Enhancing Triadic Communication About Cognition for Older Adults With Alzheimer's Disease or Related Dementias Facing a Cancer Management Decision - Focus Groups
Conditions: Focus Groups
Sponsor: University of Rochester

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Enhancing Triadic Communication About Cognition for Older Adults with Alzheimer's 
Disease or Related Dementias Facing a Cancer Management Decision – Focus Groups 
Principal Investigator – Allison Magnuson, DO, MS
1.
PURPOSE OF STUDY 
Approximately 7% of older adults diagnosed with cancer have pre-existing dementia 
(Alzheimer’s Disease or Related Dementias [ADRD]). Despite the proven benefits of cancer 
treatments, patients with ADRD and cancer experience greater treatment complications and 
higher mortality than patients without dementia. In addition, cancer treatments can cause 
cognitive decline to accelerate. Nevertheless, cancer treatments can also minimize 
cancerrelated symptoms and morbidity, thus improving quality of life for some patients. Older 
adults with cognitive impairment are rarely included in oncology clinical trials; therefore, the 
optimal approach to treatment in these patients is unknown. Thus, cancer management decision 
making in this population is complex due to the need to balance potential treatment benefits 
with possible side effects. When data to guide recommendations are limited, decisions about 
cancer treatment should rely on individual patient goals and preferences. Patients with 
cognitive impairment have varying degrees of decisional capacity and increasingly rely on care 
partners as their primary decision makers for complex cancer treatment decisions. Oncologists 
have very little knowledge and training on how to navigate this triadic interaction. Despite 
these complexities, there is no standard approach to guide oncology clinicians when discussing 
cognitive impairment in the context of cancer treatment decisions for patients with preexisting 
ADRD.
Our team has developed a Geriatric Assessment (GA)-guided communication tool for 
increasing and improving conversations about aging-related conditions in oncology 
(Improving Communication in Older Cancer Patients and Their Caregivers [COACH]). In a 
cluster-randomized trial of 541 older adults with advanced cancer and 414 of their care 
partners, the GA-guided communication tool increased care partner and patient perceptions 
of “autonomy support”, whereby they felt that their oncology clinicians were supportive 
and ensured cancer care was congruent with their values, as measured by the Health 
Care Climate Questionnaire (4-6 week HCCQ; care partners [17.6 vs 16.3; p=0.005]; patients 
[17.4 vs 16.7; p=0.03]). In a secondary analysis of patients with an impaired cognitive screen 
enrolled in this study (N=175), the COACH GA intervention significantly increased the 
number of conversations specifically about cognition (63.4% of GA intervention patients 
versus 12.1% of usual care; p<0.0001). However, conversations were largely physician 
dominated and did not provide adequate conversational space for care partner or patient 
cognitive-related concerns. Additionally, the COACH GA intervention was not evaluated in 
patients with ADRD, and adaptation of the intervention for this population is needed. 
We will adapt the COACH GA intervention for older adults with ADRD who are considering 
a decision about cancer management (adapted intervention: COACH-Cog). COACH-Cog 
adaptations will include: 1) brief, focused training for oncology clinicians about dementia in 
the context of cancer and communication training to navigate the triadic nature of these 
conversations with care partners providing decisional support and input, thereby enhancing 
oncology clinician knowledge and supporting their decision processes; and 2) care partner 
and patient Communication Coaching and Question Prompt List providing knowledge, skills, 

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and behavioral cueing for discussing their cognitive concerns and cognitive-related goals 
with their oncology clinicians. Experts in cognition, geriatric oncology, behavioral 
neurology, communication science, and palliative care as well as focus groups with 
stakeholders (care partners, patients, clinicians, experts in geriatric oncology and cognition) 
will guide these adaptations. 
Aim: To gather key stakeholder input for feedback on the adaption of the COACH GA 
intervention (i.e., develop COACH-Cog) to enhance triadic communication among 
oncologists, care partners and patients with ADRD.
2.
BACKGROUND AND RATIONALE 
Alzheimer’s Disease and Related Dementias (ADRD) are prevalent aging-related 
conditions in older patients with cancer.1 The proportion of patients with concurrent 
diagnoses of dementia and cancer varies by cancer type and age, but it is estimated in 
population-based analyses to be approximately 7-10% of older patients with cancer.2,3 
Preexisting diagnoses of dementia are more common in patients who are older, female, 
Black, unmarried, less educated, and living in areas with a higher percentage of poverty.3 A 
similar prevalence of patients with co-occurring cognitive impairment and cancer has been 
seen at our University of Rochester Wilmot Cancer Institute.4 Given the aging demographics 
of the United States, the prevalence of older patients with ADRD who are diagnosed cancer 
will continue to grow.5-9 
For older adults with cognitive impairment and cancer, medical decision making is 
more complex. Patients, care partners, and clinicians need to carefully consider competing 
comorbidities in the context of potential risks and benefits of treatment options.10 Our group 
and others have demonstrated that advanced age and low cognitive reserve are associated 
with cognitive decline following exposure to cancer therapy.11,12 Patients with pre-existing 
dementia at the time of cancer diagnosis have historically experienced worse cancer- related 
outcomes.2,13 Patients with dementia are diagnosed at later stages of cancer and are more 
likely to experience side effects from cancer therapy,3,14 although this paradigm may be 
shifting in the era of novel, targeted cancer treatments that have more favorable side effect 
profiles. For some patients, the benefits of cancer treatments outweigh the risks by 
minimizing the morbidity and symptoms from cancer, thereby improving quality of life. 
Older adults with cognitive impairment are not typically included in oncology clinical trials; 
thus the optimal approach to cancer treatment in these patients and how best to balance the 
potential risks and benefits of treatment are not well established.10,15 When limited data exist, 
decisions about cancer treatment should rely largely on patient goals and preferences, as 
supported by care partners. Unfortunately, no standard approach has been developed for 
discussions about cognition among oncology clinicians, patients with pre-existing ADRD, 
and their care partners. Due to limited access to geriatricians and palliative care specialists, 
oncology clinicians are increasingly responsible for care coordination and management for 
older adults with ADRD and cancer.16 An intervention for this population with a large 
potential to improve outcomes through better communication and more appropriate decision 
making for cancer treatment is highly desirable. 

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A Geriatric Assessment (GA) communication tool can facilitate conversations about 
aging-related conditions, including cognitive impairment, with older adults and their 
care partners.17,18 In oncology, GA captures overall health status through patient-reported 
and coordinator-administered measures evaluating aging-related conditions.19-21 Our group 
has developed a communication tool that integrates a GA summary with detailed care 
management recommendations for identified aging-related conditions. The GA 
communication tool increases discussions about aging-related conditions in the oncology 
setting.17 Care partners and patients in the GA intervention arm perceive greater autonomy 
support and shared decision making with their oncology clinicians.17 Autonomy support is 
an individual’s perception of the degree to which they experience their health professionals 
as supporting choice and ensuring congruence with their values.22,23 Autonomy support is 
based on self-determination theory, and greater autonomy support is hypothesized to lead to 
improved health outcomes.24 However, our GA-based communication tool has not been 
studied in patients with pre-existing ADRD. Given the complex decision making as well as 
the unique incorporation of the care partner as a decisional support for patients with cognitive 
impairment and cancer, adaptations are needed to improve communication about cognition 
in the context of cancer management decision making for this population. 
A critical gap in knowledge remains: How should oncology clinicians discuss cognitive 
impairment in the context of cancer management for patients with pre-existing ADRD 
who face a decision about cancer management? To address this gap in knowledge, we will 
extend our prior research by adapting our COACH GA communication tool (i.e., develop 
COACH-Cog) to enhance communication about cognitive impairment and acknowledge 
concerns about cognition and cognitive-related goals in the context of a cancer management 
decision through a multicomponent communication intervention to promote shared 
decisionmaking through autonomy support. 
3.
ADMINISTRATIVE ORGANIZATION  
This study will take place through the University of Rochester Wilmot Cancer Institute. 
4.
STUDY DESIGN
This study will consist of focus groups to guide the adaption of a communication tool. We 
will collect qualitative data from the focus groups as well as socio-demographic data about 
subjects.
A total of 40 participants will be recruited for focus groups. Focus groups will be conducted 
with 2-10 participants per group. If subjects are unavailable to join a focus group meeting, they 
may be considered to participate in an individual interview instead of a focus group. Focus 
groups and interviews will be conducted via URMC’s HIPAA compliant Zoom platform.
Focus groups will be conducted with the following stakeholders:
1) Medical oncologists
2) Clinicians with expertise in cognitive impairment and dementia
3) Older patients with cancer

Pa ge 4 of 1 1
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4) Care gi vers of patie nts wit h de me ntia or mil d c o g niti ve i m pair me nt. Of n ote, t hese 
care gi vers are n ot necessaril y ta ki n g part i n a n y ot her as pect of t he st u d y.
T here ma y be s o me s u bjects t hat fall i nt o m ore t ha n o ne of t hese gr o u ps a n d ma y be a ble t o 
pr o vi de d pers pecti ves i n o ne or m ore gr o u ps. If s u bjects i de ntif y as ha vi n g pers pecti ves fr o m 
t w o or m ore gr o u ps (e. g. cli nicia ns t hat are b ot h o nc ol o gists b ut als o ha ve f or mal trai ni n g i n 
cari n g f or ol der a d ults wit h c o g niti ve i m pair me nt, s uc h as cli nicia ns d ual trai ne d i n geriatrics 
a n d o nc ol o g y), t he n we will c o u nt t hat i n di vi d ual as pr o vi di n g pers pecti ves i n b ot h cate g ories 
t h o u g h t he y will be re gistere d o nl y o nce wit h t he cate g or y t he y pri maril y i de ntif y wit h.
5.
S U B J E C T P O P U L A TI O N
Partici pa nts f or t he f oc us gr o u ps will be dra w n fr o m t he f oll o wi n g sta ke h ol ders:
1)
Me dical o nc ol o gists
2) Cli nicia ns wit h e x pertise i n c o g niti ve i m pair me nt a n d de me ntia
3) Ol der patie nts wit h ca ncer
4) Care gi vers of patie nts wit h de me ntia
T here ma y be s o me s u bjects t hat fall i nt o m ore t ha n o ne of t hese gr o u ps a n d ma y be a ble t o 
pr o vi de d pers pecti ves i n o ne or m ore gr o u ps.
T he t otal n u m ber of partici pa nts e nr olle d will be 4 0 partici pa nts.
If t he matic sat urati o n is reac he d wit h s u bjects t hat c o m plete d t he f oc us gr o u ps, we will n ot 
re place a n y s u bjects t hat wit h dre w fr o m t he st u d y. D uri n g t he c o n d uct of t he st u d y, if 
t he matic sat urati o n is reac he d earlier t ha n 4 0 partici pa nts, we will st o p c o n d ucti n g f oc us 
gr o u ps/i nter vie ws earlier t ha n 4 0 partici pa nts.
I ncl usi o n of V ul ner a ble P o p ul ati o ns:
T his st u d y d oes n ot i n v ol ve a d ults wit h decisi o nal i m pair me nts. 
6.
I N C L U SI O N A N D E X C L U SI O N C RI T E RI A
T he i ncl usi o n a n d e xcl usi o n criteria f or all partici pa nts are t hat t he y m ust be a ble t o c o nse nt 
f or t he msel ves a n d m ust s pea k E n glis h.
T he f oc us gr o u ps will be c o n d ucte d i n E n glis h a n d t h us partici pa nts will nee d t o be a ble t o 
s pea k E n glis h t o partici pate.
•
F or t he me dical o nc ol o gist f oc us gr o u p, partici pa nts m ust be a me dical o nc ol o gist. 
•
F or t he cli nicia ns wit h e x pertise i n c o g niti ve i m pair me nt a n d de me ntia f oc us gr o u p, 
partici pa nts m ust be a cli nicia n t hat treats patie nts wit h c o g niti ve i m pair me nt a n d 
de me ntia.
•
F or t he ol der patie nts wit h ca ncer f oc us gr o u p, partici pa nts m ust be ol der t ha n 6 5 
years of a ge a n d ha ve or ha d ca ncer.

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•
For the caregivers of patients with dementia focus group, participants must be 
caregivers of patients with dementia or mild cognitive impairment. 
7.
RECRUITMENT METHODS
Focus Group subjects will be recruited through several existing networks including:
-
The Cancer and Aging Research Group (CARG)
-
Community oncologists affiliated with UR NCORP
-
Network of clinicians affiliated with the Roybal Center
-
Clinicians affiliated with the Division of Geriatric Medicine at the University of 
Rochester 
-
Member of the Stakeholders for Care in Oncology and Research for our Elders 
(SCOREBoard), a patient advocacy group with longstanding ties to the geriatric oncology 
group at University of Rochester, including the PI25
-
Wilmot Community Outreach and Engagement Office
-
Caregivers of patients with MCI or dementia will be identified a few specific ways: 1) 
We will work with clinicians affiliated with the Division of Geriatric Medicine as noted 
above to help identify potential caregivers and with clinicians support and permission will 
approach potentially eligible caregivers. We will also work with clinicians at Wilmot 
Cancer Institute that would not be eligible to participate in subsequent phases of this 
study to identify potential caregivers and with clinicians support and permission will 
approach potentially eligible caregivers. 2) If necessary, we will also consider presenting 
our study at aging research support networks for clinical trials focused on dementia 
populations, such as the Recruitment Accelerator for Diversity in Aging Research 
(RADAR-CLD; this is an NIA funded network to support aging and dementia focused 
studies) or the University of Rochester Roybal Center. The Roybal center uses the HARP 
database project (STUDY00001252, PI: Heffner), which is a research registry by the 
current study’s investigators, which affords direct contact with older caregivers who have 
previously agreed to be contacted for future research study participation. Contact 
information is collected and maintained via the IRB approved HARP database study. 
Registry participants are contacted by phone, email or letter and invited to be screened 
when new HARP studies become available. Dr. Kathi Heffner, a Co-Investigator, is a 
HARP database investigator. Presenting at these networks can facilitate recruitment of 
potential participants through disseminating knowledge about the study participation 
opportunity. 
The study coordinator will meet with the potential subject in person or via phone and explain 
the purpose of the study. 
8.
CONSENT PROCESS
This research is no greater than minimal risk and involves focus groups for which written 
consent is normally not required outside the research context. We are requesting for waiver of 
documentation of consent as the research involves no more than minimal risk to the subjects. 
The only record linking the subject and the research would be the consent document and the 

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principal risk would be potential harm resulting from a breach of confidentiality. For this 
reason, we will use a verbal consent. A member of the study team will use the verbal consent 
script, then sign and date it to confirm that s/he followed the script and the subject agreed to 
participate in the study. Following the completion of verbal consent with the subject, the 
member of the study team will mail or email the subject a study information sheet that 
summarizes what the study entails and the subject’s involvement in it. 
9.
STUDY PROCEDURES
Focus groups will be performed to adapt the intervention.
Once participants are identified and consented, the study coordinator will interface with 
participant as needed by email or phone to schedule focus group and other information needs. 
A Zoom link for the focus group will be sent out individually to participants by email.
Prior to or at the beginning of the focus group or up to one week after completion of the focus 
group, a brief questionnaire for socio-demographic data will be administered via RedCap. 
Following informed consent, the focus group participant will be sent a link to complete the 
questions via RedCap. If a participant prefers, the study coordinator can also verbally ask the 
survey questions to them via phone as an alternative method of administration. This form will 
gather participants name, age, race, ethnicity, gender, sex at birth, sexual orientation, marital 
status, living situation, education level, household income, employment status, primary 
language, insurance status, zip code, and information about the perspective that they are 
offering during the focus group. For clinicians this will include details about the number of 
years in practice and the approximate number of patients they see weekly. For caregivers, this 
will include information about the number of years in the caregiving role. For cancer survivors, 
this will include information about the time since their cancer diagnosis and general 
information about the type of treatment they previously received (e.g. surgery, radiation, 
chemotherapy, other).  The PI or other trained study staff will conduct focus groups (2-10 
participants per group) with the following stakeholders: 1) Medical oncologists, 2) Clinicians 
with expertise in cognitive impairment and dementia, 3) Older patients with cancer, and 4) 
Caregivers of patients with dementia. Field notes will be taken by a research coordinator 
observing and not moderating the discussion. A total of 40 participants will be recruited for 
focus groups. If subjects are unavailable to join a focus group meeting, they may be considered 
to participate in an individual interview instead of a focus group. 
Focus groups and interviews will be conducted via URMC’s HIPAA compliant Zoom platform. 
During the focus groups, the study team will screen share materials to prompt discussion and 
elicit feedback from focus group participants (see “other subject materials” submission for 
images that will be screen shared). Focus groups will last approximately one hour. These focus 
groups will be audio-recorded and transcribed into deidentified transcripts. Audio files and 
transcripts will be stored in a secure Box folder. After preliminary analysis of focus group 
transcripts, individual semi-structured interviews may be used to follow up on themes needing 
further elucidation if necessary.

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10. AUDIO RECORDINGS 
Audio recordings will be generated during focus groups by recording through the URMC 
HIPAA-compliant Zoom platform. Recordings will be used for data analysis. Recordings will 
be stored directly on HIPAA compliant URMC Box. Within the Box drive, data will be 
stored in a password protected folder with access restricted to the PI and a subset of study 
team members. 
Audio recordings will be transcribed by a HIPAA compliant medical transcription company 
(Execuscribe, Inc) in a de-identified manner. All personal identifiers will be deleted (e.g. 
deidentified) from the transcriptions of the audio-recordings.  Audio-recordings and 
transcripts will be stored on URMC Box and will be accessible only by the PI and relevant 
study staff. Audio recordings will be stored until 1 year after completion of all study 
procedures, and then destroyed. De-identified transcripts may be made available to other 
researchers per NIH/NIA guidelines.
11. RISKS TO SUBJECTS
An anticipated risk to subjects is loss of privacy/breach of confidentiality. All efforts have 
been made to mitigate loss of privacy. We are using URMC’s HIPAA-compliant Zoom 
platform. Subjects will provide their email address in order to be sent a zoom link for the 
focus group. The Zoom link for focus group participation will be individually emailed to 
each participant and there will be no sharing of emails of other focus group participants.
During the course of the focus group, the subjects may self-disclose information about their 
own experiences to the other subjects in the focus group. By agreeing to participate in a focus 
group, subjects are agreeing to share their experiences with other focus group participants.  If 
patients are concerned about a privacy aspect from participating in a focus group, we could 
do an individual interview with them.
Another anticipated risk to subjects is potential distress resulting from topics discussed in the 
focus group. In the event of distress, the PI would be available to speak with subjects and 
provide a referral to social work and other support resources as needed.
12. POTENTIAL BENEFITS TO SUBJECTS
There are no anticipated potential benefits to individual participants from taking part in the 
research.
13. COSTS FOR PARTICIPATION
There are no costs that participants would be responsible for because of participation in this 
research.
14. PAYMENT FOR PARTICIPATION 
We will compensate all subjects for their time with a gift card for $75 using the University of 
Rochester Advarra system. Payment will be provided after completion of the focus group. If 
a participant withdraws from the study before joining a focus group, they will not be 

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provided with payment. If a participant withdraws from the study before finishing (in the 
middle of a focus group), they will still be provided with the full payment.
15. SUBJECT WITHDRAWALS
There are not any anticipated circumstances under which participants would be withdrawn 
from the study without their consent. If a subject withdraws from the study at any point, we 
will retain and use data collected up until the moment of withdrawing from the study. If 
thematic saturation is reached with subjects that completed the focus groups, we will not 
replace any subjects that withdrew from the study.
16. PRIVACY AND CONFIDENTIALITY OF SUBJECTS AND RESEARCH DATA
All efforts have been made to mitigate loss of privacy. Subjects will provide their email 
address in order to be sent a zoom link for the focus group. The Zoom link for focus group 
participation will be individually emailed to each participant and there will be no sharing of 
emails of other focus group participants. We are using URMC’s HIPAA-compliant Zoom 
platform.
During the course of the focus group, the subjects may self-disclose information about their 
own experiences to the other subjects in the focus group. By agreeing to participate in a focus 
group, subjects are agreeing to share their experiences with other focus group participants. 
Focus groups will be used to allow for exchange of viewpoints given the heterogeneity of the 
experiences in this population. Collective sharing may draw out richer insights regarding the 
intervention being adapted. If patients are concerned about a privacy aspect from 
participating in a focus group, we could do an individual interview with them.
Audio recordings of interviews will be stored directly on HIPAA compliant URMC Box. 
Within the Box drive, data will be stored in a password protected folder with access restricted 
to the PI and a subset of study team members. Audio recordings will be transcribed by a 
HIPAA compliant medical transcription company (Execuscribe, Inc) in a de-identified 
manner. All personal identifiers will be deleted (e.g. de-identified) from the transcriptions of 
the audio-recordings.  Audio-recordings and transcripts will be stored on URMC Box and 
will be accessible only by the PI and relevant study staff. Audio recordings will be stored 
until 1 year after completion of all study procedures, and then destroyed.
Data will also be collected and managed by the research team at University of Rochester 
Medical Center using REDCap electronic data capture tools hosted at URMC. We will 
collect sociodemographic data about subjects and we will utilize REDCap to collect and 
manage this information. NIH (National Institutes of Health) is one of the organizations that 
may look at or receive copies of information in participants study records. As required by 
NIH, we will report participant demographic data to NIA CROMS (National Institute on 
Aging Clinical Research Operations & Management System).
URMC provides the following information on the REDCap program: “Vanderbilt University, 
in collaboration with a consortium of institutional partners, has developed a software toolset 
and workflow methodology for electronic collection and management of research and clinical 

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trial data, called REDCap (Research Electronic Data Capture). The REDCap system is a 
secure, web- based application that is flexible enough to be used for a variety of types of 
research. It provides an intuitive interface for users to enter data and real time validation rules 
(with automated data type and range checks) at the time of data entry. REDCap offers easy 
data manipulation with audit trails and functionality for reporting, monitoring and querying 
patient records, as well as an automated export mechanism to common statistical packages 
(SPSS, SAS, Stata, R/S-Plus). Through the REDCap Consortium, Vanderbilt has 
disseminated REDCap for use around the world. Currently, over 240 academic and nonprofit 
consortium partners on six continents with over 26,000 research end-users use REDCap.” 
De-identified transcripts may be made available to other researchers per NIH/NIA guidelines.
15. DATA / SAMPLE STORAGE FOR FUTURE USE
Once the focus group session is transcribed, the audio-recording of the session will be deleted 
within one year. Transcriptions of the focus group sessions will be deidentified and kept 
indefinitely on URMC Box accessible only by the PI and relevant research staff. Deidentified 
transcripts may be made available to other researchers per NIH/NIA guidelines.
16. DATA AND SAFETY MONITORING PLAN
Subjects will not be followed longitudinally. These participants will not be followed 
longitudinally. We will collect data on any adverse events that occur during the focus group 
that are attributable to the focus group. We do not anticipate any adverse events.
17. DATA ANALYSIS PLAN
Focus groups will be audio-recorded, transcribed, and imported to MAXQDA software for 
sorting, coding, and analysis. Focus groups transcripts will be supplemented by the transcript 
from the chat in Zoom and field notes taken by a research coordinator observing and not 
moderating the discussion.26 Inductive content analysis will use a systematic classification 
process of coding to extract themes.27 The PI (Magnuson) will train coders and guide the 
process. 
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