Jennifer Barsky Reese

Electronic patient-reported data capture as a foundation of rapid learning cancer care.

Background:“Rapid learning healthcare” presents a new infrastructure to support comparative effectiveness research. By leveraging heterogeneous datasets (eg, clinical, administrative, genomic, registry, and research), health information technology, and sophisticated iterative analyses, rapid learning healthcare provides a real-time framework in which clinical studies can evaluate the relative impact of therapeutic approaches on a diverse array of measures. Purpose:This article describes an effort, at 1 academic medical center, to demonstrate what rapid learning healthcare might look like in operation. The article describes the process of developing and testing the components of this new model of integrated clinical/research function, with the pilot site being an academic oncology clinic and with electronic patient-reported outcomes (ePROs) being the foundational dataset. Research Design:Steps included: feasibility study of the ePRO system; validation study of ePRO collection across 3 cancers; linking ePRO and other datasets; implementation; stakeholder alignment and buy in, and; demonstration through use cases. Subjects:Two use cases are presented; participants were metastatic breast cancer (n = 65) and gastrointestinal cancer (n = 113) patients at 2 academic medical centers. Results:(1) Patient-reported symptom data were collected with tablet computers; patients with breast and gastrointestinal cancer indicated high levels of sexual distress, which prompted multidisciplinary response, design of an intervention, and successful application for funding to study the interventions impact. (2) The system evaluated the longitudinal impact of a psychosocial care program provided to patients with breast cancer. Participants used tablet computers to complete PRO surveys; data indicated significant impact on psychosocial outcomes, notably distress and despair, despite advanced disease. Results return to the clinic, allowing iterative update and evaluation. Conclusions:An ePRO-based rapid learning cancer clinic is feasible, providing real-time research-quality data to support comparative effectiveness research.

Development of the NIH PROMIS ® Sexual Function and Satisfaction measures in patients with cancer.

INTRODUCTION We describe the development and validation of the Patient-Reported Outcomes Measurement Information System(®) Sexual Function and Satisfaction (PROMIS(®) SexFS; National Institutes of Health) measures, version 1.0, for cancer populations. AIM To develop a customizable self-report measure of sexual function and satisfaction as part of the U.S. National Institutes of Health PROMIS Network. METHODS Our multidisciplinary working group followed a comprehensive protocol for developing psychometrically robust patient-reported outcome measures including qualitative (scale development) and quantitative (psychometric evaluation) development. We performed an extensive literature review, conducted 16 focus groups with cancer patients and multiple discussions with clinicians, and evaluated candidate items in cognitive testing with patients. We administered items to 819 cancer patients. Items were calibrated using item-response theory and evaluated for reliability and validity. MAIN OUTCOME MEASURES The PROMIS SexFS measures, version 1.0, include 81 items in 11 domains: Interest in Sexual Activity, Lubrication, Vaginal Discomfort, Erectile Function, Global Satisfaction with Sex Life, Orgasm, Anal Discomfort, Therapeutic Aids, Sexual Activities, Interfering Factors, and Screener Questions. RESULTS In addition to content validity (patients indicate that items cover important aspects of their experiences) and face validity (patients indicate that items measure sexual function and satisfaction), the measure shows evidence for discriminant validity (domains discriminate between groups expected to be different) and convergent validity (strong correlations between scores on PROMIS and scores on conceptually similar older measures of sexual function), as well as favorable test-retest reliability among people not expected to change (interclass correlations from two administrations of the instrument, 1 month apart). CONCLUSIONS The PROMIS SexFS offers researchers a reliable and valid set of tools to measure self-reported sexual function and satisfaction among diverse men and women. The measures are customizable; researchers can select the relevant domains and items comprising those domains for their study.

Coping with sexual concerns after cancer: the use of flexible coping

IntroductionAlthough cancer treatment commonly has a negative impact on sexual functioning, sexual concerns are still largely undertreated in routine cancer care. The medical model that guides current approaches to sexual care in cancer does not adequately address key patient needs.MethodsIn this paper, we describe a broader approach to understanding and treating sexual concerns in cancer that focuses on the construct of flexibility in behavioral and cognitive coping strategies. We previously presented this model in the context of general medical conditions. We now adapt this model to the context of cancer, focusing on issues related to the benefits of flexible coping, interventions that shift perspectives following cancer, and on coping as a couple.ResultsWe argue that coping flexibly with sexual concerns is likely to lead to improvements in mood and sexual and relationship satisfaction. We present clinical applications of the flexible coping model, including suggestions for assessment and sexual concerns and methods of introducing flexible coping into both the content and process of clinical interactions with patients.DiscussionFinally, we discuss areas for future research, including the development of a validated instrument, the use of electronic methods of assessment, and intervention trials directly addressing flexibility in coping.

Pain and Functioning of Rheumatoid Arthritis Patients Based on Marital Status: Is a Distressed Marriage Preferable to No Marriage?

UNLABELLED Relationships may influence adjustment to chronic pain conditions such as rheumatoid arthritis (RA). We examined how both marital status and marital adjustment were related to pain, physical disability, and psychological disability in 255 adults with RA. Among married participants (n = 158), better marital adjustment (assessed using the Locke-Wallace Marital Adjustment Scale) was correlated with less pain and physical and psychological disability (all P values < .05). Married participants were divided into distressed (n = 44) and nondistressed (n = 114) subgroups and compared with unmarried participants (n = 97). Controlling for demographics and disease severity, unmarried participants had higher affective pain (P = .009) and higher psychological disability (P = .02) than only the nondistressed married participants, but unmarried participants did not differ from distressed married participants. These findings suggest that being married in itself is not associated with better health in RA but that being in a well-adjusted or nondistressed marriage is linked with less pain and better functioning. PERSPECTIVE This study examined relationships of marital status and marital adjustment to pain and physical and psychological disability in RA. Findings underscore the importance of considering not only marital status but also degree of marital adjustment in RA and may inform clinical interventions in this population.

Development and Initial Validation of the PROMIS® Sexual Function and Satisfaction Measures Version 2.0

INTRODUCTION The Patient-Reported Outcomes Measurement Information System (PROMIS)(®) Sexual Function and Satisfaction measure (SexFS) version 1.0 was developed with cancer populations. There is a need to expand the SexFS and provide evidence of its validity in diverse populations. AIM The aim of this study was to describe the development of the SexFS v2.0 and present preliminary evidence for its validity. METHODS Development built on version 1.0, plus additional review of extant items, discussions with 15 clinical experts, 11 patient focus groups (including individuals with diabetes, heart disease, anxiety, depression, and/or are lesbian, gay, bisexual, or aged 65 or older), 48 cognitive interviews, and psychometric evaluation in a random sample of U.S. adults plus an oversample for specific sexual problems (2281 men, 1686 women). We examined differential item functioning (DIF) by gender and sexual activity. We examined convergent and known-groups validity. RESULTS The final set of domains includes 11 scored scales (interest in sexual activity, lubrication, vaginal discomfort, clitoral discomfort, labial discomfort, erectile function, orgasm ability, orgasm pleasure, oral dryness, oral discomfort, satisfaction), and six nonscored item pools (screeners, sexual activities, anal discomfort, therapeutic aids, factors interfering with sexual satisfaction, bother). Domains from version 1.0 were reevaluated and improved. Domains considered applicable across gender and sexual activity status, namely interest, orgasm, and satisfaction, were found to have significant DIF. We identified subsets of items in each domain that provided consistent measurement across these important respondent groups. Convergent and known-groups validity was supported. CONCLUSIONS The SexFS version 2.0 has several improvements and enhancements over version 1.0 and other extant measures, including expanded evidence for validity, scores centered around norms for sexually active U.S. adults, new domains, and a final set of items applicable for both men and women and those sexually active with a partner and without. The SexFS is customizable, allowing users to select relevant domains and items for their study.

A randomized pilot trial of a telephone-based couples intervention for physical intimacy and sexual concerns in colorectal cancer.

We previously developed and piloted a telephone‐based intimacy enhancement (IE) intervention addressing sexual concerns of colorectal cancer patients and their partners in an uncontrolled study. The current study tested the feasibility, acceptability, and preliminary efficacy of the IE intervention in a randomized, controlled trial.

Gastrointestinal ostomies and sexual outcomes: a comparison of colorectal cancer patients by ostomy status

PurposeResearch examining effects of ostomy use on sexual outcomes is limited. Patients with colorectal cancer were compared on sexual outcomes and body image based on ostomy status (never, past, and current ostomy). Differences in depression were also examined.MethodsPatients were prospectively recruited during clinic visits and by tumor registry mailings. Patients with colorectal cancer (N = 141; 18 past ostomy; 25 current ostomy; and 98 no ostomy history) completed surveys assessing sexual outcomes (medical impact on sexual function, Female Sexual Function Index, International Index of Erectile Function), body image distress (Body Image Scale), and depressive symptoms (Center for Epidemiologic Studies Depression Scale—Short Form). Clinical information was obtained through patient validated self-report measures and medical records.ResultsMost participants reported sexual function in the dysfunctional range using established cut-off scores. In analyses adjusting for demographic and medical covariates and depression, significant group differences were found for ostomy status on impact on sexual function (p < .001), female sexual function (p = .01), and body image (p < .001). The current and past ostomy groups reported worse impact on sexual function than those who never had an ostomy (p < .001); similar differences were found for female sexual function. The current ostomy group reported worse body image distress than those who never had an ostomy (p < .001). No differences were found across the groups for depressive symptoms (p = .33) or male sexual or erectile function (p values ≥ .59).ConclusionsColorectal cancer treatment puts patients at risk for sexual difficulties and some difficulties may be more pronounced for patients with ostomies as part of their treatment. Clinical information and support should be offered.

Pilot feasibility study of a telephone-based couples intervention for physical intimacy and sexual concerns in colorectal cancer.

No studies have tested interventions addressing the sexual concerns of colorectal cancer patients and their partners. The authors reported findings from a pilot feasibility study of a novel telephone-based intimacy enhancement protocol that addresses the intimacy and sexual concerns of couples facing colorectal cancer. On the basis of a flexible coping model, the intervention was designed to help couples make cognitive and behavioral shifts in their intimate relationships. Participants were 18 individuals (9 dyads) who completed the intervention and measures of feasibility (frequency, ease of use, helpfulness of skills, ratings of rapport), program evaluations, and measures of sexual and relationship functioning. Most participants reported that the intervention was “quite a bit” or “extremely” helpful and that they had used the skills taught within the past week. The skills most commonly practiced and perceived as most helpful tended to be behavioral (e.g., trying a new sexual activity). The authors found the largest effect sizes (≥.60) for sexual distress, sexual function (female), and sexual communication. Findings from this pilot study suggest that the intimacy enhancement protocol is feasible and holds promise for improving sexual and intimacy outcomes in colorectal cancer patients and their partners. The authors discuss the research and clinical implications.

How to ask and what to do: A guide for clinical inquiry and intervention regarding female sexual health after cancer

Purpose of reviewAs the number of female cancer survivors continues to grow, there is a growing need to bridge the gap between the high rate of womens cancer-related sexual dysfunction and the lack of attention and intervention available to the majority of survivors who suffer from sexual problems. Previously identified barriers that hinder communication for providers include limited time, lack of preparation, and a lack of patient resources and access to appropriate referral sources. Recent findingsThis study brings together a recently developed model for approaching clinical inquiry about sexual health with a brief problem checklist that has been adapted for use for female cancer survivors, as well as practical evidence-based strategies on how to address concerns identified on the checklist. Examples of patient education sheets are provided as well as strategies for building a referral network. SummaryBy providing access to a concise and efficient tool for clinical inquiry, as well as targeted material resources and practical health-promoting strategies based on recent evidence-based findings, we hope to begin eliminating the barriers that hamper oncology providers from addressing the topic of sexual/vaginal health after cancer.

Cancer Patients' Function, Symptoms and Supportive Care Needs: A Latent Class Analysis Across Cultures

PurposePatient-reported outcomes (PROs) are an umbrella term covering a range of outcomes, including symptoms, functioning, health-related quality of life, and supportive care needs. Research regarding the appropriate PRO questionnaires to use is informative. A previously published latent class analysis (LCA) examined patterns of function, symptoms, and supportive care needs in a sample of US cancer patients. The current analysis investigated whether the findings from the original study were replicated in new samples from different countries and whether a larger sample combining all the data would affect the classes identified.MethodsThis secondary analysis of data from 408 Japanese and 189 Canadian cancer patients replicated the methods used in the original LCA using data from 117 US cancer patients. In all samples, subjects completed the EORTC-QLQ-C30 and Supportive Care Needs Survey Short Form-34 (SCNS-SF34). We first dichotomized individual function, symptom, and need domain scores. We then performed LCA to investigate the patterns of domains for each of the outcomes, both in the individual country samples and then combining the data from all three samples.ResultsAcross all analyses, class assignment was made by level of function, symptoms, or needs. In individual samples, only two-class models (“high” vs. “low”) were generally identifiable while in the combined sample, three-class models (“high” vs. “moderate” vs. “low”) best fit the data for all outcomes.ConclusionsIn this analysis, the level of burden experienced by patients was the key factor in defining classes.