Mitigating Cancer-Related Cognitive Impairment in Older Adults With Breast Cancer Receiving Chemotherapy: Memory and Attention Adaptation Training-Geriatrics (MAAT-G): A Randomized Pilot Study
Phase: NA
Conditions: Cancer-related Problem/Condition, Cognitive Impairment
Sponsor: University of Rochester

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Mitigating Cancer-Related Cognitive Impairment in Older Adults with 
Breast Cancer Receiving Chemotherapy: Memory and Attention 
Adaptation Training-Geriatrics (MAAT-G): A randomized pilot study
WILMOT CANCER INSTITUTE – UNIVERSITY OF ROCHESTER MEDICAL CENTER:
Study Chair:
Allison Magnuson, DO
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 275-7246/ Fax: 273-1042
Allison_Magnuson@URMC.Rochester.edu
Study Co-Investigators:
Supriya G. Mohile, MD, MS 
James P Wilmot CancerCenter 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: 585-273-4150/ Fax: 273-1042
Supriya_Mohile@urmc.rochester.edu
Michelle Janelsins, PhD
James P Wilmot Cancer Center 
601 Elmwood Ave
Rochester, NY 14620 
Michelle_Janelsins@urmc.rochester.edu
Lauren DeCaporale, PhD
Dept of Surgery, Strong Memorial Hospital 
601 Elmwood Ave
Rochester, NY 14620 
Lauren_Decaporale@URMC.Rochester.edu
Jeremy Kelly, PhD
Dept of Surgery, Strong Memorial Hospital 
601 Elmwood Ave
Rochester, NY 14620 
Jeremy_Kelly@URMC.Rochester.edu

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Lee Kehoe, PhD, MS, LMHC 
James P Wilmot Cancer Center 
601 Elmwood Ave
Rochester, NY 14642 
Lee_Kehoe@URMC.Rochester.edu
Kim Parkhurst
Dept of Surgery, Strong Memorial Hospital 
601 Elmwood Ave
Rochester, NY 14620
Jason Zittel, MD 
Myers Cancer Center 
111 Clara Barton Street 
Dansville, NY 14437
Phone: 585-335-6830
Jason_Zittel@URMC.Rochester.edu
Study Personnel:
Terri Lloyd
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 276-5652/ Fax: 273-1042
Terri1_Lloyd@URMC.Rochester.edu
Jessica Bauer
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: (585) 276-5652/ Fax: 273-1042
JessicaC_Bauer@urmc.rochester.edu
Megan Wells
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: 585- 275-8273/ Fax: 273-1042
Megan_Mckillip@urmc.rochester.edu

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Carrie Sylor, RN
Myers Cancer Center 
111 Clara Barton Street 
Dansville, NY 14437
Phone: 585-335-6830
Carrie_Sylor@urmc.rochester.edu
Heidi D’Aurizio, RN
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: 585-273-4150/ Fax: 273-1042
Heidi_DAurizio@URMC.Rochester.edu
Lucia Berkoff
James P Wilmot Cancer Center 
601 Elmwood Ave, Box 704
Rochester, NY 14642
Phone: 585- 275-8273/ Fax: 273-1042

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TABLE OF CONTENTS:
1.0 Study Schema and Abstract...................................................................................................................5
2.0 Specific Aims .........................................................................................................................................6
3.0 Background...........................................................................................................................................7
4.0 Subject Eligibility.................................................................................................................................10
5.0 Recruitment and Consent.....................................................................................................................11
6.0  Registration & Randomization............................................................................................................13
7.0 Treatment Protocol ............................................................................................................................14
8.0 Data Management ..............................................................................................................................18
9.0 Data Safety and Monitoring................................................................................................................21
10.0 References ........................................................................................................................................24

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1.0 STUDY SCHEMA
Baseline Assessment
Patients ≥ 65 years with breast cancer receiving systemic 
cancer therapy identified through new patient office or 
clinic schedules
Evaluated by primary oncologist and treatment plan 
recommended
Eligibility confirmed and consent obtained
Randomize
MAAT-G Workshops and participant 
workbook use (10 sessions)
10-12 week intervention
Supportive therapy control 
(10 sessions)
Follow-up assessment (within 4 weeks of intervention) completion)

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2.0 SPECIFIC AIMS
Cancer-related cognitive dysfunction (CRCD) is a significant problem. Our group and others have 
demonstrated that CRCD affects up to 75% of patients during treatment and can create difficulties in 
attention, processing speed, executive function and memory.1-3 Older adults are at greater risk of 
developing CRCD;4-8 half of women aged 65 receiving adjuvant chemotherapy for breast cancer report 
worsening of cognition, and 25% have measurable declines on neuropsychological testing six months 
post-chemotherapy.9,10 Patients with localized breast cancer have excellent overall survival but are at risk 
for CRCD as a long-term side effect of therapy.11-13 For older adults, CRCD can compromise
functional independence (e.g. Instrumental Activities of Daily Living [IADL]).14 The etiology of CRCD likely 
involves multiple factors including host factors (e.g. age, cognitive reserve), biologic factors (e.g. cortisol- 
mediated stress response), clinical factors (e.g. comorbidities) and psychological factors (e.g. coping 
mechanisms).2,15-20 While alleviating or preventing CRCD is important to older adult patients and their 
caregivers, interventions tailored to them do not exist.21
Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive behavioral therapy- 
based intervention for targeting modifiable factors of CRCD for older adults.20-23 MAAT-G provides 
instruction and practice with adaptive behavioral coping skills, stress management techniques, and 
compensation strategies for episodes of cognitive failure (e.g. lapses in memory, attention). MAAT-G is 
derived from an existing CRCD intervention (MAAT), and was adapted for the unique needs of older 
adults. MAAT-G is a series of ten manualized workshops delivered by a trained clinician (e.g. 
psychologist, psychology post-doctoral fellow, psychology intern or Research Nurse) via video- 
conferencing combined with a participant workbook. In younger cancer survivors (i.e. those who have 
completed chemotherapy), the original MAAT intervention was shown to improve self-perceived 
cognition (Functional Assessment of Cancer Therapy–Cognition [FACT-Cog], d=0.52), verbal memory 
(California Verbal
Learning Test 2 (CVLT), d=-0.63) and processing speed (Symbol Digit Subtest of 
Telephone Based Neuropsychological Status [TBANS], d=0.5).11,26 These cognitive functions are 
particularly important for older adults; and we propose to deliver MAAT-G alongside systemic cancer 
therapy to mitigate the development of CRCD (when risk is highest) and CRCD-related effects on 
functional independence for older adults.
Study Objective:
Primary Objective:

Examine the preliminary effect of MAAT-G on FACT-Cog.
o
Hypothesis: Patients receiving MAAT-G will have better perceived cognition (FACT- 
Cog) compared to control atfollow-up.
Secondary Objectives:

Estimate MAAT-G’s effect on function (e.g. IADL) and objective neuropsychological 
measures including CANTAB, FACT-Cog, COWA, HVLT-R, GDS, Brief Test of Adult 
Cognition by Telephone (BTACT), and GAD-7.
o
Hypothesis: Patients receiving MAAT-G will have better short-term 
visual/spatial memory, sustained attention, visual memory/new learning, verbal 
fluency, verbal learning and memory, and function compared to control at 
follow-up.

Develop a more complete understanding of the patient and caregiver experience with 
MAAT-G and their perceptions of MAAT-G’s benefits on cognition and function beyond 
what is captured by quantitative measures alone, through integration of quantitative

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data with semi-structured interviews.
3.0 BACKGROUND AND RATIONALE
3.1. Cancer-related cognitive dysfunction (CRCD) is a prevalent clinical problem; older adults are at 
greater risk of experiencing CRCD with cancer treatment, especially chemotherapy.1-8,15,29,30 Symptoms 
of CRCD include problems with memory, attention and executive function.2 CRCD is common; in the 
largest CRCD study to date, patients with breast cancer receiving adjuvant chemotherapy reported 
significantly greater cognitive difficulties from pre-chemotherapy to 6 months post-chemotherapy, 
compared to age-matched controls (mean change FACT-Cog score -10.4 in patients versus mean change
+1.5 in controls).1,2,15 Older patients, particularly those with lower cognitive reserve, may be most 
vulnerable to the effects of chemotherapy on cognition.4-6,29,30 Ahles and colleagues observed that the 
subgroup of older patients with low baseline cognitive reserve prior to adjuvant chemotherapy for 
breast cancer had the largest decline in processing speed post-treatment.4 Twenty-five percent of older 
women with breast cancer receiving chemotherapy develop cognitive decline from pre- to six months 
post-chemotherapy (defined as decline in 1 standard deviation in > two neuropsychological domains)10, 
and half report worsening of their cognition.9 The effects of CRCD can be long-term; up to 35% report 
CRCD months to years after completing therapy; cross-sectional studies of older breast cancer survivors 
demonstrate lower performance in multiple areas of neurocognitive function compared to age-matched 
controls without cancer, even several years after treatment.12,13
3.2. Advances in breast cancer therapies have greatly improved survival rates; older patients are living 
long enough to experience long-term complications of treatment such as CRCD. The five-year overall 
survival rate for patients with early stage breast cancer (I-III) is 98.9% for localized disease (breast only) 
and 85.2% for regional disease (lymph node involvement).11 Given these favorable cancer-related 
outcomes, CRCD and its functional consequences are particularly relevant for older adults with breast 
cancer. CRCD may create difficulties with Instrumental Activities of Daily Living (IADL), such as managing 
medications, which may compromise independence and quality of life for older adults.7,14,31-33 Nearly 
one-third of older women receiving adjuvant chemotherapy for breast cancer experience functional 
decline 1 year post-treatment.34 Despite this vulnerability, there are no available interventions to 
mitigate CRCD for older adults, because older adults are underrepresented in oncology clinical trials, and 
interventions to improve issues that are important to older adults, such as cognition, are not 
prioritized.35-37 A geriatric oncology U13 conference series supported by the NIA, NCI, and CARG 
highlighted intervention development, particularly cognitive interventions, as a high priority area for 
research.22,24,25,38,39
3.3. Multiple factors are likely involved in the etiology of CRCD including host factors (e.g. age, 
cognitive reserve), biologic factors (e.g. cortisol-mediated stress response), clinical factors (e.g. 
comorbidities) and psychological factors (e.g. coping mechanisms).2,15-20 CRCD can be conceptualized 
using a diathesis stress model, whereas under routine and low stress conditions, cognitive failures of 
daily life (e.g. mental lapses in memory, attention) are likely to occur with less frequency and when they 
do, they are readily managed.28 However, under periods of sustained physical and psychological stress 
(allostatic overload) such as chemotherapy, there may be dysregulation of the stress response leading to 
more frequent cognitive failures.19 The threshold for allostatic overload is variable and depends on an 
individual’s self-regulatory capacity (i.e. an individuals’ limited fund of “mental energy” to attend to self- 
regulatory behaviors such as decision-making, attentional demands, and emotional regulation).40,41 
Coping involves monitoring self-regulatory capacity and recognizing situations of allostatic overload that 
require adjustment/adaptation of behaviors.20 Maladaptive coping mechanisms can lead to further 
negative effects on cognition.42 Additionally, individuals possess varying abilities to compensate for

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cognitive stressors; however, compensatory strategies can be taught.
Memory and Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy 
(CBT)-based intervention for CRCD. As a CBT-based intervention, MAAT-G focuses on an individual’s 
psychological response to injury as compared to the biological events triggering CRCD, and provides 
instruction and practice with adaptive behavioral coping skills, stress management techniques, and 
compensation strategies. MAAT-G was adapted from the original MAAT intervention20-22 by the study 
team using the Contextual, Cohort-based, Maturity, Specific Challenge (CCMSC) model to account for 
the unique needs of older adults. The original MAAT intervention was evaluated in three separate 
studies of younger breast cancer survivors (n=29-47; mean age ranging 50-56 years) and improved 
perceived cognition (Functional Assessment of Chemotherapy-Cognition [FACT-Cog]) compared to 
active controls (p=0.02, d=0.52). We believe the compensatory strategy approach is advantageous to 
the retraining approach as it may be completed in a shorter format better suited to adult survivors. It 
overlaps with theoretical principals of CBT; learning new behaviors and cognitions to promote 
therapeutic, adaptive change. Compensatory strategies used in MAAT-G include self-awareness training 
(self-monitoring record keeping to identify “at risk” situations where cognitive failures may occur), Self- 
Instructional Training (SIT), or a method of “self-talk” to enhance on-task attention, mnemonic 
strategies to enhance retention and retrieval for daily working memory, and organizational and social 
skills training such as keeping a simplified schedule or active listening skills. Self-regulation skills of 
applied relaxation training and activity scheduling/pacing are also included. The overarching aim of 
MAAT-G is to enhance self-management and coping with cognitive failures in daily life to minimize 
impact on quality of life and to mitigate CRCD and its consequences for older adults with breast 
cancer.
3.4. The scientific premise of this new research is that CRCD is a significant problem, particularly for 
older adults, and interventions to improve cognitive outcomes are needed.
3.6 Preliminary Studies:
3.6a. Older patients and caregivers are concerned about the cognitive effects of chemotherapy. We 
conducted pilot work exploring goals with patients and caregivers in the SOCARE clinic. Patients and 
caregivers rated their goal to preserve cognition as high as cancer-related outcomes (e.g. improved 
survival) in the decision-making process for cancer treatment.21
3.6b. Nearly half of patients with breast cancer receiving adjuvant chemotherapy report a clinically 
significant decline in self-reported cognition.1 Additionally, in this population frailty characteristics 
increased from pre- to post-chemotherapy; and importantly patients with worse perceived cognition at 
baseline had a greater number of frailty characteristics after chemotherapy.47
3.6c. It is feasible to study behavioral interventions in clinical trials for older adults with cancer 
receiving chemotherapy.48 A pilot RCT testing the feasibility of implementing GA-guided management 
interventions for older adults with cancer receiving chemotherapy was conducted by the PI at the 
University of Rochester Wilmot Cancer Institute. 71 older adults were enrolled (75% of approached 
patients consented); 89% completed the 3-month follow-up assessment. A subset of older adults 
receiving chemotherapy experienced cognitive decline; in analysis of the Clock Draw Test, 15% 
demonstrated significant decline at 6-week follow-up.

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3.6d. MAAT was pilot-tested in three separate studies of younger breast cancer survivors (n=29-47; 
mean age ranging 50-56 years).11,26,27 Overall, MAAT improved perceived cognition (Functional 
Assessment of Chemotherapy-Cognition [FACT-Cog]) compared to active controls (p=0.02, d=0.52). For 
objective neurocognitive outcomes, MAAT participants demonstrated improved verbal memory 
(California Verbal Learning Test [CVLT]-2, p<0.05, d=-0.63) and processing speed compared to controls 
(Symbol Digit subtest of Telephone-Based Assessment of Neuropsychological Status [TBANS], p=0.03, 
d=0.5).26 Specifically, the original MAAT program was brief and consisted of 4 (30-50 minute) office visits 
and 3 phone contacts. This was tested in pilot research using a single-arm study. Twenty-nine breast 
cancer survivors (average 8.2 years post-chemotherapy; SD = 4.4 years) completed MAAT. Principal 
outcome measures included self-reported cognitive function in daily life as assessed by The Multiple 
Ability Self-Report Questionnaire (MASQ) Quality of Life- Cancer Survivors scale, satisfaction ratings and a 
brief neuropsychological test battery. Testing occurred at 4 time points: baseline, post-treatment, 2- 
month and 6-month follow-up. Results indicated a significant reduction in self-reported daily cognitive 
complaints (MASQ), improved quality of life and high satisfaction ratings. Neuropsychological test score 
improvements were observed in tests of verbal memory and in processing speed. Finally, survivors 
reported high satisfaction with MAAT. The one-group design limited conclusions about efficacy and the 
effect of practice on repeat administration of neuropsychological tests, but pilot results warranted further 
MAAT study.
In a second study utilizing a wait-list control design, 40 women were enrolled and randomized to 
treatment (n = 19) or waitlist control (n = 21) conditions and assessed at baseline, post-treatment and 3 
month follow-up time points. ANCOVA demonstrated two statistically significant outcomes controlling for 
effects of education and IQ: 1) the spiritual wellbeing subscale of the Quality of Life-Cancer Survivor Scale 
(QOL-CS); and 2) CVLT-2 Total Score. Effect size in verbal memory performance (CVLT-2 Total Score) 
among MAAT participants was large at post treatment even after subtracting the effect size observed in 
controls (.50).
In a third study, MAAT was delivered via televideo conferencing and patients were randomized to receive 
the MAAT intervention versus supportive therapy (control). One method of improving access to rural 
cancer survivorship services is through communications technologies. “Telehealth” refers to the use of a 
broad array of communications devices to improve health care access.
3.6e. Our team has adapted the MAAT intervention specifically for use in older adults through 
collaboration with key stakeholders: To refine and adapt MAAT for older adults, I used the Contextual, 
Cohort-based, Maturity, Specific Challenge (CCMSC) model for adapting CBT- based interventions for 
older adults.39 The model is informed by aging research and accounts for the social context of older 
adults.39 Subsequently, I made further refinements to MAAT-G using feedback from key stakeholders 
through a series of focus groups with members of SCOREboard, our older adult patient advisory group. 
SCOREboard members reviewed and provided feedback on workshop content, relevance to older adults, 
optimizing feasibility for delivering workshops concurrent with cancer treatment, and aspects related to 
technology support for older adults (see Table 1 for details of MAAT-G adaptations).

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3.6f. The usability of MAAT- 
G is currently being 
evaluated in four older 
adults receiving systemic 
treatment for breast cancer 
at the time of this 
submission. Regarding 
recruitment to the usability 
study, 4/4 approached 
patients consented to the 
study (100% consent rate). 
The mean age of patients 
enrolled is 73.3 (range 67-
77). Educational background 
varied; one patient has less 
than high school degree, two 
have some college education 
and one has graduate level 
education. The usability 
phase trial also enrolls 
caregivers if they are 
identified; 1 of the 4 patients 
identified a caregiver and 
this caregiver consented to
enrollment. There was 100% capture of baseline assessment measures; these measures included perceived 
and objective cognitive assessment as well as selected geriatric assessment measures of functional 
independence and psychological status. All four patients remain on study and to date have completed 
MAAT-G workshops on schedule (at time of submission, two patients have completed 9/10 workshops, one 
patient has completed 8/10 and one patient has completed 6/10).
4.0 SUBJECT ELIGIBILITY
The eligibility criteria are aimed at identifying older patients undergoing cancer treatment. As above, if 
patients are able and willing to identify a caregiver, caregivers will also be consented to participate in 
study processes.
4.1. Patient Inclusion Criteria:

Have a diagnosis of invasive breast cancer

Planned to receive systemic therapy for breast cancer or actively receiving systemic therapy for 
breast cancer with two additional cyclesremaining.

Be age 65 or older

Able to provide informed consent (or possess a designated health care proxy that can do the same 
that was designated prior to the patient losing decision-making capabilities)

Able to read and understand English (or possess a designated health care proxy that can do the 
same that was designated prior to the patient losing decision-making capabilities)
Table 1: MAAT-G Adaptations Using CCMSC Model

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4.2. Patient Exclusion Criteria:

Have surgery planned within 3 months of consent

Patients who do not have decision-making capacity (decisionally or cognitively impaired) AND do 
NOT have a previously designated health care proxy (established prior to their cognitive 
impairment) available to sign consent

Patients with breast cancer receiving endocrine therapy as their only systemic therapy will not be 
eligible.
We anticipate enrolling 85 patients to phase II over a 24-36 month timeframe.
4.3 Entry criteria for caregivers:
A caregiver can be anyone, age 21 or over, who is able to understand spoken English, understand the study 
process and provide informed consent. One caregiver for each patient will be eligible and must be chosen by 
the patient. For the purposes of this study, a caregiver is defined as a valued and trusted person in a patient’s 
life who is supportive in health care matters by providing valuable social support and/or direct assistive care.
4.3.1. Inclusion criteria for caregivers:

Selected by the patient when asked if there is a “family member, partner, friend or caregiver 
[age 21 or older] with whom you discuss or who can be helpful in health-related matters;” 
patients who cannot identify such a person (“caregiver”) will remain eligible for the study.
4.3.2 Exclusion criteria for caregivers

Caregivers unable to understand the consent form due to cognitive, health or sensory 
impairment will be excluded
5.0 IDENTIFICATION, RECRUITMENT, AND CONSENT PROCEDURES
Subjects will be enrolled at the University of Rochester Comprehensive Breast Cancer Center at Pluta 
Cancer Center,the University of Rochester Wilmot Cancer Institute at Highland Hospital, and Myers Cancer 
Center in Dansville. Patients will be recruited from the breast medical oncology clinics at these three sites. 
The clinic schedules of breast oncologists and their advanced practice providers (APPs) will be screened for 
eligible patients.
To ensure appropriate safety precautions when conducting in-person study procedures, the process for 
conducting in-person visits outlined in the Guidance for Human Subject Research will be followed.
5.1. Patient and Caregiver Identification, Recruitment, and Consent Procedures:
Potential patients will be identified in multiple ways. First, at the three sites for accrual, study participants 
will be identified by their treating physician, the nurses that work with the physicians, and the study 
coordinator. The study coordinator works closely with the physicians and nurses to monitor patients and 
identify those patients that are anticipated to begin cancer treatment. With permission from oncology 
providers, we will screen for eligible patients from clinic schedules. The study coordinator contacts the

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physician (or their designee) and lets them know that a patient may be eligible for the study. The 
physician (or their designee) then confirms if the patient is a good study candidate or not and affirms that 
the patient has decision making capacity. If there is a question about eligibility, the principal investigator 
will be contacted and will meet with the patient and/or health care proxies, review the medical records, 
and perform an assessment of eligibility if necessary. After meeting with the physician (or their designee), 
the study coordinator will meet with the patient, and explain the details of the study. Study staff will 
introduce the study to the patients and provide adequate time to read the consent.
For patients at the Dansville location, the study coordinator will contact the physician (or their designee) to 
let them know that a patient may be eligible for the study. The physician then confirms if the patient is a 
good study candidate or not and affirms that the patient has decision making capacity. The physician or a 
member of the study team then mentions the study to the patient during the visit. If the patient expresses 
interest, a member of the study team will consent the patient and provide the patient with the necessary 
materials to participate in the study. If the patient would like to consider the study further, the study team 
at Myers Cancer Center (Dansville) can provide the patient with an informational consent and with their 
permission, a member of the MAAT-G study team will contact the patient at a later date to follow-up.
Recruitment of caregivers: If patients are agreeable to participating in the study, patients will be asked if 
there is a “family member, partner, friend or caregiver [age 21 or older] with whom you discuss or who can 
be helpful in health-related matters;” to participate as a caregiver. If patients are unable to identify a 
caregiver, they will still be able to participate. If patients are able to identify a caregiver, a member of the 
study team will give the patient a contact form that summarizes the purpose of the study, what the study 
would entail for the caregiver, and study coordinator’s contact information. If the caregiver is interested in 
participating, s/he will contact the study coordinator using the contact information provided on the 
contact form. The study coordinator is not allowed to initiate the first point of contact with the caregiver.
5.1.1. Informed Consent: Informed consent will be obtained from the patient by a member of the study 
team in person during a clinic visit. The member of the study team uses the informed consent document as 
a written aid and goes over every detail of the study with the patient and/or health care proxy in person 
and recruits them to the study. Members of the study team are available to answer any questions the 
patient may have about any aspect of the study prior to consenting and throughout the entire study period. 
Patients may choose to sign the informed consent immediately on the day the study information is 
presented to them or they may choose to take the informational consent form home and discuss it with 
others. If they want to participate in the study, they can sign it the next time they meet with a member of 
the study team. If the patient is participating in a telehealth visit and expresses interest, the coordinator will 
ask patient for his/her permission to be mailed an informational consent for their review. The coordinator 
will then follow up with the patient by phone or in person a few days later to answer any questions and to 
see if the patient is willing to participate in the study. If the patient would like to participate in the study, the 
member of the study team will either meet with the patient in person to have the consent form signed, or 
the coordinator will complete a verbal informed consent with the patient over the phone. See 5.1.2.
5.1.2. Verbal Informed Consent: If the patient or caregiver cannot meet in person with a member of the study 
team to sign the informed consent, the study coordinator will verbally consent the subject. The member 
of the study team will use the verbal consent script, then sign and date it using either wet-ink or an 
Adobe Certified signature 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.
5.1.3. Baseline Measures and Study Procedures: The baseline measures will then be performed and

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study procedures will occur. The patient must be determined to have decision-making capacity to 
provide informed consent by their treating oncologist.
5.1.4. Human Subject Protection: Ethical standards for human subjects will be strictly followed in 
accordance with the University of Rochester Research Subject Review Board Investigator Guidance policy 
and the University of Rochester Policy on Enrollment of Adult Decisionally Incapacitated Research Subjects 
and Permission of Authorized Representatives.
5.1.5. Participation: Current, state, federal, and institutional regulations concerning informed consent will 
be followed. Participation in this study is voluntary. Participants are free not to take part or to
withdraw at any time, for whatever reason, without risking loss of present or future care they would 
otherwise expect to receive. In the event that a patient does withdraw from the study, the information 
they have already provided will be kept in a confidential manner. Participants may discontinue 
participation in the study at any time if they decide they do not wish to take part any longer.
Participants may be withdrawn from the study by research personnel if it is deemed in their best 
interest to no longer participate.
5.1.6. Duration: Patients who consent to the study will be in this study for five months. Patients will be 
consented to actively participate, receive phone calls or meet with the research study team for up to 5 
months after their initial workshop visit. The research team may contact patients in the future to gain 
further information first hand regarding patients’ overall health and treatment. Dr. Magnuson may decide 
to take patients off the study without their consent if the study is stopped. Additionally, patient data will 
be kept for a period of 10 years at URMC, even after the study is closed or a patient passes away. It will be 
maintained in a locked database with password access only (See Section 8).
6.0 REGISTRATION AND RANDOMIZATION
6.1. Registration:
To register a participant who meets the eligibility criteria and who has signed the informed consent 
document, study staff will enter the information outlined in section 6.2 in the OnCore database.
6.2. Information Requested atRegistration:
6.2.1
First name
6.2.2
Last name
6.2.3
eMRN
6.2.4
Birth Date
6.2.5
Gender
6.2.6
Race
6.2.7.
Ethnicity
6.3. Initial Assessment:
After consent procedures are completed, the patient, with the help of the study coordinator, will 
complete a baseline assessment (See section 7).

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6.4 Randomization Procedures:
The two intervention arms are as follows: 
Arm 1= MAAT-G intervention
Arm 2 = Supportive therapy (time and attention control)
A computer-generated random numbers table, stratified by stage (local [stage I-III] and advanced [stage IV]) 
with equal probability of block size 2 or 4 will be used to assign participants to one of the two treatment 
arms. The randomization will assign participants to the two arms in the ratio 1:1. The random numbers tables 
will be generated centrally using R software. A total enrollment of 85 participants is planned to accommodate 
for potential 15% attrition, with at least 35 participants in each treatment arm.
Subjects can be registered prior to obtaining baseline measures however, subjects will not be aware of which 
arm they are randomized to until after the baseline assessment. After registered, they will be scheduled to 
undergo baseline measures. At the end of the visit for baseline assessment, they will be randomized.
7.0 TREATMENT PROTOCOL
7.1 Measures:
Patient measures will include demographics, cognitive, psychological, and functional independence 
measures. The battery was selected based upon our experience in prior studies.1,26,50,51 Based upon 
experience in prior studies, we estimate the cognitive evaluation will take approximately 60 minutes to 
complete1,3 and the demographics, psychological and functional independence measures will take 
approximately 20 minutes.
Demographics: Patient and caregiver demographics will be collected, including age, gender, race, ethnicity, 
marital status, education and socio-economic status will be captured. Cancer and treatment variables, 
comorbidities, and medications list will be collected from the medical record by study staff.
Cognitive Evaluation will include: 1) FACT-Cog52, a validated patient reported outcome measure created to 
assess cognitive challenges identified by patients with cancer; 2) Brief Test of Adult Cognition by Telephone79 
(BTACT), a slightly modified version that assesses multiple dimensions central for effective functioning across 
adulthood; 3) Cambridge Neuropsychological Test Automated Battery (CANTAB) delayed match to sample 
test53 (DMS), Rapid Visual Information Processing (RVP), and Paired Associates Learning (PAL), validated, 
computerized tests that assess short- term visual/spatial memory, sustained attention, and visual 
memory/new learning; 4) Controlled Oral Word Association (COWA)54, a measure of verbal fluency 
evaluating expressive language and executive function; and 5) Hopkins Verbal Learning Test-Revised (HVLT- 
R)55, a validated test of verbal learning and memory. All measures are “paper and pencil”, except for the 
CANTAB (computer-based assessments that, due to COVID-19, will be administered virtually by collecting 
patients’ emails and sending a web- based link). COWA, HVLT-R, and BTACT require the study coordinator 
to administer the tests; they can be administered virtually so study coordinator will schedule a telephone 
or televideo meeting with the patient at the corresponding time points, as needed.
Psychological Assessment: will include Geriatric Depression Screen (GDS)57,Generalized Anxiety and 
Depression (GAD-7)58 , and Intolerance of Uncertainty Scale-Short Form (IUS-12). IUS-12 will be administered 
by the study coordinator over the phone or via televideo (Zoom application) at the appropriate time points.

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Functional Independence: IADLs will be measured59. IADL will be administered by the study coordinator over 
the phone or via televideo (Zoom application) at the appropriate time points.
Phase II semi-structured interview questions for patients and caregivers will focus on perceptions of cognitive 
change and potential benefit of interventionsessions.
7.1 Study Procedures:
Baseline: Following informed consent, patients will undergo Time Point (TP) 1 assessment. Patients will be 
provided with a data-enabled tablet with HIPAA-compliant video-conferencing application and instructed on 
its use, participant workbook (for MAAT-G intervention participants only), and tablet instruction manual. The 
study coordinator will give the patients a drawstring bag to hold all study materials given at TP1. At the time of 
enrollment, the study coordinator will assign each patient a unique meeting ID number within the tablet 
instruction manual. This meeting ID number allows each patient to log on to the video-conferencing 
application and speak to trained clinician (e.g. the MAAT-G Interventionist). Study coordinators will train 
and support patients on the use of the tablet and video conferencing application. No data is being stored on 
the tablet itself. If patients consent to have sessions recorded, this will be done through the HIPAA- 
compliant Zoom software application. If participants do not have access to wireless internet, the tablet will 
be equipped with a data package for participant use for the purposes of this study. At completion of the 
study, patients will return the tablet to the study coordinator. If the tablet is lost or stolen during the study, 
no PHI will be stored on the tablet and thus would not be accessible. If the tablet is broken during the 
course of the study, we will provide participants with another tablet for use during the study period. The 
participant would contact the study coordinator with any concerns or problems with using the tablet, 
contact information will be provided during training on tabletuse.
Intervention Period: The intervention period is 10-12 weeks; 10 weekly workshops will be delivered through 
video-conferencing on the tablet. Workshops will be audio-recorded for fidelity review. (See section 7.2)
Follow-up: Within 1 day to 4 weeks of intervention completion (approximately week 10-14), patients will 
undergo TP2 assessment.
Patient assessments will be performed by trained study coordinators. As a safety precaution due to COVID- 
19, patients may take surveys home for completion (e.g. demographics) and then mail back to study team 
in order to minimize the amount of in-person contact between coordinators and patients; the method of 
completing surveys at home has been successful in prior studies with good retention.43,48 However, to 
encourage the completion of the surveys, the study coordinator will schedule a telephone or televideo 
meeting with the patient, as needed, to ensure patients’ questions concerning the surveys are addressed. 
Study coordinators will score assessments and transcribe results into a database. Audio- recordings will be 
deleted following transcription.
Semi-structured interviews will be conducted by a trained study coordinator who is not responsible for any 
other component of the study. Interviews will be conducted with patients and if consented, will include 
caregivers. As a safety precaution due to COVID-19, the interviews with the patients and caregivers will be 
conducted over the phone or over Zoom televideoconferencing application. These audio-recorded 
interviews will be conducted after completion of the intervention.
Location: Participation in workshops will take place through video-conferencing. Participants will be 
encouraged to participate from their home or other private location. Due to COVID-19, the Department of 
Psychology is conducting clinical visits from their clinical office and home office locations until further 
notice. Wherever the location may be, the trained clinician (e.g. psychologist psychology post-doctoral

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fellow, psychology intern, or Research Registered Nurse [RN] trained in MAAT-G) who is conducting the 
interventions will ensure privacy in a private room with a closed door. Participants will be provided with a 
HIPAA compliant tablet to use for participation in the intervention activities and the intervention will be 
delivered using HIPAA compliant video-conferencing technology provided by the University of Rochester. 
The coordinator will be in touch with patients by phone throughout the length of the study, serving as a 
liaison between patient and trained clinician MAAT-G Interventionist. Coordinator will help organize the 
scheduling/rescheduling of workshop sessions and will be available for any patient questions.
7.2. Study Interventions
7.2a. MAAT-G Intervention
The MAAT-G intervention will be delivered by a trained clinician (also described as MAAT-G Interventionist 
and includes psychologist, psychology post-doctoral fellow, psychology intern, or Research RN trained in 
MAAT-G) at the University of Rochester Medical Center. The intervention will be delivered through 
televideoconferencing and participants will be provided a tablet equipped with a HIPAA compliant 
televideoconferencing application to use for the MAAT-G workshop sessions. We will use the University of 
Rochester Zoom application which is HIPAA compliant. A tablet instruction manual will be given to patients 
to help guide them through how to use a tablet and how to navigate the Zoom application. A unique 
meeting ID number will be given to each patient to log in to the Zoom application. If participants do not 
have access to wireless internet, the tablet will be equipped with a data package for participant use for the 
purposes of this study.
Participants will also be provided a workbook for skills practice in between workshop sessions. A 
summary of workshop content is provided in table 2 below.
During Workshop #2, the study coordinator or trained MAAT-G Interventionist will provide patients a 
link to a Vimeo video. The coordinator will email the link to patients a couple days before Workshop 
#2. The Vimeo video has been created by the study team and talks patients through how to remain 
relaxed before stressful events occur. Study patients will be able to access the video without providing 
any personal information to the website.
Table 2: MAAT- 
G workshop 
content
WORKS HOP 
VISIT:
Content/Strategies:
1

Introduction to MAAT

Self-Awareness and monitoring of memoryproblems
2

Progressive Muscle Relaxation

Quick Relaxation
3

Self-Instructional Training

Verbal and silent rehearsal
4
1.
Cognitive restructuring
5
2.
Keeping a schedule

Memory routines
6
1.
External cueing

Distraction reduction
7
1.
2.
Activity scheduling and pacing 
Active listening

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8
1.
Fatigue management
2.
Sleep improvement
9

Visualization strategies
10

Tying it all together
7.2b. Supportive care control condition
Supportive Therapy (ST) is a “behavioral placebo” and controls for non-specific psychotherapeutic factors of 
the clinician-subject relationship, such as empathy and support, but does not provide active cognitive 
training. ST utilizes reflective listening to help deepen awareness of participants’ emotional experience. ST 
was used as the control condition for a prior MAAT study.71 A clinician manual for ST has been developed.71 
Timing and duration of ST sessions will mirror the intervention, and will consist of 10 weekly sessions, 30 to 
45 minutes each, delivered by a trained clinician (e.g. psychologist, psychology post-doctoral fellow, 
psychology intern, or Research RN) via video-conferencing.
We will offer subjects who are randomized to the Supportive Therapy (ST) group the opportunity to receive 
the MAAT-G Intervention after their completion of the 10 ST sessions and the post-intervention follow-up 
time point procedures. We will not administer an additional evaluation during this time period if patients 
elect to proceed with MAAT-G after completing study procedures (e.g. no further time points for followup of 
cognition or survey measures). If patients do elect to continue with this, we will continue to monitor for 
potential adverse events that are related to the behavioral intervention (see Data Safety Monitoring section 
below). Participants electing to continue and receive MAAT-G after completing study procedures can 
discontinue at any time. If subjects decide to get the MAAT-G intervention, they do not need to complete all 
10 sessions or within a certain timeframe. We will collect data on the number of ST subjects who chose to do 
the additional MAAT-G Intervention and the number of sessions completed. The intent of allowing patients 
randomized to ST to continue and receive MAAT-G after completion of study procedures is to facilitate 
retention.
The University Advarra system will be used per WCI policy for study reimbursement for $30 per time 
point/workshop. The templated RSRB information for Advarra will be used for information for patients for use 
of the gift card system. The study team will collect W-9 to sent to University Accounts Processing for study 
payment documentation and send to accountspayable@finance.rochester.edu. Following this, the participant 
W-9 will be shredded. W-9 information will not be kept by the study team.
7.3. Potential risks:
A participant may become more aware of any attention or memory problem they are experiencing as a 
result of participation in this study, potentially increasing psychological stress. While this is unlikely to 
provoke significant problems, the PI (Dr. Magnuson) will be available for evaluation and referral to 
appropriate behavioral care if needed.
Risks to privacy using telehealth and telecommunications are a potential concern. We also recognize 
that while encryption of videoconferencing makes breeches of private information unlikely, not all 
risks to privacy can be completely eliminated. We will inform all participants using the telehealth 
equipment of this.

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Figure 1: Power Curve
7.4. Potential benefits:
There may be no direct benefits to participation in this study. However, the study will provide useful 
information about systemic cancer therapy-associated cognitive problems for older adults and strategies for 
helping patients cope with memory and attention problems.
8.0 DATA MANAGEMENT
8.1. Data Handling and Statistical Considerations:
8.1.1. The same protocols and procedures for data quality and control that are readily used for prior 
studies conducted with the Geriatric Oncology Research Group and currently being overseen by our office. 
Data will be entered into REDCap (see section 8.3.5 below).
8.1.2. After entering into REDCap, data are audited visually for errors. R, SPSS and SAS will be used for the 
statistical analyses. Unless otherwise stated, all statistical tests will be performed at the two-tailed 5% 
level of significance. Likewise, 95% confidence intervals will be constructed for the estimation of effects.
8.1.3. The assumptions underlying all statistical analyses will be thoroughly checked using appropriate 
graphical and numerical methods.65,66 In case of violations of distribution assumptions such as normality, 
appropriate nonparametric methods will be attempted.67,68 If outliers or influential data are detected, the 
accuracy of the data will be investigated. If no errors are found, analyses may be repeated after removing 
these cases to evaluate their impact on the results. However, the final analyses will include these data 
points.
8 . 2 . Data Analysis and Sample Size:
Data Analytic Plan:
Power Analysis and Sample Size Consideration: The effect size for MAAT-G concurrent with systemic cancer 
therapy in older adults is not known; the purpose of this study is to gather preliminary
efficacy data on perceived cognition (FACT-Cog). MAAT has demonstrated a medium 
effect size (d = 0.52) on FACT-Cog in younger cancer survivors. Using analysis of 
covariance (ANCOVA) design and pre-post correlation of 0.5, a sample size of n=35 
evaluable patients per group will provide 80% power to detect an effect size of 0.52 at 
the significance level of 0.10 (Figure 1). Assuming 15% attrition, we will enroll 85 
patients.
Quantitative Data Analysis: Underlying assumptions to all statistical analyses will be 
checked using appropriate graphical and numerical methods.72 In the case of serious 
violation of assumptions, appropriate transformations or nonparametric methods will be 
used.73,74 If outlying observations are encountered, data will be checked. If no errors are
found, we will conduct analyses with and without the outlying data and compare results. Bivariate 
associations between treatment group and participant variables (demographics, cancer and treatment 
characteristics, baseline assessment of outcome measures) will be examined to assess possible imbalance 
between arms. Since this is a pilot study, will use significance level=0.10 to avoid false negative results, and 
decrease the risk of abandoning a promising intervention.75,76
Analysis of the primary outcome: To assess the impact of the intervention on patient-reported cognition 
(FACT-Cog), we will employ the analysis of covariance (ANCOVA). The model will consist of post-FACT-Cog as 
the outcome and include the arm as the main effect and pre-FACT-Cog as a covariate. We will evaluate the 
interaction between pre-FACT-cog and the arm. We will adjust for baseline covariates in case that 
imbalance between arms was detected, and baseline and change in psychological measure (GDS and GAD- 
7). All non-significant covariates will be removed from the model.

Analysis of secondary and exploratory outcomes: The effect of MAAT-G on objective cognition (CVLT-R, 
TBANS, CANTAB, COWA, HVLT-R, TMT A/B), functional independence (IADL) and stress response (cortisol) will 
be assessed with the same strategy as for the primary outcome.
As above, a sample size of 85 patients is planned based upon anticipated attrition rates. If attrition of patients 
occurs at a higher proportion than anticipated during the trial conduct, we will conduct an interim data 
analysis check to assess for need in adjusting sample size.
Phase II Qualitative Data Analysis: Semi-structured interviews will be prepared and coded similar to Phase Ib. 
Potential themes from Phase II interviews include experiences of cognitive failure and perceived timing and 
mode of onset of symptoms, changes in functional independence, perception of how the intervention (either 
MAAT-G or ST) influenced symptoms and experience, and experiences with the adaptive behavioral or 
compensatory techniques used.
Mixed Methods Integration: Qualitative and quantitative data will be integrated (Table 3) to enhance our 
understanding of the participant experience with MAAT-G and explore potential benefits beyond what is 
captured in quantitative tools. Our primary outcome, FACT-Cog, is a validated tool to measure perceived 
cognition and was developed through qualitative methods. However, the average age of patients involved 
was 59.6 years old,77 and it is possible the FACT-Cog does not capture cognitive experiences that are unique 
to older adults. Quantitative data will be analyzed first to determine longitudinal change in perceived 
cognition, and then integrated with qualitative data to evaluate if qualitative themes differ between 
patients who experience longitudinal improvement in perceived cognition versus those with longitudinal 
decline as well as difference in themes between study arms. Data will be organized using MAXQDA joint 
displays.78
Table 3: Integration plan:
8.3. Records to be Kept:
FORM
Baseline
Post-
Intervention
On Study Data (Patient and caregiver demographic 
information and clinical data)
X
FACT-COG
X
X
CANTAB
X
X
BTACT
X
X
COWA
X
X
HVLT-R
X
X
X
X
GAD-7
X
X
IADL Survey
X
X
IUS-12
X
X
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8.3.1. Data Collection Table:
SCHEDULE OF DATA COLLECTION

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8.3.2 All hardcopy research records will be stored onsite in the University of Rochester Medical Center, 
in locked research files at the James P. Wilmot Cancer Center. The Cancer Center is secured with 
electronic key cards. Offices within the Cancer Center are again secured by key and data is kept in 
locked file cabinets. Electronic research records are stored on the University of Rochester Medical 
Center’s password secured and firewall protected networks. These are the same methods of security 
used for patient medical records. All study data will be kept for a period of 10 years after the study and 
all reports and publications are complete.
8.3.3 All recorded data, such as the audio-recorded interviews/transcripts and Zoom workshop sessions, 
will be stored on the UR Box drive to assess fidelity of intervention delivery. 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. All personal identifiers will be deleted (e.g. de-identified) from the transcriptions of the audio- 
recordings. Once data is uploaded to the secure server, the data will be deleted from the audio 
recorders.
8.3.4. All data collected for the current study will be used in post hoc analyses as appropriate. Data will 
not be used for future studies without prior consent of the patient. The patient’s individual research 
record will not be shared with their treating physician, unless they provide consent or the patient’s 
treating physician is a study physician, in which case they will have access to study data as a study co- 
investigator. Overall study results will be presented to participants, faculty and staff at the University of 
Rochester Medical Center after completion of the study. Study results will be presented at professional 
meetings and published.
8.3.5. The study coordinator will assign a numerical study ID to each participant once they have signed 
the consent form. All study forms and questionnaires will use this number and the participant’s first, 
middle, and last initials as identifiers, to ensure data integrity. Other identifying information will not 
exist on these forms. A complete list of study participants with study ID, name, and contact information 
will be maintained separately. This linkage information will only be accessible to the study coordinator, 
study investigators, and the individuals responsible for maintaining the database.
8.3.6. Additionally, the data can be collected and managed by the research teams at University of 
Rochester Medical Center using REDCap167 electronic data capture tools hosted at URMC.
8.3.6a. 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 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.

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Currently, over 240 academic and non-profit consortium partners on six continents with over 
26,000 research end-users use REDCap” 168.
8.3.56. According to the Clinical and Translational Science Institute (CTSI), REDCap is supported 
with the following means. “The CTSI Informatics Core, a unit of the SMD Academic Information 
Technology (AIT) Group, will serve as a central facilitator for data processing and
management. REDCap data collection projects rely on a thorough study-specific data dictionary 
defined in an iterative self-documenting process by all members of the research team, with 
planning assistance from the AIT-CTSI Informatics Core. The iterative development and testing 
process results in a well-planned data collection strategy for individual studies”168.
8.3.6c. The CTSI states that regarding security, “REDCap servers are housed in a local data center 
at the University of Rochester and all web-based information transmission is encrypted. REDCap 
was developed in a manner consistent with HIPAA security requirements and is recommended to 
University of Rochester researchers by the URMC Research Privacy Officer and Office for Human 
Subject Protection.168
9.0 DATA SAFETY AND MONITORING
This protocol should be considered low risk as the intervention is a cognitive behavioral therapy (CBT)- 
based intervention. CBT- based treatments are utilized in routine clinical care for use with community 
dwelling older adults. This study is designed to see if MAAT, a CBT-based intervention, is feasible to 
deliver to older adults receiving systemic cancer therapy for breast cancer and can improve cognitive 
outcomes for this population.
9.1. Adverse Event Reporting Requirements:
9.1.1. Adverse events will be reported using the URCC Adverse Event form and/or as required by the 
Cancer Center Clinical Trials Office.
9.1.2. Adverse events will be reported in accordance with the following guidelines. We will not report 
adverse events if it is not required per the guidelines.
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Unexpected
Expect
Unexpected
Expected
Unexpe
Expect
Unexpect
Expect
Unexpe 
cted 
and
with 
hospit
witho 
ut
with 
hospi
witho 
ut
with 
hospit
witho 
ut
Unrelat 
ed 
Unlikel
Not 
Require 
d
Not 
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ed
Not 
Requir 
ed
Not 
Requir 
ed
Not 
Requ 
ired
Not 
Requir 
ed
Not 
Requir 
ed
Not 
Requir 
ed
10
Calenda 
r Days
Not 
Requir 
ed
10
Calendar 
Days
10
Calend 
ar Days
Possibl 
e    
Probabl
Not 
Require 
d
10
Calen 
dar
Not 
Requir 
ed
Not 
Requir 
ed
10
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dar
10
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dar
Not 
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ed
24-
Hour; 
5
10
Calend 
ar Days
24-Hour; 
5
Calendar
10
Calend 
ar Days
Hospitalization is defined as initial hospitalization or prolongation of hospitalization for ≥ 24 hours, due to adverse event.
9.1.3. Adverse event reports will be submitted in one of the following ways:
(1) By email: (pdf)

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(2) By mail:
(3) By fax:
9.1.4. An unexpected adverse event is defined as any adverse experience, the specificity or severity of 
which is not consistent with the risk information. This is a low risk study as interventions have been 
shown to improve outcomes of community-dwellingolder adults.
9.1.5. A serious event refers to any event in which the outcome results in any of the following: death, a 
life-threatening adverse experience, inpatient hospitalization or prolongation of existing hospitalization, 
a persistent or significant disability, incapacity, or a congenital anomaly/birth defect. Important medical 
events that may not result in death, be life-threatening, or require hospitalization may be considered a 
serious adverse drug experience when, based upon appropriate medical judgment, they may jeopardize 
the participant and may require medical or surgical intervention to prevent one of the outcomes listed in 
this definition. We anticipate that any serious events will be related to standard of care cancer 
treatment and not due to the MAAT-G intervention, which is designed to improve outcomes and focus 
on cognitive side effects of cancer treatment. To reiterate, only adverse events attributed to the 
behavioral intervention will be captured and reported.
9.1.6. Adverse events will be reported in accordance with institutional policies (University of Rochester, 
Research Subject Review Board, local IRB, URCC CCOP, CTO, and DSMB) as per their requirements.
9.1.7. For patients randomized to ST arm who elect to receive MAAT-G after completion of all study 
procedures, we will continue to monitor for AE during the time period that they are continuing. To 
reiterate, only adverse events attributed to the behavioral intervention will be captured and reported.
9.2. Data Safety Monitoring:
9.2.1. All adverse events requiring reporting will be submitted to the current Project Coordinator as 
described in Section 9.1. Serious adverse event reports will be forwarded to the study chair and the 
Data Safety and Monitoring Committee (DSMC). Adverse events are entered into a protocol-specific 
spreadsheet.
9.2.2. Adverse event rates are monitored utilizing the spreadsheet. If a serious adverse event is 
reported frequently, the study chair will conduct a detailed review. The DSMC Committee Chair will be 
notified and will determine if further action isrequired.
9.2.3. The Data Safety Monitoring Committee (DSMC) will review study progress and cumulative reports 
of adverse events at annual meetings and as needed. An overall assessment of accrual and adverse 
events will enable the committee members to assess whether significant benefits or risks are occurring 
that would warrant study closure.
9.2.4. The URCC will notify the other sites immediately of any serious safety concerns identified by the 
DSMC.

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1.
Janelsins MC, Heckler CE, Peppone LJ, et al. Cognitive Complaints in Survivors of Breast Cancer 
After Chemotherapy Compared With Age-Matched Controls: An Analysis From a Nationwide, 
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Society of Clinical Oncology 2017;35:506-14.
2.
Janelsins MC, Kesler SR, Ahles TA, Morrow GR. Prevalence, mechanisms, and management of 
cancer-related cognitive impairment. Int Rev Psychiatry 2014;26:102-13.
3.
Janelsins MC, Heckler CE, Peppone LJ, et al. Longitudinal Trajectory and Characterization of 
Cancer-Related Cognitive Impairment in a Nationwide Cohort Study. J Clin Oncol 2018:JCO2018786624.
4.
Ahles TA, Saykin AJ, McDonald BC, et al. Longitudinal assessment of cognitive changes 
associated with adjuvant treatment for breast cancer: impact of age and cognitive reserve. Journal of 
clinical oncology : official journal of the American Society of Clinical Oncology 2010;28:4434-40.
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Cruzado JA, Lopez-Santiago S, Martinez-Marin V, Jose-Moreno G, Custodio AB, Feliu J. 
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6.
Jones D, Vichaya EG, Wang XS, Sailors MH, Cleeland CS, Wefel JS. Acute cognitive impairment in 
patients with multiple myeloma undergoing autologous hematopoietic stem cell transplant. Cancer 
2013;119:4188-95.
7.
Magnuson A, Mohile S, Janelsins M. Cognition and Cognitive Impairment in Older Adults with 
Cancer. Curr Geriatr Rep 2016;5:213-9.
8.
Mandelblatt JS, Small BJ, Luta G, et al. Cancer-Related Cognitive Outcomes Among Older Breast 
Cancer Survivors in the Thinking and Living With Cancer Study. Journal of clinical oncology : official 
journal of the American Society of Clinical Oncology 2018:JCO1800140.
9.
Hurria A, Goldfarb S, Rosen C, et al. Effect of adjuvant breast cancer chemotherapy on cognitive 
function from the older patient's perspective. Breast Cancer Res Treat 2006;98:343-8.
10.
Hurria A, Rosen C, Hudis C, et al. Cognitive function of older patients receiving adjuvant 
chemotherapy for breast cancer: a pilot prospective longitudinal study. J Am Geriatr Soc 2006;54:925- 
31.
11.
Ferguson RJ, McDonald BC, Rocque MA, et al. Development of CBT for chemotherapy-related 
cognitive change: results of a waitlist control trial. Psychooncology 2012;21:176-86.
12.
Heflin LH, Meyerowitz BE, Hall P, et al. Cancer as a risk factor for long-term cognitive deficits and 
dementia. J Natl Cancer Inst2005;97:854-6.
13.
Yamada TH, Denburg NL, Beglinger LJ, Schultz SK. Neuropsychological outcomes of older breast 
cancer survivors: cognitive features ten or more years after chemotherapy. J Neuropsychiatry Clin 
Neurosci 2010;22:48-54.
14.
Selamat MH, Loh SY, Mackenzie L, Vardy J. Chemobrain experienced by breast cancer survivors: 
a meta-ethnography study investigating research and care implications. PloS one 2014;9:e108002.
15.
Janelsins MC, Kohli S, Mohile SG, Usuki K, Ahles TA, Morrow GR. An update on cancer- and 
chemotherapy-related cognitive dysfunction: current status. Semin Oncol 2011;38:431-8.
16.
Ahles TA, Root JC, Ryan EL. Cancer- and cancer treatment-associated cognitive change: an 
update on the state of the science. J Clin Oncol 2012;30:3675-86.
17.
Ahles TA, Saykin AJ. Candidate mechanisms for chemotherapy-induced cognitive changes. Nat 
Rev Cancer 2007;7:192-201.
18.
Mandelblatt JS, Stern RA, Luta G, et al. Cognitive impairment in older patients with breast cancer 
before systemic therapy: is there an interaction between cancer and comorbidity? J Clin Oncol 
2014;32:1909-18.
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19.
Andreotti C, Root JC, Ahles TA, McEwen BS, Compas BE. Cancer, coping, and cognition: a model 
for the role of stress reactivity in cancer-related cognitive decline. Psychooncology 2015;24:617-23.
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Arndt J, Das E, Schagen SB, Reid-Arndt SA, Cameron LD, Ahles TA. Broadening the cancer and 
cognition landscape: the role of self-regulatory challenges. Psychooncology 2014;23:1-8.
21.
Mohile S, Dale W, Magnuson A, Kamath N, Hurria A. Research priorities in geriatric oncology for 
2013 and beyond. Cancer Forum2013;37:216-21.
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Mohile SG, Hurria A, Cohen HJ, et al. Improving the quality of survivorship for older adults with 
cancer. Cancer2016;122:2459-568.
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