Feasibility of Using Remotely-delivered Metacognitive Strategy Training to Address Cancer-related Cognitive Impairment in Breast Cancer
Phase: NA
Conditions: Breast Cancer Female
Sponsor: University of Missouri-Columbia

Coversheet 
 
Study Title: Feasibility of using remotely-delivered metacognitive strategy training to 
address cancer-related cognitive impairment in breast cancer 
 
Institution: University of Missouri 
 
NCT Number: NCT05505045 
 
IRB Number: 2066383 
 
Consent approval date: November 15, 2022  
 
Protocol and Statistical Analysis Plan approval date: January 9, 2023 
 
 

1 
 
Written Consent to Participate in a Research Study 
 
Project Title: Feasibility of using remotely-delivered metacognitive strategy training to address 
cancer-related cognitive impairment in breast cancer 
Principal Investigator Name: Anna E. Boone, PhD, MSOT, OTR/L 
IRB Assigned Project Number: 2066383 
 
Key Information About the Study 
 
You are being asked to participate in a research study. The purpose of the research study is to 
evaluate the feasibility and preliminary effect of metacognitive strategy training delivered via 
telehealth methods to improve activity performance, cognition, and quality of life in breast 
cancer survivors. You are being asked to participate in 10 occupational therapy intervention 
sessions through videoconferencing. You are also being asked to complete an assessment battery 
before the intervention and after the intervention.  Possible benefits include improvements from 
either participating in either the problem-solving intervention (described below) or from the 
attention control intervention by performing goal-related everyday life activities better and/or 
experiencing less CRCI-related impairment. Some possible risks may include: (1) a breach of 
confidentiality where identifiable health information related to the participants is inadvertently 
made available to individuals beyond the research team; (2) psychological distress while 
discussing changes in your abilities following cancer treatment; or (3) physical injury. 
Participants will be encouraged to perform their chosen activity-related goals at home. Some of 
these goals involve physical activity, (e.g., cooking), in which the participant could sustain a 
physical injury such as a cut on the hand. These activities will all be common everyday life 
activities that the participant is already doing at home. 
 
Please read this form carefully and take your time. Let us know if you have any questions before 
participating. The research team can explain words or information that you do not understand. 
Research is voluntary and you can choose not to participate. If you do not want to participate or 
choose to start then stop later, there will be no penalty or loss of benefits to which you are 
otherwise entitled.  
 
Purpose of the Research 
 
You are being asked to participate in this study because you are female with a history of breast 
cancer and chemotherapy treatment within the past three years. The purpose of the study is to 
evaluate the practicality and effect of a structured, problem-solving intervention delivered via 
telehealth methods to improve activity performance, cognition, and quality of life. 
 
What will happen during the study? 
 
You are being be asked to complete the following activities: 
 
• Pre-intervention assessments for approximately 2.5 hours that will consist of 
questionnaires, interviews, and thinking tests. 
IRB Approval Date: Nov 15, 2022; Written Consent Form ID #620580; Amendment ID #382005

2 
 
• 10, 45-60 minute intervention sessions delivered via videoconferencing. These 
will either consist of the problem-solving intervention or educational resources 
provided in 10, 45-60 minute intervention sessions. 
• Post-intervention sessions: for approximately 2 hours that will consist of 
questionnaires, interviews, and thinking tests. 
Your participation is expected to last a total of 12 weeks.  
 
There will be about 38 subjects participating in this study. 
 
What are the expected benefits of the study? 
 
You may or may not benefit as a result of your participation in the study. Information learned 
from the study may help other people in the future. You may potentially experience 
improvement in your ability to perform everyday life activities better and/or experience less 
cancer-related cognitive impairment.  
 
What are the possible risks of participating in this study? 
 
There are minimal risks expected when taking part in this study. There are some that we know 
about and some may not know about yet. Some possible risks include (1) a breach of 
confidentiality where identifiable health information related to the participants is inadvertently 
made available to individuals beyond the research team; (2) psychological distress while 
discussing changes in your abilities following cancer treatment; or (3) physical injury. 
 
To help lower these possible risks, we will keep your information in a password protected file on 
a secure network that has restricted access. All data will be obtained by the study team will be 
for research purposes only and will be de-identified prior to data entry into our secure electronic 
database. Any hard copy data will be locked in filing cabinets in the private offices of the PI. All 
electronic data will be maintained on one web-based, secure, centralized database. The database 
will use the REDCap® platform and can only be accessed through two password protected 
portals.  All data entered into the REDCap® database will be stored on University of Missouri 
secure servers and will have access restricted to only members of the research team. In the rare 
event participants experience psychological distress when answering questions during 
assessments, they will be reminded that they can decline to answer any questions that may make 
them uncomfortable and that participation is completely voluntary.  
 
We will tell you about any new important information we learn that may affect your decision to 
continue to participate in this study. 
 
What other choices do I have if I don’t want to be in this study? 
 
You are not required to be in this study. You can simply choose not to participate. You can look for 
other research projects you may be interested in instead of this study.  
 
Will I receive compensation for taking part in this study? 
IRB Approval Date: Nov 15, 2022; Written Consent Form ID #620580; Amendment ID #382005

3 
 
 
You will be compensated for taking part in this study. For your time and effort, you will receive $75 
via check payment within one month of your pre-assessments and post-assessments for a total of 
$150.  
 
Are there any costs for participating in this study? 
 
You should not expect any additional costs by participating in this study.  
 
Other costs to you from being in this study may include transportation, parking, childcare, and/or 
time off work.  
 
You should discuss any questions about costs with the researchers before agreeing to participate. 
 
Will information about me be kept private? 
 
The research team is committed to respecting your privacy and keeping your personal information 
confidential. We will make every effort to protect your information to the extent allowed by law. 
Your records will be given a code number and will not contain your name or other information that 
could identify you. The code number that connects your name to your information will be kept in a 
separate, secure location.  
 
When the results of this research are shared, we will remove all identifying information so it will not 
be known who provided the information. Your information will be kept as secure as possible to 
prevent your identity from being disclosed.  
 
We may share what we collected from you as part of this research, after removing your identifiers, 
for future research without additional informed consent from you.  
 
Who do I contact if I have questions or concerns? 
 
If you have questions about this study or experience a research-related injury, you can contact 
the University of Missouri researcher at (573) 882-7023 or booneae@umsystem.edu. 
If you have questions about your rights as a research participant, please contact the University of 
Missouri Institutional Review Board (IRB) at 573-882-3181 or muresearchirb@missouri.edu. 
The IRB is a group of people who review research studies to make sure the rights and welfare of 
participants are protected.  
 
If you want to talk privately about any concerns or issues related to your participation, you may 
contact the Research Participant Advocacy at 888-280-5002 (a free call) or email 
muresearchrpa@missouri.edu.  
 
Do I get a copy of this consent? 
 
You will receive a copy of this consent for your records. 
We appreciate your consideration to participate in this study. 
IRB Approval Date: Nov 15, 2022; Written Consent Form ID #620580; Amendment ID #382005

4 
 
Consent Signatures 
 
 
 
 
Subject’s Signature 
Date  
 
 
 
 
 
 
 
IRB Approval Date: Nov 15, 2022; Written Consent Form ID #620580; Amendment ID #382005

Page 1 of 9 
SOCIAL/BEHAVIORAL/EDUCATIONAL RESEARCH PROTOCOL  
UNIVERSITY OF MISSOURI 
 
Project Title: Feasibility of using remotely-delivered metacognitive strategy training to address 
cancer-related cognitive impairment in breast cancer 
IRB Number: 2066383 
Version Number: 4 
Version Date: January 9, 2023 
Principal Investigator: Anna E. Boone, PhD 
Funding Source: National Institute of Child Health and Human Development  
 
 
 
 
1. The goal of this proposed project is to evaluate the feasibility and preliminary effect of 
metacognitive strategy training delivered via telehealth methods to improve activity 
performance, cognition, and quality of life in breast cancer survivors. 
2. Breast cancer survivors often self-report cognitive changes after treatment for cancer (e.g. 
cancer-related cognitive impairment (CRCI)). These cognitive changes have a 
devastating impact on everyday life activities. Rehabilitation of CRCI faces two primary 
barriers including access to rehabilitation services and limited knowledge of what 
effective CRCI approaches are. In other conditions, such as traumatic brain injury and 
stroke, metacognitive strategy training (MCST) is a practice standard to address cognitive 
impairment. The Cognitive-Orientation to daily Occupational Performance (CO-OP) 
approach is a MCST intervention in which subjects are taught a general cognitive 
strategy that can be applied in known and novel contexts to devise task specific strategies 
to engage in an activity. Our preliminary data suggest that CO-OP may have a positive 
impact on activity performance, subjective and objective cognition, and quality of life in 
breast cancer survivors with CRCI. While current evidence supports the remote delivery 
of strategy-based interventions like CO-OP, this intervention has not been evaluated in 
breast cancer survivors with CRCI. 
 
 
 
1. All subjects will have had a breast cancer diagnosis. We will recruit participants who 
have been seen for cancer treatment at Ellis-Fischel (EF) Cancer Center at the University 
of Missouri or will be recruited from the community.  All patients seen at EF for cancer 
treatment will be available for recruitment for this study through the medical and 
rehabilitation oncology team at EF. A recruitment flyer will be used to recruit individuals 
from the community. We will share our study flyer and information about our study with 
various cancer organizations and support groups so that they can advertise our study on 
their websites, on their social media, or in their newsletters. 
 
2. The medical and rehabilitation team at EF will identify potential subjects from the 
registry based on the following inclusion/exclusion criteria of this study (see complete list 
I. 
Research Objectives/Background 
II. 
Recruitment Process 

Page 2 of 9 
below): (1) age, (2) time post-treatment; (3) cancer diagnosis; and (4) other neurological 
diagnoses.  Contact information for potential subjects will be forwarded to the research 
team for this study on a weekly basis.  Potential subjects will be contacted over the phone 
by a research coordinator to determine interest in this study.  Interested potential subjects 
will complete a prescreening survey to further establish eligibility: (1) CFQ; (2) ability to 
read, write, and speak English.  After completion of the prescreening survey, the research 
coordinator will arrange a time to obtain electronic written informed consent and to 
complete the screening/baseline assessment emotely via Zoom teleconferencing platform. 
 
 
 
1. Potential participants who are scheduled for a baseline assessment will be mailed a copy 
of the consent form and be sent an electronic version. The consent form will be mailed or 
e-mailed prior to the baseline testing session to allow sufficient time for review. On the 
first session via videoconferencing the research coordinator or research assistant will 
explain the informed consent process to the potential participant. The specific details on 
the informed consent form will be reviewed. In particular, the person will be told the 
procedures she will participate in, the potential risks and benefits of participation, and her 
right to refuse participation at any time without any effect on her subsequent health care. 
The person then will be given another opportunity to read the consent form. After reading 
it, the study team member will answer any specific questions, highlight the important 
details of the study again, and remind the person of her rights as a participant. The person 
will then be asked to show a photo ID to verify identity and then electronically sign the 
consent form. A copy of the form and a brochure explaining the person’s rights under the 
HIPAA regulations will be given to the person for her records.  The signed consent form 
then will be signed by the person administering consent. The electronic consent form will 
be filed on a secure server and will only be accessible by a few members of the research 
team.  
 
 
 
• 
Inclusion Criteria:  
•Women aged 40-80years old  
•self-reported CRCI (Cognitive Failures Questionnaire (CFQ) score >30) 
•completed full course of chemotherapy at least 6 months, but no later than 3 years, prior 
to participation 
•able to read, write, and speak English fluently 
•able to provide valid informed consent 
•have a life expectancy of greater than 6 months at time of enrollment 
•diagnosed with breast cancer (invasive ductal or lobular BrCA Stages I, II, or III) and 
completed chemotherapy within the preceding three years 
•on stable doses of medications (i.e., no changes in past 60 days) 
 
Exclusion Criteria:  
•prior cancer diagnoses of other sites with evidence of active disease within the past year  
III. 
Consent Process 
IV. 
Inclusion/Exclusion Criteria 

Page 3 of 9 
•active diagnoses of any acute or chronic brain-related neurological conditions that can 
alter normal brain function (e.g., Parkinson’s disease, dementia, cerebral infarcts, 
traumatic brain injury) 
•severe depressive symptoms (Personal Health Questionnaire (PHQ-9) score of ≥21) 
• 
The screening methods identified in parentheses next to appropriate inclusion/exclusion 
criteria will be used to verify appropriate selection of study participants.  
 
 
 
 
1. We will enroll approximately 44 (final sample of 38 human subjects) for this single-
blind, parallel, randomized clinical trial.  
2. The purpose of this R03 is to obtain estimates of effect and precision of response in 
38subjects (19/group) so that a more formal sample size calculation can accompany our 
future NIH R01 application. A total sample size of 44will be recruited to allow for 15% 
attrition. Sample size estimations are based on two primary outcome measures: the 
Canadian Occupational Performance Measure (COPM) and the NeuroQoL Cognitive 
Function Short Form. We have estimated this sample size based upon preliminary data, 
published performance data of the breast cancer population,55and theminimal clinically 
important difference (MCID) for the outcome measures specified56-58(Table 1). While 
we will not complete hypothesis testing, we usedthe following assumptions of hypothesis 
testing to estimate our sample: (1) power of 0.80; (2) a 2-tailed alpha of .05; and (3) an 
estimated attrition rate of 15% based on the pilot study. 
 
 
 
1. This is a single-blind, parallel, exploratory, randomized controlled trial to further evaluate 
the feasibility and the effect of remote delivery of CO-OP on CRCI in breast cancer 
survivors. Individuals from the community and patients who received breast cancer 
treatment at Ellis-Fischel Cancer Center within the past three years will be identified. 
Those with self-reported CRCI will undergo further screening and eligible subjects will 
complete baseline assessment remotely. After baseline assessment, subjects will be 
randomized to one of two groups: (1) a 10-session CO-OP intervention; or (2) a 10-
session attention control group. Block randomization will be used to ensure equal 
distribution between groups. The study statistician, Dr. Golzy will create and oversee the 
randomization sequence. Each CO-OP session will last 60minutes and subjects will 
complete one session per week over the course of 12 weeks. Subjects will under go the 
same assessment battery that was completed at baseline within one week post-
intervention remotely.  
a. Cognitive Orientation to daily Occupational Performance (CO-OP). CO-OP is a 
metacognitive strategy training intervention that will be used in this study. First, 
five functional, everyday life goals are identified collaboratively by the 
participant and interventionist. In the second meeting, when CO-OP actually 
begins, we introduce the approach to the subject and teach the global cognitive 
strategy (i.e., GOAL-PLAN-DO-CHECK). In all subsequent sessions, this 
strategy is used as the main problem-solving framework to facilitate skill 
V. 
Number of Subjects 
VI. 
Study Procedures/Study Design 

Page 4 of 9 
acquisition. The subject identifies a GOAL, and then is guided by the therapist to 
discover a PLANt o potentially achieve the goal. The subject is then asked to Dot 
he plan (if feasible during the therapy session otherwise asked to complete at 
home prior to the next treatment session), and subsequently to CHECK to see if 
the plan worked, i.e. the goal was achieved. This process is repeated until 
satisfactory performance is met for each established goal. 
b. Attention Control Group: Individuals in the attention control group will have 
dose-equivalent, weekly virtual contact through the Zoom platform for 10-
weekswith an occupational therapist not involved in CO-OP treatment. The 
control group will control for interpersonal interaction, maturation effects, and 
testing effects. The focus of each session will include: (1) social interaction 
characterized by warmth/empathy and (2) provision of usual care CRCI 
educational resources (e.g. exercise, using memory aids, minimizing distractions) 
from MD Anderson Cancer Center. These recommendations will be provided 
without further instruction. Any questions that arise regarding CRCI the subject is 
experiencing will be answered. The therapist will debrief with the subject on any 
changes in CRCI symptoms. The content and duration of each call will be 
tracked. 
 
2. The study duration is approximately 12weeks. This includes about 2.5 hours of pre-
intervention assessments (Table 1), 10, 45-60 minute intervention sessions, and about 2 
hours of post-intervention assessments.  
3. All study procedures are for research purposes only.  
4.  
Table 1. Study Measures  
Assessment 
Construct 
Score Evaluated 
Administration 
Time 
Specific 
Aim 
Primary Outcome Measures 
Feasibility measures 
Recruitment rate, 
retention rate 
N/A 
T2 
1 
Telehealth Usability 
Questionnaire (TUQ) 
Telehealth Usability 
Average Score 
T2 
1 
Acceptability of Intervention 
Measure (AIM)62  
Intervention 
acceptability 
Total score 
T2 
1 
Intervention Appropriateness 
Measure (IAM)62  
Intervention 
appropriateness 
Total score 
T2 
1 
Feasibility of Intervention 
Measure (FIM)62  
Intervention feasibility 
Total score 
T2 
1 

Page 5 of 9 
Canadian Occupational 
Performance Measure 
(COPM)63  
Subjective activity 
performance 
Average score 
across goals 
T1, T2 
2 
NeuroQoL Cognitive Function 
Short Form64  
Subjective cognition  
T-score 
T1, T2 
2 
Secondary Outcomes* 
Patient Health Questionnaire 
(PHQ-9)65  
Depression symptoms 
Total score 
T1, T2 
2 
Functional Assessment of 
Cancer Therapy-Breast 
(FACT-B)66 
Quality of Life 
Total Score 
T1, T2 
2 
Montreal Cognitive 
Assessment (MoCA)67  
General cognitive 
function 
Total score 
T1, T2 
2 
Delis-Kaplan Executive 
Function System (DKEFS)- 
Color-Word Interference68 
Inhibition, cognitive 
flexibility 
Total score 
T1, T2 
2 
Wechsler Adult Intelligence 
Scale (WAIS)-IV Letter-
Number Sequencing, Coding, 
Symbol Search subtests69 
Inhibition, attention, 
working memory, 
processing speed 
Total score 
T1, T2 
2 
Brief Visuospatial Memory 
Test –Revised70  
Episodic memory 
Total score 
T1, T2 
2 
Paced Auditory Serial 
Addition Test71 
Working Memory 
Total score 
T1, T2 
2 
Patient-Reported Outcomes 
Measurement Information 
System (PROMIS-57) Profile 
v2.072 
Self-reported changes 
in anxiety, depression, 
fatigue, pain, physical 
function, sleep, 
participation 
T-scores for each 
domain 
T1,T2 
2 
Additional Data Collected 
Medical record data 
Medical history 
information 
N/A 
T1 
N/A 
Demographic data 
Description of 
population 
Age, race, gender, 
education level 
T1 
1,2 

Page 6 of 9 
Therapy logs 
Description of 
treatment provided 
N/A 
Continuously 
monitored 
1, 2 
 
5. *Also used to help identify possible covariates for future studies  
 
 
 
 
1. There are minimal risks expected when taking part in this study. There are some that we 
know about and some may not know about yet. Some possible risks include (1) a breach 
of confidentiality where identifiable health information related to the participants is 
inadvertently made available to individuals beyond the research team; (2) psychological 
distress while discussing changes in your abilities following cancer treatment; or (3) 
physical injury. 
 
2. To help lower these possible risks, we will keep participant information in a password 
protected file on a secure network that has restricted access. All data will be obtained by 
the study team will be for research purposes only and will be de-identified prior to data 
entry into our secure electronic database. Any hard copy data will be locked in filing 
cabinets in the private offices of the PI. All electronic data will be maintained on one 
web-based, secure, centralized database. The database will use the REDCap® platform 
and can only be accessed through two password protected portals.  All data entered into 
the REDCap® database will be stored on University of Missouri secure servers and will 
have access restricted to only members of the research team. In the rare event participants 
experience psychological distress when answering questions during assessments, they 
will be reminded that they can decline to answer any questions that may make them 
uncomfortable and that participation is completely voluntary.  
3. The table below provides information on how AEs will be reported in this study (see 
Table 1).  The plan for reporting has been determined based on the severity of the AE and 
the study attribution of the AE per the definitions and categories previously discussed.  
The reporting timeframe meets or exceeds the reporting requirements of the University of 
Missouri IRB.  All AEs will be reported to by the University of Missouri IRB.  IRB will 
review these as they are reported and also annually when the protocol is renewed.  All 
severe adverse events below will also be reported to the sponsoring IC Program Officer 
within the timeframe listed.  The University of Missouri IRB maintains a log of all 
reported AEs, including all details related to the AE, actions taken, and outcomes, over 
the course of the study that will be used by the study team for tracking purposes.   
 
Table 1:  AE Reporting Plan 
Study Attribution 
Time for Reporting by type of AE 
 
Mild 
Moderate 
Severe 
VII. 
Potential Risks 

Page 7 of 9 
Unrelated 
Not required 
Not required 
5 days 
Definitely Related 
5 days 
5 days 
24 hours 
Probably Related 
5 days 
5 days 
24 hours 
Possibly Related 
5 days 
5 days 
24 hours 
 
 
 
1. Participants may or may not directly benefit as a result of participation in the study. 
Information learned from the study may likely help other people in the future. 
Participants may potentially experience improvement in their ability to perform everyday 
life activities better and/or experience less cancer-related cognitive impairment.  
 
 
 
1. Participants will be compensated for taking part in this study. For time and effort, 
participants will receive $75 via check payment within one month of pre-assessments and 
post-assessments for a total of $150.  
 
 
 
Data Quality and Management 
 
The research coordinator will oversee the review of all data collection forms on an 
ongoing basis for data completeness and accuracy, as well as protocol compliance. The table 
below is an overview of the schedule for data review (see Table 2). All data files completed 
during the specified time period will be reviewed. The study coordinator will assign a rater to 
review each file who was not the person who collected the data. The reviewer will complete an 
audit sheet to review the completeness and accuracy of each data file.  Data verification will be 
completed on all outcome data by double data entry.  All data will be entered into a separate 
electronic database. The research coordinator will cross-check the two data files and resolve any 
discrepancies. The results of the data verification will be reported on the audit form. All audit 
forms will be reviewed by the PI and further training of blind raters will occur if consistent errors 
are noted. Any protocol violations will be reported to the University of Missouri IRB. 
 
Intervention fidelity and protocol adherence will be reviewed by Dr. Wolf (Co-I) with 
support from the CO-OP Academy, who is a certified trainer in the CO-OP approach. The CO-
OP Academy has developed a CO-OP Fidelity Checklist that is used to monitor fidelity of the 
CO-OP intervention. This checklist will be completed by reviewing video recordings of 
intervention sessions and therapists must maintain an overall score of 80% to be compliant with 
the intervention. Any items missed on the checklist will be reviewed with the therapist during the 
next weekly meeting following the audit. Failure to maintain an 80% on any fidelity check will 
require individual instruction. For every participant, a minimum of two sessions are recorded: (1) 
one from sessions 2-5; and (2) one from sessions 6-9. Additional sessions may be recorded and 
reviewed at the Co-I’s discretion, if therapists are consistently scoring at or below the 80% 
threshold. 
 
Table 2: Schedule for Data Review 
VIII. Anticipated Benefits 
IX. 
Compensation 
X. 
Data Safety Monitoring Plan 

Page 8 of 9 
Data type 
Frequency of review 
Reviewer 
Subject accrual (including 
compliance with protocol 
enrollment criteria) 
Quarterly 
Blind rater (confirmation by 
researcher coordinator and 
Dr.Boone, PI)  
Status of all enrolled subjects, 
as of date of reporting  
Quarterly 
Blind rater (confirmation by 
researcher coordinator and Dr. 
Boone, PI) 
Outcome data accuracy 
(double-data entry) 
Quarterly 
Blind rater (confirmation by 
researcher coordinator and Dr. 
Boone, PI) 
Adherence data regarding study 
visits and intervention 
Quarterly 
PI 
Treatment fidelity 
Quarterly 
Dr. Wolf, Co-I (with CO-OP 
Academy) 
AEs and rates  
Quarterly 
PI 
 
Subject Accrual and Compliance 
     Per Table 2 above, review of the rate of subject accrual and compliance with 
inclusion/exclusion criteria will occur quarterly during the 1.25 year recruitment phase to ensure 
that: (1) a sufficient number of participants are being enrolled; (2) participants are meeting 
eligibility criteria; and (3) the targeted ethnic diversity goals outlined in the grant proposal are 
being met (see Inclusion of Women, Minorities, and Children).  
 
Stopping Rules 
     This study will be stopped prior to its completion if: (1) the intervention is associated with 
adverse effects that call into question the safety of the intervention; (2) difficulty in study 
recruitment or retention will significantly impact the ability to evaluate the study endpoints; 
(3) any new information becomes available during the trial that necessitates stopping the trial; or 
(4) other situations occur that might warrant stopping the trial 
 
Safety Review Plan 
     Study progress and safety will be reviewed quarterly per above. Annual progress reports, 
including patient recruitment, retention/attrition, and AEs, will be provided to the University of 
Missouri IRB. The annual report will include a list and summary of AEs. In addition, the annual 
report will address (1) whether AE rates are consistent with pre-study assumptions; (2) reason for 
dropouts from the study; (3) whether all participants met entry criteria; (4) whether continuation 
of the study is justified on the basis that additional data are needed to accomplish the stated aims 
of the study; and (5) conditions whereby the study might be terminated prematurely. The annual 

Page 9 of 9 
report will be provided to the sponsoring IC. The IRB and other applicable recipients will review 
progress of this study on an annual basis. 
 
 
 
 
1. N/A 
 
 
 
1. 
Hutchinson AD, Hosking JR, Kichenadasse G, Mattiske JK, Wilson C. Objective and 
subjective cognitive impairment following chemotherapy for cancer: A systematic 
review. Cancer Treatment Reviews. 2012;38(7):926-934. 
2. 
O’Farrell E, MacKenzie J, Collins B. Clearing the air: a review of our current 
understanding of “chemo fog”. Current oncology reports. 2013;15(3):260-269. 
 
3. 
Reid-Arndt SA, Hsieh C, Perry MC. Neuropsychological functioning and quality of life 
during the first year after completing chemotherapy for breast cancer. Psychooncology. 
2010;19(5):535-544. 
4. 
Reid-Arndt SA, Yee A, Perry MC, Hsieh C. Cognitive and psychological factors 
associated with early posttreatment functional outcomes in breast cancer survivors. 
Journal of psychosocial oncology. 2009;27(4):415-434. 
5. 
Cicerone KD, Dahlberg C, Kalmar K, et al. Evidence-based cognitive rehabilitation: 
recommendations for clinical practice. Archives of Physical Medicine and Rehabilitation. 
2000;81(12):1596-1615. 
6. 
Cicerone KD, Langenbahn DM, Braden C, et al. Evidence-based cognitive rehabilitation: 
updated review of the literature from 2003 through 2008. Archives of Physical Medicine 
and Rehabilitation. 2011;92(4):519-530. 
7. 
Haskins E. Cognitive Rehabilitation Manual: Translating Evidence-Based 
Recommendations into Practice. Vol 1. Reston, VA: American Congress of 
Rehabilitation Medicine; 2012. 
8. 
Wolf TJ, Doherty M, Kallogjeri D, et al. The feasibility of using metacognitive strategy 
training to improve cognitive performance and neural connectivity in women with 
chemotherapy-induced cognitive impairment. Oncology. 2016;91(3):143-152. 
 
 
 
 
 
XII. 
References 
XI. 
Multiple Sites