Decisions About Cancer Screening in Alzheimer's Disease
Phase: NA
Conditions: Cancer, Breast, Alzheimer Disease
Sponsor: Indiana University

1 
 
 
 
 
 
 
Decisions about Cancer Screening in Alzheimer’s Disease 
(DECAD) 
 
PROTOCOL 
4.28.2022 
 
BACKGROUND AND STUDY AIMS 
The incidence of both Alzheimer’s disease and related dementias (AD) and of breast cancer increases with 
age; thus, many older women with AD are faced with questions about breast cancer screening. Having AD can 
impact a women’s ability to participate in her medical decision-making about breast cancer screening. As a 
result, AD family caregivers (hereafter referred to as caregivers) are frequently involved in making decisions 
about mammography. Each year over 800,000 women with AD receive screening mammography. Caregivers 
cite decision-making and procedures related to mammograms as particularly stressful and there is a lack of 
data that mammography screening helps women with AD live longer or better. 
The average life expectancy of older women with AD is <10 years. Current guidelines recommend not 
screening women with a life expectancy of <10 years. The rationale is that these women will not live long 
enough to experience the life prolonging benefits of mammography screening. Instead, screening these 
women can put them at risk for physical and psychological harm as a result of over diagnosis, overtreatment, 
additional tests due to false positives, and the identification of clinically unimportant cancer. Conversely, while 
mammography screening may not help older women with AD live longer, it may help find breast cancers earlier 
when they are easier to treat. Therefore, it is important that women with AD and their caregivers have 
information to make an informed decision about screening. The goal of our project is to test if an evidence-
based decision aid for caregivers can improve the quality of decision-making about mammography in older 
women with AD.  
A decision aid for AD caregivers about mammography could improve the quality of medical decision-making, 
by informing caregivers about the risks, benefits, and their choices. No decision aids exist to support AD 
caregivers with decisions about mammography despite the frequency that caregivers are approached with this 
decision. The DECAD Study will test if a decision aid can support AD caregivers and patients in making 
decisions about breast cancer screening by improving markers of decision quality. The study aims are: 
 
Primary Aim: To examine the effect of a mammography screening decision aid intervention for older 
women with AD on markers of decision quality among caregivers.  
Hypothesis: Caregivers of patients who receive the decision aid will have lower levels of decisional conflict 
(primary outcome) and higher levels of decision-making self-efficacy (secondary outcome) about breast cancer 
screening in older women with AD, compared to the control group.  
Secondary Aim: To examine the effect of a mammography screening decision aid intervention for 
caregivers on the utilization of mammograms in older women with AD. 
Hypothesis: Women with AD who are randomized to receive the decision aid will receive less mammography 
screening at 15 and 24 months after the intervention, compared to the control group.  
 
Exploratory Aim: To identify the factors that are associated with impact of a decision aid intervention 
on mammography screening cessation in older women with AD. 
Exploratory Hypothesis: Among the dyads randomized to receive the decision aid, caregivers of patients with 
more severe cognitive impairment, greater co-morbidities, or older age will experience a greater reduction in 
frequency of mammograms in the 15 and 24 months following the intervention. 

2 
 
 
 
 
METHODS 
Study Design:  
 Two arm, randomized controlled trial.  
 426 AD patient-informal caregiver dyads with completed baselines. 213 dyads receive the decision aid 
on mammography 
(Appendix 1 and 
Appendix 2) and 213 
dyads to receive a control 
condition in the form of a 
two-page paper pamphlet 
on home safety 
developed by the 
American Geriatrics 
Society Foundation for 
Health in Aging (Appendix 
3). 
 
Participants:  
 Patients will be women, 
age 75 and older with a 
diagnosis of Alzheimer’s 
disease or related 
dementia.  
Table 1. Inclusion and exclusion criteria for the DECAD Trial 
INCLUSION CRITERIA 
Patients 
Caregivers 
Female and 75 years or older 
18 years or older 
At least one mammogram in the past five years 
Primary family caregiver of the patient*   
Primary care visit scheduled in the next 12 months  
Diagnosis of AD as determined by ICD-10 code 
Ability to provide informed consent  
Ability to provide informed consent or assent 
Ability to communicate in English 
Ability to communicate in English 
EXCLUSION CRITERIA 
Patients 
Caregivers 
Permanent resident of a nursing facility 
Caregiver is a non-family member who is not 
a legal Healthcare Power of Attorney 
Had a mammogram in the past 6 months 
Less than a 7th grade education**  
Primary care visit scheduled is not the first visit 
with the PCP 
Made a decision to stop getting mammograms 
Made a decision that the patient will stop 
getting mammograms 
History of Atypical Ductal Hyperplasia, lobular 
carcinoma in situ, ductal carcinoma in situ, or 
invasive breast cancer or other cancer in the past 
5 years. 
Has a diagnosis of AD or has a serious mental 
illness such as bipolar or schizophrenia as 
determined byICD-10 code 
 
Has mild cognitive impairment, serious mental 
illness such as bipolar or schizophrenia as 
determined byICD-10 code 
* Identified by the patient or listed as primary caregiver in EMR. 
**The reading level of the decision aid is 7th grade. 
Table 2. Sites for DECAD Recruitment* 
Site 
Number of 
sites 
# of 
Physician
s 
Women 
≥70 
years 
old with 
AD 
Race and Ethnicity 
for population with 
AD 
Eskenazi Health  
Aging Brain Care 
Program 
 
 
1 
 
5 
 
 
 
1,383 
White 42% 
African American 51% 
Other or unknown 7% 
Hispanic 2% 
Indiana University 
Alzheimer Disease 
Center 
 
1 
 
NA 
 
43 
White 67.5% 
African American 
32.5% 
 
Indiana University 
Health Department of 
Neurology 
1 
3 
TBD 
TBD 
Alzheimer’s 
Association- Greater 
Indiana Chapter 
5-10 
NA 
TBD 
TBD 
IU Health PC 
 
 
 
179 
 
2,026 
White 75.6% 
African American 
22.4% 

3 
 
 Caregivers will be age 18 and 
older and an unpaid, informal 
caregiver for the patient either 
self-identified, identified by the 
patent, or identified by the 
patient’s medical team. 
 See Table 1 for patient and 
caregiver inclusion and exclusion 
criteria. 
 
Recruitment Sites (as of 11/30/2021):  
 Aging Brain Care Program at 
Eskenazi Health  
 Indiana University Alzheimer 
Disease Center (research 
registry) 
 Indiana University Health Department of Neurology  
 Indiana University Health Department of Psychiatry (Drs. Bateman and Wang) 
 Alzheimer’s Association- Greater Indiana Chapter (Support Group members) 
 Indiana University Health Primary Care Practices in central Indiana 
 Eskenazi Health Primary Care Practices in central Indiana 
 Beth Israel Deaconess Medical Center, Boston, Massachusetts 
 Parkview Health, Fort Wayne, Indiana 
 CICOA Aging and In-Home Services, central Indiana  
 LifeStream Services, eastern Indiana 
 Thrive Alliance, southern central Indiana  
 SWIRCA & More, southwest Indiana 
 
 
Primary outcome: Caregiver decisional conflict at post-index visit (T3) 
Secondary outcome (caregiver): Caregiver decision-making self-efficacy at post-index visit (T3) 
Secondary outcome (patient): Utilization of mammograms at 15 (T4) and 24 months post-index visit (T5). 
Table 3. Measures 
Outcomes 
Construct/Core 
Attributes 
Outcome 
measure(s) 
Name of 
Measure 
citation 
Description 
Scoring 
When 
Source 
Primary outcome 
Feel Informed 
 
Values clarification 
Decisional 
Conflict  
Decision 
Conflict Scale 
16-items on a 1-5 Likert 
scale. Measures uncertainty 
around a decision, whether 
Scores 
range 0-100; 
Lower 
T1 
T3 
Caregiver 
reported 
14 PC 
practices 
Other or unknown 2% 
Hispanic 0.9% 
BIDMC 
7 sites 
90  
1600 
White- 64% 
Black- 23% 
Asian- 4% 
Hispanic -5% 
Parkview Health 
TBD 
TBD 
TBD 
TBD 
CICOA Aging and In-
Home Services  
NA 
NA 
988 
TBD 
LifeStream Services 
NA 
NA 
200 
TBD 
Thrive Alliance  
NA 
NA 
40 
TBD 
SWIRCA & More 
NA 
NA 
90 
TBD 
Total 
34 
277 
6280 
 
*Data as of March 2017 besides BIDMC, Parkview Health, CICOA, LifeStream, Thrive 
Alliance, SWIRCA & More 

4 
 
one feels informed, clear 
about their personal values, 
and supported in their 
decision-making. 
scores 
indicate less 
conflict. 
Secondary 
outcomes 
Belief in  ability to 
make and 
participate in 
shared decision 
making 
Decision-
making self-
efficacy 
Decision Self-
Efficacy Scale 
(DSE) 
11-items on a 5-point Likert 
scale. Measures of self-
confidence or belief in one’s 
ability to make decisions  
Low, 
medium, 
high 
decision 
self- 
efficacy. 
Scores 
range 0-100 
T1 
T3 
Caregiver 
reported 
 
Receipt of 
screening 
DECAD 
Created 
Review primary care notes, 
radiology reports, and 
documentation on 
screening/preventive care; 
caregiver report 
Yes or no 
determinatio
n 
T4 
T5 
Pt EMR;  
 
Caregiver 
reported 
Involvement in the 
decision 
 
Caregiver role 
in decision-
making 
Adapted from 
the Control 
Preferences 
Scale 
4-items to assess 
preferences for and 
involvement in making 
decisions on their own or 
sharing responsibility with 
the pt or doctor. 
Active vs. 
passive/shar
ed with 
doctor (since 
aim of 
decision aids 
is to help 
dyads be 
more active 
in decision-
making) 
 
T3 
 
Caregiver 
reported 
Patient role in 
decision-
making 
Adapted from 
the Control 
Preferences 
Scale 
2-items to assess 
involvement in making 
decisions on their own or 
sharing responsibility with 
their family or doctor. 
Active vs. 
passive/shar
ed with 
doctor (since 
aim of 
decision aids 
is to help 
dyads be 
more active 
in decision-
making) 
 
T3 
 
Patient 
reported 
Other measures 
 
Socio-
demographics 
DECAD 
Created 
32 item questionnaire to 
measure items such as 
relationship to the patient, 
frequency and type of 
contact with the patient, 
geographic distance from 
the patient, education level, 
annual income, self-
reported health status, etc. 
Co-variates 
T1 
Caregiver 
reported 
Does severity of the 
patient’s cog and 
functional 
impairment impact 
caregiver decision 
making 
Severity of 
patient’s 
cognitive 
impairment 
Dementia 
Severity 
Rating Scale 
(DSRS) 
12-item questionnaire for 
caregivers to assess 
severity of AD in 12 major 
functional and cognitive 
domains.  
Score 
ranges from 
0 (mild) to 
54 (severe). 
T1 
Caregiver 
reported 
 
 
Caregiver 
Appraisal of 
Function and 
Upset (CAFU) 
15-item questionnaire for 
caregivers to measure 
ADLs and iADLS 
impairment and how much 
those impairments upset or 
burden the caregiver 
 
T1 
Caregiver 
reported 
 
Intention for 
the patient to 
be screened 
DECAD 
Created 
3-items total. Two on a 5-
point scale to assess 
propensity to get screened. 
One to ask how many more 
mammograms they think 
the patient will get.  
Yes vs. 
those who 
are unsure 
vs. No 
screening; 
We will look 
at the scores 
continuously 
and 
categorize 
scores as 1-
2(no), 3 
(unsure), or 
4-5 (yes). 
T1 
T3 
Caregiver 
and 
Patient 
reported 

5 
 
 
Breast Cancer 
and 
Alzheimer’s 
disease 
Knowledge 
DECAD 
Created 
16-items (6 multiple choice 
and 10 true/false); 13 were 
adapted from other studies 
and 3 were developed 
based on the decision aid. 
Sum of 
correct 
answers 
T1 
T3 
Caregiver 
reported 
 
Burden of 
screening on 
the patient 
DECAD 
Created 
Review patient’s EMR for 
additional diagnostic 
procedures due to 
mammogram follow-up; 
false-positive results, 
identification of an 
abnormality on screening 
exam but further work-up 
declined, identification of a 
clinically unimportant 
cancer; documentation of 
depressive symptoms, 
anxiety, or pain related to 
the experience of getting a 
mammogram and not a 
general measure to be 
assessed independent of 
that event 
Yes or no 
 
Characteriza
tion if yes 
T4 
T5 
 
(quart
erly for 
DSMB
) 
Pt EMR 
review; 
 
 
 
Burden of 
screening on 
the caregiver 
DECAD 
Created 
5 items on a 5-point Likert 
scale. Assess perceptions 
about the burden of 
mammography for the 
patient  
& 
Semi-structured questions 
about patient’s 
mammogram experience 
and perceived burden of 
screening. 
Sum of 
scores 
T4 
Caregiver 
reported  
Values, Attitudes, 
Norms, and 
Experiences 
 
DECAD 
created 
15 items total. 5 items on a 
10 point scale re: values; 3 
items on a 7 point scale on 
attitudes; and 3 items on a 
5 point scale re; perceived 
norms; and 4-itmes on a 5 
point scale re: experience 
with mammograms 
descriptive 
T1 
T3 
Caregiver 
and 
Patient 
reported 
 
Health literacy 
 
A 4-item health literacy 
assessment with values of 
0-5 based on possible 
responses to each of the 
questions.116 
Higher 
scores being 
higher health 
literacy. 
T1 
Caregiver 
reported 
 
 
Numeracy  
 
A 3-item assessment of 
numeracy skills 
Higher 
scores being 
higher health 
literacy. 
T1 
Caregiver 
reported 
 
Mammogram 
discussion with the 
Patient’s provider  
 
 
8-items that assess if a 
discussion about 
mammograms took place 
and the content of those 
discussions.  
Descriptive 
T3 
 
Process measure 
 
Acceptability 
of the decision 
aid 
DECAD 
Created 
3-items on a yes/no scale 
and 6-items on a 5-point 
Likert scale to measure 
caregivers’ and patients’ 
perceptions about the 
length, clarity, helpfulness 
and willingness to 
recommend decision aid. 
 
Also, the number of times 
they reviewed it, how many 
pages they read, how long 
it took them to read it, how 
they would prefer to receive 
it if not part of a study. 
Sum of 
scores 
T3 
Patient 
reported 
Process measure 
 
Acceptability 
of the decision 
aid 
DECAD 
Created 
20-items on a 5-point Likert 
scale and 8 yes/no 
questions to measure 
Sum of 
scores 
T3 
Caregiver 
reported 

6 
 
caregivers’ and patients’ 
perceptions about the 
length, clarity, helpfulness 
and willingness to 
recommend decision aid. 
 
Also, the number of times 
they reviewed it, how many 
pages they read, how long 
it took them to read it, how 
they would prefer to receive 
it if not part of a study. 
 
Intervention Description and Timing of Measures 
Although participants may be recruited from specialty memory care or AD clinics, the intervention will be 
delivered in the patient’s primary care setting (e.g. the usual setting for discussions about mammography). 
Step 1: Identification of Potential Participants 
 Participants will be identified in a variety of ways and will be tailored based on the recruitment site. 
Patients identified through a clinical site (ABC, IUH) will be identified via the Indiana Network for Patient 
Care, which can access patient lists by doctors and clinic and PC clinic schedules. To identify potential 
participants at BIDMC, a data manager at BIDMC will send a research assistant a list of all women 75-
89 years with dementia (based on ICD-10 codes [will be expansive and will include codes for memory 
loss and all forms of dementia]) and without a history of breast cancer scheduled to see their primary 
care provider (PCP, physician or nurse practitioner). With a HIPAA waiver a research assistant (RA) will 
then review these patients' medical records to see if the patient meets eligibility criteria (e.g., diagnosis 
of Alzheimer's or related dementia; mammogram in the past 5 years but not in the past 6 months, no 
history of breast cancer listed in problem list).  Patients’ physicians will be notified first of their patient’s 
potential eligibility and be asked if DECAD can approach the patient and their caregiver for 
participation. Physicians are routinely given 2 weeks to review their patient list (per IU PBRN). At 
BIDMC, physicians are routinely given 2 days to respond to an email requesting permission to contact 
their patients. However, if the physician has an out-of-office response we give PCPs 2 days to respond 
after they return. The email informing PCPs that we plan to contact their patients tells PCPs that if we 
do not hear from them in 2 days then we will send their patients an informational letter about the study. 
Once approved by physician, the patient and caregiver will get a letter informing them of the study and 
that study personnel will be calling them in 1-2 weeks to provide more information. Participants 
identified from non-clinical sites (eg. Alz Assoc) will receive information about the study from the Alz 
Asso and from Trial Match. They will reach out to the study team directly or will provide permission to 
be follow-up by the study team regarding recruitment. We will also present the study at community 
events such as caregiver support groups and Alzheimer’s related events. Caregivers approached at 
these events will have the opportunity to sign a contact list that includes their phone number, to hear 
more information about our study. The study team will then reach out to those caregivers to assess 
eligibility and confirm interest in participation. We will use our pre-approved brochure for these 
caregivers. 
 We will consider any woman age ≥75 years with a diagnosis of AD or related dementia who has 
received a mammogram in the past 5 years (but not in the past 6 months) and who does not have a 
history of breast cancer or documentation in her EMR that she has decided to stop mammography.  
 We will approach the primary family caregiver/ informant for each eligible woman. Caregivers will be 
eligible if they are a caregiver for the patient and intend to accompany the patient to their next primary 
care visit.  
 
 Rolling enrollment will take place over 36 months with an average monthly enrollment of 11-12 dyads.  
 
 

7 
 
 
Step 2: Enrollment 
 Following eligibility determination and the informed consent process (which includes HIPAA release 
form), and baseline assessment the dyads will be randomly assigned in 1:1 ratio to one of two groups: 
mammogram decision aid or home safety guide, stratified by site. 
 
 Decision aid or home safety guide will be mailed to both the patient and the caregiver immediately after 
randomization but at least 1 week before the index visit. 
 
 Date of the patient’s next PCP visit will be obtained via caregiver report at the baseline interview and 
via EMR review at the time of enrollment. 
 
 For all dyads, the Research Assistant will meet them in person or by phone 0-2 days before the index 
visit to standardize the process by which all dyads review the decision aid. The pre-index visit 
assessment (T2) will occur in-person or by phone 30 minutes-2 days before the index visit either at the 
patient’s house, at the caregiver’s house, at the provider office or at a location of the dyads choice. 
Observational data only is collected at this assessment. The RAs will not discuss the content of the 
decision aid at that time; they will simply ensure that they have read it or have had it read to them 
before the index visit. We will record if the RA is asked to read the DA to either member of the dyad. If 
Figure 1. 

8 
 
the dyad has any questions about the content of the decision aid, the RA will encourage them to ask 
the patient’s provider any questions. The phone option script will provide prompts to ensure review of 
the decision aid during the phone conversation  
 If the date of the patient’s index visit is not known or not documented in the EMR, the RA will follow the 
study tracking process to obtain the patient’s index visit appointment date. This includes a 2x per month 
phone call to the caregiver and EMR review (if accessible).  
 If the index PCP visit does not occur within approximately six months of the baseline, another provider 
visit may be substituted with PI permission.  
 
 The post- index visit (T3) will occur in-person or via phone 0-5 days after the index visit.  
 
 The 15 month follow-up (T4) will be in-person or via phone and include an assessment with the 
caregiver and a review of the patient’s EMR. This interview may be audio recorded.  In the event we 
have exhausted the attempts to reach the participant/caregiver by phone or in person, we will send a 
paper copy of a letter explaining the request to have them complete the survey on paper and return to 
the research assistant.   
 
 The 24 month follow-up (T5) will include a review of the patient’s EMR (only). 
 
 See Table 3 and Figure 1 for a complete list of measures and timing of collection.  
 
 
Statistical Plan: 
 
Step 1: Overview 
 
 For analysis, we will examine univariate distributions of continuous variables in order to detect any 
potential violations of assumptions to our planned parametric methods of analyses.  
 
 We will transform variables as needed to ensure normal distribution assumptions are met.  
 
 We will use nonparametric methods if transformations are inadequate.  
 
 Demographic characteristics of the patients and caregivers will be compared between the two groups in 
order to evaluate if randomization is effectively balanced. We will include caregiver sex as a moderating 
biological variable and examine the influence of sex on caregivers’ decisional conflict and other factors 
associated with the impact of our decision aid interaction on mammography screening use.  
 
 We will use Chi-squared tests or Fisher’s exact tests to compare the frequencies of categorical 
variables. Analysis of variance (ANOVA), or its nonparametric alternative, the Wilcoxon rank sum test, 
will be used to compare the distribution of continuous variables between the groups.  
 
 We will use SAS 9.4 for all analyses (SAS Institute, Carey, NC). 
 
 
Step 2: Primary Aim  
 
 Analysis of covariance (ANCOVA) models will be used to compare mean Decisional Conflict Scale 
(DCS) scores between the intervention and control groups. For each caregiver, the difference in DCS 
scores from baseline to follow-up will be used as the dependent variable in the ANCOVA with 
randomization group assignment as the independent variable adjusting for the stratification variable of 
recruitment site and for other potential baseline covariates that are found to be significantly different 
between the two groups in univariate comparisons. 
 

9 
 
 ANCOVA models will also be used to compare secondary decision quality outcome (e.g., decision-
making self-efficacy) at follow-up between the intervention and control groups adjusting for site and 
other potential baseline covariates found to be significantly different between the two groups in 
univariate comparisons.  
 
Step 3: Secondary Aim 
 
 A binary indicator variable for receipt of mammograms within 15 months and within 24 months from the 
intervention date will be used as a secondary outcome variable.  
 
 A logistic model with group (decision aid or control) as the independent variable will be used adjusting 
for recruitment sites (e.g., EH, IUH and IADC) and other potential baseline covariates found to be 
different in univariate comparisons.  
   
Step 4: Exploratory Aim 
 
 Once we have tested our hypothesis for the main effects, we will also perform hypothesis-generating 
exploratory analyses to examine effects in sub-groups of patients and caregivers.   
 
 Hypothesized sub-group analyses will be used for both the primary and secondary outcomes 
examining the moderating effect of patients’ and caregivers’ characteristics on decision aid impact.  
 
 The following patient variables will be included in sub-group analyses: age, level of cognitive 
impairment, number of co-morbidities, and their role in mammography decisions.  
 
 The following caregiver variables will be included in sub-group analyses: relationship to the patient, 
level of education, health literacy, and perceived burden of mammography for the patient and for them.  
 
 We will include each of these variables in the ANCOVA models for the primary outcome, in the logistic 
models for the secondary outcome and test for interactions between these variables and intervention 
group adjusting for recruitment sites and other potential baseline covariates. Significant interaction 
between a patient/caregiver characteristic variable and group would indicate different intervention 
effects in the dyad subgroups defined by the variable. 
 
 
Step 5: Sensitivity analyses for the impact of refusals and other sources of missing data 
 
 We will compare patient/caregiver characteristics between those who complete the follow-up 
assessments and those who did not. Significant variables detected from these comparisons will be 
included in the ANCOVA models as covariates to control for potential bias from missing data.  
 
 
Sensitivity analyses for the impact of refusals and other sources of missing data: Given the short time 
frame for collecting decision quality measures at follow-up and our pilot data, we anticipate few missing data 
due to caregiver refusal for the primary and main secondary outcomes. We will compare patient/caregiver 
characteristics between those who complete the follow-up assessments and those who did not. Significant 
variables detected from these comparisons will be included in the ANCOVA models as covariates to control for 
potential bias from missing data. Since the secondary outcome of receipt of mammogram screening will be 
collected from the EMR, missing data would arise only in cases of patient’s death or moving out of state. We 
anticipate minimum missing data on the analysis of the receipt of mammogram screening.   

10 
 
 
 
 
 
STATISTICAL POWER 
 
Sample size for the proposed trial is calculated using our pilot data that showed effect sizes of 0.28 on 
Decision Conflict Scale (DCS) score and 0.34 for self-efficacy scores. To detect effect size of 0.28 or greater 
on DCS scores between the two groups, we will need to have 202 patient/caregiver dyads per group to 
complete both baseline and follow-up with 80.2% power using two sample t-test at 0.05 level. Allowing 5% 
missing data at follow-up, we will need to enroll 213 patient/caregiver dyads per group (total 426 dyad 
baselines). With our planned sample size, we will have 92.6% to detect effect size of 0.34 or greater on 
changes in self-efficacy scores between the two groups. 
The pilot showed the mean DCS were similar between the two groups, the control group had a large SD which 
should come down with large sample size. Table 4. 
 
Table 4. Baseline DCS scores 
Group 
N 
Mean 
Std Dev 
Std Err 
Minimum 
Maximum 
Control 
8 
26.8375 
22.6769 
8.0175 
0 
69.0000 
Decision support 
9 
26.4444 
16.4249 
5.4750 
0 
45.0000 
 
Change in DCS from baseline to follow-up: DA group had greater decrease in DCS than controls. The current 
effect size is about 0.55. Table 5.  
Table 5. Change in DCS scores from baseline to follow-up, by group 
Group 
N 
Mean 
Std Dev 
Std Err 
Minimum 
Maximum 
Control 
8 
5.2000 
8.8073 
3.1139 
-6.0000 
21.0000 
Decision support 
9 
9.7778 
7.8705 
2.6235 
0 
20.0000 
Diff (1-2) 
  
-4.5778 
8.3208 
4.0432 
  
  
 
    
TIMELINE 
 
Table 6. Timeline 
 
Oct 2017 
2018 
2019 
2020 
2021 
April 2022 
 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Q
1 
Q
2 
Q
3 
Q
4 
Study Preparation: IRB Modification, hire/train staff 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Recruitment: open new sites, organize by wave per 
site 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data collection: Enrollment & Baseline assessment 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Follow-up assessments 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Convene DSMB 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Data analysis 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Prepare abstracts and manuscripts 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Disseminate results 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
ADVERSE EVENTS REPORTING 
 
The DECAD study has a NIA approved Data Safety Monitoring Plan and a Data Safety Monitoring Board (See 
the DSMP and DSMB Charter attached).  In summary: 
 
The PI will comply with Indiana University IRB and the NIA guidelines for defining, collecting, and reporting 
serious adverse events, adverse events, and unanticipated problems. 

11 
 
Definitions-This study involves reviewing a paper-based decision aid regarding mammograms and answering 
questions and does not involve the administration of a medication or medical procedure.  While an adverse 
event is unlikely, it is possible that a subject in this study may experience an adverse event. In our study, a 
serious adverse event is defined as the following: (1) death; (2) a life-threatening episode requiring immediate 
intervention; (3) an inpatient hospitalization or prolongation of existing hospitalization; (4) a persistent or 
significant incapacitation or substantial disruption of the ability to conduct normal life functions; (5) an episode 
that requires intervention to prevent the above and/or permanent impairment or damage. 
 
Non-serious adverse events are “any untoward or unfavorable medical occurrence in a subject, including any 
abnormal sign (e.g., abnormal physical exam or laboratory finding), symptom, or disease temporally associated 
with the subject’s participation in the research” that do not meet the definition for serious adverse event.  
 
Unanticipated problems are defined as any incident, experience, or outcome that is unexpected, in terms of 
nature, severity, or frequency and that may be related or possibly related to the research procedures, or 
suggests that, as a result of the problem, participants may be at higher risk than previously known or 
recognized. 
 
Collecting- All adverse events, unanticipated problems and potential risks will be monitored and collected 
ongoing and throughout the study by the DECAD research assistants and research manager. Monitoring 
events related to an increased risk that a malignancy of the breast may go undetected or any complications, 
distress, or pain that arise from receiving a mammogram or as a result of follow-up procedures after a 
mammogram will be will be done via electronic medical record reviews of study patients’ primary care 
encounter notes, radiology reports, and other documentation on screening/preventive care for breast cancer 
and from caregiver reports. Events related to any patient and caregiver loss of privacy or confidentiality or 
fatigue, frustration or distress related to completing the intervention or the outcome questionnaires will be 
assessed by the research manager via monitoring of the delivery of the study protocols and procedures and by 
patient and caregiver reports. 
For all participants, adverse events will be collected starting at enrollment and continue until after the 
participant has completed the study. If an adverse event occurs, it will be documented on the NIA adverse 
event and serious adverse event forms found at https://www.nia.nih.gov/research/dgcg/clinical-research-study-
investigators-toolbox/adverse-events. Unanticipated problems, that do not meet the definition of an adverse 
event, will be documented in a DECAD study log that will be stored in a secure electronic folder behind the IU 
fire wall. Details in the log may include participant study ID, date that the problem was reported or discovered 
by the study, a description of the problem, and a corrective plan and measures to prevent reoccurrence. 
Measurement and Reporting of Adverse Events- Adverse events associated with reviewing a paper-based 
decision aid on mammography are infrequent. Therefore, adverse event rates are expected to vary little 
between the treatment and control groups. Adverse events will be monitored by the research manager on an 
ongoing basis. All adverse events and unanticipated problems will be reported to the study PI within 24 hours. 
We plan to present unblinded adverse events data to the DSMB when requested and at scheduled meetings. 
The NIA adverse event form will be used by the study staff to report all adverse events caused by the 
intervention.  
In the case of a participant death, the NIA Program Official, the IU IRB and the DSMB Chair will be notified 
within 24 hours using NIA standardized forms for reporting serious adverse events (noted above). If 
unanticipated, serious adverse events occur (i.e., not listed in the Data and Safety Monitoring Plan) and that 
are related to the intervention, they will be reported to NIA Program Official, the IU IRB, and to the DSMB Chair 
within 48 hours of study’s knowledge of the event using NIA standardized forms for reporting serious adverse 
events. In cases where there is any question regarding the level of an adverse event or attributable cause, or 
areas of uncertainty, the DECAD Study Team will consult with the DSMB and IU IRB. Further details are 
provided in the DECAD DSMB charter. The summary of all other adverse events and unanticipated problems 
should be reported to NIA Program Official and to the DSMB quarterly, unless otherwise requested by the 
DSMB.  

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