Involving Family to Improve Communication in Breast Cancer Care
Phase: NA
Conditions: Active Breast Cancer Treatment
Sponsor: Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

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Date: June 19, 2017    NCT03283553 
Principal Investigator: Antonio Wolff  
Application Number: IRB00129995  
Involving Family to Improve Communication in Breast Cancer Care 
  
JHM IRB - eForm A – Protocol  
  
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 1.  
Abstract  
Breast cancer is the most common cancer among survivors in the US and is second only to lung cancer in 
contributing to cancer death among women. Most patients with breast cancer receive help from family in 
making complex decisions about treatment, handling logistically demanding care coordination, and 
managing symptoms and side effects. Although family members (as defined by each patient) play a vital role 
in cancer care, they are not formally recognized or assessed in care delivery, and their need for information 
and support is typically unmet. Lack of attention to family in care delivery is an important gap that too often 
leaves families without adequate information about patient health and treatments. This may prevent families 
and patients from engaging in open conversations, cause them unnecessary anxiety, and negatively affect the 
quality of cancer care and delivery.  
Communication is particularly important in cancer care, as the optimal course of action is determined through 
longitudinal discussion of prognosis, treatments, and patient goals, preferences, and concerns. Strategies to 
improve communication for serious illnesses such as cancer have been developed, but typically target a 
specific decision, conversation, or setting, most often the inpatient hospital. There is growing agreement that 
communication among patients, families, and providers should be initiated early and continue throughout the 
disease trajectory. However, little is known about how to provide both patients and families with access to 
timely information about patient health and mechanisms to communicate directly with health care providers, 
as proposed in this study.  
The goal of this study is to test a multicomponent intervention to strengthen communication and longitudinal 
partnerships among women with breast cancer and their family members. Recent work by the study team has 
demonstrated the feasibility, acceptability, and benefit of intervention components which will be combined 
into a single model of care. Our preliminary studies indicate that clarifying patient and family expectations 
regarding the role of family and providing family with timely and comprehensive information about patient 
health (as desired by the patient) leads to more effective family involvement, more frequent patient-
familyprovider interactions, more patient-centered communication, and greater preparedness to manage care.   
This study will evaluate the feasibility of delivering a multicomponent communication intervention in the 
outpatient setting comprising: 1.) a patient-family agenda-setting checklist completed immediately before a 
regularly scheduled medical oncology visit with a participating medical oncologist, 2.) facilitated registration 
for the patient portal (for patient and family member, as desired by the patient), and 3.) education (as 
relevant) on access to doctor’s electronic visit notes. We will enroll up to 70 patients who are in active 
treatment for breast cancer. We will enroll up to 14 medical oncologists and 70 patient-family members. We 
will focus on patients who typically attend medical oncology visits with a family member or trusted friend as 
they are already present and involved in communication. We will compare study outcomes of patients and 
family members who are in the intervention group and receive the multicomponent communication 
intervention (n=35 dyads) with patients and family members who are in the control group and receive usual 
medical oncology care (n=35 dyads). We are asking whether intervention group patients and families have 
higher quality communication with medical oncology providers, a better understanding of patient’s cancer, 
are more confident in managing patient’s care and are more satisfied with cancer care than control group 
patients and families after 3 months, and 9 months of follow-up. We will also examine symptoms of anxiety.  
2. 
Objectives   
We will conduct a two-group randomized pilot trial of a multicomponent communication intervention to 
strengthen communication and longitudinal partnerships among up to 70 patients being actively treated for 

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breast cancer (early or advanced stage) and their family “caregiver” in an academic medical oncology clinic 
at Johns Hopkins. The intervention arm comprises: 1.) a patient-family agenda-setting checklist to be 
completed immediately before a routinely scheduled medical oncology visit, 2.) facilitated registration for 
the provider-sponsored patient portal (for the patient and family member, as desired by the patient), and 3.) 
education (as relevant) on access to doctor’s electronic visit notes. The control arm comprises usual medical 
oncology care. We will compare the intervention arm and a control arm of usual care with respect to patient 
and family-reported outcomes at 3 months and 9 months. We expect that patients and families who receive 
the intervention will engage in more frequent, higher quality communication with each other and medical 
oncology providers, and that 3 months and 9 months after enrollment patients and families will have a greater 
understanding of the patient’s illness, higher self-efficacy with respect to their ability to manage the patient’s 
care, and that families will be more highly satisfied with the quality of cancer care as compared with 
participants who receive a control arm of usual care. We will secondarily assess the effects of the 
intervention on patient and family symptoms of anxiety at 3 months and 9 months.  
  
3. 
Background:  This study will evaluate the feasibility of delivering a multicomponent communication 
intervention in the outpatient setting comprising: 1.) a patient-family agenda-setting checklist completed 
immediately before a regularly scheduled medical oncology visit, 2.) facilitated registration for the patient 
portal (for patient and family member, as desired by the patient), and 3.) education (as relevant) on access to 
doctor’s electronic visit notes.  In the text that follows we summarize available evidence regarding each of 
the three intervention components.  
3a. Agenda Setting: The study team has designed and established proof-of-concept for a patient-family 
agenda-setting checklist for older primary care patients. The checklist aims to elicit and align patient and 
family perspectives regarding issues to discuss with the doctor, and to stimulate discussion about the role of 
the family member in the visit. The premise for the checklist is that family members are typically motivated 
to support patients during medical visits, but that they often lack knowledge of the patient’s health concerns 
and visit goals as well as preferences for communication assistance from their family. The checklist involves 
two activities that are completed by a patient and their family member in the waiting room before a 
scheduled appointment. The first activity involves patients clarifying the help they would like from their 
family member during the upcoming visit. The second activity involves patients and families completing a 
checklist of common health issues. The instructions ask patient and family to separately identify their 
concerns for each issue, and decide together what to discuss with the doctor. In a proof of concept 
randomized study of 32 older patient-family dyads in a primary care setting, the checklist was highly 
endorsed by patients, families, and doctors. Analyses of audiotaped medical visits indicated that 
communication was significantly more patient-centered among dyads who completed the checklist (n=17) as 
compared with those who received usual care (n=15), and did not receive the checklist.29 In post-visit 
surveys, doctors were 34% more likely to agree that intervention versus usual care families “helped them 
provide good care to the patient” (94.1% vs. 60.0%; p=0.02). Intervention patients were more likely than 
usual care patients to agree that because their family was present they “better understood their doctor’s 
advice and explanations” (82.4% vs. 46.7%; p=0.03). As the checklist was developed for older primary care 
patients, we have refined the content to attend to the specific needs of patients with breast cancer (see 
attachment D1 Checklist).  
3b. Shared Access to the Patient Portal.  Health information technology presents new opportunities to 
rationalize and better support family in delivery processes and communication, as we propose in this study. 
Through the provider-sponsored patient portal, patients may access information about their health and 
treatments, exchange electronic messages with providers, and perform health care tasks such as refilling 
prescriptions and scheduling appointments.99,100 Many electronic health record vendors, including EPIC 
MyChart as implemented at Johns Hopkins, afford patients the ability to authorize specific family member to 
“share access” to their patient portal account using their own identity credentials. Thus, shared access is a 
strategy that may be used to clarify and respect patient preferences for including family in their care by 
facilitating access to the patient’s electronic health information and a mechanism to communicate directly 
with providers.43 Although little empirical evidence exists regarding the effects of shared access, work by our 
team indicates that shared access is acceptable to patients and families, and that family members who have 

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been granted their own identity credentials to access the patient’s portal account commonly perform health 
management activities electronically and engage in secure messaging with providers.31    
3c. Access to Provider’s Visit Notes (OpenNotes).  Many electronic health records (including EPIC 
MyChart) have the capacity to allow providers to share their visit notes (OpenNotes) through the patient 
portal so that patients may read, reflect, and discuss these notes with family or other medical professionals 
after the visit. In a quasi-experimental pilot study involving more than 100 providers and 18,000 patients at 3 
medical institutions, OpenNotes was found to improve patient-provider communication and increase patient 
engagement in their care.99 More than 10 million patients across the country are estimated to have access to 
their provider’s visit notes. At some organizations, OpenNotes is standard practice among primary and 
specialty providers, including medical oncology. Preliminary studies provide evidence of the feasibility and 
acceptability of sharing doctor’s electronic visit notes with both patients and families through shared access 
to the patient portal. After 12 months of having access to OpenNotes, the majority of patients and families 
read doctor’s visit notes, reported clinically relevant benefits, and wanted to continue to have access to 
OpenNotes in the future. Patients and families reported that joint access led to more productive discussions 
about the patient’s care, better agreement about the patients’ treatment plan, and improved their ability to 
formulate questions for the doctor. Families were more likely to access and use the patient portal and 
reported better communication with doctors, while patients were more confident in their ability to manage 
clinically important elements of their care.30 OpenNotes has now been piloted through three stages of 
physician adoption at Johns Hopkins, including oncology providers, with high acceptability among providers 
and no reported adverse outcomes. The Johns Hopkins Clinical Practice Association’s Board of Governors 
voted in early June to move toward system-wide standard access to OpenNotes across most lines of business, 
including ambulatory oncology effective January 1 2018.    
  
4. 
Study Procedures  
a. Study design, including the sequence and timing of study procedures This is a two-group 
randomized pilot trial of a multi-component communication intervention to more effectively and 
purposefully engage family members in cancer care. We will enroll up to 70 patients with breast cancer 
and the family member they identify as most typically attending medical oncology visits with them, for a 
total of 70 patients and 70 family members. After providing informed consent, each patient-family 
member dyad will be randomized to the intervention arm or to a control arm of usual care.   
We will invite practicing breast cancer medical oncologists at Johns Hopkins to participate in the pilot 
trial. We expect to enroll up to 14 medical oncologists in this study.  As noted in Section 3.c., JHMI is 
moving toward system-wide use of OpenNotes effective January 1 2018.  Participating providers will be 
invited to turn Open Notes “on” for patients under their care prior to January 2018, and the study team 
will record the decision made by each provider.  Patient/family participants of providers who do not elect 
to turn “on” OpenNotes prior to January 2018 will receive agenda-setting checklist and facilitated access 
to MyChart but will not have education about or access to OpenNotes.  We will mail letters to 
established patients of participating doctors who have a scheduled appointment two to four weeks prior 
to their visit to explain the study, invite them to participate, and invite family members to call us for 
more information. Patients who do not “opt-out” by mailing back a card to the study team will be 
contacted by telephone to further describe the trial, answer questions, and complete a screening call. 
Patients who are eligible and interested in participating will be asked to speak with their family member 
about the study in cases where the family member has not yet initiated contact with the study team. After 
the patient has discussed the study with their family member, the patient will ask the family member to 
call the study team, or given the family member’s permission, the patient can call the study team with the 
family member’s contact information. Both the patient and family must consent to participate for the 
dyad to be enrolled. Patients may identify more than one family member to participate in the intervention 
processes, but will be asked to identify the person who most typically attends medical oncology visits to 
participate in this study.     
Eligible patient-family dyads will meet a member of the research team in the clinic waiting room 30 
minutes in advance of the patient’s scheduled appointment.  Each dyad will be randomized to the 
intervention (investigational arm) or the control arm in a 1:1 ratio using stratified, blocked randomization 
by doctor with alternating block sizes. Participants assigned to the intervention will meet with the 

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research staff to receive a copy of the patient-family agenda-setting checklist, a clipboard and pen, and 
instructions describing how to complete the checklist, which they will complete together in the clinic 
waiting room.  Participants who are randomized to the control arm will receive care as usual. Medical 
oncologists, patients, and families will complete post-visit surveys immediately after the visit. After the 
visit, patients in the intervention group will meet briefly with research staff to facilitate registration for 
the EPIC patient portal MyChart, including informational handouts about OpenNotes (as relevant) and 
MyChart. After the visit, participants in both groups will be offered general breast cancer resource 
handouts that are available to all breast cancer patients at the Johns Hopkins SKCCC. Patients and 
families will complete baseline, 3-month and 9-month follow-up telephone interviews by a research 
assistant who is blind to assignment status.  Telephone interviews will be audio recorded for quality 
control purposes.  Patients who decline audio recording will not be excluded from the study.  Medical 
oncologists will complete an exit interview upon completion of patient recruitment.  
b. Study duration and number of study visits required of research participants.  
Medical oncologist participation in the study will occur throughout the duration of recruitment.   
Immediately after providing informed consent, medical oncologists will be asked to complete a one-page 
survey of socio-demographic characteristics, training, and experiences in the care of persons with breast 
cancer.  Medical oncologists will subsequently complete a brief one-page survey immediately after the 
visit of participating patients, and a one-page exit survey upon completion of patient recruitment for the 
study.  Patient and family participation in this study will transpire over no longer than 26 weeks, and will 
involve a screening telephone call to determine eligibility, one in-person encounter at the time of a 
regularly scheduled physician office visit, and two follow-up telephone calls of approximately 30 
minutes duration at 1 weeks (range: 0-3 weeks), 3 months (range: 10-20 weeks) and 9 months (range: 
3555 weeks).  The in-person encounter is not expected to require more than 45 minutes time beyond the 
regularly scheduled physician visit.  Participants will provide written consent to participate in the study 
(10 minutes) complete a pre-visit communication tool (10 minutes), and complete a brief post-visit 
survey (10-15 minutes).  The expected duration of the study from the perspective of patient and family 
participants will proceed over the course of about 16 weeks (but may transpire over a longer period for 
some participants who are unavailable to complete the follow-up calls at the scheduled 16 week 
interview); the duration of the study for medical oncologist participants will proceed throughout the 
course of patient/companion enrollment.  The overall study duration is expected to be about 12 months.  
  
c. Blinding, including justification for blinding or not blinding the trial, if applicable. This is a 
single blind, two group randomized trial where the study team will be blinded to group assignment.  
Outcome measures will be assessed by interviewers masked to treatment assignment and without 
interventionist contact.  Patient/family dyads will not be blinded to group assignment.    
d. Justification of why participants will not receive routine care or will have current therapy 
stopped.  
Not applicable.  This is a study of a behavioral intervention to improve communication.  
e. Justification for inclusion of a placebo or non-treatment group.  
We will undertake a single blind, two group randomized trial to estimate the potential effects of the 
intervention on outcomes for patients with breast cancer and their family caregivers.  The strategies that 
are being proposed are low cost, already exist, have been designed to minimize impact on clinical 
workflow, and are readily transferrable to other provider systems. The study will examine the effects of 
the intervention protocol on communication outcomes, as well as provide evidence of its acceptability in 
mainstream medical oncology practice that would support broader diffusion. For these reasons, the 
control group protocol will comprise usual care which is in this case existing clinical practice.   
f. Definition of treatment failure or participant removal criteria.  
Not applicable.  This is a study of a behavioral intervention to improve communication.  
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely.  
Not applicable/relevant.  Participation in the study is voluntary. This is a study of a behavioral 
intervention to improve communication.  

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5. 
Inclusion/Exclusion Criteria  
Participants of this study will include three groups: (1) medical oncology patients, (2) family members 
(broadly defined), and (3) medical oncologists.  Inclusion/exclusion criteria for each of these groups are as 
follows:  
A. Medical oncology patients. Inclusion criteria:  established patient of participating medical oncologist 
greater than 18 years of age, have a diagnosis of early stage or advanced breast cancer, are receiving 
active systemic therapy (in the form of IV adjuvant systemic therapy if early stage), are English 
speaking, able to provide informed consent themselves, and identify a family member who they would 
like to include in their care.   Exclusion criteria: younger than 18 years, pregnant, not being treated for 
breast cancer, do not attend medical visits with family member or unpaid friend or unwilling for their 
family member or unpaid friend to be contacted.  
B. Family.  Inclusion criteria: Family member (spouse, adult child, parent, adult sibling) or unpaid friend 
who accompanies patient to medical visits.  Exclusion criteria: paid non-family member.  
C. Medical oncologist.  Inclusion criteria: practicing medical oncologist at a participating clinic who 
provides care to patients with breast cancer.  
  
6. 
Drugs/ Substances/ Devices  
a. The rationale for choosing the drug and dose or for choosing the device to be used.   
Not applicable  
b. Justification and safety information if FDA approved drugs will be administered for 
nonFDA approved indications or if doses or routes of administration or participant 
populations are changed.  
Not applicable  
c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered.   
Not applicable  
  
7. 
Study Statistics  
a. Primary outcome variable.   
We will assess a comprehensive set of process measures and outcomes that correspond to the efficacy 
and implementation potential of the intervention.  We will assess clinical efficacy of the intervention by 
examining communication processes and outcomes.  Implementation measures will be assessed from 
practice-based metrics relating to infrastructure, resources, and clinician and staff time and effort for 
intervention start-up and delivery.  Clinical efficacy measures have been selected based on the following 
criteria: 1.) known reliability and validity, 2.) sensitivity to change, 3.) clinical relevance to quality of 
life, 4.) reflection of objective indicators of the domains we seek to impact, and 5.) psychometric 
properties of instruments balanced with practical considerations relating to respondent burden. Efficacy 
measures will be derived from survey responses provided by patients, families, primary care providers, 
health and service utilization from the patient’s electronic medical record, and date and time-stamped 
records of MyChart interactions. Our four primary outcomes will be assessed at 3 months and 9 months 
on the basis of patient and family caregiver surveys.  These outcomes include: patient and family illness 
understanding, family satisfaction with cancer care, patient and family self-efficacy in managing patient 
care, and symptoms of anxiety.  
  
Patient and family illness understanding will be measured from four items that assess knowledge 
that is considered to be essential to making informed treatment decisions in serious illness, 
including: 1.) understanding of illness, 2.) knowledge of disease status, 3.) awareness of disease 
state, and 4.) expectation of duration of life (months, years, or decades).(1)  Each item will be 
coded 1 or 0 to reflect the presence or absence of each element of illness understanding.  We 
will use scoring that is adapted to reflect patient stage of disease.  These four items will be 

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summed to construct a summary score (range: 0-4) that reflects illness understanding. This 
measure has been found to be responsive to communication with oncologists.(1)   
  
Family satisfaction with cancer care will be measured with the short-form 10-item version of the 
FAMCARE, a validated instrument that was developed to assess family perspective on cancer 
care.(2, 3)  Respondents are asked to rate 10 items that relate to emotional support, 
personalization of care, support of decision-making, accessibility, and coordination.  Response 
categories include “very satisfied” (2 points), “satisfied” (1 point), or “not satisfied” (0 points), 
and the 10-items may be summed to yield a total score (range: 0 to 20) with higher scores 
reflecting greater satisfaction.  The internal reliability coefficient of the 10-item FAMCARE is 
0.94 across varied age, gender, education, ethnic, and relationship groups. The FAMCARE is 
responsive to change and has been widely used to support findings of the benefit of 
interventions to improve the quality of cancer care.   
  
Self-efficacy refers to the extent that patients(4, 5) and families(6-9) are equipped to manage 
their experiences with care and enact the patient’s care plan.  Following measurement 
conventions(5) questions will begin with the phrase “how certain are you right now that you can 
...” and respondents will be asked to place themselves on a 10-point scale ranging from 1 (not at 
all certain) to 10 (very certain).  We will ask patients and families to report their self-efficacy for 
engaging in tasks related to managing patient care that include managing health information and 
communicating with patients’ health care providers. The scale is scored by calculating the mean 
of all items; higher scores reflect greater confidence.  Prior work finds self-efficacy is inversely 
associated with anxiety and stress, positively associated with behavioral outcomes including 
physical and mental health, and responsive to change.(10)    
  
Anxiety will be measured using the Generalized Anxiety Disorder 7-item (GAD-7) scale, a well-
established 7-item instrument that asks about symptoms of anxiety in a two-week recall period 
from 0 (“not at all”) to 3 (“nearly every day”).  
  
b. Secondary outcome variables.   
Secondary outcomes involve the following process measures: patient and doctor reports of 
family effectiveness in visit communication, patient and family satisfaction with the doctor, and 
reported quality of communication.  
c. Statistical plan including sample size justification and interim data analysis. In this two-
group randomized pilot trial, we will compare the effects of the intervention in the investigational arm 
on communication and outcomes for up to 70 patients (35 per group) with (a) advanced (stage IV) or (b) 
early (stage I-III) breast cancer (if receiving IV adjuvant systemic therapy) and their family member. As 
a Stage 1 developmental study of a complex behavioral intervention, the sample size is based on 
pragmatic considerations related to available resources, project duration, and study objectives.  Analyses 
will be performed in SAS statistical software, with each patient-family dyad as the unit of analysis. We 
will rely on established cut-points and approaches to constructing outcome measures, as well as 
measures of patient and family attributes that will serve as control variables (sociodemographic 
characteristics, health status, aspects of the patient and family relationship, family role appraisal). We 
will stratify the study sample based on AJCC TNM staging (stage I-III or stage IV). We will primarily 
evaluate the consistency, direction, and magnitude of differences in study outcomes by undertaking 
analyses that are stratified by treatment group (intervention versus control arm) and for subgroups of 
patients by cancer stage (early or advanced stage). We will evaluate recruitment, retention, and the 
timeliness and completeness of collected data, as well as intervention acceptability (utility, burden, 
helpfulness) using questions from our formative work. We recognize the need for caution in interpreting 
pilot trial results. Therefore, inferential statistical testing is not planned in analyses of the pilot trial. 
However, we will evaluate recruitment and dropout rate as well as effect size of primary and secondary 

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outcomes to help inform the design and sample size calculations for a larger trial. d. Early stopping 
rules. None.  
  
8. 
Risks  
a. 
Medical risks, listing all procedures, their major and minor risks and expected 
frequency. The risks of participating in this study involve inconvenience, personal time, the 
potential for becoming upset, psychologically stressed or fatigued, and potential loss of 
confidentiality.  There may be some inconvenience to patients and families associated with arriving 
to a scheduled oncology visit earlier than otherwise necessary and staying later to complete a survey. 
There are risks associated with a breach of confidentiality.  Subjects may experience discomfort 
discussing health or worries.  Family members who screen positive for depressive symptoms (on the 
basis of PHQ-2 scores >=3 at follow-up) or anxiety (on the basis of Generalized Anxiety Disorder 
scores of>= 10) will receive oral notification of this finding and will be asked if they would like to be 
mailed an educational brochure about depression or anxiety (as appropriate) and options for 
treatment.   Companions will be encouraged to follow-up with their health care provider.   
b. 
Steps taken to minimize the risks.  
Participants will be instructed that participation in the study is completely voluntary and that they may 
decide to stop at any time.  They will be informed of the length and nature of participation.  Protection of 
participant information and audio recordings of telephone interviews will be a key responsibility of study 
staff.  Information from participants will be reported anonymously.  All participant surveys, consent 
forms, and other records containing participant identifiers will be kept in a locked file cabinet.  Data will 
be password protected; only study personnel will have access to identifying information.  Redacted 
(deidentified) versions of the data collection sheets will be used for coding and analysis. No personal 
identifiers will be included in the analytic database.   
c. 
Plan for reporting unanticipated problems or study deviations.  
This is a study of communication in breast cancer care.  The study will evaluate a multicomponent 
intervention for patients with breast cancer and their family caregivers – each of the intervention 
components has been successfully tested and found to be acceptable. Adverse events that result from this 
study are unlikely.  Unanticipated problems or adverse events will be reported promptly to the IRB by 
the PI.  Study deviations will be documented and monitored in keeping with Good Clinical Practice in 
Social and Behavioral Research.   
d. 
Legal risks such as the risks that would be associated with breach of confidentiality. 
Participant privacy will be ensured by asking sensitive questions by telephone so that others who are 
present at the time of the survey are unable to hear the questions that are being asked.  Research staff 
will assist patient participants in completing study surveys and questions that are asked in person will 
not involve sensitive topics. Pre-consultation consent and post-visit surveys for patients and family 
participants will typically be completed in a private room proximal to the clinic waiting room for 
additional privacy.  Information collected from patients and families will not be shared with one 
another.   e. Financial risks to the participants. None  
  
9. 
Benefits  
a. 
Description of the probable benefits for the participant and for society.  
Benefits accrued by individual study participants will be minimal for the control group.  Benefits accrued 
by treatment group participants may include greater clarity regarding patient treatment goals, family 
roles in medical care, and more effective communication with the medical oncologist. We hypothesize 
that the intervention might improve satisfaction with medical care, as well as outcomes that pertain to 
information recall and treatment adherence.  Information to be gained may improve care processes and 
benefit people in the future.  
  
10. 
Payment and Remuneration  
a. 
Detail compensation for participants including possible total compensation, proposed 
bonus, and any proposed reductions or penalties for not completing the protocol.  

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All patient and family participants will receive a $20 gift card at the conclusion of the post-visit survey 
and they will have the potential to receive $20 gift cards if they complete baseline, 3-month and 9-month 
follow-up telephone calls ($80 in total) that will be mailed to their place of residence. There are no 
consequences for participants who do not complete both phases of the research.  
  
11. 
Costs  
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them.  
Not applicable/relevant.  This is a study of a behavioral intervention to improve communication and 
does not involve the administration of a drug or treatments.