Mitigating Cancer-Related Cognitive Impairment in Older Adults With Cancer: Memory and Attention Adaptation Training-Geriatrics (MAAT-G) Phase I
Phase: NA
Conditions: Cognitive Dysfunction
Sponsor: Allison Magnuson

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Mitigating Cancer-Related Cognitive Impairment in Older Adults with Cancer: Memory and Attention 
Adaptation Training-Geriatrics 
(MAAT-G) Phase I
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 Cancer Center
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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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
Jessica Mortimer
James P Wilmot Cancer 
Center 601 Elmwood Ave, 
Box 704
Rochester, NY 14642
Phone: (585) 276-5652/ Fax: 273-1042
Jessica_mortimer@urmc.rochester.edu
Carrie Sylor
Myers Cancer Center
111 Clara Barton Street
Dansville, NY 14437
Phone: 585-335-6830
Carrie_Sylor@urmc.rochester.edu
Jason Zittel, MD
James P Wilmot Cancer 
Center 601 Elmwood Ave, 
Box 704
Rochester, NY 14642
Phone: 585- 275-8273/ Fax: 273-1042
Jason_zittel@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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TABLE OF CONTENTS:
1.0 Study Schema and Abstract….……….………………………………………………………………………..…………………………4
2.0 Specific Aims……………………………………………………………………………………………………………..………………………5
3.0 Background…………………………………………………………………………………………………………………………….…………7
4.0 Subject Eligibility……………………………………………………………………………………………………………………….……10
5.0 Recruitment and Consent………………………………………………………………………………………………………….……12
6.0 Registration & Randomization……………………………………………………………………………………………………..….15
7.0 Treatment Protocol………………………………………………………………………………………………………………………...15
8.0 Data Management…………………………………………………………………………………………………………………………..19
9.0 Data Safety and Monitoring…………………………………………………………………………………………..………………..23
10.0 References…………………………………………………………………………………………………………………………………....25

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1.0 STUDY 
SCHEMA
Eligibility confirmed and consent obtained; secondary screening for capacity to 
consent (University of California, San Diego Brief Assessment of Capacity to 
Consent (UBACC), has either: 1) clinical diagnosis of MCI, OR 2) MOCA score 
<26, OR 3) MOCA-BLIND score <18, and no presence of ADL impairment          
Time Point 1: Baseline Assessment (perceived and objective cognitive 
assessment, select GA measures about functional independence and 
psychological measures)
Time point 2: 
Patients ≥ 65 years with prior diagnosis of cancer, completed planned cancer 
treatment, identified through clinic schedules. Patients receiving maintenance  
endocrine therapy are still eligible.
MAAT-G Workshops and participant 
workbook use (10 workshops)
Quantitative – Follow-up cognitive 
and geriatric assessment measures
Qualitative – Semi-structured 
interviews
Mixed Methods Integration (Enhanced understanding about 
feasibility/usability and intervention experience)

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2.0 SPECIFIC AIMS
Older cancer survivors are a rapidly growing population; in the United States there are >10 million 
cancer survivors aged 65. Older cancer survivors experience long-term side effects from their diagnosis 
and prior therapy, such as Cancer-Related Cognitive Dysfunction (CRCD).1,2 CRCD is a prevalent side 
effect and creates difficulties in memory, attention and executive function. Up to 35% of cancer 
survivors experience CRCD symptoms months to years after completion of their cancer therapy.3,4 In 
older cancer survivors with Mild Cognitive Impairment (MCI), the long-lasting effects of CRCD may be 
contributing to their cognitive difficulties. CRCD symptoms may represent a reversible component of a 
patient’s cognitive decline and an intervention targeting CRCD in this population may afford 
improvements in perceived and objective cognitive function.   
Prior studies evaluating non-pharmacologic interventions (e.g. Cognitive Training) for older adults with 
MCI have demonstrated improvement in cognitive and neuropsychiatric symptoms.5-9 Memory and 
Attention Adaptation Training-Geriatrics (MAAT-G) is a cognitive-behavioral therapy (CBT)-based 
intervention for CRCD. Providing MAAT-G to older cancer survivors with MCI who are at greatest risk 
for developing progressive cognitive decline may afford improvements in perceived and objective 
cognitive function and alter the trajectory of cognitive symptoms by addressing the reversible 
components of CRCD. MAAT-G provides instruction and practice with adaptive behavioral coping skills, 
stress management techniques, and compensation strategies for CRCD. MAAT-G is delivered by a 
trained clinician (e.g. clinical psychologist, registered nurse) via videoconferencing during a series of 
ten workshop sessions. 
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.10-12 Older adults are at greater risk of 
developing CRCD;2,13-16 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.17,18 Patients with localized breast cancer have excellent overall survival but 
are at risk for CRCD as a long-term side effect of therapy.3,19,20 For older adults, CRCD can compromise 
functional independence (e.g. Instrumental Activities of Daily Living [IADL]).21 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).11,22-27 While alleviating or preventing CRCD is important to older adult patients and their 
caregivers, interventions tailored to them do not exist.28 Developing CRCD interventions for older adults 
is a high-priority area of research for the NIA.29-32
The Memory and Attention Adaptation Training (MAAT) intervention shows promise for targeting 
modifiable factors of CRCD.19,33-35 MAAT 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 is a series of eight manualized workshops delivered by a 
trained clinician via video-conferencing combined with a participant workbook. In younger cancer 
survivors (i.e. those who have completed chemotherapy), MAAT improves 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).19,33 These cognitive functions are particularly important for 
older adults. MAAT has been adapted to meet the unique needs of older adults and we have evaluated 
the usability of MAAT-G in older adults with cancer receiving systemic therapy. However, more data is 

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needed regarding the usability of MAAT-G in patients with pre-existing cognitive impairment.  Because 
MCI is clinically underdiagnosed, we will utilize an abnormal cognitive screening result (Montreal 
Cognitive Assessment [MOCA]) to define our population. The MOCA has demonstrated a sensitivity of 
80-90% for detecting MCI in older adults using a scoring cutoff of <26,36,37 with a specificity of 81-87% for 
excluding patients with normal cognition.36,37
Study Objective: 
Primary Objective: We will test the feasibility of delivering the adapted MAAT (MAAT-Geriatrics 
[G]) in older adults with breast cancer receiving adjuvant chemotherapy by determining usability of the 
intervention using the System Usability Scale (SUS).
Second Primary Objective: Evaluate the feasibility of MAAT-G in older cancer survivors with mild 
cognitive impairment by determining consent rate, intervention adherence rate, and study completion 
rate in this specific population (n=35).
1.
Hypothesis: We will achieve a consent rate of >70%, intervention adherence rate >75%, and 
study completion rate of >75%.
Secondary Objective: To obtain descriptive feedback on the usability of the intervention and 
guide further adaptation, qualitative interviews with patients and their caregivers (if available) will be 
conducted at completion of the intervention.
Tertiary Objective:
2.
Examine the pre-post change in perceived and objective cognitive function in older cancer 
survivors with MCI.
1.
Hypothesis: Older cancer survivors with MCI receiving MAAT-G will demonstrate 
improvement in perceived and objective cognitive assessment.
3.
Enhance our understanding of the usability of a telehealth CRCD intervention (including barriers 
and facilitators) for older cancer survivors with MCI and the perceived MAAT-G intervention 
effect through integration of quantitative data (from tertiary objective) with qualitative data 
from semi-structured interviews of patients and caregivers.

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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.2,10-16,22,38,39 
Symptoms of CRCD include problems with memory, attention and executive function.11 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).10,11,22 Older patients, particularly those with lower cognitive 
reserve, may be most vulnerable to the effects of chemotherapy on cognition.13-15,38,39 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.13 
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)18, and half report worsening of their cognition.17 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.3,20 
3.2 There is a large and growing number of older cancer survivors in the United States. Of the nearly 17 
million cancer survivors in the U.S., 64% (approximately 10.7 million) are aged 65 and over.78 This 
increase in older cancer survivors is due in part to improvements in cancer treatment, in addition to the 
aging demographics of our population. However, cancer therapy incites side effects, some of which can 
be long term and exacerbate other comorbid conditions.40 One prevalent side effect is CRCD.2,10-16,22,38,39 
CRCD affects up to 75% of patients during treatment, creating difficulties in memory, attention and 
executive function.2 CRCD is a significant concern for older cancer survivors, as older adults with lower 
cognitive reserve are most vulnerable to the effects of cancer treatment on cognition.2,13,32 Ahles and 
colleagues observed that older patients with low baseline cognitive reserve prior to adjuvant 
chemotherapy for breast cancer had the largest decline in processing speed post-treatment.13 For many 
patients, the effects of CRCD can be long-term and up to one-third of cancer survivors report CRCD 
symptoms months to years after completing therapy.3,20 This is particularly relevant for older adults, 
who are most susceptible to CRCD, as the deleterious effects of CRCD may contribute to loss of 
functional independence (e.g. Instrumental Activities of Daily Living [IADL]).21
3.3 MCI is also a prevalent condition in older adults41, including older cancer survivors. The prevalence of 
MCI in community-dwelling older adults aged 71 and older is up to 22%.420  MCI has also been observed 
in older cancer survivors.43,44 For example, using the National Institute on Aging/Alzheimer’s Association 
(NIA/AA) criteria for MCI in a cohort of breast cancer survivors who received chemotherapy, 43% of 
patients met diagnostic criteria for MCI.81 The relationship between the risk of cancer and risk of 
dementia is unclear, with some studies demonstrating higher rates of dementia in cancer survivors4,45,46 
and other reporting lower rates.47,48 Although this relationship is not fully understood, several indicators 
suggest that older cancer survivors are at greater risk of developing cognitive problems following cancer 
treatment, as compared to their younger counterparts.2,13,32,46 In a recent Surveillance, Epidemiology 
and End Results (SEER) registry analysis including over 3.5 million cancer survivors, long-term cancer 
survivors ( 10 years) were observed to be more likely to die from Alzheimer’s disease (AD) compared to 

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the general population (OR 1.13; 95% CI 1.12-1.15) and those who were aged 70+ at time of cancer 
diagnosis were most likely to develop AD (OR 1.29; 95% CI 1.26-1.31).46 In older cancer survivors with 
MCI, the long-lasting effects of CRCD may be contributing to their cognitive difficulties. An intervention 
targeting the reversible components of CRCD in older cancer survivors with MCI may afford 
improvements in perceived and objective cognitive function. Because MCI is underdiagnosed, we will 
also utilize the MOCA in our screening process to identify potentially eligible patients that do not have a 
clinical diagnosis of MCI but have a MOCA score consistent with MCI. The MOCA has demonstrated a 
sensitivity of 80-90% for detecting MCI in older adults using a scoring cutoff of <26,36,37 with a specificity 
of 81-87% for excluding patients with normal cognition.36,37
3.4. 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).11,22-27  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.35 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.26 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).49,50 
Coping involves monitoring self-regulatory capacity and recognizing situations of allostatic overload that 
require adjustment/adaptation of behaviors.27 Maladaptive coping mechanisms can lead to further 
negative effects on cognition.51 Additionally, individuals possess varying abilities to compensate for 
cognitive stressors; however, compensatory strategies can be taught.
3.5. Memory and Attention Adaptation Training (MAAT) is a cognitive-behavioral therapy (CBT)-based 
intervention for CRCD. MAAT was designed as a practical and short-term CBT intervention to help 
cancer survivors learn adaptive, compensatory skills for chemotherapy-related memory dysfunction.  In 
the literature, cognitive rehabilitation involves 2 broad approaches.  This distinction is important and 
remains a source of debate.  Traditional cognitive rehabilitation, or a “retraining” approach, emphasizes 
practice and drill of cognitive exercises to promote neuro-circuitry repair of damaged brain regions. 
However, some investigators contend performance at everyday tasks requiring memory (e.g., “memory 
related disability”) does not improve with the retraining approach or generalize or “transfer” to daily 
living. By contrast, a “compensatory strategy” approach emphasizes direct teaching of adaptive skills on 
everyday tasks, which require memory, to minimize the impact of memory dysfunction on daily quality 
of life and function. 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 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 is to enhance self-
management and coping with cognitive failures in daily life to minimize impact on survivor quality of life.

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As a CBT-based intervention, MAAT focuses on an individual’s psychological response to injury as 
compared to the biological events triggering CRCD. MAAT is a series of manualized workshops delivered 
by a trained clinician via video-conferencing, supplemented by a participant workbook, which provide 
instruction and practice with adaptive behavioral coping skills, stress management techniques, and 
compensation strategies.
3.6. The scientific premise of this new research is that CRCD is a significant problem, particularly 
for older cancer survivors with MCI, and interventions to improve cognitive outcomes are 
needed. We are expanding the eligibility criteria for this study 
to test an intervention for CRCD that is adapted specifically 
for use in older adults to determine the feasibility of 
delivering the intervention in an expanded population, older 
cancer survivors with MCI.
3.7 Preliminary Studies:
3.7a. Abnormal cognition is common in older adults with 
cancer.52 In a large, multi-site study of older adults with 
cancer (N=541), our team demonstrated that 33.5% of 
patients had an abnormal cognitive screen (Mini-Cog). 
Patients with an abnormal Mini-Cog were more likely to have 
impairments in other Geriatric Assessment (GA) domains 
(Table 1).53 
3.7b. It is feasible to study behavioral interventions in 
clinical trials for older adults with cancer receiving chemotherapy.54  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.
3.7c. We have adapted an existing 
telehealth CRCD intervention 
specifically for use in older adults. 
To refine and adapt MAAT for older 
adults, we used the Contextual, 
Cohort-based, Maturity, Specific 
Challenge (CCMSC) model for 
adapting CBT- based interventions 
for older adults.55 Subsequently, we 
made further refinements to MAAT-
G using feedback from key 
stakeholders through a series of 
focus groups with members of 
Table 1: Association between abnormal 
cognitive screen and other GA impairments 
in older adults with cancer.
Table 2: MAAT-G Adaptations Using CCMSC Model

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SCOREboard, our older adult patient advisory group. SCOREboard members, the majority who are 
cancer survivors, 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 2 for details of MAAT-G adaptations).
3.7d.  To date, the usability of MAAT-G has been evaluated in four older adults receiving systemic 
treatment for breast cancer. 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). 
Two patients self-describe as limited technology knowledge. There was 100% capture of baseline 
assessment measures; these measures included perceived and objective cognitive assessment as well 
as selected GA measures of functional independence and psychological status. All four patients 
completed all study procedures and MAAT-G workshop sessions on schedule (e.g. 100% intervention 
adherence). However, none of these patients had a pre-existing diagnosis of cognitive impairment, and 
based upon the scientific rationale outlined above, we are expanding the eligibility criteria for this 
usability study to evaluate usability of MAAT-G in a population of older cancer survivors with a clinical 
diagnosis of MCI, a MOCA score < 26, or a MOCA-BLIND score < 18.
4.0 SUBJECT ELIGIBILITY
The eligibility criteria are aimed at identifying older cancer survivors. 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:
1. Be age 65 or older
2. Able to provide informed consent. All patients will be assessed using the University of California, San 
Diego Brief Assessment of Capacity to Consent (UBACC)56 – a score >14.5 will define ability to 
independently provide informed consent. For patients scoring <14.5, or if investigators have additional 
concerns, we will require that their health care proxy participate in the consenting process and sign an 
informed consent and patients will required to provide assent. 
3. Able to read and understand English 
4. Have a prior diagnosis of cancer of any stage. Patients must have completed their planned cancer 
treatment. Patients are permitted to be receiving maintenance therapy (e.g. endocrine therapy).
5. Have a clinical diagnosis of MCI, a score <26 on the Montreal Cognitive Assessment (MOCA), or a 
score <18 on the Montreal Cognitive Assessment-BLIND (MOCA-BLIND). If the patient had a MOCA 
evaluation completed as a part of routine clinical care in the preceding 6 months prior to consent date, 
this may be used for eligibility purposes.
6. Be independent in Activities of Daily Living (ADL)
4.2. Patient Exclusion Criteria:  
1. Have surgery planned within 3 months of consent

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2. Patients who do not have decision-making capacity (as determined by UBACC as described above) 
AND do NOT have a previously designated health care proxy (established prior to their cognitive 
impairment) available to sign consent 
3. Have an ADL dependence
We anticipate enrolling 39 patients (35 patients consented in the MCI cohort).  Because the usability of 
telehealth in populations with pre-existing cognitive impairment is less well established, we are 
proposing a larger sample size for a better estimation of usability and feasibility of this study). Enrolled 
patients will also be allowed to enroll with a caregiver although patients without a caregiver can also 
enroll. Therefore, we do not have a target enrollment for caregivers. We are proposing a larger sample 
size for better estimation of usability and feasibility in the expanded eligibility criteria (which is a more 
diverse population of older cancer survivors with any cancer type).
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:
1.
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
2.
Caregivers unable to understand the consent form due to cognitive, health or sensory 
impairment will be excluded
If patients possess independent capacity to consent, they do not require a caregiver to consent in order 
to participate in the study. 
5.0 IDENTIFICATION, RECRUITMENT, AND CONSENT PROCEDURES
Subjects will be enrolled at the University of Rochester Wilmot Cancer Institute (including Strong 
Memorial Hospital,  Highland Hospital, and Pluta Cancer Center sites)  and Myers Cancer Center in 
Dansville. Patients will be recruited from the medical oncology clinics at these sites. The clinic schedules 
of 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.

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5.1. Patient and Caregiver Identification, Recruitment, and Consent Procedures:  
Potential patients will be identified in multiple ways.  First, at all 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 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. 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.  Afterwards, 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, as long as they have independent capacity to consent as 
described above. 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, the oncologist and the nurses 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 member of the study team will ask patient for his/her 
permission to be mailed an informational consent for their review.

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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, a member of the study team will verbally consent the subject. 
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.
Waiver of documentation of consent: 
We are requesting for waiver of documentation of consent as the research involves no more than 
minimal risk to the subjects (patient or caregiver) and involves procedures for which written consent is 
normally not required outside the research context. The only record linking the subject and the research 
would be the consent document and the principal risk would be potential harm resulting from a breach 
of confidentiality.
Alteration of HIPAA Authorization:
We are requesting an alteration of HIPAA authorization. We will provide an information sheet to 
subjects (patient or caregiver) who provided verbal consent. Verbal consent will allow for reduction of 
in-person visits, thus maximizing the safety of both subjects and study staff. Nonetheless, when possible 
and if we are able to coordinate study and clinic visits, we will obtain written informed consent.
The study cannot be conducted without the use of protected health information (PHI) as we have to link 
patient reported data with medical history collected on electronic medical record. We have adequate 
plans to protect the PHI from improper use and disclosure. We will destroy identifiers after completion 
of the study for 7 years. We will not reuse or disclose the PHI to another person or entity other than the 
study investigators. The waiver will not adversely affect the privacy rights of the individual and the 
research cannot be practicably done without access to the use of the PHI.
5.1.3. Baseline Measures and Study Procedures: The baseline measures will then be performed and 
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.
Patients with MCI may be considered a vulnerable population but are necessary to answering our 
research questions. For all patients, we will formally assess capacity to consent using the University of 
California San Diego Brief Assessment of Capacity to Consent (UBACC), adapted for our study. 
Following the informed consent process, decisional capacity for clinical research participation will be 
confirmed with the UBACC. The UBACC is a 10-item scale that can be administered by a Bachelor 
Degree-level research coordinator. The UBACC determines patient’s understanding of key aspects of 
the consent process (e.g. purpose of study, risks of study).  A UBACC total score >14.5 will be 
considered confirmed for decisional capacity for clinical research. For patients scoring <14.5, or if 
investigators have additional concerns, patients Health Care Proxy can participate in the consenting 
process and sign an informed consent. We will also require that patients who fail the screen or cases 
where investigators have additional concerns give consent, or at minimum assent if fully informed 

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consent is not possible. If a patient does not have a designated Health Care Proxy and scores <14.5 on 
the UBACC, they will be unable to participate. 
Once consented is confirmed, if the patient does not have a clinical diagnosis of MCI a member of the 
study team will administer MOCA to the patient. If a member of the study team is able to administer the 
MOCA in person, the following scoring will be used: The traditional paper-pencil MOCA (i.e. 30-point 
MOCA scoring total) will be used for in person assessment and if the MOCA score is ≥26, the patient is 
informed that they are not eligible to participate in the study and will be considered a screen failure. If 
the MOCA score is <26, the patient is eligible to continue. If a member of the study team cannot 
administer the MOCA in person (e.g. when verbally consenting patients over the phone), s/he will follow 
up with the patient over the phone and administer the MOCA-BLIND and use the following scoring: The 
MOCA-BLIND scoring total is 22-point; if the MOCA-BLIND score is ≥18, the patient is informed that they 
are not eligible to participate in the study and will be considered a screen failure. If the MOCA-BLIND 
score is <18, the patient is eligible to continue. We utilize the MOCA (or MOCA-BLIND) in our screening 
process to identify potential cognitive impairment since MCI is underdiagnosed. The 30-point MOCA has 
demonstrated a sensitivity of 80-90% for detecting MCI in older adults using a scoring cutoff of <26, 57 
with a specificity of 81-87% for excluding patients with normal cognition. 57 The 22-point MOCA-BLIND 
has demonstrated a sensitivity of 63% for detecting persons who are affected with MCI, and a specificity 
of 98%.97
A member of the study team must also identify whether the patient is independent in Activities of Daily 
Living (ADL) using the ADL questionnaire. The ADL questionnaire will be verbally asked to patients for 
both in person and phone assessments. If the patient has ADL impairment, the patient is not eligible 
and will be considered a screen failure. Because we are aiming to target older cancer survivors with 
MCI, we are excluding patients with ADL impairment whereby their cognitive impairment may be more 
consistent with dementia, similar to methods in other studies targeting patients with MCI. 77
For patients that provide informed consent, the following components as described above will be 
subsequently assessed to confirm eligibility:
1.
UBACC score >14.5; or for patients scoring <14.5 a health care proxy available to provide 
informed consent and patient able to provide assent
2.
Established diagnosis of MCI or MOCA sore <26 or a MOCA-BLIND score <18
3.
No presence of ADL impairment
If patients meet all of the above criteria the will be permitted to continue with the study. For patients 
that do not meet the above criteria, they will be considered a screen failure.
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.

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5.1.6. Duration: Patients who consent to the study will be in this study for 8 months. Patients will be 
consented to actively participate, receive phone calls or meet with the research study team for up to 8 
months after their initial 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 and caregiver 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 at Registration:
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). For phase I of this study, there will not be 
randomization of subjects.
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.10,33,58,59 Based upon 
experience in prior studies, we estimate the cognitive evaluation will take approximately 60 minutes to 
complete10,12 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. 

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Cognitive Evaluation will include: 1) FACT-Cog60, a validated patient reported outcome measure created 
to assess cognitive challenges identified by patients with cancer; 2) Controlled Oral Word Association 
(COWA)61, a measure of verbal fluency evaluating expressive language and executive function; and 3) 
Hopkins Verbal Learning Test-Revised (HVLT-R)62, a validated test of verbal learning and memory, (two 
different versions will be used-form 1 and form 2), and 4) Cognitive Difficulties Scale (CDS)63; a patient 
reported outcome measure to estimate how many and how often cognitive symptoms impact daily life in 
older adults with MCI. All measures are “paper and pencil” or verbally administered. COWA and HVLT-R 
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)64 and Generalized Anxiety and 
Depression (GAD-7).65 
Functional Independence: IADLs and ADLs will be measured.66 
Usability will be assessed quantitatively with the System Usability Survey.67,68 
Phase I semi-structured interview questions for patients and caregivers will focus on usability of 
MAAT-G (e.g. barriers and facilitators to intervention) and explore patient/caregiver experience with 
MAAT-G and their perception of how MAAT-G altered cognitive symptoms and functional 
independence
7.2 Recruitment and Retention Metrics:
These measures include: 1) Consent rate (proportion of participants enrolled of those approached), 
intervention adherence rate (proportion of enrolled participants that complete the 10 weekly MAAT-G 
sessions within the defined study window), and study completion rate (proportion of patients 
completing all study procedures including time point 2 assessment and interview). In order to better 
understand the usability and experience of older cancer survivors with MCI with engaging in a 
videoconferencing-based cognitive intervention, we will incorporate a quantitative usability measure 
(System Usability Scale) as well as additional qualitative questions highlighted in Table 3 (next page).
7.3 Study Procedures: 
Baseline: Following informed consent, 
patients will undergo Time Point (TP) 
1 assessment. Patients will be 
provided with a data-enabled tablet 
with HIPPA-compliant video-
conferencing application and 
instructed on its use, participant 
workbook, and tablet instruction 
manual. At the time of enrollment, a 
member of the study team will assign 
each patient a unique meeting ID 
number within the tablet instruction 
Table 3: Measures overview

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manual. This meeting ID number allows each patient to log on to the video-conferencing application and 
speak to the trained psychologist, psychology post-doctoral fellow, or psychology intern for the 
workshops. 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 HIPPA-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 a member of 
the study team. 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 a 
member of the study team with any concerns or problems with using the tablet, contact information will 
be provided during training on tablet use. The patient may elect to use their personal computer and 
decline the study ipad if that is their preference.
Intervention Period: The intervention period is 8-12 weeks; 10 weekly MAAT-G workshops will be 
delivered through video-conferencing on the tablet. MAAT-G workshops will be audio-recorded for 
fidelity review with patients’ permission.  (See section 7.5)
Follow-up: Within 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.54,69 
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 also 
be conducted with caregivers. As a safety precaution due to COVID-19, the interviews with the patients 
and caregivers will be conducted over the phone. These audio-recorded interviews will be conducted 
after completion of the intervention. 
Location: MAAT-G participation 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, individuals who are conducting the MAAT-G intervention 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 the trained clinician administering MAAT-G workshops. The 
coordinator will help organize the scheduling/rescheduling of workshop sessions and will be available 
for any patient questions.
7.4. MAAT-G Intervention

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The MAAT-G intervention will be delivered by a trained clinician (e.g. psychologist, psychology post-
doctoral fellow, psychology intern, or registered nurse) 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 1 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 the 
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.  
MAAT-G 
workshop 
content
WORKSHOP 
VISIT:
Content/Strategies:
1
1.
Introduction to MAAT
2.
Self-Awareness and monitoring of memory problems
2
1.
Progressive Muscle Relaxation
2.
Quick Relaxation
3
1.
Self-Instructional Training
2.
Verbal and silent rehearsal
4
1.
Cognitive restructuring
5
2.
Keeping a schedule
3.
Memory routines
6
4.
External cueing
5.
Distraction reduction
7
6.
Activity scheduling and pacing
7.
Active listening
8
1.
Fatigue management
2.
Sleep improvement
9
3.
Visualization strategies
10
4.
Tying it all together
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 

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for use of the gift card system. The study team will collect W-9 and send to University Accounts 
Processing for study payment documentation and sent 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.
7.5. Quality and Fidelity for MAAT-G:
A clinician manual for MAAT-G has been developed and will be used to standardize interventionalist 
behavior. Sessions will be audio-recorded and reviewed to ensure intervention fidelity and adherence to 
clinician manual (with patient’s permission).
7.6. 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.
7.7. Potential benefits:
There may be no direct benefits to participation in this study. However, the study will provide useful 
information about the feasibility of enrolling and delivering a videoconferencing-based intervention to  
older cancer survivors with MCI 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.70,71 In case of violations of distribution assumptions such as normality, 
appropriate nonparametric methods will be attempted.72,73   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 

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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: The expanded population for the current amendment (N=35; patients meeting 
revised eligibility criteria) will be analyzed separately from the 4 patients in the original cohort.
Sample Size Considerations: A sample size of 35 patients will allow for the assessment of feasibility of 
delivering MAAT-G in this population57 and also allow for thematic saturation of qualitative interviews. 
The effect size of MAAT-G in older adults with MCI is not known. MAAT has demonstrated a medium 
effect size (d = 0.52) on perceived cognition (FACT-Cog) in younger cancer survivors. 57 Using Repeated 
Measures Analysis of Variance (ANOVA) design and pre-post correlation of 0.5, and 25% attrition, 57 a 
sample size of n=25 evaluable patients will provide 80% power to detect an effect size of 0.52 at the 
significance level of 0.10. This sample size is appropriate for preliminary studies and will allow us to 
conduct Aim 2 analysis and evaluate distribution parameters (mean, standard deviation) of key measures 
of perceived and objective cognitive function to inform future studies.
Analysis Plan (Second Primary Aim): To evaluate feasibility of enrolling and delivering a 
videoconferencing-based intervention to older cancer survivors with MCI, we will calculate the 
proportion of: 1) approached patients who enrolled; 2) identified caregivers who enrolled; 3) enrolled 
patients who completed all 10 MAAT-G sessions on schedule [e.g. intervention adherence]; and 4) 
enrolled patients who completed timepoint 2 assessment [e.g. study completion]. We will consider the 
delivery of the telehealth-based intervention feasible if the following are met: 1) >70% of eligible 
patients that are approached agree to enroll; 2) >70% of identified potential caregivers agree to enroll; 
3) >75% of patients complete the 10 MAAT-G sessions; and 4) >75% of patients complete the timepoint 
2 assessment. This analysis on the patients enrolled from this amendment forward (e.g. analysis will 
only include older cancer survivors with MCI. Mean SUS score will also be calculated for all patients 
completing TP2 assessment. The SUS ranges 0-100; a score >68 is above average.68
Tertiary Objective Analysis Plan: To examine the pre-post change in perceived and objective cognitive 
function in older cancer survivors with MCI, we will utilize repeated measures ANOVA. Because this is a 
preliminary analysis with a small sample size primarily focused on feasibility, our goal with the analysis 
of Aim 2 is to estimate key distribution parameters (mean, median, standard deviation). We will also 
calculate the SUS (usability) score for each individual patient. The Usability Scale ranges 0-100; a score 
>68 is above average. 61
Secondary Aim Analysis plan:
Qualitative Analysis of transcripts from participant/caregiver interviews will be analyzed for themes on 
barriers and facilitators to intervention participation. Potential themes include relevance of workshop 
content to older adults, potential barriers to using video-conferencing technology for the target 
population and mechanisms for minimizing this barrier, and/or the content and formatting of 
participant workbook to ensure relevance and usability for older adults. 
Mixed Methods Integration: Qualitative and quantitative data will be integrated to develop a more 
complete understanding of the usability of MAAT-G . In addition, it will enhance our understanding of 

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the participant experience with MAAT-G and help to explore potential benefits beyond what is captured 
in qualitative tools alone. Data will be organized using MAXQDA joint displays.74 
8.3. Records to be Kept: 
8.3.1. Data Collection Table:
SCHEDULE OF DATA COLLECTION
FORM
Baseline 
Post-Intervention
On Study Data (Patient and caregiver demographic 
information and clinical data)
X
Eligibility confirmation components:
1.
UBACC
2.
MOCA, MOCA-Blind, or diagnosis of MCI
3.
ADL
X
FACT-COG
X
X
Cognitive Difficulties Scale (CDS)
X
X
COWA
X
X
HVLT-R (two different versions-form 1 and form 2)
X
X
GDS
X
X
GAD-7
X
X
IADL Survey
X
X
SUS (usability measure)
X
Semi-structured interview with patient and caregiver (if 
enrolled)
X
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 the 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 

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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, including 
exploratory secondary analyses with data collected as described above.  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. 
Currently, over 240 academic and non-profit consortium partners on six continents with over 
26,000 research end-users use REDCap”.
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”. 
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 

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University of Rochester researchers by the URMC Research Privacy Officer and Office for Human 
Subject Protection.
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 cancer survivors with MCI 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:
9.1.3. Adverse event reports will be submitted in one of the following ways:
(1) By email: (pdf)
(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-dwelling older adults. To reiterate, only adverse events 
attributed to the behavioral intervention will be captured and reported.
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 
Grade 1
Grade 2
Grade 3
Grade 4
Grade 5
Unexpected
Expect
d
Unexpected
Expected
Unexpe
t d
Expect
d
Unexpect
d
Expect
d
Unexpe
cted
and 
Expecte
with 
hospit
witho
ut 
with
hospi
witho
ut 
with
hospit
witho
ut 
Unrelat
ed
Unlikel
Not
Require
d
Not
Requir
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 
Calen
dar 
10 
Calen
dar 
Not
Requir
ed
Not
Requir
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.

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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. 
9.2. 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 is required.
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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