Affect regulation as a moderator of intentions for breast cancer chemoprevention.

Women at high risk for breast cancer (BC) may consider chemoprevention for risk reduction, but uptake is low. This study examined the role of affect regulation (the attempt to alter or control one's emotions) in decision-making about BC chemoprevention. A cross-sectional, single group design was used. High-risk women (N = 81) were surveyed. Moderation analyses specified cancer-specific distress as the independent variable, affect regulation (cognitive reappraisal or expressive suppression) as the moderator, and chemoprevention intentions (yes = 1, unsure = 0, no = -1) as the dependent variable. Cognitive reappraisal significantly moderated the relationship between cancer-specific distress and chemoprevention intentions (p = 0.03), but expressive suppression did not (p = 0.31). For the 44% of participants who were highest on reappraisal, higher cancer-specific distress was associated with greater intentions for chemoprevention. For the remaining 56%, there was no relationship between cancer-specific distress and chemoprevention intentions. Cognitive reappraisal may play an important role in decisions regarding uptake of chemoprevention.

Longitudinal Risk Management for Patients with Increased Risk for Breast Cancer.

INTRODUCTION: This study aims to characterize longitudinal care management and evaluate the relationship between various patient factors and the likelihood of choosing risk-reducing behaviors in women with increased risk of developing breast cancer. METHODS: A retrospective study was conducted to evaluate all adult female patients who had at least one clinic visit with a surgical provider for discussion of breast cancer risk assessment between January, 2017 to July, 2020 at an academic center. Patients with prior history of breast cancer were excluded. Patient details and strategies pursued at clinic visits were recorded. A time-to-event analysis was performed, and hazard ratios were determined to characterize associations between patient characteristics and time to pursuing risk-reducing care management. RESULTS: There were 283 participants with at least one follow-up visit and 48 (17.0%) ultimately changed their initial strategy to either chemoprevention or prophylactic mastectomy. Patients with gene mutations were 6 times more likely to engage in risk-reducing management compared to those without (hazard ratio (HR) 5.99, P < 0.001). Those with histories of high-risk proliferative changes (HR 7.62, P < 0.001) and hysterectomy (HR 2.99, P = 0.019) were also more likely to engage in risk-reducing management. Age, race, and increased predicted risk of developing breast cancer (estimated by various calculators) were not associated with increased likelihood of engaging in risk-reducing strategies. CONCLUSION: Known gene mutations, history of high-risk proliferative changes, and prior hysterectomy were factors associated with women who were more likely to engage in risk-reducing strategies. These findings, when paired with patient reported outcome measures, may help guide shared decision-making.

Acceptable interventions to reduce syphilis transmission among high-risk men who have sex with men in Los Angeles.

OBJECTIVES: We examined perceptions of and attitudes toward existing and potential syphilis interventions, including case management and Web-based programs, to increase syphilis testing among high-risk men who have sex with men (MSM). METHODS: Between October 2010 and June 2011, we conducted in-depth interviews with 19 MSM in Los Angeles, California, with repeat early syphilis infections (primary, secondary, and early latent syphilis) within the previous 5 years. We analyzed the interviews inductively to determine the most acceptable potential interventions. RESULTS: Experiences with health department and community-based standard of care case management were generally positive. The most popular interventions among respondents included a Web site providing information on syphilis and syphilis testing, automated Web reminders to test, being paid to test, free online home testing kits, and preexposure prophylactic medication. Respondents' beliefs that they would continue to practice high-risk sexual behaviors reinforced their reasons for wanting increased accessibility and convenient testing strategies. CONCLUSIONS: Public health officials should consider participant responses to potential interventions for syphilis, which suggest that high-risk MSM would consider testing more often or using other interventions.

Predictors of willingness to use HIV pre-exposure prophylaxis among female sex workers in Southwest China.

This research examined predictors of willingness to use pre-exposure prophylaxis (PrEP) among female sex workers (FSW) in Southwest China. The final sample included 395 women (mean age=26.73 years, SD=6.74 years) who were predominantly of Han majority ethnicity (84.6%) and had completed middle-school education or lower (63.0%). Participants were recruited initially from commercial sex venues (e.g., saunas, massage parlors) in the cities of Nanchang, Luizhou, Nanning, Urumqi, and Karamay as well as two districts of Chongqing municipality and subsequently via snowball procedures. They completed a battery of self-report measures assessing beliefs about HIV and PrEP, psychosocial influences, demographics and willingness to use HIV PrEP. Willingness to use HIV PrEP was predicted by high levels of trust in physicians and more reported unmet interpersonal belongingness needs. Beyond these factors, willing and unwilling groups were differentiated on the basis of intervention-specific beliefs (perceived stigma and self-efficacy in use of PrEP). Together, findings suggested interpersonal factors should be considered in concert with perceptions of intervention characteristics in assessing motivations to enroll in PrEP within this particular at-risk group.

Determinants of intermittent preventive treatment of malaria during pregnancy (IPTp) utilization in a rural town in Western Nigeria.

BACKGROUND: Malaria infection in pregnancy is a major risk factor for maternal and child death, and substantially increases the risk of miscarriage, stillbirth and low birthweight. The aim of this study therefore is to assess the prevalence and determinants of Intermittent preventive treatment of Malaria [IPTp] utilization by pregnant women in a rural town in Western Nigeria. METHODS: This study is an analytical cross-sectional study. All pregnant women that were due for delivery and were attending the three primary health care center in Sagamu town, Nigeria within a 2 months period were recruited into the study. A semi- structured questionnaire was used to collect relevant information. RESULTS: A total of 255 pregnant women were recruited into the study. The mean age of respondents was 28.07 ± 5.12 years. The mean parity and booking age was 2.7 ± 1.67 and 4.42 ± 1.7 months respectively. The prevalence of Malaria attack in the last 3 months was 122(47.8%). Only 107/255 (40.4%) practice IPTp for malaria prevention during the current pregnancy, with only 14.6% of them taking the second dose during pregnancy as recommended. Chloroquine [27.1%] was the most frequently used medication for the treatment of Malaria in Pregnancy. Early booking age [OR = 1.11, C.I = 0.61-2.01], adverse last pregnancy outcome [OR = 1.23, C.I = 0.36-4.22], and parity [OR = 1.87, C.I = 0.25-16.09] were not statistically significantly associated with IPTp utilization. The only predictor of IPTp use was the knowledge of prophylaxis for malaria prevention [OR = 2.47, C.I = 1.06-3.52] using multivariate analysis. CONCLUSION: The study concludes that most women who attend ANC in rural areas in Nigeria do not receive IPTp as expected. A major determinant of utilization of IPTp among the study population was the knowledge of prophylaxis for malaria prevention. This study highlights the importance of health education of the pregnant women in increasing IPTp uptake despite the regular drug stock out at the facility level in rural areas in low resource countries.

A worked example of "best fit" framework synthesis: a systematic review of views concerning the taking of some potential chemopreventive agents.

BACKGROUND: A variety of different approaches to the synthesis of qualitative data are advocated in the literature. The aim of this paper is to describe the application of a pragmatic method of qualitative evidence synthesis and the lessons learned from adopting this "best fit" framework synthesis approach. METHODS: An evaluation of framework synthesis as an approach to the qualitative systematic review of evidence exploring the views of adults to the taking of potential agents within the context of the primary prevention of colorectal cancer. RESULTS: Twenty papers from North America, Australia, the UK and Europe met the criteria for inclusion. Fourteen themes were identified a priori from a related, existing conceptual model identified in the literature, which were then used to code the extracted data. Further analysis resulted in the generation of a more sophisticated model with additional themes. The synthesis required a combination of secondary framework and thematic analysis approaches and was conducted within a health technology assessment timeframe. CONCLUSION: The novel and pragmatic "best fit" approach to framework synthesis developed and described here was found to be fit for purpose. Future research should seek to test further this approach to qualitative data synthesis.

I Would Never Take Preventive Medication! Perspectives and Information Needs of People Who Underwent Predictive Tests for Rheumatoid Arthritis.

OBJECTIVE: Little is known about the experiences, values, and needs of people without arthritis who undergo predictive biomarker testing for the development of rheumatoid arthritis (RA). Our study aimed to explore the perspectives of these individuals and describe their information needs. METHODS: A qualitative, multicenter interview study with a thematic analysis was conducted in Austria, Germany and the UK. Individuals were interviewed who underwent predictive biomarker testing for RA and had a positive test result but no diagnosis of any inflammatory joint disease. Participants included patients with arthralgia and asymptomatic individuals. Information and education needs were developed from the qualitative codes and themes using the Arthritis Educational Needs Assessment Tool as a frame of reference. RESULTS: Thematic saturation was reached in 34 individuals (76% female, 24 [71%] with arthralgia, and 10 [29%] asymptomatic individuals). Thirty-seven codes were summarized into 4 themes: 1) decision-making around whether to undergo initial predictive testing, 2) willingness to consider further predictive tests, and/or 3) preventive interventions, including medication, and 4) varying reactions after receiving a positive test result. Individuals with arthralgia were more likely to be willing to take preventive action, undergo further testing, and experience psychological distress than asymptomatic individuals. All participants expressed the need for tailored, patient-understandable information. CONCLUSION: Individuals at risk of RA are currently the subjects of research aimed at developing better predictive strategies and preventive approaches. Their perceptions and needs should be addressed to inform the future development of interventions combined with education.

Non-adherence to malaria prophylaxis: The influence of travel-related and psychosocial factors.

BACKGROUND: The effectiveness of malaria chemoprophylaxis is limited by a lack of compliance in travellers. This study assesses the demographic, travel-related, and psychosocial determinants of non-compliance with chemoprophylaxis. METHODS: 715 adults, who received a pre-travel malaria prophylaxis prescription, were invited to complete a post-travel digital questionnaire on non-compliance, demographics, travel-related and psychosocial variables. RESULTS: 330 travellers (53% response) reported 32% non-compliance with malaria chemoprophylaxis. Logistic regression analyses revealed that 3/11 assessed psychosocial variables uniquely predicted non-compliance: 'negative attitude towards chemoprophylaxis' (ß=0.694, OR 2.0, p<0.01), 'low perceived severity of malaria' (ß=0.277, p=0.04) and 'fatigue during travel' (ß=2.225, OR 9.3, p<0.01). Furthermore, the age and education of the traveller were uniquely predictive of non-compliance (ß=-0.023 (p=0.02) and ß=0.684 (p=0.04)). None of the travel-related variables predicted non-compliance. CONCLUSIONS: About one-third of the travellers in our study were non-compliant with malaria prophylaxis, especially young travellers and highly educated travellers. Fatigue during travel seems to lead to non-compliance. Further research should focus on addressing the psychosocial factors in pre-travel consultation, since these appear to be better predictors for intention to comply than travel-related variables.

Acceptability of Localized Cancer Risk Reduction Interventions Among Individuals at Average or High Risk for Cancer.

Individuals at high risk for cancer, including those already diagnosed with premalignant lesions, can potentially benefit from chemopreventive interventions to reduce cancer risk. However, uptake and acceptability have been hindered due to the risk of systemic toxicity and other adverse effects. Locally delivered chemopreventive agents, where direct action on the primary organ may limit systemic toxicity, are emerging as an option for high-risk individuals. While a number of clinical trials support the development of chemopreventive agents, it is crucial to understand the factors and barriers that influence their acceptability and use. We conducted 36 focus groups with 198 individuals at average and high risk of breast/ovarian, gynecologic, and head/neck/oral and lung cancers to examine the perceptions and acceptability of chemopreventive agents. Participants' willingness to use chemopreventive agents was influenced by several factors, including perceived risk of cancer, skepticism around prevention, previous knowledge of chemopreventive agents, support from trusted sources of health information, participation in other cancer-related risk-reduction activities, previous experience with similar modalities, cost, regimen, side effects, and perceived effectiveness of the preventive intervention. Our findings indicate that individuals may be more receptive to locally delivered chemopreventive agents if they perceive themselves to be at high risk for cancer and are given the necessary information regarding regimen and side effects to make an informed decision. Clinical trials that collect additional patient-centered data including side effects and how these interventions fit into an individual's lifestyle are imperative to improve uptake of chemopreventive agents.

Parental Refusal of Standard-of-Care Prophylactic Newborn Practices: In One Center's Experience, Many Refuse One but Few Refuse All.

OBJECTIVES: Several interventions to reduce neonatal morbidity and mortality are universally recommended: intramuscular (IM) vitamin K (VK), erythromycin ophthalmic prophylaxis, and hepatitis B vaccine for newborns, and maternal pertussis vaccine. Despite robust efficacy and safety evidence, parental refusal of these practices is increasing. We sought to define the current declination rate and characterize the association between declination of 1 intervention and declination of the others. METHODS: A retrospective cohort study was performed of all inborn singletons admitted to the well newborn nursery over a 12-month period (November 15, 2015 through November 15, 2016) at a large quaternary center. RESULTS: In total, 3758 infants met inclusion criteria. 25% (n = 921) did not receive at least 1 of the 4 interventions. 13.6% (n = 511) did not receive the hepatitis B vaccine, 2.3% (n = 85) did not receive IM VK, 5.9% (n = 223) did not receive erythromycin, and 7.2% (n = 271) of mothers did not receive the prenatal tetanus, diphtheria, pertussis vaccine. Odds of refusal of IM VK were 6.2 times greater for infants delivered by a certified nurse midwife versus physician (95% confidence interval 3.3-11.6). Pattern of declination was variable; of 921 mother-infant dyads who did not receive at least 1 intervention, only 2 dyads received none of the interventions. CONCLUSIONS: Our study is one of the first in which patterns of refusal of standard-of-care perinatal practices are characterized. Alarmingly, one-fourth of our cohort did not receive at least 1 core infant health intervention. Our finding of only modest overlap in declination of each intervention carries implications for the development of targeted interventions.

Acceptability of cancer chemoprevention trials: impact of the design.

BACKGROUND: Chemoprevention could significantly reduce cancer burden. Assessment of efficacy and risk/benefit balance is at best achieved through randomized clinical trials. METHODS: At a periodic health examination center 1463 adults were asked to complete a questionnaire about their willingness to be involved in different kinds of preventive clinical trials. RESULTS: Among the 851 respondents (58.2%), 228 (26.8%) agreed to participate in a hypothetical chemoprevention trial aimed at reducing the incidence of lung cancer and 116 (29.3%) of 396 women agreed to a breast cancer chemoprevention trial. Randomization would not restrain participation (acceptability rate: 87.7% for lung cancer and 93.0% for breast cancer). In these volunteers, short-term trials (1 year) reached a high level of acceptability: 71.5% and 73.7% for lung and breast cancer prevention respectively. In contrast long-term trials (5 years or more) were far less acceptable: 9.2% for lung cancer (OR=7.7 CI(95%) 4.4-14.0) and 10.5 % for breast cancer (OR=6.9 CI(95%) 3.2-15.8). For lung cancer prevention, the route of administration impacts on acceptability with higher rate 53.1% for a pill vs. 7.9% for a spray (OR=6.7 CI(95%) 3.6-12.9). CONCLUSION: Overall healthy individuals are not keen to be involved in chemo-preventive trials, the design of which could however increase the acceptability rate.

Chemoprevention Uptake among Women with Atypical Hyperplasia and Lobular and Ductal Carcinoma In Situ.

Women with atypical hyperplasia and lobular or ductal carcinoma in situ (LCIS/DCIS) are at increased risk of developing invasive breast cancer. Chemoprevention with selective estrogen receptor modulators or aromatase inhibitors can reduce breast cancer risk; however, uptake is estimated to be less than 15% in these populations. We sought to determine which factors are associated with chemoprevention uptake in a population of women with atypical hyperplasia, LCIS, and DCIS. Women diagnosed with atypical hyperplasia/LCIS/DCIS between 2007 and 2015 without a history of invasive breast cancer were identified (N = 1,719). A subset of women (n = 73) completed questionnaires on breast cancer and chemoprevention knowledge, risk perception, and behavioral intentions. Descriptive statistics were generated and univariate and multivariable log-binomial regression were used to estimate the association between sociodemographic and clinical factors and chemoprevention uptake. In our sample, 29.3% had atypical hyperplasia, 23.3% had LCIS, and 47.4% had DCIS; 29.4% used chemoprevention. Compared with women with atypical hyperplasia, LCIS [RR, 1.43; 95% confidence interval (CI), 1.16-1.76] and DCIS (RR, 1.54; 95% CI, 1.28-1.86) were significantly associated with chemoprevention uptake, as was medical oncology referral (RR, 5.79; 95% CI, 4.80-6.98). Younger women were less likely to take chemoprevention (RR, 0.61; 95% CI, 0.42-0.87), and there was a trend toward increased uptake in Hispanic compared with non-Hispanic white women. The survey data revealed a strong interest in learning about chemoprevention, but there were misperceptions in personal breast cancer risk and side effects of chemoprevention. Improving communication about breast cancer risk and chemoprevention may allow clinicians to facilitate informed decision-making about preventative therapy. Cancer Prev Res; 10(8); 434-41. ©2017 AACR.

Clinician-Reported Barriers to Implementing Breast Cancer Chemoprevention in the UK: A Qualitative Investigation.

AIMS: The use of tamoxifen and raloxifene as preventive therapy for women at increased risk of breast cancer was approved by the National Institute for Health and Care Excellence (NICE) in 2013. We undertook a qualitative investigation to investigate the factors affecting the implementation of preventive therapy within the UK. METHODS: We recruited general practitioners (GPs) (n = 10) and clinicians working in family history or clinical genetics settings (FHCG clinicians) (n = 15) to participate in semi-structured interviews. Data were coded thematically within the Consolidated Framework for Implementation Research. RESULTS: FHCG clinicians focussed on the perceived lack of benefit of preventive therapy and difficulties interpreting the NICE guidelines. FHCG clinicians felt poorly informed about preventive therapy, and this discouraged patient discussions on the topic. GPs were unfamiliar with the concept of preventive therapy, and were not aware that they may be asked to prescribe it for high-risk women. GPs were reluctant to initiate therapy because it is not licensed, but were willing to continue a prescription if it had been started in secondary or tertiary care. CONCLUSIONS: Barriers to implementing preventive therapy within routine clinical practice are common and could be addressed by engaging all stakeholders during the development of policy documents.

What people want from sex and preexposure prophylaxis.

PURPOSE OF REVIEW: As demand for preexposure prophylaxis (PrEP) increases, we are learning more about what people want from sex and PrEP. RECENT FINDINGS: PrEP demand has reached a tipping point in the USA and is increasing rapidly. Although the primary benefit of PrEP use is biological, to reduce risk of HIV infection, PrEP users often express an alternative set of social and emotional benefits that are provided by PrEP. These collateral benefits of PrEP have salience, affect, and are experienced in the present, which are compelling drivers of human behavior. PrEP use has been associated with feeling safe during sex, usually in contrast to ruminations related to fear of HIV or intimate partner violence or control. PrEP can create empowerment, or agency, defined as the capacity and autonomy to act on one's own behalf, because it provides control over one's vulnerability to HIV and relief to women and men who may otherwise worry about whether their partners will use a condom, take antiretroviral therapy, or disclose their HIV status accurately. Planning for sexual and social goals in calm moments is also empowering. These highly desired collateral benefits of PrEP could be undermined, or eliminated, if PrEP is implemented in ways that are coercive or that foment fear of sexual risk compensation, drug resistance, toxicity, or moral judgment. SUMMARY: Current PrEP implementation provides direct and indirect benefits that are highly desired.

Affective forecasting and medication decision making in breast-cancer prevention.

OBJECTIVE: Over 2 million American women at elevated risk for breast cancer are eligible to take chemoprevention medications such as tamoxifen and raloxifene, which can cut in half the risk of developing breast cancer, but which also have a number of side effects. Historically, very few at-risk women have opted to use chemoprevention medications. Affective forecasting theory suggests that people may avoid these medications if they expect taking them to increase their health-related stress. METHOD: After receiving an individually tailored decision aid that provided personalized information about the risks and benefits of these medications, 661 women at elevated risk of breast cancer were asked to make 3 affective forecasts, predicting what their level of health-related stress would be if they took tamoxifen, raloxifene, or neither medication. They also completed measures of decisional preferences and intentions, and at a 3-month follow-up, reported on whether or not they had decided to use either medication. RESULTS: On the affective forecasting items, very few women (<10%) expected the medications to reduce their health-related stress, relative to no medication at all. Participants with more negative affective forecasts about taking a chemoprevention medication expressed lower preferences and intentions for using the medications (Cohen's ds from 0.74 to 0.79) and were more likely to have opted against using medication at follow-up (OR range = 1.34-2.66). CONCLUSION: These findings suggest that affective forecasting may explain avoidance of breast-cancer chemoprevention medications. They also highlight the need for more research aimed at integrating emotional content into decision aids. (PsycINFO Database Record

Reasons for Refusal of Newborn Vitamin K Prophylaxis: Implications for Management and Education.

OBJECTIVE: The American Academy of Pediatrics recommends intramuscular (IM) vitamin K prophylaxis for all newborns to prevent vitamin K deficiency bleeding. Given the serious implications of late-onset vitamin K deficiency bleeding, our objective was to examine factors influencing parents' decisions to refuse IM vitamin K prophylaxis. METHODS: Parents intending to refuse IM vitamin K prophylaxis at delivery were recruited from 5 community hospitals, 1 academic medical center, and 2 birthing centers in a single Southeastern state. Participants completed a written survey including demographics, birth and parenting decisions (eg, breastfeeding), and open-ended questions about their vitamin K information sources, concerns, and knowledge of risks. RESULTS: The incidence of refusal was highest at the birthing centers. Fifty-four parents intending to refuse IM vitamin K completed the survey. Most were white (78%), over age 30 (57%), and college graduates (65%). All reported intention to exclusively breastfeed. Most refused hepatitis B vaccine (90%) and erythromycin eye ointment (77%). The most common source of information was the Internet (70%). Concerns included synthetic or toxic ingredients (37%), excessive dose (28%), and side effects (24%). Eighty-three percent of parents reported awareness of risks associated with vitamin K refusal. However, only 6 parents (11%) decided to accept IM prophylaxis. CONCLUSIONS: This study provides an understanding of the concerns, mindset, and information sources used by parents refusing IM vitamin K. Educating parents about the importance of IM prophylaxis should begin in the prenatal period and must address concerns parents identify on the Internet.

Historical Review: Problematic Malaria Prophylaxis with Quinine.

Quinine, a bitter-tasting, short-acting alkaloid drug extracted from cinchona bark, was the first drug used widely for malaria chemoprophylaxis from the 19th century. Compliance was difficult to enforce even in organized groups such as the military, and its prophylaxis potential was often questioned. Severe adverse events such as blackwater fever occurred rarely, but its relationship to quinine remains uncertain. Quinine prophylaxis was often counterproductive from a public health viewpoint as it left large numbers of persons with suppressed infections producing gametocytes infective for mosquitoes. Quinine was supplied by the first global pharmaceutical cartel which discouraged competition resulting in a near monopoly of cinchona plantations on the island of Java which were closed to Allied use when the Japanese Imperial Army captured Indonesia in 1942. The problems with quinine as a chemoprophylactic drug illustrate the difficulties with medications used for prevention and the acute need for improved compounds.

What Matters to Women When Making Decisions About Breast Cancer Chemoprevention?

PURPOSE: Despite the effectiveness of chemoprevention (tamoxifen and raloxifene) in preventing breast cancer among women at high risk for the disease, uptake is low. The objective of this study was to determine the tradeoff preferences for various attributes associated with chemoprevention among women not currently taking the drugs. METHODS: We used rating-based conjoint analysis to evaluate the relative importance of a number of attributes associated with chemoprevention, including risk of side effects, drug effectiveness, time needed to take the drugs, and availability of a blood test to see if the drugs were working in an Internet sample of women. We generated mean importance values and part-worth utilities for all attribute levels associated with taking chemoprevention. We then used multivariable linear regression to examine attribute importance scores controlling for participant age, race, Hispanic ethnicity, educational level, and a family history of breast cancer. RESULTS: Overall interest in taking chemoprevention was low among the 1094 women included in the analytic sample, even for the scenario in which participants would receive the greatest benefit and fewest risks associated with taking the drugs. Time needed to take the pill for it to work and 5-year risk of breast cancer were the most important attributes driving tradeoff preferences between the chemoprevention scenarios. CONCLUSIONS: Interest in taking chemoprevention among this sample of women at average risk was low. Addressing women's concerns about the time needed to take chemoprevention for it to work may help clinicians improve uptake of the drugs among those likely to benefit.

Tamoxifen for the prevention of breast cancer: psychosocial impact on women participating in two randomized controlled trials.

PURPOSE: The purpose of this study was to evaluate the psychosocial implications of tamoxifen versus placebo in women who are at increased risk of breast cancer. PATIENTS AND METHODS: The 488 women in the psychosocial study were recruited from participants in two placebo-controlled, double-blind, randomized, controlled trials that investigated the efficacy of tamoxifen in the prevention of breast cancer in women who are at high familial risk. During a 5-year period, repeated assessments were made of anxiety, psychological distress, and sexual functioning using standardized questionnaires before treatment at baseline and at 6-month intervals during the trial. RESULTS: Questionnaire completion over 5 years was good, with 71.1% of women returning at least 8 of 10 follow-up assessments. Although scores from individuals showed considerable fluctuation and variation over time, changes in anxiety, mood, and sexual functioning were not associated with treatment group. The number of symptoms reported at 48 months via a self-report checklist were not associated with treatment group, but vasomotor symptoms were more frequent among tamoxifen-treated women. Symptoms of low energy, breast sensitivity, and visual blurring were reported most frequently in the placebo group. CONCLUSION: In general, these results are comparable to those from the National Surgical Adjuvant Breast and Bowel Project psychosocial study despite differences in study populations, methodology, and instruments. The long-term use of tamoxifen and other selective estrogen response modulators as preventive agents in high-risk groups has been questioned, but we found no evidence of treatment-related side effects that affect women's psychosocial and sexual functioning.