Sara Vargas

Sleep dysfunction and psychosocial adaptation among women undergoing treatment for non-metastatic breast cancer

Objective: The current study aimed to determine the frequency of sleep disturbances in women prior to adjuvant therapy for breast cancer (BCa), and whether greater sleep dysfunction uniquely predicts poorer functional outcomes.

Willingness to use microbicides is affected by the importance of product characteristics, use parameters, and protective properties:

Background:Along with efficacy, a microbicides acceptability will be integral to its impact on the pandemic. Understanding Product Characteristics that users find most acceptable and determining who will use which type of product are key to optimizing use effectiveness. Objectives:To evaluate psychometrically the Important Microbicide Characteristics (IMC) instrument and examine its relationship to willingness to use microbicides. Results:Exploratory and confirmatory factor analyses revealed 2 IMC subscales (Cronbachs coefficient α: Product Characteristics subscale (α = 0.84) and Protective Properties subscale (α = 0.89)). Significant differences on Product Characteristics subscale scores were found for history of douching (P = 0.002) and employment status (P = 0.001). Whether a woman used a method to prevent pregnancy or sexually transmitted disease (STD) in the last 3 months (P < 0.001) and whether she used a condom during the last vaginal sex episode (P < 0.001) were significantly related to her rating of the importance of microbicides being contraceptive. Product Characteristics (r = 0.21) and Protective Properties (r = 0.27) subscale scores and whether a microbicide had contraceptive properties (r = 0.24) were all significantly associated (P < 0.001) with willingness to use microbicides. Conclusions:Formulation and use characteristics and product function(s) affect willingness to use microbicides and should continue to be addressed in product development. The IMC instrument serves as a template for future studies of candidate microbicides.

Willingness to Use Microbicides Varies by Race/Ethnicity, Experience With Prevention Products, and Partner Type

OBJECTIVE To investigate womens willingness to use vaginal microbicides to reduce/prevent HIV infection, using measures grounded in the individual, behavioral, and social contexts of sex. DESIGN A cross-sectional study that enrolled a sample (N = 531) of 18-55 year old Latina, African-American, and White women in the U.S. between October, 2004, and July, 2005. MAIN OUTCOME MEASURES Willingness to use microbicides and individual- and context-related variables (e.g., demographics, relationship status). RESULTS Exploratory and confirmatory factor analyses supported a one-dimensional, 8-item scale, with high internal consistency (alpha = .91). Subgroup analyses within the Latina (n = 166), African- American (n = 193), and White sub-samples (n = 172) also supported a unidimensional scale with strong internal validity and high reliability. Race/ethnicity as a contextual factor, a womans history of using prevention products, and the nature of the sexual partnership were predictive of willingness to use microbicides (R = .41). That is, women with greater frequencies of condom use, a history of spermicide use, and non-main sexual partners had higher predicted Willingness to Use Microbicides scale scores, while White women had lower predicted scores. CONCLUSION The Willingness to Use Microbicides scale serves as the first psychometrically validated measure of factors related to microbicide acceptability. Developing and implementing psychometrically validated and contextualized microbicide acceptability measures, in an effort to understand microbicide users and circumstances of use, is crucial to both clinical trials and future intervention studies.

The Utility of Non-proportional Quota Sampling for Recruiting At-risk Women for Microbicide Research

In the context of a measurement development study designed to contextualize microbicide acceptability, a sample that represented a range of at-risk women and maintained the statistical power needed for validity analyses was required. A non-proportional quota sampling strategy focused on race/ethnicity and number of sexual partners was utilized. This strategy resulted in enrollment of approximately equal proportions of Latina (31%), Black (36%), and White (32%) women, and an approximately 1:2 ratio of single-partnered (29%) and multi-partnered (71%) women. About 17% of women screened were ineligible based on eligibility criteria; an additional 16% were ineligible based on quota closures. Most participants were recruited through word of mouth (39%), community-based organizations (19%), or media sources (19%). Women recruited through word of mouth had the highest screen-to-interview completion percentage (67%). Non-proportional quota sampling is a feasible option for ensuring adequate representation of sample characteristics in microbicide research, but this goal should be weighed against cost and staff burden.

The promise of intravaginal rings for prevention: User perceptions of biomechanical properties and implications for prevention product development

Intravaginal rings (IVRs) are currently under investigation as devices for the delivery of agents to protect against the sexual transmission of HIV and STIs, as well as pregnancy. To assist product developers in creating highly acceptable rings, we sought to identify characteristics that intravaginal ring users consider when making decisions about ring use or non-use. We conducted four semi-structured focus groups with 21 women (aged 18–45) who reported using an IVR in the past 12 months. Participants manipulated four prototype rings in their hands, discussed ring materials, dimensionality, and “behavior,” and shared perceptions and appraisals. Five salient ring characteristics were identified: 1) appearance of the rings’ surfaces, 2) tactile sensations of the cylinder material, 3) materials properties, 4) diameter of the cylinder, and 5) ring circumference. Pliability (or flexibility) was generally considered the most important mechanical property. Several ring properties (e.g., porousness, dimensionality) were associated with perceptions of efficacy. Women also revealed user behaviors that may impact the effectiveness of certain drugs, such as removing, rinsing and re-inserting the ring while bathing, and removing the ring during sexual encounters. As product developers explore IVRs as prevention delivery systems, it is critical to balance product materials and dimensions with use parameters to optimize drug delivery and the user experience. It is also critical to consider how user behaviors (e.g., removing the ring) might impact drug delivery.

Does a Community-Based Stress Management Intervention Affect Psychological Adaptation Among Underserved Black Breast Cancer Survivors?

BACKGROUND In this randomized trial, Project CARE, we examined whether participation in a cognitive-behavioral stress management and breast cancer wellness and education program improved psychological outcomes among a sample of underserved black breast cancer survivors. METHODS Both complementary medicine interventions were 10-sessions, manualized, group-based, and were culturally adapted for black women in the community from evidence-based interventions. Participants were 114 black women (mean age = 51.1, 27-77 years) who had completed breast cancer treatment 0-12 months before enrollment (stages 0-IV, mean time since cancer diagnosis = 14.1 months). Women were enrolled upon completion of curative treatment (ie, surgical, chemotherapy, radiation oncology) and randomized to receive cognitive-behavioral stress management or cancer wellness and education program. RESULTS There was a remarkable 95% retention rate from baseline to 6-month follow-up. Participants in both conditions showed statistically significant improvement on indices of psychological well-being, including overall quality of life (Functional Assessment of Cancer Therapy-Breast), intrusive thoughts (Impact of Event Scale-Revised), depressive symptoms (Center for Epidemiologic Studies-Depression), and stress levels (Perceived Stress Scale) over the 6-month postintervention follow-up (all repeated measures analysis of variance within-subjects time effects: P < .05, except for overall mood; Profile of Mood States-Short Version). Contrary to hypotheses, however, condition × time effects were not statistically significant. CONCLUSIONS Findings suggest that improvements in multiple measures over time may have been due to intensive training in stress management, extensive provision of breast cancer information, or participation in an ongoing supportive group of individuals from a similar racial background. Implications bear on decisions about appropriate control groups, the timing of intervention delivery during the treatment trajectory, and perceived support from the research team.

Adaptation of a Psycho-Oncology Intervention for Black Breast Cancer Survivors: Project CARE

Black women are traditionally underserved in all aspects of cancer care. This disparity is particularly evident in the area of psychosocial interventions where there are few programs designed to specifically meet the needs of Black breast cancer survivors. Cognitive-behavioral stress management intervention (CBSM) has been shown to facilitate adjustment to cancer. Recently, this intervention model has been adapted for Black women who have recently completed treatment for breast cancer. We outline the components of the CBSM intervention, the steps we took to adapt the intervention to meet the needs of Black women (Project CARE) and discuss the preliminary findings regarding acceptability and retention of participants in this novel study.

Using Integrated Mixed Methods to Develop Behavioral Measures of Factors Associated With Microbicide Acceptability

Our current understanding of factors associated with microbicide acceptability and consistent use typically has been derived from separate and distinct qualitative or quantitative studies. Specifically, rarely have investigators used mixed methods to both develop and validate behavioral measures. We utilized an integrated mixed methods design, including qualitative metasyntheses, cognitive interviews and expert reviews, psychometric evaluation, and confirmatory qualitative analyses of the correspondence between quantitative items and original qualitative data to develop and validate measures of factors associated with microbicide acceptability and use. We describe this methodology and use the development of the Relationship Context Scale to illustrate it. As a result of independent confirmatory analyses of qualitative passages corresponding to survey items, we demonstrated that items from the same subscales are frequently double coded within a particular textual passage, and thematically related, suggesting associations that resulted in a unique factor structure within the subscale. This integrated mixed method design was critical to the development of this psychometrically validated behavioral measure, and could serve as a model for future measure development.

Coping and Health

This chapter addresses the topic of coping and health. Several extensive literatures have built up around the ways in which these two concepts intersect. Given this wealth of information, this chapter is limited to serving as an introduction to some of the ideas and themes of this topic rather than being a comprehensive review. The chapter is organized along the logical flow of the experiences under examination. Before we can understand the functions of coping and its role in promoting or impeding health, we must first consider why coping happens. Thus we begin with the concept of stress. Then we turn to coping, considering several distinctions in how coping is conceptualized. Finally, we consider the broad implications of these diverse ways of coping with stress for well-being, focusing on physical well-being.

User input in iterative design for prevention product development: leveraging interdisciplinary methods to optimize effectiveness

The development of HIV-preventive topical vaginal microbicides has been challenged by a lack of sufficient adherence in later stage clinical trials to confidently evaluate effectiveness. This dilemma has highlighted the need to integrate translational research earlier in the drug development process, essentially applying behavioral science to facilitate the advances of basic science with respect to the uptake and use of biomedical prevention technologies. In the last several years, there has been an increasing recognition that the user experience, specifically the sensory experience, as well as the role of meaning-making elicited by those sensations, may play a more substantive role than previously thought. Importantly, the role of the user—their sensory perceptions, their judgements of those experiences, and their willingness to use a product—is critical in product uptake and consistent use post-marketing, ultimately realizing gains in global public health. Specifically, a successful prevention product requires an efficacious drug, an efficient drug delivery system, and an effective user. We present an integrated iterative drug development and user experience evaluation method to illustrate how user-centered formulation design can be iterated from the early stages of preclinical development to leverage the user experience. Integrating the user and their product experiences into the formulation design process may help optimize both the efficiency of drug delivery and the effectiveness of the user.