The New NCI Precision Medicine Trials.

Basket, umbrella, and platform trial designs (master protocols) have emerged over the last decade to study precision medicine approaches in oncology. First-generation trials like NCI-MATCH (Molecular Analysis for Therapy Choice) have proven the principle that studying targeted therapies on a large scale is feasible both from the laboratory and clinical perspectives. However, single-agent targeted therapies have shown limited ability to control metastatic disease, despite careful matching of drug to target. As such, newer approaches employing combinations of targeted therapy, or targeted therapy with standard therapies, need to be considered. The NCI has recently embarked on three second-generation precision medicine trials to address this need: ComboMATCH, iMATCH, and myeloMATCH. The design of these trials and necessary infrastructure are discussed in the following perspective.

Do men make informed decisions about prostate cancer screening? Baseline results from the "take the wheel" trial.

BACKGROUND: Baseline data from a randomized trial in 12 worksites were analyzed. Men aged 45+ (n = 812) completed surveys documenting screening history, screening preferences and decisions, CaP knowledge, decision self-efficacy, and decisional consistency. Psychosocial and demographic correlates of IDM were also assessed. RESULTS: Approximately half of the sample had a prior PSA test, although only 35% reported having made an explicit screening decision. Across the sample, CaP knowledge was low (mean = 56%), although decision self-efficacy was high (mean = 78%), and the majority of men (81%) made decisions consistent with their stated values. Compared with those who were undecided, men who made an explicit screening decision had significantly higher levels of knowledge, greater decisional self-efficacy, and were more consistent in terms of making a decision in alignment with their values. They tended to be white, have high levels of income and education, and had discussed screening with their health care provider. CONCLUSIONS: Many men undergo CaP screening without being fully informed about the decision. These findings support the need for interventions aimed at improving IDM about screening, particularly among men of color, those with lower levels of income and education, and those who have not discussed screening with their provider.

Parental decision making about the HPV vaccine.

BACKGROUND: Prophylactic human papillomavirus (HPV) vaccines are available, but uptake is suboptimal. Information on factors influencing parental decisions regarding vaccination will facilitate the development of successful interventions. METHODS: Parents of girls ages 9 to 17 years (n = 476; cooperation rate = 67%) from a panel of U.S. households completed online surveys between September 2007 and January 2008, documenting vaccine knowledge, attitudes, and intentions. RESULTS: Among those aware of the vaccine, 19% had already vaccinated their daughter(s), 34% intended to, 24% were undecided, and 24% had decided against vaccination. Awareness of HPV was high but knowledge levels were suboptimal (mean 72%, SEM 0.8%). Black and Hispanic parents were significantly less likely to be aware of the vaccine compared with White parents. In multivariate analyses, compared with parents who opposed vaccination, those who had already vaccinated their daughter(s) or who intended to do so had more positive attitudes, reported fewer barriers, and were more likely to perceive that family and friends would endorse vaccination. They also reported higher levels of trust in pharmaceutical companies that produce the vaccine. CONCLUSIONS: Despite limited knowledge, most parents had decided to vaccinate their daughter(s). Given evidence of diminished access to information among Black and Hispanic parents, programs should focus on reaching these groups. Interventions should address parental concerns about behavioral consequences, reduce structural barriers, and promote the perception that vaccination is endorsed by significant others. Moreover, interventions may need to address mistrust of pharmaceutical companies. IMPACT STATEMENT: This study documents factors associated with parental decisions about HPV vaccination for their daughter(s) and provides direction for intervention development.

A randomized trial of a computer-tailored decision aid to improve prostate cancer screening decisions: results from the Take the Wheel trial.

OBJECTIVE: To evaluate a decision aid (DA) designed to promote informed decision making for prostate cancer screening. METHODS: Twelve work sites were randomly assigned to an intervention or nonintervention comparison condition. Intervention sites received access to a computer-tailored DA at the workplace. Male employees age 45 years and above (n = 625) completed surveys at baseline and at 3-month follow-up, documenting aspects of informed decision making. RESULTS: Using an intention-to-treat analysis, men in the intervention group were significantly more likely to have made a screening decision and to have improved knowledge without increased decisional conflict, relative to men in the comparison group. These changes were observed despite the fact that only 30% of men in intervention sites used the DA. Among DA users, similar improvements were observed, although the magnitudes of changes were substantially greater, and significant improvements in decision self-efficacy were observed. CONCLUSIONS: A DA offered in the workplace promoted decision making, improved knowledge, and increased decision self-efficacy among users, without increasing decisional conflict. However, participation was suboptimal, suggesting that better methods for engaging men in workplace interventions are needed. IMPACT STATEMENT: This trial shows the efficacy of a computer-tailored DA in promoting informed decisions about prostate cancer screening. The DA was delivered through work sites, thereby providing access to resources required to participate in informed decision making without requiring a medical appointment. However, participation rates were suboptimal, and additional strategies for engaging men are needed.

Stage of adoption of the human papillomavirus vaccine among college women.

BACKGROUND: Certain types of human papillomavirus (HPV) can cause cervical and other cancers. A vaccine that protects against HPV types responsible for 70% of cervical cancers is available to females ages 9-26. OBJECTIVE: To examine correlates of stage of vaccine adoption among women ages 18-22. METHODS: In 2007, female students (n=4774) at a New England University in the U.S. were invited to complete an on-line survey that assessed knowledge of HPV, perceived susceptibility, severity, vaccine benefits/barriers, social and subjective norms, and stage of vaccine adoption RESULTS: 1897 women (40%) responded; complete data were available for 1401. About half (53%) were planning to be vaccinated, 12% had received the vaccine, 15% were undecided, and 7% had decided against vaccination. HPV knowledge was low (mean 58%). In multivariate analyses, social norms was the strongest correlate of stage; each standard deviation increase in social norms score was associated with more than four times the odds of intending to be vaccinated within the next 30 days, compared with those who had decided against vaccination (OR=4.15; 95% CI 2.17-6.36). CONCLUSIONS: Acceptance of the vaccine was high, although misconceptions about viral transmission, availability of treatment, and the role of Pap tests were common. Perceived norms were strongly associated with intentions. Interventions on college campuses should stress vaccination as a normative behavior, provide information about viral transmission, and stress the role of continued Pap screening.