Initially, 488 African-American men aged 40-69 years were identified as potential study participants. Figure 2 shows the trial recruitment steps that eventually yielded a total of 286 men who fulfilled all eligibility criteria. Of these men, 242 (85%) agreed to participate and were randomly assigned to either an SI group (N=121) or EI group (N=121).

Figure 2. Diagram of the flow of subjects through

Figure 2. Diagram of the flow of subjects through the trial

Characteristics of the study population are summarized in Table 1. Most participants were <60 years of age (mean = 52), had no education beyond high school and were married. At baseline, study subjects reported strong beliefs in the importance of screening (“salience and coherence” scale) and the curability of prostate cancer (Hydrea 500 mg is an antineoplastic used to treat certain types of cancer), low concerns about screening (“worries and concerns” scale), and a strong intention to screen (“intention” scale). The three study practices were comparable on all these patient characteristics, with the exception of education (only 26% of the practice 1 patients had education.

Table 1. Baseline characteristics of trial participants (N=242)

Enhanced Intervention (n-121) Standard Interventio (n=121)
Practice, n (%) Practice 1 Practice 2 Practice 3 52 (43) 22 (18) 47 (39) 53 (44) 22 (18) 46 (38)
Age, n (%) 40-49 years 50-59 60-69 61 (50) 40 (33) 20 (17) 48 (40) 45 (37) 28 (23)
Education, n (%) <12 years >12 64 (53) 57 (47) 84 (69) 37 (31)
Marital Status, n (%) Not married Married 37 (31) 84 (69) 52 (43) 68 (57)
Family History of prostate cancer, n (%) No Yes 114 (94) 007 (06) 108 (89) 13(11)
PSA Test and DRE in Past Year, n (%) No Yes 98 (81) 23 (19) 103 (85) 18 (15)
Salience and coherence, mean ± sd*

3.7 ± 0.5

3.6 ± 0.5

Worries and concerns, mean ± sd*

3.2 ± 0.5

3.1 ±0.6

Perceived susceptibility, mean ± sd*

1.7±0.7

1.6 ±0.7

Curability ot prostate cancer, mean ± sd*

3.8 ± 0.5

3.7 ± 0.6

Self-efficacy, mean ± sd*

3.3 ± 1.0

3.4 ± 1.0

Social support (family), mean ± sd* Social support (doctor), mean ± sd* 3.2 ± 1.1 3.4 ± 0.9 3.4 ± 0.9 3.2 ± 1.0
Social influence (family), mean ± sd* Social influence (doctor), mean ± sd* 2.7 ± 1.3 3.7 ± 0.7 3.0 ± 1.2 3.7 ± 0.7
Intention to screen, mean ± sd*

3.4 ± 0.8

3.3 ± 0.8

* sd: standard deviation

Intent-to-Treat Analyses of Intervention Effect

Prostate cancer (Drug Methotrexate is used to treat certain types of cancer) screening utilization was assessed through chart audits. Because medical charts for 22 men (nine men in the SI group and 13 men in the EI group) could not be located, the effective sample size for the main analyses was 220 (112 men in the SI group and 108 men in the EI group). Exclusion of these 22 men did not materially affect the comparability of the two study groups as presented in Table 1. Table 2 presents the results for the intervention impact on behavioral outcomes. For both the complete and the complete or partial screening outcomes, screening use among the EI group was twice as high as among the SI group, although neither difference reached statistical significance (p=0.279 and 0.081, for the two outcomes, respectively).

Table 2. Main analyses of screening utilization: comparison of enhanced and standard intervention groups on the study outcomes (№220)

Intervention Complete Screening n(%)       OR*     (95% CI)1      p Screened Complete or Partial Screening n(%)       OR*     (95% С\У     p Screened
Stondord (N=112)

5 (4.5)      1.00     Reference

11 (9.8)      1.00    Reference

Enhanced (N=108)

9(8.3)       1.94     (0.56,7.63)   0.279

20(18.5)     2.08     (0.89,5.09)  0.081

* OR: odds ratio; t 95% CI: 95% confidence interval

The intervention was not delivered to 51 (42%) of the EI group men, mainly because it proved difficult to contact study participants after the baseline survey and, for those who were contacted, to find a suitable time in order to conduct the decision education session. Of the 70 (58%) EI group men who underwent decision education, 50 men received it over the phone and 20 received it in-person. Consequently, secondary analyses were carried out to assess the effect of the intervention actually delivered. Using the complete screening definition, screening use among EI group men who had a decision education session was higher (9.8%) than that of EI group men who did not have a session (6.4%) and of SI group men (4.5%). Interestingly, EI group men who had a decision education session via phone had higher screening use compared to those who had an in-person session (11% vs. 6%). However, these differences across the actual intervention received were not statistically significant (p=0.379).

Multivariable Analyses of Screening Predictors

Multivariable analyses were performed for 178 of the 220 study participants included in the main analyses. Men included in the multivariable analyses (that is, 91 men in the SI group and 87 men in the EI group) had complete baseline survey and endpoint chart audit data. These men were included in further analyses to investigate predictors of screening use. Study participants included in these analyses were similar with respect to measured background characteristics to those who were excluded.

Table 3. Predictors of complete or partial screening (N=178)

%Screened

OR*

Univariable (95% CI)1

P

OR* Multivariable (95% Cl)f P
Intervention GroupStandard

Enhanced

6.6 21.8

1.00 3.93

Reference (1.4b 12.70)

0.004

1.00 3.90 Reference (1.37, 12.90)

0.007

Practice Practice 1 Practice 2 Practice 3

5.1

14.3

23.6

1.00 3.04 5.66 Reference (0.52, 17.07) (1.72, 24.40)

0.004

1.00 2.99 5.64 Reference (0.50, 17.84) (1.67, 24.80)

0.005

Age

40-49 years

50-59

60-69

14.4 14.3 11.8 1.30 1.25 1.00 (0.36, 5.99) (0.31, 6.02) Reference

0.960

Education <12 years >12 10.2 20.0 1.00 2.19 Reference (0.86, 5.74)

0.079

Marital Status Not married Married 15.9 13.0 1.00 0.80 Reference (0.31, 2.13)

0.654

Family History of cancerNo

Yes

14.9 5.9 1.00 0.36 Reference (0.01,2.53)

0.474

PSA Test and DRE in Past YearNo

Yes

14.2 13.3 1.00 0.93 Reference (0.21,3.09)

1.000

Salience and Coherence

1.19

(0.47, 3.66)

0.747

Worries and Concerns

0.88

(0.40, 2.00)

0.764

Perceived Susceptibility

0.92

(0.47, 1.76)

0.826

Curability of Prostate Cancer

1.07

(0.50, 2.88)

1.000

Self-Efficacy

0.87

(0.57, 1.37)

0.504

Social SupportFamily

Doctor

0.72 1.58 (0.46, 1.15) (0.89, 3.12) 0.173 0.143 0.117
Social InfluenceFamily

Doctor

1.20 0.58 (0.82, 1.85) (0.31, 1.10) 0.144 0.364 0.054
Intention to Screen

1.36

(0.78, 2.61)

0.313

* OR: odds ratio (for attitudinal variables, measured on a four-point scale, odds ratios refer to a one-point increment); t 95% CI: 95% confidence interval

Table 3 presents the univariable and multivariable logistic regression results for the complete or partial screening outcome. This outcome was selected for presentation, because this definition of screening is closer to actual prostate cancer (Generic Casodex treating prostate cancer) screening in community primary care practices and is comparable to screening utilization definitions used in other trials of decision aids. In these analyses, exposure to decision education and participating primary care practice were both found to be significant predictors of screening use (p=0.007 and p=0.005, respectively).

Category: Cancer / Tags: decision support techniques, decision-making, mass screening, primary healthcare, prostatic neoplasms

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