Educating African American Men about the Prostate Cancer

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Screening Dilemma: A Randomized Intervention
Kathryn L. Taylor, Jackson L. Davis III, Ralph O. Turner, et al.
Cancer Epidemiol Biomarkers Prev 2006;15:2179-2188.
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2179
Screening Dilemma: A Randomized Intervention
Kathryn L. Taylor,1 Jackson L. Davis III,2 Ralph O. Turner,2 Lenora Johnson,3 Marc D. Schwartz,1
Jon F. Kerner,4 and Chikarlo Leak1
1
Cancer Control Program, Lombardi Comprehensive Cancer Center, Georgetown University Medical Center; 2Most Worshipful Prince Hall Grand
Lodge of the District of Columbia, Washington, District of Columbia; 3Office of Education and Special Initiatives, The National Cancer Institute,
Rockville, Maryland; and 4Division of Cancer Control and Population Sciences, National Cancer Institute, Rockville, Maryland
Abstract
Background: Until there is a definitive demonstration that
early diagnosis and treatment of prostate cancer reduces
disease-related mortality, it is imperative to promote informed screening decisions by providing balanced information about the potential benefits and risks of prostate cancer
screening. Within a community/academic collaboration, we
conducted a randomized trial of a printed booklet and a
videotape that were designed for African American (AA)
men. The purpose of the trial was to determine the effect of
the interventions on knowledge, decisional conflict, satisfaction with the screening decision, and self-reported
screening.
Methods: Participants were 238 AA men, ages 40 to 70
years, who were members of the Prince Hall Masons in
Washington, DC. Men were randomly assigned to the (a)
video-based information study arm, (b) print-based information study arm, or (c) wait list control study arm.
Intervention materials were mailed to men at home.
Assessments were conducted at baseline, 1 month, and 12
months postintervention. Multivariate analyses, including
ANCOVA and logistic regression, were used to analyze
group differences.
Results: The booklet and video resulted in a significant
improvement in knowledge and a reduction in decisional
conflict about prostate cancer screening, relative to the wait
list control. Satisfaction with the screening decision was not
affected by the interventions. Self-reported screening rates
increased between the baseline and the 1-year assessment,
although screening was not differentially associated with
either of the interventions. In exploratory analyses, prostatespecific antigen testing at 1 year was more likely among
previously screened men and was associated with having
low baseline decisional conflict.
Conclusions: This study represents one of the first randomized
intervention trials specifically designed to address AA men’s
informed decision making about prostate cancer screening.
We have developed and evaluated culturally sensitive,
balanced, and disseminable materials that improved knowledge and reduced decisional conflict about prostate cancer
screening among AA men. Due to the high incidence and
mortality rates among AA men, there is a need for targeted
educational materials, particularly materials that are balanced
in terms of the benefits and risks of screening. (Cancer
Epidemiol Biomarkers Prev 2006;15(11):2179 – 88)
Introduction
Prostate cancer is the most commonly diagnosed cancer and
the third leading cause of cancer death among men in the
United States, with 234,460 expected diagnoses and 27,350
expected deaths this year (1). These statistics have led some
organizations to recommend routine prostate cancer screening, particularly for men at high risk for the disease, including
African American (AA) men. Compared with white men, AA
men have a 60% higher incidence rate and a mortality rate that
is more than double that of white men (1). However, the
available data on screening outcomes are not yet definitive,
leading to inconsistent screening recommendations from
different professional organizations. Consequently, men and
their health care providers are left to make their own decisions
about the utility of screening.
The efficacy of screening asymptomatic men is a contentious issue. Although surveillance data indicate that prostate
Received 6/6/06; revised 8/15/06; accepted 8/23/06.
Grant support: Centers for Disease Control and Prevention grant TS290 and National Cancer
Institute grant K07 CA72645-01.
The costs of publication of this article were defrayed in part by the payment of page charges.
This article must therefore be hereby marked advertisement in accordance with 18 U.S.C.
Section 1734 solely to indicate this fact.
Requests for reprints: Kathryn L. Taylor, Cancer Control Program, Lombardi Comprehensive
Cancer Center, Georgetown University Medical Center, 3300 Whitehaven Street, Northwest,
Suite 4100, Washington, DC 20007. Phone: 202-687-0649; Fax: 202-687-8444.
E-mail: [email protected]
Copyright D 2006 American Association for Cancer Research.
doi:10.1158/1055-9965.EPI-05-0417
cancer is being diagnosed at earlier stages and that prostate
cancer mortality has decreased since the advent of prostatespecific antigen (PSA) testing (2, 3), there has not yet been a
definitive demonstration that early diagnosis and treatment
of prostate cancer reduces disease-related mortality. The
debate centers around whether PSA testing may result in
overdiagnosis, the detection of disease that otherwise would
not have caused a clinical problem (4, 5), and whether the
stage shift and decreased mortality are indeed due to the
increased rates of screening. The National Cancer Institute’s
Prostate, Lung, Colorectal, and Ovarian (PLCO) cancer
screening trial is addressing these issues, but the results
will not be available for several years (6). In addition to the
uncertain efficacy, screening also results in a substantial
false-positive rate, leading to a biopsy for a sizeable portion
of disease-free men.
Although the professional community debates the merits of
screening (7-12), millions of asymptomatic men in the United
States undergo screening each year. However, several studies
have reported low knowledge and little awareness of the lack
of consensus for the efficacy of screening (13-18). Most men
who are screened believe that the medical community
unequivocally accepts the benefits of screening. This situation
parallels earlier controversies, in which hotly debated cancer
screening techniques were in widespread use before the
completion of definitive studies, and the tests either did
(cervical cancer screening; ref. 19) or did not (lung cancer
screening; ref. 20) ultimately prove effective. As the efficacy
of prostate cancer screening will not be known for some time,
Cancer Epidemiol Biomarkers Prev 2006;15(11). November 2006
2180 African American Men and Prostate Cancer Screening
it is imperative to promote informed screening decisions by
providing accurate and balanced information about the
potential benefits, risks, and limitations of prostate cancer
screening.
To date, there have been 13 published randomized trials
of print, verbal, videotape, and face-to-face patient education trials for prostate cancer screening (18, 21-32). Of the
eight trials that have measured knowledge (18, 23-29),
all have shown improved knowledge about the advantages
and disadvantages of screening. Four trials measured
additional psychosocial outcomes and reported that, relative
to the control arms, men in the intervention arms reported
lower decisional conflict at post-test (22, 24, 25) and a
more active role in doctor/patient discussions (22, 29). Of
the 10 trials that assessed actual screening behavior
(excluding those that only measured intentions), 3 reported
reduced screening among participants who received educational interventions (26-28), 4 reported no difference in
screening rates (18, 22, 23, 29), and 3 reported increased
screening rates in the active intervention condition (30-32).
Two of the three trials that reported increased screening
rates included interventions that were not informed
decision making trials but were designed to increase
screening (30, 32), whereas one of the trials was designed
to improve informed decision making (31). A further
difference is that these three trials were the only trials that
have had either an exclusively AA (30, 31) or largely AA
sample (32). Although AA men have been well represented
in several observational studies (15, 33-38), to date only
these three randomized trials have included a significant
number of AA men (30-32).
The present study represents a community/academic
collaboration with the Most Worshipful Prince Hall Grand
Lodge of the District of Columbia (Prince Hall Masons), an
international, fraternal, AA organization dedicated to community service. We sought to develop and evaluate accessible
and easily disseminable health communication methods that
were targeted specifically to AA men and that contained
balanced information about the benefits and limitations of
prostate cancer screening. We selected video and print media
because these were the preferred media suggested in our
formative research for this project (39). Although all men
need information and support in making the screening
decision, it is particularly difficult for AA men, given their
high-risk status, the prevalence of the disease among friends
and family, and the fact that the focus of the media and much
of the medical establishment is on increasing screening. As a
result of these factors, particularly strongly held beliefs in
support of screening may already be in place (39), making it
particularly challenging to communicate the existence of a
controversy. A final reason for developing and evaluating
materials for AA men is that much of what is known about
men’s understanding of the controversy and effective
methods to communicate that controversy has been conducted in studies that primarily consisted of samples of
Caucasian men.
Our goal was to develop balanced materials that were
specifically designed for AA men and that did not provide a
recommendation for or against screening but encouraged
men to reach their own decision in collaboration with their
doctor and family members. We conducted a randomized
clinical trial to evaluate the effect of a printed booklet and a
videotape intervention and hypothesized that both interventions would result in increased knowledge, decreased
decisional conflict, and increased decisional satisfaction at
the 1-month assessment, relative to a wait list control group.
We also evaluated the effect of the materials on self-reported
screening behavior assessed 1 year following the intervention
and conducted exploratory analyses of predictors of screening behavior.
Materials and Methods
Participants. Participants were members of the Most
Worshipful Prince Hall Grand Lodge of the District of
Columbia (Washington, DC). Inclusion criteria were the
following: 40 to 70 years of age, no history of prostate
cancer, and not having been a participant in the focus
groups conducted for the formative research. Prior screening was not an exclusion criterion. Participants were
accrued between January 2001 and August 2002 and
follow-up interviews were completed by July 2003. The
Georgetown University Institutional Review Board approved this study and informed consent was obtained from
each subject.
Figure 1 presents the study procedures, baseline accrual
rate, retention rates at each stage of the study, and reasons for
subject attrition. Loss to follow-up between baseline and the
1-month interviews was equally distributed across the three
arms [X 2 (277) = 0.56; P > 0.20]. The reasons for loss to followup at the 1-month assessment are presented in Fig. 1.
Compared with the 238 participants who completed the
1-month assessment (n = 119 in the print arm and n = 119 in
the video arm), the 39 noncompleters were more likely to be as
follows: younger (P < 0.01), unmarried (P < 0.01), and working
(P < 0.05).
For the 1-year assessment, 193 completed the mailed
questionnaire, an 81% (193 of 238) retention rate since the
1-month assessment, a 65.6% (193 of 294) overall retention
rate, and 62.9% (185 of 294) completed all three assessments.
Due to incomplete data (see Fig. 1), 164 subjects were
available for analysis at 1 year. We assessed whether the
74 noncompleters of the 12-month interview differed from
the 164 completers. Completers were more likely to have
been screened in the past year than the noncompleters: PSA
[X 2 (237) = 6.6; P = 0.01] and digital rectal examination
[DRE; X 2 (237) = 3.2; P = 0.07]. There were no other
demographic or screening differences between completers
and noncompleters, including age, education, marital status,
employment status, family history of prostate cancer, or
intention to be screened in the future.
Procedure. The Most Worshipful Prince Hall Grand Lodge
of the District of Columbia consists of 27 groups (lodges), each
containing 100 or more members. Within each lodge, a lodge
coordinator was designated to identify interested men. The
lodge coordinators discussed the project at lodge meetings,
distributed project brochures, identified interested men, and
were paid $50 for their assistance in accruing participants. The
Lombardi Comprehensive Cancer Center research assistant
called the interested men to describe the study further, obtain
verbal consent, enroll eligible men, and conduct the baseline
interview.
Following completion of the baseline interview, participants
were randomly assigned to one of three arms: (a) video-based
information, (b) print-based information, or (c) wait list control
(see Fig. 1).
Participants in the print and videotape arms were mailed
a cover letter, the intervention materials, and the written
consent form. The cover letter included a statement about
the rationale for the study, length of time needed to watch
the video/read the booklet, instructions about return of the
consent form, a reminder about the upcoming 1-month
follow-up interview, a request to not share the intervention
materials with other Masons (to prevent contamination
between groups), and phone numbers to call for more
information. We did not provide information about local
prostate cancer screening locations, as the goal of the study
was not to provide men with a particular screening
opportunity but to provide an educational intervention and
then to measure whether men sought screening (as well as
measurement of the three other outcome variables).
Cancer Epidemiology, Biomarkers & Prevention 2181
Figure 1. Study procedures.
After 1 month, video and print arm participants completed
the first follow-up telephone assessment. Men who reported
that they had not yet had a chance to read/watch the materials
were given an additional week to do so and called again to
complete the follow-up assessment. Men in the wait list arm
were called 1 month following study enrollment to complete
their baseline interview (see Fig. 1). Following their baseline
interview, wait list participants were randomly assigned to
either the print or videotape arm. After 1 month, wait list
participants were called for their first follow-up interview. All
participants were mailed $25 for their participation following
completion of the 1-month interview. At 1-year postintervention, all participants completed a brief mailed questionnaire to
assess whether men had been screened postintervention.
We used a wait list control group due to community
collaborators’ concerns that a ‘no treatment’ control would
adversely affect participation and retention rates and add to
participant burden. As a result of these concerns, we did not
use a traditional wait list control, in which participants
complete two interviews before the intervention. Rather, wait
list participants completed a single preintervention interview
that occurred 1 month following randomization but before
their receipt of the intervention (Fig. 1). The timing of the
baseline assessment for the wait list group coincided with the
1-month assessments of the print and videotape arms,
providing a randomized comparison group who had not yet
been exposed to an intervention. After completing their
delayed baseline assessment, wait list participants were
randomized to one of the two active intervention arms.
Development of the Intervention Materials. The development of the videotape and booklet are described in detail
elsewhere (39, 40). Briefly, to determine the educational needs
of AA men between 40 to 70 years of age, we conducted a
series of eight focus groups with members of the Prince Hall
Mason as well as two focus groups with urologists and
internists. The print and video materials were designed to be
identical in content and to provide a balanced presentation of
the benefits and the limitations of prostate cancer screening.
Our research team consisted of five AA health professionals
(two urologists, a registered nurse, and two Master of Public
Health-level health educators), two AA men who were
members of the Masons, the Centers for Disease Control and
Prevention behavioral science staff (as this was funded by a
cooperative agreement from the Centers for Disease Control
and Prevention), and the Georgetown University behavioral
science staff. Each of these groups was closely involved in the
writing and production of the intervention materials and
reviewed them at each step during their development.
Further, as some team members were in support of screening
for AA men and others were more conservative in their view
of screening, all members of the team had a vested interest in
insuring that the message was balanced and was not slanted
toward one decision or the other. Although we did not test
whether the materials were balanced according to a lay group
of AA men, they were considered balanced by a group of
community members and a group of experts.
Printed Guide. The 16-page, three-color, printed guide
includes prostate cancer symptoms, anatomy and function,
prostate cancer risk factors, the benefits and limitations of
screening, sample questions for men to ask their doctors, and a
glossary of terms (40). Frank Robinson, the Hall of Fame
baseball player and the first AA manager of a major league
baseball team, as well as a prostate cancer survivor, was
highlighted as the celebrity spokesperson. Although Frank
Robinson is a prostate cancer survivor, this was not a widely
known fact at the time that this study was completed. Most
importantly, in the intervention materials, Mr. Robinson did
not refer to himself as a survivor and his message was
completely neutral (i.e., along with the advice of professionals
and your family, the choice is yours about whether you are
tested for prostate cancer). There was no mention of Mr.
Robinson’s own screening practices or of his treatment choices
for prostate cancer.
Videotape. The 25-minute videotape focuses on a middleaged AA man as he discusses prostate cancer screening with
his friends, family, and doctor. The videotape shows his
attempts to understand the screening dilemma, including his
fears, doubts, and questions about prostate cancer. In the
doctor’s office, he is shown with diagrams of the prostate and
the rationale for and against screening. The videotape also
included Frank Robinson as the celebrity spokesperson.
Measures
Demographic and Medical Information. We assessed age,
education, marital status, employment status, access to and
utilization of medical care, availability of health insurance,
personal history of cancer, and family history of prostate
cancer.
Prostate Cancer Screening History, Intentions, and Behavior. We
assessed participants’ self-reported prostate cancer screening
history, prior abnormal findings, and the results of subsequent
work-ups. Subjects’ intent to undergo screening was assessed
at baseline and 1 month using the following question: Do you
plan to undergo prostate cancer screening within the next year
(rated on a five-point scale from ‘definitely’ to ‘definitely not’).
At the 1-year assessment, subjects’ self-reported screening
behavior in the past year was assessed: When were you last
tested for prostate cancer (month/date for PSA and for DRE or
never). Although there are limitations of self-reported prostate
cancer screening (41, 42), verification of screening in this
community-based study was not feasible given the number of
possible places where screening may occur.
Process Variables. At the 1-month assessment, we assessed
men’s use and perception of the intervention materials (see
Table 2 for the list of items assessed).
Prostate Cancer Knowledge. Based on our prior research (17),
we developed an 11-item knowledge scale. Items were drawn
from (a) the National Cancer Institute Cancer Facts sheet on
prostate cancer, (b) a qualitative study of patients’ and experts’
opinions of what men should be told about prostate cancer
screening (43), and (c) a study of prostate screening by Volk
et al. (44). The measure assessed symptoms of prostate cancer,
the controversy surrounding screening, risk factors for prostate
cancer, false-positive and false-negative results, and the
natural history of the disease. The response format was true/
false/don’t know. ‘Don’t know’ was coded as an incorrect
response. Correct items were summed to form a total score.
Decisional Conflict Scale. We used the 10-item version of the
decisional conflict scale (DCS) (45). The 10-item version has a
three-level response format (yes, no, and unsure) and the items
were worded in the form of a question. A higher score
indicates greater decisional conflict. Two items were excluded
as they were confusing to pilot subjects (‘Are you choosing
without pressure from others’ and ‘Do you know which
options are available to you’). The a reliability of the eight-item
total score was 0.76. Due to the skewed responses (the majority
of subjects had low decisional conflict), we dichotomized the
total score for use in the analyses.
Satisfaction with the Screening Decision. We assessed satisfaction with a single item, ‘Are you satisfied with your decision
about prostate cancer testing.’ Participants responded on a
four-point scale, from ‘very satisfied’ to ‘not at all satisfied.’ As
the majority reported that they were ‘very satisfied,’ we used a
dichotomized score in the analyses.
Data analytic Strategy and Power Calculation. We conducted
the data analyses in several steps. We evaluated baseline
group differences on the demographic, medical, and process
variables (Tables 1 and 2). We have presented the following
analyses for each outcome variable. First, for each outcome
variable, we evaluated baseline group differences and whether
there were within group changes from baseline to 1 month
Table 1. Baseline demographic and medical characteristics
Age (mean, SD), y
Education
<High school degree
Some college
>College degree
Married
Employment status
Working (full time/part time)
Retired
VCR at home
Regular doctor
Have insurance
Family history of prostate cancer
Personal cancer history
Ever had a DRE
DRE within past year*
Plan to have DRE within next year
Ever had a PSA
PSA within past year*,c
b
Plan to have PSA within next year
DRE and PSA within past year
Print (n = 84), %
Video (n = 80), %
Wait list* (n = 74), %
Entire sample (N = 238), %
56.6 (7.8)
56.3 (7.8)
55.1 (8.6)
56.0 (8.0)
28.6
46.4
25.0
77.4
29.1
32.9
38.0
70.0
29.7
45.9
24.3
79.7
29.1
41.8
29.1
75.6
67.9
31.0
98.8
95.2
98.8
20.2
1.2
86.9
53.6
81.0
61.9
41.7
81.0
35.7
63.8
36.3
98.8
92.5
98.8
20.0
1.3
92.5
50.6
78.8
65.8
49.4
90.0
37.5
77.0
18.9
98.6
94.6
98.6
16.4
2.7
87.8
44.6
77.0
63.5
40.5
94.6
27.0
69.3
29.0
98.7
94.1
98.7
19.0
1.4
89.1
49.6
79.0
63.4
43.7
88.2
33.6
*Percentages for DRE and PSA in past year is the percentage of the entire samples not just those who have ever been screened. This makes these percentages
comparable with screening in past year at the 1-year assessment.
cWhen the wait list participants are collapsed into their respective print or video arms, there is a single group difference on ‘PSA within the past year,’ which is greater
among video arm Ss (P < 0.05). This variable is controlled in multivariate analyses, in which the wait list arm is combined with the print and video arms and in the
analyses predicting PSA completion at the 1-year assessment.
bP < 0.05.
Table 2. Participants’ evaluation of the print and video interventions at the 1-month assessment
Watched/read the materials
Once
Two or more times
Discussed prostate screening with others (yes)
Learned new information (yes)*
c
Helpful in decision (very helpful)
Think of questions for doctor (yes)
Length about right (‘about right’)
b
Amount of information (‘about right’)
Held your attention (yes)
Made you nervous (no)
Used other informational sources (yes)*,x
Reading pamphlets/booklets*
b
Talking with friends or family
Talking with your doctor*
Using the internet
Recalled celebrity (correct)
b
Recalled final information in materials (correct)
Contamination between trial arms
Saw material from other arm
Showed intervention material to other Masons
The intervention materials suggest
You should be screened
You should not be screened
Did not suggest one decision over another
Print
(n = 119), %
Video
(n = 119), %
53.5
46.5
46.2
75.6
90.6
59.7
94.1
94.1
94.9
88.2
17.6
5.9
9.2
5.0
5.9
54.6
49.6
45.9
54.1
53.8
58.0
81.3
54.6
91.6
84.0
93.3
89.1
35.3
16.8
18.5
16.8
7.6
46.2
62.2
2.5
6.0
1.7
3.4
79.0
0
21.0
75.6
0
24.4
*P < 0.01.
cP < 0.10.
bP < 0.05.
xLess than 3% of the sample reported using books, radio, other videos, newspaper, or TV.
(Table 3). Second, to evaluate the effect of the two active
interventions relative to the wait list arm, we compared the
outcomes at 1 month using one-way ANCOVA, adjusting for
the relevant covariates. Third, we conducted bivariate analyses
between potential covariates (baseline demographic and
medical variables) and the 1-month and 1-year outcome
variables (Table 4). Fourth, we collapsed wait list participants
into their subsequent group assignment and evaluated the
effect of print versus video on each outcome variable,
adjusting for the respective baseline score and covariates. A
repeated measure ANCOVA was used for the continuous
measure of knowledge and logistic regression was used for the
dichotomized outcomes of decisional conflict and satisfaction.
Finally, to test for group differences (print versus video) on the
self-reported screening outcome at 1 year, we used logistic
regression followed by an exploratory logistic regression
analysis to identify predictors of the screening outcome.
In terms of power, this study had an adequate sample size
to detect our predicted effects. For example, for analyses
comparing the print to video interventions after collapsing
the wait list control condition, our sample size (N = 238)
provided 80% power to detect differences as small as 0.36 SDs
at follow-up. This minimum detectable effect size falls about
midway between a small (0.20 SDs) and medium (0.50 SDs)
effect (46). For analyses involving comparisons with the wait
list control condition, we hypothesized a somewhat larger
effect—because we were comparing active interventions to an
inactive control. Thus, we powered the study to be able to
detect medium effect sizes of 0.5 SDs. For continuous outcomes,
we had power of 87% to detect the difference between the video
and control arms and power of 88% to detect the predicted
difference between the print and control arms.
Results
Descriptive Information. Table 1 presents demographic and
medical information, stratified by group membership. There
was only one significant group difference: fewer men in the
print arm intended to have a PSA test within the next year (this
variable was included as a covariate in subsequent analyses).
The sample was well educated, (29% had a college degree) and
almost all participants reported having a regular doctor and
insurance. In the past year, approximately one half had
received a DRE and/or a PSA test.
Table 3. Descriptive information for outcome variables at baseline and 1 month
Knowledge (mean, SD)
Baseline
1 Month
Decisional conflict (% high)
Baseline
1 Month
Decisional satisfaction (% high)
Baseline
1 Month
Print
(n = 84)
Video
(n = 80)
Wait list
(n = 74)
Entire sample
(N = 238)
7.2 (1.5)*
c
9.2 (1.4)
7.2 (1.6)*
c
8.5 (1.7)
6.9 (1.3)*
N/A
7.1 (1.5)
8.9 (1.5)
33.3*
c
8.3
31.3*
24.1*
41.9*
N/A
35.3
15.2
76.1*
84.5*
78.1*
79.7*
75.7*
N/A
76.6
83.5
NOTE: The analyses to assess for baseline group differences are adjusted for the variable ‘Plan to have a PSA in the next year’ due to the baseline group difference on
this variable.
*There were no between group differences at baseline on any of the measures, as indicated by the like superscripts.
cThere were three significant within group changes from baseline to 1 month, as indicated by the differing superscripts (* versus c).
Table 4. Bivariate analyses for 1-month and 1-year outcomes
Baseline categorical
predictors
Levels
1-Month assessment
Knowledge
(N = 238)
DCS
(% high; N = 238)
1-Year assessment
Decisional satisfaction
(% high; n = 237)
Screening in past year
(% yes)
PSA and DRE
(n = 148)
Age
Education
Marital status
Employment status
Regular doctor
Family history of
prostate cancer
DRE past year
PSA past year
Plan to have DRE
in next year
Plan to have PSA
in next year
V55
>56
VHigh school degree
Some college
zCollege degree
Not married
Married
Employed
Retired
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
No
Yes
8.9
8.8
8.8
9.1
8.7
8.7
8.9
8.8
9.1
8.8
8.9
8.9
8.9
8.9
8.9
8.9
8.8
8.8
8.9
8.9
9.0
(1.5)
(1.6)
(1.7)
(1.5)
(1.4)
(1.5)
(1.5)
(1.5)*
(1.6)
(1.4)
(1.5)
(1.6)
(1.4)
(1.4)
(1.6)
(1.4)
(1.8)
(1.6)
(1.4)
(1.5)
(1.7)
10.9*
19.5
c
25.0
11.1
11.6
c
24.1
12.3
20.8
12.7
c
35.7
13.9
16.8
8.9
16.8
13.7
c
19.7
9.6
13.4
22.0
15.3
14.3
87.4
79.5
79.7
84.5
85.5
79.3
84.8
84.5
83.0
92.9
82.9
83.7
82.2
83.2
83.6
84.8
81.6
c
71.4
86.6
77.8
84.2
c
54.1
70.3
61.7
63.8
59.5
71.4
59.3
58.9
67.9
66.7
62.0
63.6
56.7
c
50.8
71.1
c
53.8
72.1
c
42.9
66.7
53.3
63.2
PSA
(n = 164)
DRE
(n = 159)
c
66.7
83.1
70.0
75.0
80.0
82.1
72.8
78.2
73.4
85.7
74.5
76.2
70.6
c
67.1
81.8
63.9x
86.4
67.6
76.9
64.7
76.2
c
63.8
78.5
68.1
72.7
71.1
81.6
67.8
78.2
67.3
71.4
71.1
72.4
64.5
b
58.8
80.2
65.9
77.5
60.7
73.3
77.8
70.2
* P < 0.10.
cP < 0.05.
bP < 0.01.
x P < 0.001.
1-Month Outcomes
Process Variables. Table 2 presents participants’ responses to
the educational materials, stratified by intervention arm (wait
list participants were combined into their respective intervention arms for these analyses). All participants reported
reviewing the materials at least once, and the majority reported
that the materials were helpful in making a screening decision,
that the length and amount of information provided was about
right, that the materials held their attention, and that the
information did not make them nervous. Print arm participants were more likely to report that they learned new
information, whereas video arm participants were significantly
more likely to have used other information sources, particularly other pamphlets or booklets, talking with friends or
family, or talking with their doctor. About our assessment of
whether participants watched/read the materials in their
entirety, only about one half correctly recalled the celebrity
spokesperson, and the correct recall of the final piece of
information presented was significantly better in the video
arm. There was a minimal contamination between the arms.
Finally, although our goal was to present a balanced picture of
the pros and cons of screening, approximately three quarters of
men thought that the materials suggested they should be
screened, whereas one quarter thought that the materials were
neutral, and no one reported that the materials discouraged
screening.
Knowledge. Table 3 presents descriptive information for
knowledge (and the other outcome variables) at the baseline
and 1-month assessments. There were no baseline group
differences for knowledge. Knowledge improved significantly
from baseline to the 1-month assessment within both the print
[t (83) = 10.3; P < 0.0001] and video [t (79) = 5.9; P < 0.0001]
arms (Table 3). Next, to determine whether the two active
intervention arms improved knowledge relative to the wait list
control, we conducted a one-way ANCOVA (adjusting for
employment status; see Table 4). We compared the baseline
assessment of the wait list group with the 1-month assessments of the print and video groups (see study design in
Fig. 1). There was a significant main effect for group
[F (2, 234) = 49.1; P < 0.0001]. Mean comparisons indicated
that, relative to the wait list arm, knowledge was higher in
the print [F (1, 155) = 112.9; P < 0.0001] and video arms
[F (1, 151) = 43.2; P < 0.0001; see Fig. 2]. These analyses
provide evidence that the interventions were having the
expected effect on knowledge. Further, the results remained
significant when the sample was limited to those who correctly
recalled the celebrity spokesperson [F (2, 116) = 34.2;
P < 0.0001], indicating that differential exposure to the two
interventions did not explain the group differences.
Next, we collapsed the wait list participants into their
respective active intervention arms (print or video) and
conducted a repeated measure ANCOVA adjusting for the
significant covariate, employment status (see Table 4). This
Figure 2. Effect of the interventions on knowledge of prostate cancer
screening at the 1-month assessment. The wait list arm was assessed
once before the intervention.
analysis revealed a significant group time interaction
[F (1, 235) = 3.9; P < 0.05], indicating that the print arm
resulted in improved knowledge relative to the video arm at the
1-month assessment. Neither age nor education moderated the
group time interaction (Ps > 0.20). Again, when the sample
was limited to those who correctly recalled the celebrity, the
analysis remained significant [F (1, 117) = 5.4; P < 0.05].
Decisional Conflict. There were no baseline group differences on the DCS (Table 3). The percentage of participants
reporting high decisional conflict decreased significantly
from baseline to the 1-month assessment only in the print
arm [X 2 (1, n = 84) = 14.8; P < 0.0001]. After adjusting for the
relevant covariates (Table 4), logistic regression revealed that
relative to the wait list arm, the print [odds ratio (OR), 0.098;
95% confidence interval (95% CI), 0.04-0.26] and video arms
(OR, 0.46; 95% CI, 0.21-0.99) both resulted in significantly
reduced decisional conflict (see Fig. 3 and Table 3). Limiting
the sample to those who correctly recalled the celebrity
revealed that, relative to the waitlist arm, the print (OR, 0.089;
95% CI, 0.02-0.36) resulted in significantly reduced decisional
conflict, and the video arm (OR, 0.34; 95% CI, 0.10-1.07)
approached a significant reduction (P = 0.065).
We conducted a logistic regression, collapsing the wait list
participants into their respective active intervention arms
(print or video) and adjusted for baseline DCS and the
significant covariates (Table 4). The print intervention resulted
in significantly reduced decisional conflict, relative to the
video arm (OR, 0.21; 95% CI, 0.09-0.52). Limiting the sample to
those who correctly recalled the celebrity spokesperson (n =
118) resulted in similar results (OR, 0.30; 95% CI, 0.08-1.1)
although attenuated due the reduced sample size.
Satisfaction with the Screening Decision. There were no
baseline group differences on satisfaction. Participants were
highly satisfied with their screening decision at baseline and
there were no within group changes in satisfaction for either
the print or video arms (Table 3). In addition, the wait list arm
at baseline was not significantly different from the two
intervention arms at the 1-month assessment.
We conducted a logistic regression, collapsing the wait list
participants into their respective active intervention arms
(print or video) and adjusted for the significant covariate
(Table 4). Satisfaction with the screening decision was not
related to intervention arm (OR, 0.64; 95% CI, 0.28-1.4).
1-Year Screening Outcomes
There was an overall increase in the self-reported rate of DRE
and PSA screening between the baseline and 1-year assessments. Among the men who completed the 1-year assessment,
57.2% reported having received a DRE within the past year at
baseline compared with 71.1% who had received a DRE within
the past year at the 1-year assessment [X 2 (1, 159) = 8.7;
P < 0.01]. Similarly, 49.4% reported having had a PSA test
within the past year at baseline compared with 75.0% at the
1-year assessment [X 2 (1, 164) = 11.1; P = 0.001]. For PSA and
DRE combined, 38.5% reported having received both tests
within the past year at baseline compared with 62.2% at the
1-year assessment [X 2 (1, 148) = 11.1; P = 0.001]. As the wait list
participants were provided with the intervention before the
1-year assessment, we were not able to determine the effect of
interventions on screening relative to no intervention.
We assessed whether the interventions were differentially
associated with self-reported completion of either of the screening tests at the 1-year assessment. In a logistic regression predicting whether men had had a DRE within the year following
the intervention, we controlled for DRE in the year before
baseline (OR, 2.7; 95% CI, 1.3-5.6) and age (OR, 1.6; 95% CI,
0.75-3.3) on step 1 followed by intervention arm (OR, 1.8; 95%
CI, 0.87-3.8) on step 2. These results suggest that the print
(77.0%) and video (65.9%) arms were not significantly
associated with having had a DRE in the past 12 months. None
of the baseline values of the knowledge or decisional variables
interacted with intervention group to predict the DRE outcome.
In the logistic regression predicting whether men reported
having had a PSA during the year following the intervention,
we controlled for PSA (OR, 2.9; 95% CI, 1.2-7.2) and DRE in the
year before baseline (OR, 1.2; 95% CI, 0.52-2.9) and age (OR,
1.7; 95% CI, 0.76-3.7) on step 1 followed by intervention arm
(OR, 1.5; 95% CI, 0.69-3.1) on step 2. These results also
indicated that intervention arm was not related to having had a
PSA in the 12 months following the intervention (77.9% in the
print arm versus 72.4% in the video arm). Similarly, intervention arm was not related to having both a PSA and a DRE (OR,
1.6; 95% CI, 0.79-3.3). As reported above for the DRE analyses,
the baseline values of the knowledge and decisional variables
did not interact with intervention group to predict PSA
screening (or the PSA/DRE combined) at 1 year.
Exploratory Analyses of 1-year Screening Rates. Given that the
interventions were not differentially related to either of the
screening outcomes at 1 year, we conducted exploratory analyses to determine whether any of the baseline knowledge or
decisional variables were predictive of the increase in screening.
We collapsed the print and video arms into one group and
controlled for intervention arm in the multivariate analyses.
There was only one significant bivariate association with
self-reported screening rates at 1 year: high baseline decisional
conflict was significantly associated with a lower rate of PSA
screening at 1-year [X 2 (164) = 4.5; P < 0.05; Table 5]. We
conducted a hierarchical logistic regression analysis to
determine whether decisional conflict would remain in the
model predicting PSA screening after adjusting for the relevant
covariates (Table 4). For the final model predicting PSA
screening, prior DRE screening (OR, 1.1; 95% CI, 0.48-2.7),
older age (OR, 1.9; 95% CI, 0.83-4.2), and the intervention arm
(OR, 1.5; 95% CI, 0.70-3.3) were not significantly associated
with the outcome. Prior PSA screening (OR, 2.7; 95% CI, 1.16.8) was significantly associated with PSA screening at 1 year.
There was a marginally significant association between lower
decisional conflict at baseline and having undergone screening
at 1 year (OR, 2.1; 95% CI, 0.98-4.7; P = 0.056).
Discussion
Figure 3. Effect of the interventions on decisional conflict at the
1-month assesment.
This study represents one of the first randomized interventions
designed to address informed decision making about prostate
cancer screening among AA men. As hypothesized, the
interventions resulted in improved prostate cancer knowledge
and reduced decisional conflict about screening, relative to the
wait list control. Satisfaction with the screening decision was
not affected by the interventions, largely due to very high
baseline satisfaction.
Table 5. Evaluation of baseline knowledge and decisional predictors of screening at 1 year
PSA (n = 164), %
Screened
Knowledge
Low
56.9
High
43.1
Decisional conflict
Low
71.5
High
28.5
Decisional satisfaction
Low
21.1
High
78.9
DRE (n = 159), %
Not screened
PSA and DRE (n = 148), %
Screened
Not Screened
Screened with both
Screened with none or 1
51.2
48.8
63.7
36.3
47.8
52.2*
58.7
41.3
53.6
46.4
53.7
c
46.3
72.6
27.4
63.0
37.0
73.9
26.1
58.9
41.1*
33.3
66.7
21.4
78.6
27.5
72.5
20.0
80.0
30.0
70.0
*P < 0.10.
cP < 0.05.
Our findings replicate prior prostate cancer informed
decision making trials, as each of the eight trials that measured
knowledge also reported a significant improvement in
knowledge in the intervention arm, relative to the control
arm (18, 23-29). Compared with other trials, our sample began
with a much higher level of knowledge, as on average, 65% of
items were answered correctly at baseline, compared with
other samples, in which f30% of items were answered
correctly at baseline (e.g., refs. 25, 44). In these prior studies,
the percentage of correct knowledge items improved by 20% to
25% in the intervention conditions, whereas, in our study, they
improved slightly less, presumably due to the high baseline
scores: 14% (video) to 18% (print arm) improvement in the
percentage answered correctly. About decisional conflict, the
three prostate screening informed decision making trials that
have measured it also reported lower decisional conflict in the
intervention arm, relative to the control arm (22, 24, 25). These
studies used a summed measure of the 16-item DCS; thus, we
were unable to compare our sample to previous samples on
this measure. To date, there are no published studies on any
topic that have used the short-form of the DCS, although there
are several under way.
In the current study, the print intervention had a greater
effect on knowledge and decisional conflict outcomes compared with the video intervention. There have been two prior
randomized trials in prostate cancer screening that have
compared video and print interventions (25, 29). Gattellari
and Ward (25) showed that written materials had a greater
effect on knowledge and decisional conflict when compared
with the video, whereas Partin et al. (29) found that the video
condition resulted in greater knowledge than the print
condition (decisional conflict was not measured). As different
intervention materials were used in each of these three
studies, it is difficult to determine whether group differences
were due to the quality of the actual materials or to the
medium, in which they were delivered. However, we
speculate that in our study, these differences may have been
due to the relative ease of rereading sections of the booklet
and perhaps due to this age cohort’s greater familiarity with
using print materials for obtaining health information
compared with using a videotape.
About screening behavior, our results were contrary to
several randomized trials in informed decision making in
prostate cancer screening, which have reported that screening
rates decreased following the intervention (18, 22, 23, 26-29).
However, our results corroborated two other studies that have
found a significant increase in screening following exposure to
a decision tool, one with AA men (31), and another that found
this result among a subsample of AA men (27). Whether these
findings may be due to racial or cultural differences and/or to
being at high risk for prostate cancer (31) is unclear at present.
Our findings suggest that among men who have a considerable screening history and a favorable view of screening,
balanced educational materials may serve to reduce any
uncertainties that may have existed before the intervention
and, in fact, strengthen previously held beliefs. This finding is
somewhat counterintuitive, as it would seem that potential
disadvantages would be most salient to men who are ‘pro
screening.’ However, one post-hoc interpretation is that men
were drawn to the information that confirmed their preexisting positive beliefs about screening, which led to the
increased rates of self-reported screening. To address this
possibility, we are in the development phase of a web-based
decision tool designed to insure that men are exposed to the
viewpoint that differs from their own. For example, men who
report that they favor screening at baseline will be systematically exposed to the potential limitations of screening, and
men who do not favor screening will be exposed to the
potential benefits of screening. This method may help to better
educate men who are highly committed to their beliefs either
for or against screening.
Similarly, the fact that 75% to 80% of our sample reported
that the intervention suggested that men should be screened
indicates that men may have selectively focused on the positive
aspects of screening that were contained in the materials.
Alternatively, this finding could suggest that the interventions
subtly promoted screening. However, our community and
expert reviewers did not find evidence for this, and as noted
earlier, the bias against prostate cancer screening among
several members of the team makes it unlikely that the
materials favored screening. As the men who volunteered for
this study had a strong screening history and clear intentions to
continue screening, their interpretation that the materials
favored screening (as well as their increased screening rates)
may suggest that men were simply making a decision
consonant with their own pre-existing values and/or that
exposure to balanced materials served to deepen their existing
beliefs. It will require further research to determine the extent to
which these findings are related to this sample’s strong preexisting beliefs about screening, to their high-risk status, racial
or cultural differences, or some combination of these factors.
Participation in a prostate cancer educational study may be
associated with a willingness to be screened. In a quasiexperimental study of balanced prostate cancer screening
education, there was a significant increase in screening
regardless of intervention arm, and previous screening was
positively associated with screening postintervention (47). In
exploratory analyses, we found that previously screened men
and men with low baseline decisional conflict were more likely
to have undergone PSA testing by the 1-year assessment. These
findings corroborate the role that past screening (47) and a
positive attitude toward screening (20) have in subsequent
screening and lend support for the conclusions of several
recent reviews of patient decision aids, which suggested that
decisional factors play a role in understanding screening
behavior (48-50).
There are multiple challenges inherent in educating patients
about controversial medical procedures, such as prostate
cancer screening. For numerous reasons, the public’s ability
to consider the full spectrum of facts about screening effectiveness is becoming more and more limited (51). For example, due
to the rapidity with which new technologies are accepted into
clinical use by both physicians and patients, educational efforts
have the difficult task of asking people to reconsider a decision
they have already made. Further, the detrimental effect that the
media has on people’s understanding of controversial public
health issues has been highlighted (52) as well as the
implications of the widespread enthusiasm for cancer screening
(53). Therefore, innovative methods to help the public contend
with increasingly complex health-related decisions are essential. For AA men, the increased prostate cancer incidence and
mortality rates serve to only further complicate these already
difficult issues, as there is a drive to address these disparities,
and screening is the only tool available at present. Thus, until
the PLCO results are released, improved methods are needed to
assist men in understanding these complex issues. If the PLCO
results do not provide a definitive recommendation for or
against screening, then these issues will need to be addressed
going forward. Thus, it is critical that we develop improved
methods for fostering informed decisions for controversial
medical tests and procedures.
Several study limitations should be considered in the
interpretation of the results. First, due to concerns about the
potential for participant drop out, the wait list arm was not
followed for the entire year, which meant that we did not have
the ‘no treatment control’ group needed to fully understand the
rate of screening at 1 year. Further, the wait list group was not
measured on two consecutive occasions before the intervention.
However, the strength of this design was that the delayed
baseline assessment of the wait list arm coincided in time with
the 1-month follow-up assessment of the two active intervention
arms, providing a randomized comparison group who had not
been exposed to an intervention. Second, this sample was a
relatively homogenous group of AA men, in terms of education
level and screening history. Thus, these results may not apply to
lower SES men or an unscreened sample of AA men. However,
for this initial intervention conducted with these newly
developed educational materials, we believed it was preferable
to obtain a more representative sample of a homogeneous group
than to risk having a very low response rate in a populationbased study. Third, retention at 1 year was higher among those
who had been screened previously, so the rates of self-reported
screening after 1 year may have been unusually high.
A fourth limitation was that we were unable to verify
screening behavior by medical record review due to the fact
that this was a community-based study without a specified
screening location. Previous randomized trials of prostate
screening decision tools, with one exception (27), have used a
medical record review to assess screening outcomes. However,
there are limitations of a medical record review as an
assessment of screening outcomes, as men may be screened
in settings other than the observed clinics; therefore, it may
present an underestimate of the percentage of men who are
screened (29, 31, 42). This suggests that the screening rates in
the current study may be higher than in previous studies due
to this measurement difference. On the other hand, self-reports
of PSA testing also need to be interpreted with caution, as
Chan et al. (41) has reported in an observational study that
PSA screening was underreported due to men’s lack of
awareness that they had been tested.
Finally, it is possible that socially desirable responding
may have resulted in the fact that all men reported using the
materials and in the highly prevalent belief that the
materials were proscreening. However, there are several
other potential explanations for the report that 100% of the
sample reviewed the materials. (a) When men were called
for their 1-month follow-up assessment, those men who had
not yet viewed the materials were called again in 1 week’s
time to provide men with an additional opportunity to
review the materials before completing the assessment. (b)
As the proscreening response is consistent with subjects’
significant screening history, it is arguable that this was not
socially desirable responding but simply a reflection of their
beliefs. (c) As the materials were designed to provide a
balanced picture of screening by presenting an equal
number of ‘pro’ and ‘con’ viewpoints, we believe that men
may have focused on the message that matched their preexisting beliefs, suggesting that the positive responses were
not necessarily socially desirable but, again, just a reflection
of the belief that men should be screened. Thus, although
socially desirable responding may have played a role in
men’s report of their use and perception of the materials,
there are several equally plausible alternative explanations to
these findings. Most importantly, when considering the
screening outcomes of the randomized trial, socially desirable responding was equally likely to occur in the print and
video arms, as both are active interventions. Therefore,
socially desirable responding is unlikely to have had an
effect on the conclusions made about comparisons of the
print and video arms.
The strength of this research began with the unique
opportunity for conducting collaborative research within this
community/academic partnership. The involvement of the
Masonic leadership was central to overcoming many of the
barriers that are typically encountered in community-based
research with minority populations. We have developed and
evaluated culturally sensitive, inexpensive, balanced, and
disseminable materials that were successful in improving
knowledge and reducing decisional conflict among AA men.
Due to the high incidence and mortality rates among AA
men, there is a need for targeted educational materials,
particularly materials that are balanced in terms of the
benefits and limitations of screening. However, it is increasingly difficult to fully educate the public about a behavior
that is widely practiced and that is promulgated as a
certainty by the media, suggesting that educational materials
that are accessible to large groups of men will be necessary to
ensure informed decision making on this topic. Finally,
decision tools to help men evaluate the usefulness of
screening tests must be a central aspect of educational
campaigns of this kind. Providing screening to men without
giving them every opportunity to understand the current
state of the science is unethical. Until the results of the PLCO
trial are available, the task at hand is to help men make the
best decision for themselves, based on a clear understanding
of the available data.
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Educating African American Men about the Prostate Cancer

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