Laura J. Fish

A tailored minimal self-help intervention to promote condom use in young women: results from a randomized trial.

Objective: To evaluate the efficacy of a theory-based tailored minimal self-help intervention to increase condom use among young women at risk for HIV/sexually transmitted disease (STD). Design: Randomized controlled trial on an intent-to-treat basis in two managed care plans, in Washington state and North Carolina, with follow-up at 3 and 6 months. Participants: A proactively recruited sample of 1210 heterosexually active, non-monogamous, non-pregnant women, aged 18–24 years recruited June 1999–April 2000; 85% completed the 6-month follow-up. Method: Arm 1 received usual care. Arm 2 received a mailed computer-generated self-help magazine, individually tailored on survey items including stage of readiness to use condoms, barriers to condom use, partner type; condom samples and a condom-carrying case were included in the packet; this was followed 3 months later by a tailored ‘booster’ newsletter. The a priori 6-month main outcomes were percentage of women using condoms during the previous 3 months (overall and by partner type) and proportion of total episodes of intercourse during which condoms were used in the previous 3 months. Results: Relative to usual care, intervention group women reported significantly more condom use overall [adjusted odds ratio (OR), 1.86; 95% confidence interval (CI), 1.32–2.65; P = 0.0005] and with recent primary partners (OR, 1.97; 95% CI, 1.37–2.86; P = 0.0003). They also reported using condoms for a higher proportion of intercourse episodes (52.7% versus 47.9%; P = 0.05). Significantly more intervention women carried condoms, discussed condoms with partners, and had higher self-efficacy to use condoms with primary partners. Conclusions: Tailored cognitive/behavioral minimal self-help interventions hold promise as HIV/STD prevention strategies for diverse populations of young at-risk women.

Adherence to nicotine replacement therapy among pregnant smokers.

INTRODUCTION This secondary analysis examined the association between adherence to nicotine replacement therapy (NRT) and smoking cessation among pregnant smokers enrolled in Baby Steps, an open-label randomized controlled trial testing cognitive-behavioral therapy (CBT) versus CBT plus NRT. METHOD The analysis included only women who received NRT for whom we had complete data (N = 104). Data came from daily calendars created from recordings of counseling sessions and from telephone surveys at baseline and 38 weeks gestation. RESULTS Overall, 29% of the 104 women used NRT for the recommended 6 weeks and 41% used NRT as directed in the first 48 hr after a quit attempt. Ordinal logistic regression modeling indicated that using NRT as directed in the first 48 hr and having made a previous quit attempt were the strongest predictors of longer NRT use. Univariate analyses suggested that primigravid women and women who used NRT longer were more likely to report quitting at 38 weeks gestation. DISCUSSION Findings indicated that adherence to NRT is low among pregnant smokers, but adherence was a predictor of cessation. Future trials should emphasize adherence, particularly more days on NRT, to promote cessation during pregnancy.

A Tailored Intervention to Aid Decisionmaking About Hormone Replacement Therapy

Decision aids related to hormone replacement therapy (HRT), whether delivered in written form,1,2 along with audiotapes,3 or as part of discussion groups,4 have outperformed generic brochures in increasing knowledge and accuracy of risk assessments. However, these decision aids have provided women with population-based estimates of average risk, not individual risk levels that may have bearing on their decisions about HRT. Decision aids individually customized or “tailored” to include only the most relevant information could make it easier for women to consider HRTs risks and benefits.5,6 Tailored interventions have yet to be evaluated for HRT decisions. We describe the effect of a tailored decision aid on womens accuracy of perceived risk for breast cancer, confidence to decide about HRT, and satisfaction with the decision.

Ineffective use of condoms among young women in managed care.

Condoms must be used effectively in order to prevent pregnancy and the spread of HIV/STD. This study investigated two types of ineffective condom use, delayed condom use (initiated after penetration has occurred) and condom slippage and/or breakage. We estimated prevalence and identified predictors of ineffective condom use among young women at risk of STDs. The study used baseline survey data from a randomized trial of women 18-24 years old at two managed care sites; 779 participants who were recent condom users were included in this analysis. Forty-four per cent of the sample reported delayed condom use in the past three months and 19% reported condom slippage and/or breakage. In multivariate logistic regression, younger age, primary partner, lack of partner support, multiple recent sexual partners and using condoms for contraception were positively associated with delayed condom use. Correlates of condom slippage and/or breakage were non-white race/ethnicity and history of any STD. Greater frequency of condom use independently predicted both outcomes. Ineffective condom use was common in this sample of experienced condom users and predictors were different for each outcome. HIV/STD prevention interventions must address more specific aspects of condom use than have previously been their focus, especially when condom use is already high.

Evaluating participants’ use of a hormone replacement therapy decision-making intervention

BACKGROUND Associations between optimal use of a tailored decision-aid and levels of accuracy of perceived breast cancer risk, confidence in decision-making, and satisfaction with decisions about HRT were evaluated in a randomized intervention trial with a community sample of women aged 45-54. METHODS Data are from 289 women randomized to receive a computer-tailored three-step decision-aid. RESULTS Forty-seven percent of participants reported optimal use of the intervention materials. African American women and those with low confidence in decision-making were less likely to use the intervention optimally than white women and those with higher confidence (P<0.05). Optimal use of the decision-aid was associated with increased accuracy of perceived risk and confidence to make a decision. DISCUSSION When used optimally, self-directed decision-aids can improve womens ability to make decisions about HRT. Additional refinement of these aids is needed. For some subgroups of women, adjuncts such as telephone counseling also might be considered.

Challenges and Solutions for Recruiting Pregnant Smokers into a Nicotine Replacement Therapy Trial

Improvements in smoking cessation interventions for pregnant smokers are needed. One major step is to examine the potential effectiveness of nicotine replacement therapy (NRT). The potential benefits of providing pregnant women with NRT to help them quit smoking are still unknown; early interventions to test the effectiveness and efficacy are vital to advancing the field. This paper describes recruitment efforts for a multiclinic trial to test the effectiveness of NRT use in addition to behavioral therapy in promoting cessation during pregnancy. The biggest challenge is recruiting sufficient numbers of pregnant women. This paper discusses specific obstacles for recruitment and solutions. Knowing the potential pitfalls to recruiting pregnant women into these trials can lead to better studies and thus improved outcomes.

PREDICTORS OF ADVERSE EVENTS AMONG PREGNANT SMOKERS EXPOSED IN A NICOTINE REPLACEMENT THERAPY TRIAL

OBJECTIVE The purpose of this study was to determine the contribution of randomization to nicotine replacement therapy (NRT), sociodemographic and psychosocial factors, and pregnancy and medical history to serious perinatal adverse events among pregnant smokers. STUDY DESIGN We performed a retrospective review of all medical records for participants in the Baby Steps Trial. Data that were abstracted from 157 records were combined with baseline characteristics for logistic regression modeling of serious adverse events and adjusted for covariates. RESULTS Serious adverse events occurred in 17% (9/52 pregnancies) and 31% (33/105 pregnancies) of participants in the control and NRT arms, respectively. Black race, adverse pregnancy history, and use of analgesic medication during pregnancy were significant predictors (P = .02, .04, and .01, respectively). Remaining covariates, which included randomization to NRT, were not statistically significant. CONCLUSION Although race, poor pregnancy history, and use of analgesics were associated with serious adverse events, randomization to NRT during pregnancy was not a significant factor. Further research is needed to examine the safety of analgesic medications during pregnancy.

Factors Associated with African Americans’ Enrollment in a National Cancer Genetics Registry

This study explored whether reactions to the Cancer Genetics Network (CGN) or CGN enrollment differed by receipt of a standard informational brochure versus a targeted version addressing factors previously associated with African Americans’ health behavior decisions and research participation. The 262 participants, identified through tumor registries or clinic contacts, were mailed brochures and completed phone interviews. When asked whether – based on the brochure – they were or were not ‘leaning toward’ CGN enrollment, about 75% of both standard and targeted groups reported leaning toward. When given the opportunity at the end of the interview, 68% enrolled in the CGN. Trust was strongly related to enrollment. Less education, less satisfaction with cancer care, and individualistic rather than collective orientation were associated with lower trust. Education was also bivariately associated with enrollment, but mediation analysis indicated that the operational mechanism of education’s influence on enrollment was through trust.

Prospective trial of a video educational tool for radiation oncology patients.

Objectives:Prospective assessment of the informational needs of radiation oncology patients and efficacy of an educational video in meeting them. Methods:Subjects completed baseline self-administered questionnaires and subsequently viewed the patient education video. Post-testing was performed after initiation of therapy and subjects rated their satisfaction with the video, its relevance, and their emotional response. Analyses were performed with respect to patient and disease characteristics. Results:Fifty-three subjects were enrolled and completed both before and after video measures. The mean age of participants was 58 years (range, 33 to 83). Pretreatment, >90% of patients reported specific information needs. One hundred percent of patients watched the video and 77% rated it as highly relevant. High levels of satisfaction (>90%) were reported with video information describing radiation and simulation. Older subjects (58 years and older) found video information significantly more relevant than those younger (55% versus 27%, P = 0.04) and rated greater satisfaction with side effect information (78% versus 41%, P = 0.006). Subjects with breast cancer exhibited a trend towards feeling better informed by the video. Conclusions:Radiation oncology patients reported informational needs unmet by standard educational measures. High levels of satisfaction were reported with video education. It promoted better understanding of radiotherapy. Older patients found the video to be significantly more relevant and informative.

Efficacy of a couple-based randomized controlled trial to help Latino fathers quit smoking during pregnancy and postpartum: the Parejas trial.

Background: Although many Latinos in the United States smoke, they receive assistance to quit less often than non-Latinos. To address this disparity, we recruited Latino couples into a randomized controlled trial and provided a smoking cessation program during a teachable moment, when mens partners were pregnant. Methods: We compared two interventions: (i) written materials plus nicotine replacement therapy (NRT) to (ii) materials, NRT, and couple-based counseling that addressed smoking cessation and couples communication. We recruited 348 expectant fathers who smoked via their pregnant partners from county health departments. Our primary outcome was 7-day point prevalence smoking abstinence and was collected from November 2010 through April 2013 and analyzed in February 2014. Results: We found high rates of cessation but no arm differences in smoking rates at the end of pregnancy (0.31 vs. 0.30, materials only vs. counseling, respectively) and 12 months after randomization (postpartum: 0.39 vs. 0.38). We found high quit rates among nondaily smokers but no arm differences (0.43 vs. 0.46 in pregnancy and 0.52 vs. 0.48 postpartum). Among daily smokers, we found lower quit rates with no arm differences but effects favoring the intervention arm (0.13 vs. 0.16 in pregnancy and 0.17 vs. 0.24 postpartum). Conclusions: A less intensive intervention promoted cessation equal to more intensive counseling. Postpartum might be a more powerful time to promote cessation among Latino men. Impact: Less intensive interventions when delivered during teachable moments for Latino men could result in a high smoking cessation rate and could reduce disparities. Cancer Epidemiol Biomarkers Prev; 24(2); 379–85. ©2014 AACR.