telecoaches on a weekly basis. Training will include 
sensitivity to issues relevant for Hispanic BCS, including cultural beliefs that may influence coping 
and health behaviors. Telecoaching sessions will be audio-recorded to monitor intervention fidelity, 
and this has been included in the consent. The protocol/script for this weekly call is attached to the IRB 
application.
After the completion of the  week field trial, we will schedule a final meeting with participants at a 
location of their choice. During this final meeting, they will complete a follow up assessment 
consisting of the exact same questions from the baseline, as well as an exit interview (see attached 
script). The duration of the final in-person meeting will be 1 hour, and this meeting will not be audio 
recorded. During this meeting we ask all participants if they would like to remove the application from 
their phones, and follow the described procedures to do so if they would like to have it removed; 
however, participants that would like to keep the phone application to access information will be 
allowed to keep it. Those participants will be instructed to not continue to answer weekly 
questionnaires, and will be told that if the application is moved to another server, they will to be able to 
access it any more. Participants will then receive $65 for the completion of Aim 1c, and might be 
reimbursed $40 if they used their personal phone during the trial.  
Aim 1d. We will conduct 5-10 interviews with community stakeholders about the phone application 
My Guide. In the past we have worked with multiple support groups and organizations actively 
involved in the Latino/Hispanic community. We will reach out to our contacts at these organizations 
via phone call or email to see if they would like to provide feedback about My Guide. If these 
community stakeholders would like to participate, we will consent them verbally (see section on aim 
1d consent below), and provide them with instructions on how to download My Guide to their phones. 
We will encourage these participants to explore My Guide on their own for 2-4 weeks, and to 
participate in 1 interview about the application that lasts about 1hr. We will use the Exit interview 
guide already approved for Aim 1c participants for this interview. We will not ask Aim 1d participants 
any questions about themselves, but only about how to improve My Guide. 
Although the application My Guide has a questionnaire built into the application (the FACT-B/see 
above), we will ask community stakeholders to review the design/interphase of the questionnaire, but 
to not input any personal information in the app. 
Aim 1d participants will be reimbursed $100 for their participation.
Specific Aim 2. 
Aim 2 (Phase 2): Optimize components for Mi Guia through a 6-week randomized trial to evaluate the 
efficacy of Mi Guia relative to a smartphone application on health education (My Health), our control 
condition. Participants will complete the same procedures regardless of randomization assignment to 
help minimize potential confounding factors during the intervention or control delivery. Participants 
will be early-stage women completing active treatment (n= 90), see eligibility criteria above. A 
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minimum of 25 participants will meet the compromised cancer-related symptom burden and HRQOL. 
We hypothesize that Hispanic BCS will find the smartphone application, My Guide, an acceptable and 
feasible way of accessing post-treatment relevant information. Furthermore, we expect that, in 
comparison to the control condition, My Guide will have a measurable, positive impact on this 
population’s HRQOL and cancer-specific distress.
Participants will be individually randomized, 1:1, to the health promotion application (control 
condition) or to the My Guide application (intervention condition). A longitudinal mixed effects linear 
model will be fit with the outcome (the Functional Assessment of Cancer Therapy-Breast; FACT-B) 
score as the dependent variable.  Type of treatment (e.g., surgery type, hormonal therapy), time since 
completion of active treatment, stage of diagnosis, education, marital status, language, comorbidities 
and age at diagnosis will examined for their associations with study outcomes for potential entry as 
covariates in the statistical model. Effect sizes will be calculated by dividing by the baseline standard 
deviation. The potential moderating effect will be examined by entering interaction terms into the 
model. Similar models will be fit to examine the subscales of the FACT-B. A total of 90 participants 
will be randomly assigned to one of 2 conditions (control or intervention), resulting in 45 participants 
per condition. The main effect of each intervention component will be evaluated by comparing the 
outcomes for participants who receive the intervention (n= 45) to those who did not receive the 
intervention (control; n=45), allowing a comparison of main effects. Participants will be compensated 
$100 and reimbursed up to $22 for travel and data usage. 
Technology. 
Both My Guide (Mi Guia) and My Health (Mi Salud) will be interactive study applications developed 
for use with a Nexus 6 Smartphone on the T-Mobile© network (see Appendix). Study content will be 
delivered by a combination of text, video, and audio. The health education application, Mi Salud, 
includes health education content on nutrition, and general advice on lifestyle choices and prevention 
(see submitted Mi Salud content under supporting documents in our IRB application).We selected 
Smartphones due to their smaller, more discrete size, and transportable nature that we believe will 
provide participants with greater accessibility to lessons and assessments. Moreover, Hispanics own 
Smartphones, go online from a mobile device and use social networking sites at similar or higher rates 
than do other groups in the US12 and Hispanic women are more likely to use the Internet to access 
health care information than men.49 Among participants already having a Smartphone with an Android 
platform (we anticipate 25% of the sample), we will evaluate compatibility to run each application to 
be installed by a member of the research team onto their Smartphone. Participants’ scores on 
assessments and application usage (e.g., logins, time spent on application) will be captured and sent 
wirelessly to a secure server at CBITs. All participants will be trained to use the application. 
Trial Design. 
Recruitment and screening procedures will remain the same for Aim 2 as they were for earlier Aims in 
the study (see Aim 1c procedures above, and recruitment procedures below). We will have the same 
study sites, and the same procedures for identifying and contacting participants as before. 
The screening was slightly modified to address the changes to the eligibility criteria mentioned above. 
Also, as we have done in pervious Aims, the data collected in the EMR Extraction Screening form 
(applicable to NU participants only) will not be retained as participant records. However, for eligible 
subjects that consent to participate in this study, the data collected during the eligibility phone 
screening will be used as study data across both aims. This will clearly be stated in in the consent 
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forms. Using the phone screening data as study data will allow us to minimize participant burden by 
not re-asking the same questions post-consent.
Eligible participants who want to participate will be randomized to the control (My Health/Mi Salud) 
or intervention conditions (My Guide/Mi Guia) for a total of six weeks. In order to minimize potential 
confounding factors during the intervention or control delivery, participants will complete the same 
procedures regardless of randomization assignment. 
We will follow the same consenting and scheduling procedures we used for previous study aims. When 
participants are eligible and agree to participate, we will ask them to set up a time for an in-person 
consenting process (see consent section below) and for an initial meeting. As we did during Aim 1c, 
during the call when we set up a meeting for the initial interview, we will also ask participants whether 
they would like to borrow a study phone or use their own, and if they will need the study team to create 
a temporary email address to log into the phone application. These preparatory questions will help the 
research team have all study materials ready for the first meeting. At this point we will also tell 
participants they can receive a text message to remind them of the appointment location (see Study’s 
Text Messages and Phone Screening documents). All text messages will be sent only from a secure 
Northwestern’s Outlook account. 
As it was done during Aim 1c, during the first meeting after the consent and HIPAA authorization, 
participants will be asked to complete a demographics questionnaire. We are requesting HIPAA 
authorization in order to obtain medical and treatment-related information from participants’ medical 
records (e.g., stage of diagnosis, cancer treatments and dates of treatment) as these data will be 
considered covariates in our data analyses. Only the information listed in the Post-Consent EMR 
Extraction form used in previous aims will be collected. During the consent process, we will tell 
participants that they will receive text message reminders for their weekly call and final two 
appointments (see Study’s Text Messages document). 
Participants will then complete a multiple choice baseline assessment consisting of 9 validated 
questionnaires: the Impact of Event Scale (IES), Knowledge about Breast Cancer, the Communication 
and Attitudinal Self-Efficacy scale for cancer (CASE-cancer), the COPE, the Social Provisions Scale, 
the Nutrition Questionnaire, the International Physical Activity Questionnaire, and the FACT-B. This 
baseline assessment is estimated to take 15 minutes to complete. In order to make it easier for 
participants to complete this questionnaire, we created a page with the response options to use when 
answering the questions in the assessment. This same document would also be used during their 
follow-ups assessments, which consist of the same questions as the baseline assessment. 
Once the baseline assessment is completed, participants will go through an orientation of their 
corresponding application. 
Participants will be given the option to either use their own phone to download the application, and be 
reimbursed $15 for data usage at the end of the trial; or they can choose to borrow a study phone (an 
Android Nexus 5X) with the application already downloaded. Once the participant downloads the 
application or is provided with a new phone, we will create a unique account with the participant. Only 
an email address and password is required to register. If the participant does not have an email address, 
we will create a temporary email address using pseudonyms. During the registration we will go over 
all the features of the application with the respondent, and address any questions. At this point we 
would give participants a copy of the orientation document so that they can refer to the images and 
instructions in the document in the future if they have questions during their individual use. 
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Additionally during the orientation, participants will be a given a packet of documents to take home 
that will include responses to all of the questionnaires for the second and third meetings (in case they 
would like to complete the 2 follow up questionnaires over the phone), as well as a calendar to help 
them track their study progress. Participants who borrowed a study phone will also receive a mailing 
packet with instructions on how to mail our study phone. All participants will have the option of 
receiving a headset to interact with the application, it will be provided free of charge. During the first 
meeting, participants will receive the first portion of the study incentive $30, and be reimbursed for up 
to $7 for transportation expenses. 
The baseline assessment, and the protocols to be used during registration/orientation is attached to this 
IRB application. The total estimated time for completing the demographics questionnaire, baseline 
assessment and orientation process is 1 hour. 
During the first six weeks, participants will be encouraged to use their respective application for two 
hours each week, and will be assigned weekly telecoaching calls based on their level of adherence to 
the recommended application use (see Figure 1). We will use a stepped-care approach to schedule 
telecoaching calls with participants in order to enhance adherence during the first six weeks of active 
application use for both control and intervention conditions. Based on this approach, participants will 
stop receiving regular telecoaching calls if they continue to use the application for a minimum of 1.5 
hours per week. Adherent participants who continue to meet the goal will receive encouraging text 
messages in lieu of a call (see Study’s Text Messages document), unless they fall under the 1.5 hour 
threshold, and trigger a telecoaching call. All participants are also asked to complete a 7 question 
FACT-G7 questionnaire every week for the first six weeks of the study.
After six weeks of active application use and telecoaching in the intervention or control conditions, 
participants will complete two follow-up appointments. At the end of week six, they will complete 
their first follow-up meeting, they will complete an assessment consisting of the same questions from 
the baseline questionnaire, as well as an exit interview (the baseline questionnaire, and exit interviews 
were previously used in Aim 1c of this study). The duration of the meeting is estimated to be under one 
hour. This meeting can be completed over the phone, or in person at Northwestern depending on the 
participant’s request. 
Two weeks later, we will contact participants for a final 30-minute long assessment consisting of the 
questions same questions from the baseline which measure our primary outcomes and intervention 
targets. Participants will not be expected to use the phone application, and will not receive 
telecoaching calls during the 1st follow-up and the 2nd follow-up period. 
Participants also have the option of coming to our office at Northwestern for our last meeting. If they 
choose to come to Northwestern for the final meeting, they can have their compensation in cash rather 
than receiving the amount in a gift card via mail. 
We will first submit all English versions of our Aim 2 documents and application conten to the IRB. 
Once the English versions of the documents are approved, we will submit final clean versions of the 
Spanish documents. This will help minimize back-and-forward resubmission of documents due to any 
changes requested prior to final approval.
After the 8 weeks, participants will have the opportunity to receive the application they did not have 
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access to during the trial. We would like to make sure that even participants that were not assigned the 
intervention application (My Guide) have the opportunity to learn from it if they want to. Similarly, it 
is possible that the My Health application will be useful for My Guide participants. Participants will be 
promised access to the other application for 8 weeks. 
We cannot promise indefinite access to either of the study applications since we are not sure of the cost 
to host the applications long-term. However, if a participant wants to continue to use either application, 
we will allow them to keep it, but we will inform them that they could lose access to the application at 
any time after the initial 8 weeks. 
Cultural Awareness. 
Mi Guia will be culturally informed so that it is aligned with Hispanic values and beliefs such as 
familism, fatalism and external locus of control, and gender roles.27,43,60 All study content will be 
available in English and Spanish. Much of our study content has already been translated into Spanish13 
and content that requires translation will be translated by an in-house team of IRB-approved translators 
at Northwestern and reviewed by all bilingual investigators and staff for approval. Bilingual 
telecoaches will receive additional intensive training based on models of multicultural awareness. In 
instances where beliefs, spirituality and mental health stigma are discussed, the telecoach will strive to 
balance tradition with medical practice, respect spiritual beliefs and destigmatize mental health care. 
Dr. Penedo and Dr. Yanez have successfully implemented these models in psychosocial interventions 
in Hispanic cancer survivors. 
More on Weekly Telephone Coaching. 
Telecoaching calls are designed to increase adherence to the recommended time of use during the first 
six weeks of the study, and to resolve any issues when accessing the application if any. We will use a 
stepped-care approach to schedule telecoaching calls with participants in order to enhance adherence 
during the first six weeks of active application use for both control and intervention conditions. We 
will use a stepped-care approach to schedule telecoaching calls with participants based on their level of 
adherence to the recommended application use (see Figure 1). Using this model, participants who 
continue to use the application for at least 1.5 hours per week will stop receiving regular telecoaching 
calls, and will receive encouraging weekly text messages instead. Participants who fall under the 1.5-
hour weekly threshold will receive regular telecoaching calls with trained telecoaches. The 
telecoaching calls will be delivered in a Motivational Interviewing style.19 During the first call, 
telecoaches will conduct a decisional balance exercise with participants to resolve potential 
ambivalence around using the application regularly. During the decisional balance exercise, 
participants will weigh the advantages and disadvantages of using the application regularly, and will 
set personalized weekly goals regarding their usage with their telecoaches. During subsequent calls, 
telecoaches will review participants’ weekly usage and will give them personalized feedback regarding 
goal attainment. Barriers and facilitators to usage will be discussed, and telecoaches will problem solve 
with participants to set future usage goals. All telecoaches will complete training on Therapist Training 
Manual comprised of intensive in-class training in psychosocial interventions such as motivational 
interviewing (see Telecaoaching Guide attached to application). Coaches will have access to 
participants’ activities through the study website interface. The PI and Co-Investigators have prior 
experience from CBITs trials. Dr. Buscemi will conduct training for the telecoaches and Dr. Buscemi 
will supervise the telecoahes on a weekly basis. Training will include sensitivity to issues relevant for 
Hispanic BCS, including cultural beliefs that may influence coping and health behaviors. Telecoaching 
sessions will be audio-recorded per CBITs procedures to monitor fidelity. More specifics about the 
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recruitment procedures, consent process and other aspects of the study for Aim 2, as well as all the 
corresponding documents will be submitted at a later modification upon completion of Aim 1. 
Telecoaching sessions will be audio-recorded to monitor intervention fidelity.
5.0 Multiple sites: 
Participants will be recruited from Northwestern during all study aims, and Northwestern will be the 
lead site throughout the duration of the study. Participants for Aims 1c and 2 will be also recruited 
from the University of Illinois at Chicago (UIC). Researchers at UIC will be engaged in research 
procedures, and will also have access to PHI. The NU IRB will be the IRB of record, we will upload 
documentation to corroborate this agreement, and we will add UIC researchers engaged in research to 
the NU IRB. We will for the most part use the same documents for UIC and NU participants. 
However, since recruitment and consenting documents differed significantly prior to the IAA, we will 
keep a unique UIC brochure and consent document. We will also submit a recruitment script with a 
different introduction for UIC participants who are recruited in a different way from NU participants 
(see Recruitment procedures). 
Northeastern Illinois University investigators Rachel Addler and Francisco Iacobelly will collaborate 
with the Northwestern team in developing and conducting Aim 1b of the project only. The NEIU IRB 
has also agreed to make Northwestern the IRB of record (see attached agreement between the 3 
institutions), and we will add NEIU researchers to the NU IRB. However please note that NEIU 
researchers will only access participant PHI during Aim 1b. Starting the field trial, NEIU will assist 
with the development of materials, but they will not access PHI, or be engaged with researching 
participants directly.  
DePaul University investigator Joanna Buscemi will collaborate with the Northwestern team during 
Aim 1c and Aim 2. Dr. Buscemi will guide tele-coaching calls during Aim 1c and Aim 2, and she will 
be accessing PHI during these two phases of the study. Northwestern will request an IRB 
Authorization Agreement from DePaul University prior to Dr. Buscemi’s engagement in the research, 
and upload the signed IAA form to the supporting documents page once approved. We will also upload 
her CITI training to the supporting documents page. 
6.0  Recruitment:
Participants for Aims 1a, 1b, 1c and 2 will be recruited from the Robert H. Lurie Comprehensive 
Cancer Center (RHLCCC). During Aim 1c and 2, the University of Illinois at Chicago Cancer Center 
will be added as a recruitment site.  Across all Aims, participants will also be recruited through Judy 
Guitelman, the associate director of the Latina Association of Breast Cancer. 
During Aim 2, we will also begin recruiting from ELLAS, a breast cancer support group organized 
through The Resurrection Project Chicago. Araceli Lucio, the organizer of ELLAS has agreed to let us 
distribute brochures through her organization. However, since she works closely with, and holds 
meetings at various community organizations and clinics in Chicago,  she recommended a more 
general brochure that highlights our collaboration with ELLAS and the community. As we continue to 
make more relationships with community stakeholders, we hope to be able to distribute this brochure 
across different groups that are willing to share it with the community.
 
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Finally, the PI has previously conducted studies with the same patient population where participants 
have been asked if they would like to hear about similar studies. Whenever possible, participants that 
have consented to be contacted for similar studies who are eligible will be asked if they would be 
interested in participating. 
For participants recruited from the cancer center at Northwestern, once a patient is identified as 
potentially eligible based on the EMR screening, and following physician approval to make contact 
with the patient, prospective participants will be contacted via a mailed pre-recruitment letter. Study 
staff will send the potential participant this letter, which introduces the study. One week later, unless 
the potential participant contacts the study staff to opt out of the study, the study staff will call the 
potentially eligible participant to provide additional information about the study. During this call, if the 
potential participant expresses interest, bilingual and bicultural study staff will proceed with a brief 
eligibility phone screening to determine further eligibility. 
For participants recruited at the University of Illinois, Dr. Perez-Tamayo and Yvette Castro will be 
involved in identifying potentially eligible participants from her clinic. In order to minimize the 
possibility of coercion, neither she nor her staff, Yvette Castro, will be involved in consenting 
participants. Both Dr. Tamayo and Yvette Castro will be added as research staff, however, other 
members of the study staff at Northwestern will be involved in consenting patients recruited from UIC. 
This recruitment and consent structure will minimize possibility of coercion for participants recruited 
from Dr. Perez-Tamayo’s clinic. Dr. Perez Tamayo and Yvette Castro will introduce the study to 
potentially eligible patients using the study brochure and recruitment scrip, if patients agree to 
participate they will forward their name and phone number to the NU research staff to continue with 
the phone screening and setting up a time of their first meeting.  At UIC, the EMR screening form will 
be used as a guideline only in order to guide the initial participant screening by Yvette Castro and Dr. 
Perez Tamayo. However, no information from the EMR will be recorded on this form by UIC 
personnel, only contact information necessary to call participants will be recorded in order to continue 
with recruitment and phone screening.
Potential subjects recruited from the Latina Association of Breast Cancer will be identified by Judy 
Guitelman, the association director. Ms. Guitelman is informed of the study goals, procedures, and 
eligibility. Ms. Guitelman will briefly discuss the study goals and procedures with potentially 
interested women, and provide them with a study brochure. The study staff will call the women that 
express interest and agree to being contacted.  During this call, research staff will provide the 
potentially eligible participant with additional information about the study, if the potential participant 
expresses interest, bilingual and bicultural study staff will proceed with a brief eligibility phone 
screening to determine further eligibility. 
 
7.0  Consent Process.
Upon meeting study eligibility, participants will be scheduled for an in-person visit at our laboratory 
space in the Department of Medical Social Sciences, or at a location of their choice if travel to the 
university is not feasible, where they will be provided additional information on the study (e.g., risks, 
benefits, procedures). We will assure that participants have a full understanding of the written 
informed consent by asking them several questions to ascertain comprehension (e.g., what is your 
understanding of the purpose of the study? Can you briefly explain to us what is expected of you? Can 
you please tell us what are the risks involved? The benefits involved?). We have used this approach in 
the past and it has helped us ascertain that our participants fully understand all procedures, and 
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provides us with an opportunity to clarify or answer any questions. In order to minimize the possibility 
of coercion or undue influence, all study staff who are involved in the consent process will repeatedly 
remind potential participants that their participation is voluntary and that participation or lack of 
participation in the study is not related to the receipt of their medical care. 
Written consent will be obtained for each aim of the study. Women participating in the longitudinal 
aspects of the study (i.e., Aims 1c and 2) will only be asked to complete consent one time. Only the PI, 
CO-Is, and trained members of the study staff will be able to consent participants. We anticipate that 
the consent process will take between 15-20 minutes for Aims 1a and 1b and 20-25 minutes for Aims 
1c and 2 as these aims will require additional explanation regarding the longitudinal intervention. 
All participants will have the choice to complete the consent form in English or Spanish. Participants 
who request to complete the consent in Spanish will be consented by a fully bilingual members of the 
research team. Consent will be translated into Spanish by Diana Buitrago. Ms. Buitrago is a native 
Spanish speaker and is IRB-certified to translate documented from English into Spanish. 
Community stakeholder participants for Aim 1d will be read a verbal consent to inform them about the 
study. There are no risks associated with this aim of the study, and many of the initial interactions with 
stakeholders will be via phone call or email. It would not be feasible to attain written consent prior to 
their use of My Guide. Additionally, the questions to these participants will not be about them, but 
about the application (see exit interview already being used with Aim 1c participants).
8.0  Process to Document Consent: 
As stated above, participant consent will be obtained by bicultural and bilingual study staff using site 
appropriate IRB approved informed consent documents. These forms will be reviewed, discussed as 
needed, and then signed and dated by the participants on the date of their interview for Aims 1a, and 
1b, and on the first meeting for the longitudinal portion of the study (Aims 1c and 2). The translated 
final Spanish versions of all participant-facing materials for Aim 1c will be submitted prior to 
recruitment once the final English versions of the documents have been approved by the IRB. This will 
help minimize back-and-forward resubmission of documents due to any changes requested prior to 
final approval.
Community stakeholder participants for Aim 1d will be read a verbal consent to inform them about the 
study. There are no risks associated with this aim of the study, and many of the initial interactions with 
stakeholders will be via phone call or email. It would not be feasible to attain written consent prior to 
their use of My Guide. Additionally, the questions to these participants will not be about them, but 
about the application (see exit interview already being used with Aim 1c participants).
9.0  Risks to Participants:
It is possible that participation in the study interviews may cause minimal psychological discomfort 
among women for some women. In our past research on breast cancer survivors, a few participants 
have at times become tearful when being interviewed about their experiences with cancer treatments. 
However, this psychological discomfort has always been brief, lasting a few minutes, and appropriate 
regarding the nature of the discussion. If women become psychologically uncomfortable during our 
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interviews, we will offer the participants the opportunity to take a break, remind the participant that her 
participation is voluntary and that she has the right to not answer any questions.  
We have not encountered serious psychiatric disturbance (e.g., suicidal ideation) in our previous 
psychosocial research in cancer. However, in the event we encounter participants in acute crisis 
during the interviews, we will provide immediate assistance in-person as appropriate and refer 
them for local treatment. Speaking privately with the participant, we will assess for suicidal 
ideation, plan of action, and likelihood of carrying out the plan. We will help the participant obtain 
immediate assistance in the home (e.g., ask if spouse/friend can be contacted) and will encourage 
her to seek medical attention if she is at high risk. Local resource referrals will be kept on file to be 
used in the event of such an emergency. Dr. Penedo is a licensed clinical health psychologist, 
experienced in psychotherapy, and counseling of patients and families dealing with chronic and 
acute medical conditions, particularly cancer. Drs. Yanez and Penedo are have doctorates in clinical 
psychology and have provided individual therapy for patients through the supportive oncology 
program at the RHLCCC.
Specifically regarding the individual (unsupervised) use of the application, we do not foresee that the 
use of the application will cause distress. This application is meant to increase self-efficacy in 
communication and coping with emotions, as well as increase knowledge about breast cancer. It 
contains information only from legitimate sources, and it has been vetted by multiple clinical 
psychologists and doctors at Northwestern and UIC. Still, we have included disclaimers in the Aim 1c 
consent, the application and the scripts, reminding participants that the use of the application does not 
replace standard care provided by a doctor, and they are encouraged to tell their physical before about 
any changes to their health regimen. They are also instructed to call 911 if they have an urgent medical 
or mental health issue.
Additionally, women will be able to contact us if they have less pressing questions regarding the phone 
application, and they will also receive a weekly call, during which we will ask about any issues or 
concerns they have experienced. It is important to note that we included an additional disclaimer, 
letting them know that if they attempt to contact us, it might take up to 72 hours for us to respond. 
Once again, if they are having any urgent medical or mental health issues they are instructed to call 
911, or their nearest emergency department. 
There is a slight risk of loss of confidentiality. While any information transmitted through the 
application is protected (see data security section), there is some possibility that others may see 
participants open the application on the smartphones. We have included language in the consent 
reminding participants of this potential risk. Although the application does not collect any identifiable 
information except for the email address during login, if they have privacy concerns, they are 
instructed to use the application in private.  
One final foreseen risk is that patients occasionally try to access the smartphone or participate in 
assessments while walking or driving. Risks associated with cell phone use and walking or driving will 
be managed by informing the participants that they are not permitted to use the phones while driving or 
walking. 
We do not anticipate the need to withdraw participants from any of the study aims without their 
consent. All study data that is already collected, including screening data, will be considered usable 
data in the event that a participants voluntarily withdraws from the study. 
There are no risks associated with participation in Aim 1d for community stakeholder participants. 
10.0  Potential Benefits to Participants: 
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Participants in Aims 1a and 1b will not receive any direct benefit from study participation. However, 
we have found in our previous work that participants have often expressed gratitude for the 
opportunity to share their cancer-related experiences and to have the opportunity to contribute to 
research that may benefit other patients with cancer. 
Participants in Aim 1c and Aim 2 will most likely benefit from the intervention content that is 
designed to improve health-related quality of life and reduced symptom burden. The magnitude of this 
potential benefit is expected to be moderate to high with a potential duration of several years. 
Participants randomized to health control in Aim 2 will benefit from learning more about breast cancer 
and healthy living (e.g., diet, exercise, nutrition). In our previous research, we have found that former 
cancer patients have reported medium to high satisfaction with learning about healthy living and have 
reported that they have been able to incorporate the information on healthy living into their everyday 
routines.  
There are no benefits associated with participation in Aim 1d for community stakeholder participants. 
11.0  Financial Compensation:
Participants will receive $35 dollars, in cash, for their participation in Aims 1a and 1b. Participants will 
be compensated even if they withdraw from the study before finishing. Participants will be 
compensated $100 for participation in Aim 1c , the field trial. Participants will be compensated $35 at 
the start of the trial, and will receive the remaining $65 upon completion of the trial. Participants who 
withdraw from the trial before finishing will not receive their remaining $65. Participants will be paid 
in cash. We do not foresee any costs to participants because we will cover transportation costs to our 
laboratory space within the Department of Medical Social Sciences (e.g., reimbursement for parking, 
CTA travel).
In Aim 2 participants will receive a total of $100 at the end of the study. $30 will be given at the end of 
the first in-person meeting. At the end of the third meeting after completion of eight weeks, they will 
receive $70 through a gift card if they complete the appointment over the phone, or cash if they 
complete the final appointment in person. In addition those who did not receive a study phone will 
receive $15 to help cover the cost of data. In addition, there is an option for participations to receive 
transportation reimbursement for the first in-person meeting of a maximum of $7. Additionally, all 
participants who completed all three study appointments will be entered into 3 raffles to win an 
additional $50 gift card received via mail. The raffle will occur no later than 3 months after completion 
of the study and participants will be notified the day of the raffle via text. Only one win per participant 
will be available. 
Aim 1d participants will receive $100 dollars for reviewing the application Mi Guia and for 
participating in the 1-time, 1hr interview.
12.0 Provisions to Protect the Privacy Interests of Participants:
For all aims, we will ensure privacy by interviewing or assessing participants in a private room in the 
Department of Medical Social Sciences or a location selected by the participant. Only the study PIs, 

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the Co-Investigators, and trained members of the research staff will have access to any sources of 
information about the participants. Access to the computer data files will be by password codes. The 
list matching participant number to identifying information will be maintained in a locked drawer 
located at Northwestern University in the office of Dr. Betina Yanez, Northwestern PI for the study. 
Additionally, in order to be able to track participants, we will keep a separate record of each 
participant’s address, telephone number and contact person information. This record will indicate 
whether or not a participant has completed the study but will not include information concerning their 
assessment or intervention performance. Participants will be made explicitly aware at the time of the 
informed consent of the nature of the two separate records that will be kept.
13.0 Confidentiality and Data Management:
All participants’ files including the signed, dated informed consent documents will be stored in a 
secure, locked cabinet. Participants’ identities will be protected by removing all identifying 
information from interview and additional demographic and medical/treatment data. Participant 
names and phone numbers, which are obtained for the purpose of recruitment and scheduling, will 
be stored on a password protected FSMserver and destroyed at the end of data collection. All 
names and contact information will be stored securely and separately from the completed consent 
forms and electronic data collected from the medical record. Confidentiality will be maintained by 
keeping all research paper-based records (e.g., study data, consent forms) in locked file cabinets 
located at Northwestern University in the office of Dr. Betina Yanez, Northwestern PI for the study 
and for electronic data access to the computer database will be restricted to key study personnel and 
will be stored on the password protected  FSMserver. No information will be stored directly on 
desktops/individual computers, but only on the server. Audio-recordings will be destroyed following 
data analyses by being deleted from the FSM server, the only location where they are stored. All 
personnel involved in this project will be trained with regard to the importance of maintaining patient 
confidentiality.
For Aim 2,  all research data will be organized and managed using REDCap electronic data capture 
tools hosted at Northwestern University. REDCap (Research Electronic Data Capture) is a research 
management tool which enables a secure study website accessible to all IRB approved research team 
members regardless of study site. The REDCap website will be used to administer the screening, 
sociodemographics, baseline and follow-up questionnaires, and to organize medical record review 
data. My Guide usage data and weekly questionnaires will be captured via the CBITs My Guide 
interface and uploaded to REDCap to centralize all research information. Once collected, all research 
data will be imported into SPSS for cleaning and analysis. (The REDCap platform provides automated 
export procedures for seamless data downloads to common statistical packages.)
All data collected from participants will be kept strictly confidential, except as mandated by law. All 
research files, including study data, are kept on secure, password protected departmental and medical 
school servers. All electronic data will be stored on secure servers behind firewalls meeting all security 
requirements of the medical school.  
For Aim 1c and Aim 2, all procedures regarding self-reported and EMR recorded data remain the same 
as were described above.  Regarding confidentiality of information collected and transmitted via the 
smartphone application in in Aim 1c and Aim 2 of the study, all data collected will be transmitted 
using Transport Layer Security (TLS) encryption to prevent eavesdropping and tampering of 
information and data while they are in the transmission pipeline. To prevent unauthorized access to the 
Smartphone, all phones will be set up to be password protected (password selected by the participant at 
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the time of phone training). All electronic data will be stored on secure servers behind firewalls at the 
Center for Behavioral Intervention Technologies at the Northwestern University Feinberg School of 
Medicine. Internet interventions and mobile assessments will be conducted through Purple 
Development Environment, which is a development and deployment platform created and maintained 
by the Northwestern University Center for Behavioral Intervention Technologies (CBITs).  This 
platform uses up to date security measures that are consistent with those used by Electronic Medical 
Records and are HIPAA compliant. All data collected via the interventions and assessments are 
transmitted using Transport Layer Security (TLS) encryption to prevent eavesdropping and tampering 
information while it is in the transmission pipeline. In addition, all data stored within the intervention 
is de-identified with a unique key. Security measures to protect privacy threats associated with users’ 
computers and devices include the following measures: users are automatically logged off of 
intervention and assessment tools after 5 minutes of no activity; any data stored locally is 
automatically encrypted using 128-bit Blowfish encryption based on the user authentication 
information and cannot be accessed without this information. (After five failed attempts to access, this 
information is deleted and must be restored from remote backup).  All information collected by this 
application will be immediately transmitted to CBITs, this application does not save any data to the 
phone’s memory.
During Aim 1c and Aim 2, each participant will login to the application with a unique password using 
an email address. Besides the email required for login, no other PHI will be collected by this 
application, or stored/requested by the application at any point. The FACT-G7, already administered to 
patients during the phone eligibility screening, will be re-administered weekly by the application, 
however note that the FACT-G7, a multiple choice questionnaire, does not collect any PHI. 
Application usage (e.g., number of logins to the application) will also be collected by the application. 
Participants will be given the option to either use their own phone to download the application, or they 
can choose to borrow a study phone (an Android Nexus 5X) with the application already downloaded. 
Once the participant downloads the application or is provided with a study phone, we will create a 
unique account with the participant. Only an email address and password is required to register, if the 
participant does not have an email address, we will create a temporary email address using 
pseudonyms, which will be deleted at the end of the trial. 
At the end of participation, the application will be deleted from the participant’s phone, and no other 
information will be collected, unless the participant explicitly requests to continue using the 
application. Participants that elect to continue using the phone, will be instructed to not complete a 
weekly questionnaire. For participants that borrowed a study phone, the application will also be deleted 
from the phone, and the phone will be reset to the factory setting.
The master key with unique identifiers used to track the data collected during the application (the list 
with the unique application identifier and the email address) will be stored on a password protected 
server at Northwestern Feinberg School of Medicine and destroyed at the end of data collection by 
deleting it from the server. Only IRB approved members of the research staff will have access to the 
master key. The Northwestern site PI and a trained, bilingual research assistant will conduct the 
interviews in Aim 1a. The interviews for Aim 1a will be audio-recorded and transcribed resulting in a 
more complete data set than if only notes were taken of the responses. Audio recording for Aim 1a 
interviews is mandatory for the study as all recordings will be transcribed and analyzed for thematic 
content. Participants will not have the opportunity to edit the recordings or the transcripts. The 
audio tapes from Aim 1a will be reviewed by the Northwestern PI. In order to facilitate 
confidentiality, the patient’s name will not be mentioned during the interview. The interviews will 
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be transcribed by GMR Transcription (a company used by many departments at Northwestern 
that already has an NU business associate agreement in place to work with study data). Five to 
10% of the taped interviews will be chosen at random and their transcriptions checked for accuracy 
by the Northwestern PI or a trained research assistant working with the Northwestern PI. A code 
book will be developed to categorize the responses to the open-ended questions from the 
interviews.
Planned Analyses Aim 1: Grounded theory methods will be used to guide analyses for Specific Aim 
1a. Grounded theory is appropriate when the study of social experiences aims to explain a process. 
Recordings from the interviews will be transcribed verbatim. All data will be coded using NVivo 
software. Responses from the interviews will be examined systematically. Based on the principles of 
grounded theory, two independent raters will generate a list of themes expressed by participants. 
Members of the study team will participate in an iterative group process to develop a coding manual 
used to identify themes from the interviews. We will reduce subjectivity by using two coders and a 
calculated agreement between coders (Kappa). The codes will then be compiled in frequency tables. 
For qualitative data analysis, an analogue to statistical power is “data saturation,” or the point at which 
successive information serves only to replicate previous content themes and no new information is 
obtained. Based upon recommended methods for determining saturation, we will consider a concept as 
“saturated” when it has been mentioned by at least 70% of the sample. Past research reveals that 
saturation often occurs within the first ten to twelve interviews and basic elements for themes are 
sometimes present as early as six interviews. We therefore expect to achieve data saturation with our 
proposed sample of 20 women. Analyses from Aim 1b include descriptive statistics on the USE 
Questionnaire and qualitative summaries of participants’ comments regarding the usability of the 
Smartphone-based application. Information obtained from participants in Aim 1b will be reviewed by 
the PI and Co-Investigator and based on these data they will make decisions to modify the 
Smartphone-based application, Mi Guia. Analyses for Aim 1c include descriptive statistics on the 
Smartphone-based application, Mi Guia (e.g., number of logins to the application, mean time spent on 
the application). These descriptive statistics will provide valuable information to the investigators as to 
how often participants are engaging with the mobile application and therefore using the intervention. 
Planned Analyses Aim 2: Descriptive statistics will be used to characterize the overall sample and each 
condition. We will use Chi-square, Fisher’s exact tests, and Mann-Whitney U test for nonnormal data, 
as appropriate, to preliminarily examine differences in feasibility between the study conditions. While 
the sample sizes of 40 per condition will have 80% power to detect 0.63 standard deviations for our 
main outcomes. For all outcomes, change from baseline will be calculated and the mean changes 
within study condition will be converted to effect sizes. Effect sizes will be defined as the difference in 
means or proportions between the study conditions divided by the standard deviation of the outcome. 
Follow-up scores on the outcomes, HRQoL and cancer-specific distress, as well as all intervention 
targets, will be compared between study conditions, adjusted for baseline score, using analysis of 
covariance (ANCOVA). We will also reference established cutoffs for clinically meaningful 
differences for scores on the FACT, and FACT subscales, to identify ranges and patterns of change 
scores in HRQoL across the study conditions from study baseline to the follow-up assessments. Mixed 
effects models will be used to model the study outcome scores, and all intervention targets, over time 
for each group. Type of treatment, time since completion of active treatment, stage of diagnosis, 
education, marital status, language, comorbidities and age at diagnosis will examined for their 
associations with study outcomes for potential entry as covariates in the statistical model.  
14.0 Data Monitoring Plan to Ensure the Safety of Participants:
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For Aim 1a and 1b the informed consents, all assessment measures and intervention modules will be 
reviewed and subject to approval by the Institutional Review Board at NU. As detailed in the Human 
Subjects section of the protocol and in the informed consent document, this study involves minimal 
risk to study participants. Regarding participant safety, any occurrence of a serious adverse event (e.g., 
hospitalization, injury, death) will be discussed at the weekly project meeting. Adverse events will be 
documented, logged, and submitted to the IRB within the mandated time frame. The PI will review the 
data safety quarterly, and a cumulative report will be submitted to the IRB on an annual basis as 
required for continuing review and/or final report. Interim analyses for the purposes of discontinuing 
the study will only be conducted if during a review of adverse events it seems that risks or 
complications appear to be greater than those originally stated. For Aims 1c and 2, if the PI or IRB 
suspects that an unusual number of adverse events are occurring, the PI will determine if the adverse 
events occur significantly more frequently in any one condition. In the unlikely event of such analyses, 
the IRB will be informed of these results in a timely manner. Moreover, the IRB will be informed 
within one working day of any temporary or permanent suspension of the protocol. 
15.0  Data and if applicable, Specimen Banking: 
All data is kept in encrypted and password protected files on a locked Northwestern University 
network. Participant names and all other identifying information are kept in a separate, locked and 
protected location Data will be stored for a period of five years after the study results have been 
published. At this point any paper-based data will be shredded and electronic data will be deleted. Data 
will not be stored for future use nor will data be stored outside of Northwestern. Data may be released 
to a third party if required by law (e.g., court order). All data will be kept in encrypted and password 
protected files on a locked Northwestern University network. Participant names and all other 
identifying information are kept in separate, locked and protected locations to ensure participant 
identity cannot be linked to their study data. 
16.0 Qualifications to Conduct Research and Resources Available:
Dr. Betina Yanez will serve as the Northwestern site PI and Dr. Frank Penedo will serve as the study 
Co-Investigator. 
Since her faculty appointment in 2013, Dr. Yanez has received funding from the NCI and American 
Cancer Society to conduct research in cancer control and survivorship and health disparities in cancer 
outcomes. Dr. Penedo is the leader of the Cancer Control and Survivorship Program and the director of 
the Cancer Survivorship Institute at the RHLCCC. He has received numerous grants to investigate 
cancer survivorship outcomes and disparities in patient-reported outcomes and culturally tailored 
interventions in oncology. Both Dr. Yanez and Dr. Penedo have numerous peer-reviewed publications 
in the area of cancer control and survivorship and ethnic minority health. 
The research will be conducted within Dr. Yanez’s laboratory space in the Department of Medical 
Social Sciences. Dr. Yanez and her staff have computers, audio recorders for recording the interviews, 
and software for analyzing interviews (NVivo). Dr. Yanez’s office and laboratory space also has 
locked filing cabinets for storing paper-based data. 
We have not encountered serious psychiatric disturbance (e.g., suicidal ideation) in our previous 
psychosocial research in cancer. However, in the event we encounter participants in acute crisis 
during the interviews, we will provide immediate assistance in-person as appropriate and refer 
them for local treatment. Speaking privately with the participant, we will assess for suicidal 
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ideation, plan of action, and likelihood of carrying out the plan. We will help the participant obtain 
immediate assistance in the home (e.g., ask if spouse/friend can be contacted) and will encourage 
her to seek medical attention if she is at high risk. Local resource referrals will be kept on file to be 
used in the event of such an emergency. Dr. Penedo is a licensed clinical health psychologist, 
experienced in psychotherapy, and counseling of patients and families dealing with chronic and 
acute medical conditions, particularly cancer. Drs. Yanez and Penedo have doctorates in clinical 
psychology and have provided individual therapy for patients through the supportive oncology 
program at the RHLCCC.
All research staff will be trained on the research protocol by the PI, Dr. Yanez. Diana Buitrago, the 
study research assistant, is bilingual and has ample experience in research, including consenting 
participants in Spanish and conducting qualitative interviews. Additional research staff will receive 
training on all aspects of human subjects ranging from screening participants to consenting and storing 
study data to ensure confidentiality. Study staff will also receive training on cultural sensitivity and 
awareness by the PI or by the Co-I Dr. Penedo and all study staff will receive training on delivering the 
study intervention Aims 1c and Aim 2 (e.g., conducting assessments, telecoaching calls, participant 
payments). This training will occur prior to implementing Aims 1c 2. 
Figures
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Figure 1 Illustration of the Step-care Protocol for telecoach sessions.
1.
Kagawa-Singer M, Valdez Dadia A, Yu MC, Surbone A. Cancer, Culture, and Health 
Disparities: Time to Chart a New Course? CA Cancer J. Clin. 2010;60(1):12-39.
2.
American C. Cancer Facts & Figures for Hispanics/Latinos 2012-2014 Atlanta, GA: American 
Cancer Society; 2012: 
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/ac
spc-034778.pdf. Accessed October 2, 2014.
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3.
Yanez B, Thompson EH, Stanton AL. Quality of life among Latina breast cancer patients: a 
systematic review of the literature. J. Cancer Surviv. 2011;5(2):191-207.
4.
Luckett T, Goldstein D, Butow PN, et al. Psychological morbidity and quality of life of ethnic 
minority patients with cancer: a systematic review and meta-analysis. Lancet Oncol. 
2011;12(13):1240-1248.
5.
Fu O, Crew K, Jacobson J, et al. Ethnicity and persistent symptom burden in breast cancer 
survivors. J. Cancer Surviv. 2009;3(4):241-250.
6.
Molina Y, Thompson B, Espinoza N, Ceballos R. Breast cancer interventions serving US-based 
Latinas: current approaches and directions. Womens Health (Lond Engl). 2013;9(4):335-348; 
quiz 349-350.
7.
Juarez G, Hurria A, Uman G, Ferrell B. Impact of a bilingual education intervention on the 
quality of life of Latina breast cancer survivors. Oncol. Nurs. Forum. 2013;40(1):E50-60.
8.
Ashing K, Rosales M. A telephonic-based trial to reduce depressive symptoms among Latina 
breast cancer survivors. Psychooncology. 2014;23(5):507-515.
9.
Collins L, Baker T, Mermelstein R, et al. The Multiphase Optimization Strategy for 
Engineering Effective Tobacco Use Interventions. Ann. Behav. Med. 2011;41(2):208-226.
10.
Collins LM, Murphy SA, Strecher V. The Multiphase Optimization Strategy (MOST) and the 
Sequential Multiple Assignment Randomized Trial (SMART): New Methods for More Potent 
eHealth Interventions. Am. J. Prev. Med. 2007;32(5, Supplement):S112-S118.
11.
Byers TE, Wolf HJ, Bauer KR, et al. The impact of socioeconomic status on survival after 
cancer in the United States : findings from the National Program of Cancer Registries Patterns 
of Care Study. Cancer. 2008;113(3):582-591.
12.
Lopez MH, Gonzalez-Barrera A, Patten E. Closing the Digital Divide: Latinos and Technology 
Adoption. 2013. http://www.pewhispanic.org/2013/03/07/closing-the-digital-divide-latinos-
and-technology-adoption/. Accessed October 1, 2014.
13.
Penedo FJ, Traeger L, Dahn J, et al. Cognitive behavioral stress management intervention 
improves quality of life in Spanish monolingual hispanic men treated for localized prostate 
cancer: results of a randomized controlled trial. Int. J. Behav. Med. 2007;14(3):164-172.
14.
Yanez B, Stanton AL, Maly RC. Breast cancer treatment decision making among Latinas and 
non-Latina whites: A communication model predicting decisional outcomes and quality of life. 
Health Psychol. 2012;31(5):552-561.
15.
Yanez B, Hermiller M, Wortman K, et al. Initial Findings from a Technology Based 
Intervention for Advanced Prostate Cancer Patients. International Congress of Behavioral 
Medicine; 2014; Groningen, Netherlands.
16.
Yanez B, Mohr DC, Begale M, et al. Preliminary Evidence for the Efficacy of a Technology 
Based Intervention for Patients with Advanced Prostate Cancer. International Society for 
Research on Internet Intervention; 2014; Valencia, Spain.
17.
American C. Cancer Facts & Figures 2013. Atlanta, GA: American Cancer Society; 2013: 
http://www.cancer.org/acs/groups/content/@epidemiologysurveilance/documents/document/ac
spc-036845.pdf. Accessed October 2, 2014.
18.
Carver CS, Smith RG, Antoni MH, Petronis VM, Weiss S, Derhagopian RP. Optimistic 
personality and psychosocial well-being during treatment predict psychosocial well-being 
among long-term survivors of breast cancer. Health Psychol. 2005;24(5):508-516.
19.
Eversley R, Estrin D, Dibble S, Wardlaw L, Pedrosa M, Favila-Penney W. Post-treatment 
symptoms among ethnic minority breast cancer survivors. Oncol. Nurs. Forum. 
2005;32(2):250-256.
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PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
Page 28 of 29
20.
Maly RC, Stein JA, Umezawa Y, Leake B, Anglin MD. Racial/ethnic differences in breast 
cancer outcomes among older patients: effects of physician communication and patient 
empowerment. Health Psychol. 2008;27(6):728-736.
21.
Ashing-Giwa K, Rosales M, Lai L, Weitzel J. Depressive symptomatology among Latina breast 
cancer survivors. Psychooncology. 2013;22(4):845-853.
22.
Ashing-Giwa KT, Tejero JS, Kim J, Padilla GV, Hellemann G. Examining predictive models of 
HRQOL in a population-based, multiethnic sample of women with breast carcinoma. Qual. Life 
Res. 2007;16(3):413-428.
23.
Sweeney C, Baumgartner KB, Byers T, et al. Reproductive history in relation to breast cancer 
risk among Hispanic and non-Hispanic white women. Cancer Causes Control. 2008;19(4):391-
401.
24.
Janz N, Mujahid M, Hawley S, et al. Racial/ethnic differences in quality of life after diagnosis 
of breast cancer. J. Cancer Surviv. 2009;3(4):212-222.
25.
Fagerlin A, Lakhani I, Lantz PM, et al. An informed decision? Breast cancer patients and their 
knowledge about treatment. Patient Educ. Couns. 2006;64(1-3):303-312.
26.
Chen JY, Diamant AL, Thind A, Maly RC. Determinants of breast cancer knowledge among 
newly diagnosed, lowincome, medically underserved women with breast cancer. Cancer. 
2008;112(5):1153-1161.
27.
Gallo LC, Penedo FJ, Espinosa de los Monteros K, Arguelles W. Resiliency in the Face of 
Disadvantage: Do Hispanic Cultural Characteristics Protect Health Outcomes? J. Pers. 
2009;77(6):1707-1746.
28.
Andersen BL, Yang HC, Farrar WB, et al. Psychologic intervention improves survival for 
breast cancer patients: a randomized clinical trial. Cancer. 2008;113(12):3450-3458.
29.
Andersen BL, Thornton LM, Shapiro CL, et al. Biobehavioral, Immune, and Health Benefits 
following Recurrence for Psychological Intervention Participants. Clin. Cancer Res. 
2010;16(12):3270-3278.
30.
McGregor BA, Antoni MH. Psychological intervention and health outcomes among women 
treated for breast cancer: A review of stress pathways and biological mediators. Brain. Behav. 
Immun. 2009;23(2):159-166.
31.
Myers HF. Ethnicity- and socio-economic status-related stresses in context: an integrative 
review and conceptual model. J. Behav. Med. 2009;32(1):9-19.
32.
Taylor SE, Stanton AL. Coping resources, coping processes, and mental health. Annu. Rev. 
Clin. Psychol. 2007;3(1):377-401.
33.
Ashing-Giwa K. The contextual model of HRQoL: A paradigm for expanding the HRQoL 
framework. Qual. Life Res. 2005;14(2):297-307.
34.
Duijts SF, Faber MM, Oldenburg HS, van Beurden M, Aaronson NK. Effectiveness of 
behavioral techniques and physical exercise on psychosocial functioning and health-related 
quality of life in breast cancer patients and survivors--a meta-analysis. Psychooncology. 
2011;20(2):115-126.
35.
Tatrow K, Montgomery GH. Cognitive behavioral therapy techniques for distress and pain in 
breast cancer patients: a meta-analysis. J. Behav. Med. 2006;29(1):17-27.
36.
Falagas ME, Zarkadoulia EA, Ioannidou EN, Peppas G, Christodoulou C, Rafailidis PI. The 
effect of psychosocial factors on breast cancer outcome: a systematic review. Breast Cancer 
Res. 2007;9(4):R44.
37.
Antoni MH, Lechner SC, Kazi A, et al. How stress management improves quality of life after 
treatment for breast cancer. J. Consult. Clin. Psychol. 2006;74(6):1143-1152.
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.

PROTOCOL TITLE: An e-Health Intervention to Improve Symptom Burden and Health-Related Quality 
of Life among Hispanic Women Completing Active Treatment for Breast Cancer
Page 29 of 29
38.
Stanton AL, Ganz PA, Kwan L, et al. Outcomes From the Moving Beyond Cancer 
Psychoeducational, Randomized, Controlled Trial With Breast Cancer Patients. J. Clin. Oncol. 
2005;23(25):6009-6018.
R: 1/29/2016
IRB #: STU00201961-MOD0034 Approved by NU IRB for use on or after 1/22/2018 through 11/6/2018.