To Enhance Breast Cancer Survivorship of Asian Americans
Phase: NA
Conditions: Breast Cancer
Sponsor: Emory University

Version date: 6/3/2020 
Title Page: 
 
 
o Full study title 
To Enhance Breast Cancer Survivorship of Asian Americans 
Short study title: TICAA 
 
 
o Name, Title(s), and Department of Principal Investigator 
Eun Ok Im, PhD, MPH, RN, CNS, FAAN, Professor, Nursing 
 
 
o Sponsor(s)  
National Cancer Institute 
 
 
o Protocol version number and version date 
June 3, 2020 
 
 
o NCT Number: 
NCT02803593  
 
 

Version date: 6/3/2020 
Background and Significance 
Breast cancer is the leading cancer by site in Asian American women.1–3 For some sub-ethnic 
groups, breast cancer is the leading cause of death.4–8  Asian Americans have been reported to 
have higher relative risks and lower 5-year survival rates with increasing age at diagnosis, 
grade, and stage of cancer.1–3,9–11  Furthermore, Asian American breast cancer survivors often 
carry significant physical and psychological burden; they rarely complain about their 
symptoms, delay seeking help until symptoms become severe, and seldom ask or get support 
due to their cultural values, beliefs, and language barriers.12–16 Subsequently, they report a 
lower quality of life and fewer sources of information and support compared to Whites.1–3,6,9–
11,17–19  Here, a breast cancer survivor means anyone who has been diagnosed with breast 
cancer, from the time of diagnosis through the balance of her life.20 
 
The Institute of Medicine report, From Cancer Patient to Cancer Survivors: Lost in 
Transition,21 explicitly identifies the need of cancer survivors for information on symptom 
management, accurate surveillance of late and long term effects, psychosocial supportive 
interventions to promote well-being, and communication with health care providers. Yet, few 
interventions have been developed to meet the need of cancer survivors including Asian 
American breast cancer survivors.22  Survivorship programs that are increasingly instituted at 
cancer centers have serious impediments to providing information and coaching/support 
because of the lack of staff time and insurance reimbursement.23,24 Furthermore, the pressure 
of fast-paced clinical patient-provider interactions leaves little time for health care providers 
to provide up-to-date information and coaching or support for these women based on their 
cultural attitudes.12–16 All these circumstances necessitate an innovative and creative delivery 
method of information and coaching/support.  
 
A technology-based approach using computers and mobile devices (smart phones and tablets) 
promises to meet this necessity with high flexibility and accessibility, and minimizes the cost 
of the intervention in busy health care settings.25–27  Also, a technology-based intervention that 
does not involve face-to-face interactions could work better for many women from cultures 
where breast cancer is still a stigmatizing experience.28–31, 32–35 Despite the high potential, few 
technology-based interventions are available for ethnic minority breast cancer survivors, 
especially for Asian Americans.36–45  Therefore, based on Preliminary Studies (PSs), the 
research team has developed and pilot-tested a theory-driven technology-based information 
and coaching/support program that: (a) is tailored to Asian American breast cancer survivors 
by incorporating actual data on individual sub-ethnic groups cultural attitudes from PSs; (b) 
uses multiple languages; (c) provides both group and individual (real-time and personalized) 
coaching/support by culturally matched bilingual health care providers; (d) incorporates peer 
support through a social media function; and (e) integrates existing general and culture-specific 
evidence-based educational content from scientific authorities. Among over 71 sub-ethnic 

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groups of Asian Americans,46 only three sub-ethnic groups (Chinese, Korean, and Japanese) 
were selected for the program development for the convenience of the approach (e.g., 
language). Within Asian Americans, Chinese are the largest sub-ethnic group,47,48 Koreans are 
the fastest growing sub-ethnic group,47,48 and Japanese are the sub-ethnic group at the highest 
risk of breast cancer.1,2,11,49 
 
Goals/Aims 
The purpose of the proposed randomized intervention study is to test the efficacy of the 
technology-based information and coaching/support program for Asian American breast 
cancer survivors (TICAA) in enhancing the women’s breast cancer survivorship experience.  
 
The specific aims of the study are to: 
 
Aim 1. Determine whether the intervention group (who uses the TICAA and the information 
on breast cancer by the American Cancer Society [ACS]) will show significantly greater 
improvements than the control group (who uses only the information on breast cancer by the 
ACS) in primary outcomes of the TICAA (needs for help, physical and psychological 
symptoms, and quality of life) from baseline (pre-test) to Time Points 1 (post 1-month; 
primary) and 2 (post 3-months; secondary). 
 
Aim 2. Identify theory-based variables (attitudes, self-efficacy, perceived barriers, and social 
influences related to breast cancer survivorship) that mediate the intervention effects of the 
TICAA on the primary outcomes of the TICAA from baseline to Time Point 1. 
 
Aim 3 (exploratory). Explore whether the effects of the TICAA on the primary outcomes are 
moderated by background factors and disease factors. 
 
 
Study Design 
o 
Organizational structure of the study team: 
 
This is a PI initiated R01 research project that is funded by the National Cancer Institute 
(National Institute of Health).  Due to PI's move from Duke University to Emory University, the 
study is being transferred from Duke Univ. to Emory University. This is the fourth year of the 
total 5 year of funding. This IRB approval is needed for the grant transfer. 
 

Version date: 6/3/2020 
The study team includes the PI, 1 Co-Investigator, 1 Statistician, multiple Consultants, 3 
interventionists and 1 or 2 research assistants. Except the consultants, all research team members 
will be Emory affiliated. The research team will conduct the study at School of Nursing, Emory 
University. 
 
  
o 
Setting and location: 
The settings of the study will include (a) online support groups including social media groups 
and (b) communities/groups for Asian Americans. Over 400,000 online support groups 
currently exist, each with up to 3,587 members.60-62 They have become an important resource 
for researchers investigating cancer survivors residing in different geographic areas, both 
nationally and internationally.60-62 Furthermore, potential participants could be easily recruited 
through the recruitment announcement services provided by social media (a fee is usually 
required though). For example, through a Facebook announcement, Altshuler et al.63 recruited 
women from multi-ethnic groups (within 3 months) for a study on attitudes toward abortion. 
Yet, PSs also suggested that ethnic minority cancer survivors might not be easily recruited only 
through online support groups. Thus, communities/groups for Asian Americans (e.g., churches, 
organizations, health care centers, and professional groups, all of which are for Asian 
Americans) will also be targeted, which allows to recruit those who do not use online support 
groups or who do not have access to the computers. Ethnic minorities are more successfully 
recruited in churches and support/social groups with culturally specific memberships.64 When 
communities/groups for Asian Americans in the U.S. were searched with Google, 1,170,000 
communities/groups were retrieved, each with up to 30,298 members. In addition to these major 
recruitment settings, cancer registries throughout the nation (e.g., Texas and California) will be 
contacted to request the data, which will be used for identifying and reaching out to potential 
participants to send the study announcement and informed consent. 
o 
Population to be studied: 
The participants will be 330 self-reported Asian American women aged 21 years and older who 
have had a breast cancer diagnosis; can read and write English, Mandarin Chinese, Korean, or 
Japanese; and have access to the Internet through computers or mobile devices (smart phones and 
tablets). A total of 210 participants have already been recruited at Duke University and have 
completed their participation before the PI’s move. A total of 120 participants will be newly 
recruited at Emory University. Those who are in treatment or not in treatment will be included 
because the TICAA can be used by those in all stages of treatment. A specific fatigue level was 
not set because compared to those who do not have fatigue or have a low level of fatigue, those 
with a medium or high levels of fatigue would be more likely to need support through technology-
based programs. We excluded those under 21 years old because their cancer experience would be 
different from adults.’ An upper age limit was not set because elderly could be a good target group 
for technology-based programs because technology-based programs do not require physical 

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transportation and because women over 75 years old have the highest incidence rate of breast 
cancer.2 Because using more than four languages is infeasible in a study (Dr. Meleis, Personal 
Communication), and given the diversity of Asian Americans, only four languages including 
English, Mandarin Chinese, Korean, and Japanese will be used. Mandarin Chinese is a primary 
language in China, Taiwan, and Hong Kong; Korean is the primary language in South Korea; and 
Japanese is the primary language in Japan.  
 
o 
Recruitment: 
First, Internet searches will be conducted using multiple search engines including Google, Yahoo!, 
and Bing to identify/verify online support groups and communities/groups for Asian Americans. 
Then, we will contact and ask administrators of the first 100 online support groups and 90 
communities/groups for Asian Americans (30 for each sub-ethnic group) on the verified lists to 
post the study announcement on their sites or listservs and through instant messaging. We will also 
make supplementary/additional announcements through Web postings, listservs, and regular 
meetings with communities/groups that primarily serve Asian Americans of low SES to have an 
adequate number of Asian American breast cancer survivors from low SES (they are less likely to 
be recruited than those from middle or high SES in PSs). The communities/groups that primarily 
serve Asian American women of low SES will be identified through both Internet searches and 
recommendations by research team members including consultants. All the identified 
communities/groups will be contacted and asked to post study announcements with assistance 
from the research team members including consultants. Further recommendations will be sought 
from the communities/groups that are contacted. Then, the study will be announced in the newly 
identified communities/groups. If we do not recruit the target number, the study will be announced 
through an additional 20 online support groups and 30 communities/ groups for Asian Americans 
(10 per sub-ethnic group) each month. This process will be continued until the target number is 
recruited. In addition, we will utilize the cancer registries throughout the nation to contact potential 
participants and solicit their participation in the study. 
A total of 330 Asian American breast cancer survivors will be recruited. Because information is 
limited on which to base power analyses, estimates are based on a two-sided Mann-Whitney test 
(assuming a uniform distribution) using an estimated effect size equal to 1/2 of a standard 
deviation, as suggested in the literature.65  In addition to being clinically meaningful, large effect 
sizes demonstrated in PS4 suggest that 0.5*SD is a statistically meaningful effect size to assume.  
Sample size is based on 80% power, and a type I error rate equal to 0.00625 to account for eight 
primary outcome measures modeled within the two primary aims (group main effects). 
Accordingly, group sample sizes of 105 each achieve 80% power to detect a difference of 0.5*SD 
between group means overall in a single follow-up period. The primary analysis will be an 
assessment of differences by intervention group in changes from baseline to Time Point 1, or one 
month post intervention.  A secondary analysis will include similar modeling for sustainability of 

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intervention effects, or for changes from baseline to Time Point 2. Assuming an attrition rate of 
35% by the Time Point 2, 330 Asian American breast cancer survivors would be an adequate 
number for the study with multiple outcomes. Considering the attrition rates reported in the 
literature66–68 and in PSs, the assumption of a 35% attrition rate is reasonable. 
At the completion of their participation, the participants will be reimbursed with $50 electronic 
gift cards for their participation.  The reimbursement will be prorated. The participants will be 
allowed to choose “do not want to respond”, which will NOT be considered missing data. The 
amount was determined based on preliminary studies. 
 
o 
Description of recruitment materials and their use 
Sample study announcement, sample study announcement in flyer format, and flyer for TICAA 
recruitment will be distributed through and displayed on cancer support groups and 
communities/groups for Asian Americans. 
o 
Describe the procedures for data collection 
 
The data are mainly collected through the Internet survey questionnaire. When potential 
participants visit the project Web site (after receiving/reviewing a study announcement), they 
will be asked to review the informed consent. When participants click I agree to participate, 
they will have given their consent. Then, after checking them against the inclusion criteria and 
quota requirements, only those who meet the criteria and requirements will be automatically 
assigned a serial number, and randomized into two groups using an automated random number 
generator accessible through the Web site.  
 
Then, the women will be asked to fill out the Internet survey questionnaire (if requested, paper-
and-pencil questionnaires will be provided/used, or research staff will assist in administering the 
Internet surveys over the phone.) and sign up the Web site by creating their own ID and 
passwords. Whenever they visit the Web site, they need to use the ID and passwords to log in 
the site. If they want, they can change their ID and passwords. Then, both groups will be 
provided with an electronic instruction sheet on when they need to come back and fill out 
additional questionnaires and/or use the program.  
 
Biweekly, the research team will send reminders and thank-you emails. Two weeks before the 
end of the 1st month, both groups will be asked to fill out the next set of the instruments by the 
end of the 1st month. Then, 2 weeks before the end of the 3rd month, both groups will be asked 
to fill out the next set of the instruments by the end of the 3rd month. 
 
 
o 
Description of research instruments to be used (e.g., questionnaires, surveys, interview or 
focus group guides, scales) 

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Multiple instruments will be used: the Support Care Needs Survey-34 Short Form (SCNS-
34SF),50 the Memorial Symptom Assessment Scale-Short Form (MSAS-SF),51 the Functional 
Assessment of Cancer Therapy Scale-Breast Cancer (FACT-B),52 the modified Questions on 
Attitudes, Self-Efficacy, Perceived Barriers, and Social Influences (QASPS),53 the Cancer 
Behavior Inventory (CBI),54,55,56 the Perceived Isolation Scale (PIS),57,58 the Personal Resource 
Questionnaire (PRQ-2000),59 and 27 questions on background characteristics, level of 
acculturation, and disease factors. The reliability and validity of all the instruments have been 
established among Asian Americans. Cronbach’s alpha of individual instrument ranged from .76 
to .96 among Asian Americans. 
o 
Describe any other study-related interactions or interventions: The Intervention: The 
TICAA 
This study consists of two groups of research participants: (a) 165 Asian American breast cancer 
survivors (55 per sub-ethnic group) who do not use the TICAA, but use the information on breast 
cancer by the American Cancer Society (ACS)(a control group); (b) 165 Asian American breast 
cancer survivors (55 per sub-ethnic group) who use the TICAA and the information by the ACS 
(an intervention group). The ACS website includes information on treatment, prevention, 
genetics, causes, screening, testing, coping, clinical trials, research findings, and statistics related 
to breast cancer in multiple languages including Mandarin Chinese and Korean. At the 
completion of the study, both will be allowed to use or continue to use the TICAA. 
Theoretical Bases, Information Architecture, and Menus. The TICAA was developed based on 
the findings from PSs using the information mapping approach.69 The TICAA is theoretically 
based on the Bandura’s theory. Based on the Bandura’s theory,70–72 most self-management 
programs include coaching/support and information interventions as part of the program 
content.73 Likewise, the TICAA includes group and individual (real-time and personalized) 
coaching/support by health care providers, peer coaching/support, and information to change the 
women’s attitudes, self-efficacy, perceived barriers, and social influences. The TICAA uses a 
free-form matrix information architecture74 and includes menus based on the three components 
(see below). Graphic User Interface controls75 (e.g., push buttons, check boxes, drop-down lists) 
are used. Presentation styles (e.g., colors, menus, etc.) are tailored based on PSs. 
Technological Tools.  The Ruby on Rails (ROR) framework (http://rubyonrails.org) and the Xen 
hypervisor (http://xen.org) were used to develop the TICAA. ROR is a web application 
framework based on the Model-View-Controller (MVC) architecture that can separate software 
logic and data handling from user interface.75 Using ROR, multiple language versions as well as 
mobile versions of a web page generated from the same software logic can be easily handled, 
and this allows various interactive features.75 The Xen hypervisor allows virtualization, which 
has the computer hardware to run multiple guest operating systems concurrently.76 Each guest 
system, called a virtual machine, runs as an independent computer. By populating several virtual 
machines, if any of the virtual machines fail, the web service will be still available, which 
ensures the efficiency of the servers and the safety and security of the data. 

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Components.  The TICAA has three components in four languages (English, Mandarin Chinese, 
Korean, and Japanese): (a) social media sites; (b) interactive online educational sessions; and (c) 
online resources. To incorporate cultural differences among three different sub-ethnic groups, 
three separate social media sites are designed for each sub-ethnic group. The sites provide a 
mechanism by which participants can connect to each other and share their own breast cancer 
survivor experiences with peers, have interactions with and get support from peers, and receive 
coaching/support from culturally matched peers and health care providers.77 In each site, cultural 
tailoring will be done through incorporating both general and sub-ethnicity-specific materials to 
discuss and culturally appropriate examples from PSs. The sites will incorporate Asian cultural 
values related to family (e.g., family as the center of the women’s daily life) and the collectivistic 
values for Asian women as a way to frame discussions and to present content. Each site consists 
of a social media function (like the timeline of Facebook), a chat function with a culturally 
matched bilingual interventionist and a symptom log function. Interventionists are required to 
have a bachelor’s degree in a health-related field and be bilingual. We will have a registered 
nurse (RN) monitoring or supervising the coaching/support provided by the interventionists. The 
RN will provide consultation to the interventionists while consulting with two MD consultants. 
For the intervention period, weekly group and individual coaching/support by culturally matched 
bilingual interventionists will be provided. Group coaching/support through the social media 
function will not have time limits because it will be based on asynchronous interactions. Yet, 
real-time and personalized individual coaching/support will be provided in a specific designated 
time period (each participant sets a specific time period for getting individual coaching/support) 
by the chat function. In addition, the use of phone calls and mobile chat functions (e.g., Wechat, 
Line, KaKao Talk, Skype et. al) as supplementary methods for individual coaching/support is 
permitted for the study-related communications. Group coaching/support will start once the first 
10 women per sub-ethnic group are enrolled, but individual coaching/support will start as soon 
as a participant is enrolled. Starting the group coaching/support with 10 women is reasonable 
when considering that 10~30 are usually an adequate number for a focus group, and group 
cohesiveness needs to be established.78 Each week, the interventionists will post at least 5 group 
messages related to each topic to give group coaching/support, and send at least 1~2 message(s) 
to each participant for individual coaching/support. Coaching/ support will focus on enhancing 
breast cancer survivorship by changing cultural attitudes, building self-efficacy, minimizing 
perceived barriers, and enhancing social influences through multiple ways (see Table 1). 
Messages in other languages will be translated into English, and those in English will be 
translated into other languages (using both Google translator and daily reviews/corrections by the 
bilingual interventionists with consultation of professional translators). The interventionists will 
minimally interfere the interactions among the participants.  
A total of 15 interactive online educational sessions (users can choose the content and ask 
questions and/or provide feedback by clicking buttons on the menu) provide information about 
general and sub-ethnicity-specific topics related to breast cancer survivorship. These sessions are 
also available in the four languages (already translated using the standard-back translation 
process79,80). The content is differently constructed by sub-ethnic group based on the cultural 
findings from PSs. For example, because Chinese women tended to use Chinese herbal medicine 
for their symptom management in PSs, we have added an education module on Chinese herbal 
medicine for Chinese participants. These sessions will provide correct and updated information 
on breast cancer and treatment/management strategies so that stigmatization could be reduced by 

Version date: 6/3/2020 
correcting misinformation. Culturally relevant contents (e.g., Red Ginseng, herbal medicine, 
Acupuncture, etc.) were also incorporated into the sessions. Finally, sub-ethnicity-specific 
online resources include 35 Web links to resources related to breast cancer survivorship in 
English, Mandarin Chinese, Korean, and/or Japanese from scientific authorities and from general 
and sub-ethnicity-specific health organizations/institutes. General resources will be available to 
all groups, but sub-ethnic-specific resources will be available only for the applicable group. Six 
experts reviewed the TICAA against the criteria for rigor in cross-cultural research.81,82  
Table 1.  A Summary of the TICAA Components 
Intervention 
Component 
Working 
Mechanisms 
Concepts 
Selected Examples of Intervention Activities 
Social media 
sites 
Sub-Ethnic-
Specific 
Coaching/ 
Support 
and  
Information 
Attitudes  
- Weekly introduce and discuss a new topic related to breast cancer 
survivorship (from the educational sessions and online resources). 
- Initiate and promote individual and/or group dialogues to discuss 
breast cancer survivorship experience within their specific cultural 
contexts. 
- Provide feedback on the discussion by providing sub-ethnic-specific 
examples from PSs (e.g., breast cancer as a genetic disease, stigma). 
- Correct misinformation by providing most updated information.  
- Help identify the areas that need more information. 
- Address any general and sub-ethnic-specific concerns, and provide 
individual and group feedback on breast cancer survivorship. 
Self-
efficacy  
- Support participants in identifying culturally appropriate and 
acceptable ways to manage their needs for help.  
- Individually work with the women to set goals that gradually try 
several strategies to manage their needs for help (e.g., promoting 
physical activity, changing poor eating habits, learning to search the 
Internet, etc.) in culturally appropriate and acceptable ways. 
- Provide examples of symptom management strategies that can be 
easily used in daily life (general and culture-specific). 
- Individually help set the weekly goal of symptom management and 
monitor their symptoms using the symptom log (date, symptoms 
[frequencies and severity], changes in health status & medication, 
usages of any strategies, and effectiveness of the strategies)  
- Provide individual feedback on: (a) calculated mean frequencies and 
severity of symptoms for the week reported; (b) symptom strategies 
used in the prior week; (c) trends in symptoms experienced by the 
women; and (f) suggestions for the next goal.  
- Help understand the educational sessions and resources (Q&A) 
individually and as a group (in each sub-ethnic group). 
Perceived 
Barriers 
- Initiate dialogues to discuss general and cultural-specific barriers. 
- Support participants in identifying culturally appropriate ways to 
recognize and manage breast cancer survivorship in daily life. 
- Use specific educational modules related to perceived barriers to 
breast cancer survivorship and tips in managing their needs for help 
in daily life (with sub-ethnic-specific examples from PSs).  
Social 
Influences 
- Moderate peer interactions and group dialogues in each sub-ethnic 
group. 
- Provide individual and group support to enhance understanding on 
materials related to breast cancer survivorship. 

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- Promote culturally matched peers’ interactions and feedback on 
breast cancer survivorship and management strategies for their 
needs for help. 
Interactive 
online 
educational 
sessions 
Information 
Attitudes  
Providing information/knowledge on (examples): 
- “What do you know about breast cancer”/ “What’s new about breast 
cancer treatment”/ “After treatment topics”/ “Facts for life”/ “Genetic 
testing” 
Self-
efficacy  
Providing information on (examples): 
- “Complementary and alternative medicine for breast cancer”/ “Breast 
cancer pain”/ “Chinese herbal medicine”/ “Insomnia among breast 
cancer survivors”/ “What to know about osteoporosis and pain” 
Perceived 
Barriers 
Providing information on (examples): 
- “What breast cancer survivors need to know”/ “Talking about breast 
cancer and cancer pain”/ “After treatment topics (general and culture-
specific)”/ “Grief, mourning, and bereavement”/ “Post trauma stress 
disorder and breast cancer” 
Online 
Resources 
Information 
Attitudes/ 
Self-
efficacy/ 
Perceived 
Barriers 
Culture specific resources (Examples of Korean-specific resources) 
-Korean cancer society (all about living with cancer)/ Asan medical 
center (breast cancer)/ Korean breast cancer foundation (breast health) 
General resources (examples): Patient Summary on Pain by the NCI/ 
Pain Control: A Guide for Those With Cancer and Their Loved Ones 
by the American Cancer Society/ Cancer Pain Treatment by 
International Association for the Study of Pain  
 
o Describe processes for translating  
The study announcement, informed consent sheet, the TICAA, and Internet survey 
questionnaires will be available in four languages. Mandarin Chinese, Korean, and Japanese 
versions have already been prepared using the standard translation and back-translation process 
by professional translators. 
A total of 15 interactive online educational sessions provided to the intervention group are also 
available in the four languages (already translated using the standard-back translation 
process79,80). 
In addition, messages used in the intervention in other languages will be translated into English, 
and those in English will be translated into other languages (using both Google translator and 
daily reviews/corrections by the bilingual interventionists with consultation of professional 
translators). The interventionists will minimally interfere the interactions among the participants. 
 
o 
Informed Consent Process: 
 
The participants will be able to consent at any time after reviewing the informed consent sheet on 
the project website. They are free to go and come back later and consent if needed. Participants 

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will be informed that their participation is voluntary, and they can withdraw their participation at 
any time. 
 
The reason for waiving the standard signed consent is multiple. First, we believe that it is 
unnecessary to meet with participants or to mail hard copies of the informed consent form for the 
sole purpose of obtaining signed consent. Second, obtaining signed consent from the participants 
across the nation raises a feasibility issue related to mailing and possible follow-up phone calls. 
Third, previous studies indicated that ethnic minorities including Asian Americans did not wish 
to sign a written consent for a historical reason: For example, in Korea, data from surveys were 
once used to identify tax fraud, and some people’s honest answers on the survey were used to 
assess an additional tax. This Internet-based consent process has been used in all previous studies 
by the PI without any issues or concerns from participants or research staff members. The 
previous studies by the PI, which compared the paper-and-pencil survey with the Internet survey 
questionnaire, showed that the Internet-based consent process was similar to that of the paper-
and-pencil survey in terms of its ability to explain the study and respond to questions from 
participants. Interestingly, some participants in the previous studies indicated that they preferred 
Internet communications to ask questions about the study because Internet communications are 
asynchronous (they could ask questions at any time) and e-mail is a written form of 
communication. 
 
When potential participants visit the project Web site, they will be asked to review the informed 
consent form that provides general information on the proposed project, including: (a) the 
purpose of the study, (b) staff on the study, (c) the data collection period, (d) potential physical 
and psychological risks involving inconvenience, confidentiality, and invasion of privacy, (e) 
their rights to withdraw, (f) how to maintain complete confidentiality (using IDs and passwords), 
(g) what they are being asked to contribute to the study, and (h) how their participation will be 
reimbursed. The consent process will be automatic through the project website; the participants 
will be asked to click "I agree to participate" after reviewing the informed consent sheet that is 
loaded on the project website.  
 
 
o 
Potential Risks/Discomforts to Study Participants and measures to prevent occurrence: 
There are no risks of injury or bodily harm. There are no risks to employment/employability, 
reputability, financial standing, and/or criminal/legal status. However, participation in this study 
may be inconvenient, and some of the questions may make the participants uncomfortable or 
upset; however, the participants are free to decline to answer any questions if they do not wish to 
answer and to stop participating in the project at any time. 
The participants' records will be handled as confidentially as possible. The collected data will 
remain confidential unless a participant appears at risk of harm. Only the research team will have 
access to the study records, which will be directly saved in a computer file format called ASCII. 
No individual identities will be used in any reports or publications that will result from this 
study. However, as an online participant in this research, the participants will always run the risk 

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that outside agents, such as hackers will try to access the site, and if they do, the participants may 
be identified. 
o 
Benefits: 
The participant may not directly benefit from participation in this study; however, she will gain 
some knowledge and peer support from using the program. Also, she may get some satisfaction 
from knowing that the information she provides will assist health care providers in developing 
and refining a culturally competent information and coaching/support program for Asian 
American breast cancer survivors. Further, she may gain additional knowledge by using the 
information provided as online links to additional resources related to breast cancer that will be 
part of the project Web site.  
 
 
o 
Compensation for time and effort: 
At the completion of their participation, the participants will be compensated with $50 electronic 
gift cards for their participation. The compensation will be prorated. The amount was determined 
based on preliminary studies. 
o 
Data Analysis: Data Management and Monitoring: 
The data will be stored on research dedicated, secure folder, firewall protected servers maintained 
by Emory University, IT office. Subsequently, the security and safety measures to protect the data 
will just follow those of the Emory University, IT office. All documentation related to the study 
will be stored in a locked cabinet file in a secured office that is only accessible to approved doctoral 
fellows and faculty.  
 
 
o 
Plans for analysis, statistical and/or otherwise: 
Data analysis will be conducted at Emory University, School of Nursing. Data collected through 
the Internet will remain confidential unless a participant appears at risk of harm. Only the 
research team will have access to the study records, which will be directly saved in a computer 
file format called ASCII. No individual identities will be used in any reports or publications that 
will result from this study. 
 

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Preliminary Analysis & Missing Data. Serial ID numbers will be assigned and attached to the 
data. Descriptive statistics will be used to characterize all variables, and distributions of variables 
will be examined for outliers and normality. Then, transformations will be applied as 
appropriate. Internal consistency reliability estimates for multi-item scales of at least 0.7 will be 
considered acceptable. We will use an intent-to-treat approach; participants will be analyzed in 
their original randomized conditions regardless of the usages of the TICAA or follow-ups 
missed. The mechanism underlying missing data will be evaluated and appropriate imputation 
methodology will be implemented (e.g., missing at random and multiple imputation by chained 
equations).84 All enrolled patients with at least one follow-up assessment will be included in 
outcome modeling, and the linear mixed effects modeling will take advantage of all available 
data. Baseline characteristics will be compared among patients with and without complete 
follow-up. To assess potential biases, a comparison of withdrawal rates will be included. 84 If 
the number of participants dropping out is small (10%) and the missing observations can be 
considered random, then the primary hypotheses will be tested using the complete observed data. 
If missing observations cannot be assumed to be random, more complex approaches (e.g., shared 
parameter models85) will be considered. 
Aim #1: Effects on Primary Outcomes. Separate intent-to-treat general linear models86 will be 
used to examine differences in continuous outcome measures by intervention group at each time 
point, adjusting for baseline outcome and any variables that demonstrate imbalances in 
preliminary analyses.  Model assumptions will be assessed, and modifications will be 
implemented as necessary to improve mode fit. Differences in continuous outcome measures 
over time will be examined using an intent-to-treat linear mixed-model growth curve analysis 
with SAS Proc Mixed.86 Mixed models will be used in which all available data collected during 
follow-up is used.87,88 Separate mixed effects regression models will be generated for each 
outcome measure. Both random slopes and intercepts will be modeled to represent the subject 
level deviation from the average, or fixed-effect, slope over time and intercept, respectively. 
Restricted maximum likelihood estimation will be used, and the most appropriate covariance 
structure will be examined. The outcomes will be analyzed as repeated observations of the 
dependent variables, with mean-centered baseline outcome scores serving as a covariate. Other 
predictors will include intervention group, time from baseline to follow-up, the interaction of 
group and time, and the interaction of baseline measures and time. Baseline outcome and group 
will be analyzed as time-independent covariates. Other demographic or treatment time-
independent variables identified in preliminary analyses may be included as covariates. Main 
effects and higher order interaction terms will be examined. The Akaike information criterion 
will evaluate overall model fit and to select the best-fitting longitudinal change pattern.89   
Aim #2: Mediation of Intervention effects. Sequential process random regression growth curve 
modeling90 will be performed to explore the hypotheses that attitudes, self-efficacy, perceived 
barriers, and social influences, separately, mediate the relationship between intervention group 
and change over time in primary outcomes. Specifically, we will examine whether the women 
who receive the TICAA show more favorable changes on the mediators at post-intervention and 
the follow-up periods relative to pre-intervention than do those in the control group. Mediational 
analyses will be performed to examine whether there is statistical support for the view that the 
putative mediator variables actually mediate effects of the TICAA on participants’ needs for 

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help, physical and psychological symptoms, and quality of life. Although various methods are 
appropriate for evaluating mediation in this setting, random regression growth curve modeling90 
was chosen as it prospectively and longitudinally tests the three criteria of mediation proposed by 
Baron and Kenny. 91 Modeling will rely on incorporating time varying [mediator] as a predictor 
of outcome in each sequential assessment.  To test the mediation hypothesis, individual slope and 
intercept parameters will be estimated for each participant based on intervention, mediator, and 
outcome. The intercept parameters will be coded to represent the value of the linear growth 
trajectory for each participant at baseline. The sequential process, or lagged approach, will allow 
for stronger inference regarding causality. Model assumptions will be assessed, and 
transformations will be applied as necessary. A series of four regressions will be used to test 
each of the mediational chains according to the criteria specified by Baron and Kenny.91 
Significant decreases in outcome will be assessed using the Sobel test. 92   
Aim #3: Moderation of Intervention Effects.  The moderating role of background and disease 
factors will be generated for each outcome.  Intention-to-treat mixed-modeling procedures86 as 
described above will be used to test and estimate differences in outcome across intervention 
groups and how moderators modify such differences. Accordingly, coefficient estimates for 
these measures by time represent the extent to which mediators affect slopes of change for 
outcome across time. Initial models will include all main effects and possible two- and three-way 
interactions between moderator, intervention group, and time. With respect to random effects, in 
addition to random intercepts, random slopes for time, moderator variables will be estimated to 
account for within-individual variability. As before, each model will control for baseline 
outcome values, which will be centered about the grand mean for all patients. Accordingly, 
intercepts represent the mean baseline outcome score across patients, adjusting for all other 
values included in the respective models. 
o 
Training of study team 
All research team members will complete CITI training before engaged in the study.  Also, to 
eliminate contamination across interventionists and minimize risk of differential treatment 
delivery among different interventionists, the interventionists will be trained by the PI with the 
intervention protocol developed through PSs. The interventionists’ first 5 messages through the 
social media sites and the chat function will be monitored and evaluated by the research team, 
and the team’s feedback will be incorporated into their subsequent coaching/support. Also, the 
interventionists will learn methods of facilitating discussions without influencing participants 
and helping women to set goals and solve problems. Two culturally-matched RAs will be trained 
on the logistics for the participant recruitment, the online survey system, and the delivery of the 
online questionnaires. Team meetings will be held monthly to address problems, reinforce 
learning, and monitor progress. Retraining of the interventionists and RAs will be done every 18 
months to prevent drift. 
o 
Plans for Monitoring the Study for Safety 
 

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Since Data and Safety Monitoring Boards (DSMBs) are required only for phase III clinical trials 
(NOT-OD-00-038.html), we do not include a DSMB for this intervention study. For the 
proposed intervention study, we have the following data safety monitoring plan (DSMP). First, 
to manage and protect the data collected, only summary data will be openly accessible to funding 
agency or will appear in publications. Research participants will be informed that they are free to 
decline to answer any questions they do not wish to answer or to stop participating in the project 
at any time. When a participant withdraws from participation, the data that they have provided 
will be immediately removed. Also, the data will have no identifying information to link a 
subject to the data. The participants' records will be handled as confidentially as possible. Only 
the research team will have access to the study records. Only a serial ID number assigned by the 
researcher will be attached to the data, and the data will be stored in a locked file cabinet in a 
research office. No identity information, including IP addresses, will be attached to any of the 
individual or group data. Therefore, research participants will not be identifiable directly or 
through the identifying information linked to subjects. No individual identities will be used in 
any reports or publications that will result from this study. Additionally, as explained above, the 
Web site will be developed and maintained such that it conforms to the HIPAA standards and 
SANS/FBI recommendations. Finally, data in the servers will be daily monitored by Dr. Chee to 
ensure its safety and security. All the participants will be asked (before participating in the study) 
if they have a regular source of health care so that the researcher could refer them if there is an 
adverse event identified during the data collection process. If the participants do not have a 
regular source of health care, then the researcher will get on the web and find a clinic or health 
care center near the participants’ locations that they can go to for emergency health care, if 
needed. During the data collection process, online records of the TICAA implementation will be 
monitored daily by a culturally matched RA under the supervision of Drs. Im, Mao, and 
Schapira, and any potential and actual adverse health problems will be identified through the 
monitoring process. In addition, the research team will meet regularly to monitor the research 
process, monitor the online records, monitor participant adherence, and address any issues that 
arise and consult as necessary with consultants. 
 
o 
Confidentiality: 
All e-mail/Internet communication between participants and the research team will be kept 
confidential by saving e-mails on the study team secure server with restricted access only to 
research team members. All e-mails received or sent by participants or the research team and 
other identity information will not be shared with others, and they will be on a firewall-protected 
computer to which only the research team can access.  Also, at the completion of the study, the 
saved e-mails will be permanently destroyed to ensure confidentiality. In addition, as described 
earlier, e-mail addresses will be used only for reminders and participation compensation, and 
will be kept separate from other participant data. Furthermore, their email addresses will be 
accessed only by the research team, and the participants can communicate with other participants 
only through the social media sites (no email address will be disclosed to other participants). 

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As described above, the data that the participants will provide will not include any information 
linked to their identities except email addresses, and only research staff will have access to the 
data. E-mail addresses will be used only for the reminders and reimbursement. As explained 
above, at the completion of the study, the saved e-mails will be permanently destroyed to ensure 
confidentiality. 
 
o 
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