Profiles of women's adjustment after cancer based on sexual and psychosocial wellbeing: results of a cluster analysis.

BACKGROUND: Sexual wellbeing is a critical yet often overlooked aspect of overall wellbeing for women across cancer diagnoses. OBJECTIVE: We identified profiles of women cancer survivors by sexual and psychosocial outcomes and compared groups for differences in relevant outcomes and individual characteristics. METHODS: Partnered women treated for cancer (n = 226; M age = 51.1 (12.6); 54% breast cancer; 86% White) completed a cross-sectional survey assessing sexual and psychosocial wellbeing. K-means cluster analysis modeled subgroups (clusters) with similar response patterns on measures of sexual wellbeing (sexual function, distress, sexual communication, and self-efficacy for communication), psychosocial wellbeing (quality of life (QOL), anxiety and depressive symptoms), and time since treatment. ANOVAs with Tukey post-hoc analyses and chi-square analyses tested cluster mean differences. RESULTS: Three distinct clusters of women differed by levels of adjustment in sexual and psychosocial wellbeing: higher-adjustment (32.7%), intermediate (37.6%), and lower-adjustment (29.6%). Significant differences among the clusters were found for all outcomes, with largest effect sizes for sexual distress (η2p = 0.66), sexual communication (η2p = 0.51), sexual satisfaction (η2p = 0.44), and anxiety and self-efficacy for communication (η2p = 0.32). The intermediate adjustment group was characterized by lower adjustment on measures of sexual and relationship function, and better adjustment on measures of QOL and mood. CONCLUSIONS: Findings suggest that for women cancer survivors, measures of sexual and psychosocial wellbeing can model distinct profiles to inform targeted interventions to meet women's needs. Evidence-based targeted interventions could lead to better sexual function, and ultimately to better QOL and overall wellbeing. IMPLICATIONS FOR PRACTICE: A stepped intervention approach to sexual health care for women with cancer, where content and format depend on degree of sexual and psychosocial adjustment after cancer, may be most appropriate. Interdisciplinary teams may address sexual, emotional, and relationship functioning.

Psychological and sexual distress in rectal cancer patients and partners.

BACKGROUND: Rectal cancer (RC) patients experience unique sources of distress, including sexual dysfunction and body image concerns, which can also cause distress among partners. This preliminary study investigated patterns of psychological distress, sexual functioning, sexual distress, and relationship satisfaction among RC patient-partner couples at pivotal points during cancer treatment. METHODS: Twenty couples participated (N = 40). Patients and partners completed a series of validated measures of psychological distress (ET), sexual functioning (FSFI; IIEF), sexual distress (GMSEX; Sexual Distress Scale) and relationship satisfaction (GMREL) at time of diagnosis, 3 weeks after radiation, 4 weeks post-surgery, and after chemotherapy and surgery for ostomy closure. Descriptive statistics, t-tests, and repeated-measures ANOVA were used to analyze scores over time, first for patients and partners, and then by sex. RESULTS: Relationship satisfaction remained elevated over time. In this sample, 55% of patients and 78.9% of partners reported clinically significant rates of psychological distress at diagnosis, which decreased to 23% and 46% respectively at the last assessment. Sexual satisfaction and distress worsened for patients and partners between baseline and surgery for ostomy closure. Both male and female participants reported statistically significant declines in sexual function from baseline to end of treatment (p < 0.05). DISCUSSION: Relative to relationship satisfaction, psychological and sexual health outcomes seem more vulnerable to the effects of RC treatment during the first year after diagnosis, both for patients and partners and for men and women. Results support the need for psychosocial care and sexual education/counseling for couples coping with RC.

Investigating the impact of the COVID-19 pandemic on breast cancer clinicians' communication about sexual health.

PURPOSE: We assessed breast cancer clinicians' perspectives on how the COVID-19 pandemic and increased use of telehealth affected their clinical communication about sexual heath. METHODS: Breast cancer clinicians participating in a sexual health communication intervention study (N = 29; 76% female; 66% oncologists; 34% advanced practice clinicians) completed an online survey. Data analysis consisted of descriptive statistics and thematic analysis. RESULTS: All clinicians were using telehealth, with most (66%) using it for up to half of their clinic appointments. Although only 14% of clinicians reported having shorter clinic visits, 28% reported having less time to discuss sexual health; 69% reported no change; and 3% said they had more time. Forty-one percent reported sexual health was less of a priority; 55% reported no change; and 3% said it was more of a priority. Thirty-five percent reported telehealth was less conducive to discussing sexual health; 59% reported no change; and 7% reported more conducive. Qualitative analysis revealed key issues underlying the perceived impact of the pandemic on discussions of sexual health including heightened clinician discomfort discussing such issues via telehealth, the less personal nature and privacy issues in telehealth visits, increased concerns about risk of COVID-19 infection and other health concerns (e.g., missing recurrence, mental health) taking priority, and clinician-perceived patient factors (e.g., discomfort, decreased priority) in discussing sexual concerns. CONCLUSION: Pandemic-related changes in breast cancer clinicians' practice could be exacerbating challenges to discussing sexual health. Methods for integrating sexual health into cancer care are needed, regardless of the mode of delivery.

Including partners in discussions of sexual side effects from breast cancer: a qualitative study of survivors, partners, and providers.

PURPOSE: Ensuring there are clear standards for addressing cancer-related sexual side effects is important. Currently, there are differences in two leading sets of clinical guidelines regarding the inclusion of survivors' romantic partners into clinical discussions between survivors and their providers about this issue. To help refine guidelines, we examine breast cancer survivor, partner, and oncology provider perspectives about including partners in discussions about cancer-related sexual side effects in a secondary analysis of a broader qualitative study. METHODS: Partnered female breast cancer survivors (N = 29) completed online surveys, and intimate partners of breast cancer survivors (N = 12) and breast oncology providers (N = 8) completed semi-structured interviews. Themes were derived from thematic content analysis. RESULTS: Among survivors who reported a discussion with their provider, fewer than half indicated their partner had been present, despite most survivors expressing it was - or would have been - helpful to include their partner. Partners also largely indicated being included was or would have been helpful, when welcomed by the survivor. Providers similarly emphasized the importance of survivors' autonomy in deciding whether to discuss sexual concerns in the presence of a partner. CONCLUSIONS: Partners were infrequently included in conversations about cancer-related sexual side effects, even though survivors, partners, and providers alike expressed value in these discussions occurring with the couple together - when that is the survivor's preference. Findings suggest future clinical guidelines should emphasize that incorporating partners into clinical discussions about sexual concerns is important for many breast cancer patients. Soliciting and enacting patients' preferences is essential for truly patient-centered care.

Mobile Technology-Based (mLearning) Intervention to Enhance Breast Cancer Clinicians' Communication About Sexual Health: A Pilot Trial.

BACKGROUND: Most breast cancer clinicians lack training to counsel patients about sexual concerns. The purpose of this study was to assess the feasibility, acceptability, and preliminary effects of a mobile learning (mLearning) intervention (improving Sexual Health and Augmenting Relationships through Education [iSHARE]) aimed at enhancing breast cancer clinicians' knowledge of, beliefs about, and comfort with discussing patients' sexual health concerns. METHODS: Clinicians listened to a 2-part educational podcast series offering information on breast cancer-related sexual health concerns and effective communication on the topic, which consisted of interviews with expert guests. Intervention feasibility was assessed through rates of enrollment, retention, and intervention completion, with benchmarks of 40%, 70%, and 60%, respectively. Acceptability was assessed through program evaluations, with 75% of clinicians rating the intervention favorably (eg, relevance, satisfaction) signifying acceptability. Clinicians self-reported their knowledge about breast cancer-related sexual health concerns, beliefs (ie, self-efficacy for discussing sexual health concerns), and comfort with discussing sexual concerns measured at preintervention and postintervention. Qualitative analysis examined clinicians' perceptions of lessons learned from the intervention. RESULTS: A total of 32 breast cancer clinicians enrolled (46% of those invited; 97% of those who responded and screened eligible), 30 (94%) completed both the intervention and study surveys, and 80% rated the intervention favorably, demonstrating feasibility and acceptability. Results showed positive trends for improvement in clinician knowledge, beliefs, and comfort with discussing sexual health concerns. Clinicians reported key lessons learned, including taking a proactive approach to discussing sexual health concerns, normalizing the topic, addressing vaginal health, sending the message that help is available, and assessing sexual health concerns with patients from different backgrounds. CONCLUSIONS: Breast cancer clinicians were amenable to participating in the iSHARE intervention and found it useful. iSHARE showed promise for improving clinician's knowledge and comfort discussing patients' sexual health concerns. A larger trial is required to demonstrate efficacy. Future studies should also examine whether iSHARE can improve patient-clinician communication and address patients' sexual concerns.

Understanding Sexual Help-Seeking for Women With Breast Cancer: What Distinguishes Women Who Seek Help From Those Who Do Not?

BACKGROUND: Sexual problems are extremely common for women after breast cancer (BC). AIM: To determine, in a sample of BC outpatients, how commonly women sought help for sexual concerns, from a health care provider (HCP), from other individuals, or from alternate sources; and to examine whether help-seeking was associated with women's sexual function/activity, self-efficacy for clinical communication about sexual health, or sociodemographic/medical characteristics. METHODS: BC patients participating in a sexual/menopausal health communication intervention trial completed web-based baseline self-report surveys. One-way analysis of variances compared effects of the level of sexual help-seeking (none; 1 outlet; 2-3 outlets) on sexual function domains. Chi-square or t-tests compared women seeking help with those not seeking help on other study variables. MAIN OUTCOME MEASURES: Patient-reported outcome instruments assessed sexual help-seeking (past month), sexual function and activity (PROMIS Sexual Function and Satisfaction Brief Profile Version 2.0), and self-efficacy (confidence) for communicating with their BC clinician about sexual health. RESULTS: 144 women (mean age = 56.0 years; 62% partnered; 67% white; 27% black/African American; 4% Hispanic/Latina; 15% stage IV) participated in this study. 49% of women sought help for sexual concerns, most often from intimate partners, family and/or friends (42%), followed by HCPs (24%), or online/print materials (19%); very few women (n = 4; 3%) sought help only from a HCP. Women seeking help were younger and more likely to be partnered and sexually active than those not seeking help. Sexual function was impaired for all domains but was most impaired for sexual interest. Among sexually active women, those seeking help from 2 to 3 sources reported worse sexual function in certain domains (sexual interest, lubrication, vaginal discomfort, vulvar discomfort-labial, satisfaction). Women seeking help from outlets other than HCPs had significantly lower self-efficacy than those who did not. CLINICAL IMPLICATIONS: BC patients with access to a partner and who are sexually active but find sex unsatisfying, uncomfortable, or lack interest may be in particular need of sexual help. Further, women may turn to outlets other than HCPs for sexual help partly because they lack the confidence to do so with a HCP. Sexual health information should be made available to women's partners, family, and friends, so they may effectively discuss such issues if needed. STRENGTHS & LIMITATIONS: Strengths of the study included examination of a range of sexual function domains and a theoretical construct in relation to BC patients' sexual help-seeking and a medically diverse sample. Limitations include a cross-sectional design. CONCLUSION: Women treated for BC should receive accurate and timely sexual health information. Reese JB, Sorice KA, Pollard W, et al. Understanding Sexual Help-Seeking for Women With Breast Cancer: What Distinguishes Women Who Seek Help From Those Who Do Not? J Sex Med 2020;17:1729-1739.

A brief intervention to enhance breast cancer clinicians' communication about sexual health: Feasibility, acceptability, and preliminary outcomes.

OBJECTIVE: Sexual concerns are often unaddressed for breast cancer patients; one reason is inadequate clinician training. We examined the feasibility, acceptability, and potential benefits of a novel intervention, improving Sexual Health and Augmenting Relationships through Education (iSHARE) for breast cancer clinicians. METHODS: Clinicians received training in communicating about sexual concerns with breast cancer patients. Intervention feasibility and acceptability were measured through enrollment/participation and postintervention program evaluations, respectively. Intervention effects were assessed through (1) clinician self-reported beliefs about sexual health communication, assessed at baseline, post-intervention, and 1- or 6-month follow-up, (2) clinical communication coded from audio recorded, transcribed clinic encounters at preintervention or postintervention, and (3) patient satisfaction with clinical care, reported immediately after the clinic visit. Patients also reported sociodemographic characteristics and level of sexual concerns. RESULTS: Seven breast cancer clinicians enrolled (88% participation), completed the intervention, and were audio recorded in clinic encounters with 134 breast cancer outpatients (67 each at preintervention or postintervention). Program evaluations supported intervention acceptability. Effect sizes suggest iSHARE increased clinicians' self-efficacy (d = 0.27) and outcome expectancies for communicating about sexual concerns (d = 0.69) and reduced communication barriers (d = -0.14). Clinicians' sexual health communication behaviors increased from baseline to postintervention, including for raising the topic (28% vs 48%), asking questions (33% vs 45%), and offering information (18% vs 24%). Neither patient satisfaction nor duration of sexual health communication changed (mean duration less than 1 minute at both time points). CONCLUSIONS: The iSHARE intervention was feasible and well received by clinicians and may change breast cancer clinicians' beliefs and communication behaviors regarding sexual health.

A randomized pilot trial of a couple-based intervention addressing sexual concerns for breast cancer survivors.

The purpose was to test the feasibility, acceptability, and preliminary efficacy of a 4-session couple-based Intimacy Enhancement (IE) intervention addressing breast cancer survivors' sexual concerns delivered via telephone. Twenty-nine post-treatment breast cancer survivors reporting sexual concerns and their intimate partners were randomized (2:1) to the IE intervention or to an educational control condition, both of which were delivered by trained psychosocial providers. Feasibility and acceptability were measured through recruitment, retention, session completion, and post-intervention program evaluations. Couples completed validated sexual, relationship, and psychosocial outcome measures at pre- and post-intervention. Between-group effect sizes and 95% confidence intervals were calculated using the Hedges g. Data supported intervention feasibility and acceptability. For survivors, the IE intervention had medium to large positive effects on all sexual outcomes and most psychosocial outcomes. Effects were less visible for relationship outcomes and were similar but somewhat smaller for partners. The IE intervention demonstrated feasibility, acceptability, and promise in addressing breast cancer survivors' sexual concerns and enhancing their and their partners' intimate relationships and psychosocial well-being. Implications for Psychosocial Oncology Practice The IE intervention demonstrated feasibility and acceptability, suggesting it could be well-received by breast cancer survivors with sexual concerns and their partners. Effects of the IE intervention on breast cancer survivors' sexual concerns and on their and their partners' intimate relationships and psychosocial well-being could not be attributed to therapist time and attention. Interventions that psychosocial providers can use to address breast cancer survivors' sexual concerns are important to the growing number of breast cancer survivors living for many years after their diagnosis.

A systematic review of dyadic studies examining relationship quality in couples facing colorectal cancer together.

BACKGROUND: Despite the adverse effects that treatment for colorectal cancer can have on patients' quality of life and, in particular, their intimate relationships, very little research has been conducted on the psychosocial adjustment for both patients and their partners/spouses. OBJECTIVES: The aim of this systematic review was to examine dyadic studies of adjustment in couples in which one partner has been diagnosed with colorectal cancer. METHODS: Pub Med, PsychINFO, MEDLINE, Social Sciences Abstracts (EBSCO), and the Cochrane Library were systematically searched for studies reporting quality of life outcomes for colorectal cancer patients and their partners/spouses. Only studies that included dyads in the sample were eligible for inclusion. The Quality Assessment Tool for Quantitative Studies was used to evaluate each study. RESULTS: A total of 277 studies were identified, of which 9 studies met the inclusion criteria (N = 388 couples). The methodological quality of the studies was high in that they used standardized instruments validated with their samples, conducted dyadic data analyses (when appropriate), and used longitudinal designs. A synthesis of the studies revealed that (1) relationship factors (eg, support, communication, dyadic coping, and relationship satisfaction) affect adjustment to cancer; (2) cancer-related distress impacts each partner's adjustment or the relationship; and (3) gender, role (patient/caregiver), and clinical characteristics (treatment, mental health) can mediate adjustment to cancer. CONCLUSION: The quality of the relationship can influence patients' and their partners' adjustment to colorectal cancer. Psychosocial interventions that address relationship issues may be beneficial to couples facing the challenges of colorectal cancer.

Sexual quality of life, body image distress, and psychosocial outcomes in colorectal cancer: a longitudinal study.

PURPOSE: The objectives were to assess changes in sexual QOL and body image distress over time and to examine longitudinal associations between sexual QOL and body image variables with psychosocial outcomes in a sample of colorectal cancer patients. METHODS: Participants (N = 141) completed a mail-based survey assessing sexual QOL [sexual distress (ISS), treatment impact on sexual function (SFQ), sexual function (FSFI; IIEF)], body image distress (BIS), and psychosocial outcomes [relationship quality (DAS-4), depressive symptoms (CESD-SF), and health-related QOL (HRQOL; FACT-C)]; 88 patients completed 6-month follow-up surveys (62%). Gender and cancer subgroups (male vs. female; rectal vs. colon cancer) were compared and longitudinal models examined associations between sexual QOL and body image variables with psychosocial outcomes over time and by subgroup. RESULTS: Impairments in sexual QOL and body image distress were common. Women and patients with rectal cancer reported worse body image distress compared to men (p = .005) and those with colon cancer (p = .03), respectively; compared to patients with colon cancer, those with rectal cancer reported worse treatment impact (p < .001) and marginally worse sexual function and HRQOL (p's = .05). At 6-month follow-up, body image distress decreased (p = .02), while sexual QOL was stable (e.g., 58% classified as dysfunctional at both time points, p = .13). For most sexual and body image predictors, worse impairment was associated with worse psychosocial outcomes over time. Several significant gender and cancer subgroup effects were found. CONCLUSIONS: Sexual QOL and body image are compromised after colorectal cancer and tend to remain impaired if unaddressed. Sexual concerns should be addressed early to limit broader-reaching psychosocial effects.

Assessment of vulvar discomfort with sexual activity among women in the United States.

BACKGROUND: Multidimensional self-report measures of sexual function for women do not include the assessment of vulvar discomfort, limiting our understanding of its prevalence. In an effort to improve the measurement of patient-reported health, the National Institutes of Health funded the creation of the Patient Reported Outcomes Measurement Information System (PROMIS). This included the development of the PROMIS Sexual Function and Satisfaction measure, and version 2.0 of the Sexual Function and Satisfaction measure included 2 scales to measure vulvar discomfort with sexual activity. OBJECTIVES: The objectives of the study were to describe the development of 2 self-reported measures of vulvar discomfort with sexual activity, describe the relationships between these scales and scales for lubrication and vaginal discomfort, and report the prevalence of vulvar discomfort with sexual activity in a large, nationally representative sample of US women. STUDY DESIGN: We followed PROMIS measure development standards, including qualitative development work with patients and clinicians and psychometric evaluation of candidate items based on item response theory, in a probability sample of 1686 English-speaking US adult women. We tested 16 candidate items on vulvar discomfort. We present descriptive statistics for these items, correlation coefficients among the vulvar and vaginal scales, and mean PROMIS scores with 95% confidence intervals separately by menopausal status for the 1046 women who reported sexual activity in the past 30 days. RESULTS: Based on the psychometric evaluation of the candidate items, we created 2 separate 4 item scales, one to measure labial discomfort and pain and one to measure clitoral discomfort and pain. Additional items not included in the scales assess pain quality, numbness, and bleeding. The correlations between the lubrication, vaginal discomfort, and the 2 vulvar discomfort measures ranged from 0.46 to 0.77, suggesting that these measures represent related yet distinct concepts. In our nationally representative sample, 1 in 5 US women endorsed some degree of vulvar discomfort with sexual activity in the past 30 days. Menopausal status was associated with lower lubrication and higher vaginal discomfort but not with vulvar discomfort. CONCLUSION: The PROMIS Vulvar Discomfort with Sexual Activity-Labial and Vulvar Discomfort with Sexual Activity-Clitoral scales are publicly available for use in research and clinical settings. There is limited overlap between vulvar discomfort and lubrication or vaginal discomfort. The importance of measuring vulvar discomfort as part of a comprehensive assessment of sexual function is underscored by its prevalence.

Effective patient-provider communication about sexual concerns in breast cancer: a qualitative study.

PURPOSE: Breast cancer patients commonly experience sexual concerns, yet rarely discuss them with clinicians. The study examined patient and provider experiences and preferences related to communication about breast cancer-related sexual concerns with the goal of informing intervention development. METHODS: Patient data (n = 28) were derived from focus groups and interviews with partnered and unpartnered women treated for breast cancer reporting sexual concerns. Provider data (n = 11) came from interviews with breast cancer oncologists and nurse practitioners. Patient and provider data were analyzed separately using the framework method of qualitative analysis. RESULTS: Findings revealed individual and institutional barriers to effective communication about sexual concerns and highlighted key communication facilitators (e.g., a positive patient-provider relationship, patient communication as a driver of provider communication, and vice versa). Patients expressed preferences for open, collaborative communication; providers expressed preferences for focused intervention targets (identifying concerns, offering resources/referrals) and convenient format. A model of effective communication of sexual concerns was developed to inform communication interventions. CONCLUSIONS: Findings suggest that to improve patient-provider communication about sexual concerns, knowledge and skills-based interventions that activate patients and that equip providers for effective discussions about sexual concerns are needed, as are institutional changes that could incentivize such discussions.

Emotional approach coping and depressive symptoms in colorectal cancer patients: The role of the intimate relationship.

This study examined whether emotional approach coping was associated with lower depressive symptoms, and whether intimacy moderated this association, in 121 married/partnered colorectal cancer (CRC) outpatients. Prospective analyses of survey data on emotional approach coping, depressive symptoms, and intimacy measured at baseline and 6-month follow-up showed that depressive symptoms were inversely related to processing, expression, and intimacy. At baseline, the association between processing and depressive symptoms was moderated by intimacy: greater processing was associated with lower depressive symptoms only for those in relatively high-intimacy relationships. Enhancing emotional approach coping efforts and relationship quality may benefit CRC patients' adjustment.

Sexual Satisfaction and the Importance of Sexual Health to Quality of Life Throughout the Life Course of U.S. Adults.

INTRODUCTION: Discussions about sexual health are uncommon in clinical encounters, despite the sexual dysfunction associated with many common health conditions. Understanding of the importance of sexual health and sexual satisfaction in U.S. adults is limited. AIM: To provide epidemiologic data on the importance of sexual health for quality of life and people's satisfaction with their sex lives and to examine how each is associated with demographic and health factors. METHODS: Data are from a cross-sectional self-report questionnaire from a sample of 3,515 English-speaking U.S. adults recruited from an online panel that uses address-based probability sampling. MAIN OUTCOME MEASURES: We report ratings of importance of sexual health to quality of life (single item with five-point response) and the Patient-Reported Outcomes Measurement Information System Satisfaction With Sex Life score (five items, each with five-point responses, scores centered on the U.S. mean). RESULTS: High importance of sexual health to quality of life was reported by 62.2% of men (95% CI = 59.4-65.0) and 42.8% of women (95% CI = 39.6-46.1, P < .001). Importance of sexual health varied by sex, age, sexual activity status, and general self-rated health. For the 55% of men and 45% of women who reported sexual activity in the previous 30 days, satisfaction with sex life differed by sex, age, race-ethnicity (among men only), and health. Men and women in excellent health had significantly higher satisfaction than participants in fair or poor health. Women with hypertension reported significantly lower satisfaction (especially younger women), as did men with depression or anxiety (especially younger men). CONCLUSION: In this large study of U.S. adults' ratings of the importance of sexual health and satisfaction with sex life, sexual health was a highly important aspect of quality of life for many participants, including participants in poor health. Moreover, participants in poorer health reported lower sexual satisfaction. Accordingly, sexual health should be a routine part of clinicians' assessments of their patients. Health care systems that state a commitment to improving patients' overall health must have resources in place to address sexual concerns. These resources should be available for all patients across the lifespan.

Importance of sexuality in colorectal cancer: predictors, changes, and response to an intimacy enhancement intervention.

PURPOSE: The primary objectives were (1) to examine the importance of sexuality within the self-view and cross-sectional correlates for 120 colorectal cancer patients and (2) to determine whether the importance of sexuality changed for 46 colorectal cancer patients and partners participating in an intimacy enhancement intervention. METHODS: Two newly developed items assessed importance of sexuality within the self-view (1) currently and (2) before cancer; a calculated change score assessed perceived change. In the cross-sectional sample, associations between importance of sexuality and demographic and medical factors and sexual function status were examined. Intervention participants' importance ratings before and after participation were used to calculate effect sizes. RESULTS: For patients, importance of sexuality before cancer was greater (M = 65.7) than current importance (M = 56.8, p = .001). Greater current importance of sexuality was associated with partnered status, non-metastatic disease, and not being in treatment. Scoring in the sexually functional range was associated with greater current importance of sexuality for men and a smaller perceived change in importance for both men and women (p values <.05). Sexual function status also significantly predicted current importance independent of covariates. Small to medium effect sizes for intervention patients (.37) and partners (.60) were found for increases in importance of sexuality. Items showed evidence of test-retest reliability and construct validity. CONCLUSIONS: Coping with sexual concerns is important to those affected by colorectal cancer. Findings suggest that the importance of sexuality can decrease through colorectal cancer and associated sexual problems and can increase through participating in an intimacy-focused intervention.

Development and Validation of a Single-Item Screener for Self-Reporting Sexual Problems in U.S. Adults.

BACKGROUND: Brief self-assessment of sexual problems in a clinical context has the potential to improve care for patients through the ability to track trends in sexual problems over time and facilitate patient-provider communication about this important topic. However, instruments designed for research are typically too long to be practical in clinical practice. OBJECTIVE: To develop and validate a single-item self-report clinical screener that would capture common sexual problems and concerns for men and women. DESIGN: We created three candidate screener items, refined them through cognitive interviews, and administered them to a large sample. We compared the prevalence of responses to each item and explored the discrepancies between items. We evaluated the construct validity of the items by comparing them to scores on the Patient-Reported Outcomes Measurement Information System® Sexual Function and Satisfaction (PROMIS® SexFS) measure. PARTICIPANTS: Local patients participated in two rounds of cognitive interviews (n = 7 and n = 11). A probability-based random sample of U.S. adults comprised the item-testing sample (n = 3517). MAIN MEASURES: The items were as follows: 1) a yes/no item on any sexual problems or concerns ("general screener"), 2) a yes/no item on problems experienced for 3 months or more during the past 12 months, with a list of examples ("long list screener"), and 3) an item identical to the long list screener except that examples appeared individually as response options and respondents could check all that applied ("checklist screener"). KEY RESULTS: All of the screeners tested showed evidence for basic validity and had minimal missing data. Percentages of women and men endorsing the screeners were 10 % and 15 % (general); 20 % and 17 % (long list); and 38 % and 30 % (checklist), respectively. Participants who endorsed the screeners had lower function compared to those who did not endorse them. CONCLUSIONS: We recommend the checklist screener for its specificity and ability to identify specific problems associated with decreased sexual function.

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.

Cancer patients' function, symptoms and supportive care needs: a latent class analysis across cultures.

PURPOSE: Patient-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. METHODS: This 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. RESULTS: Across 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. CONCLUSIONS: In this analysis, the level of burden experienced by patients was the key factor in defining classes.

Self-Reported Sexual Function Measures Administered to Female Cancer Patients: A Systematic Review, 2008-2014.

A systematic review was conducted to identify and characterize self-reported sexual function (SF) measures administered to women with a history of cancer. Using 2009 PRISMA guidelines, we searched electronic bibliographic databases for quantitative studies published January 2008-September 2014 that used a self-reported measure of SF, or a quality of life (QOL) measure that contained at least 1 item pertaining to SF. Of 1,487 articles initially identified, 171 were retained. The studies originated in 36 different countries with 23% from US-based authors. Most studies focused on women treated for breast, gynecologic, or colorectal cancer. About 70% of the articles examined SF as the primary focus; the remaining examined QOL, menopausal symptoms, or compared treatment modalities. We identified 37 measures that assessed at least one domain of SF, eight of which were dedicated SF measures developed with cancer patients. Almost one third of the studies used EORTC QLQ modules to assess SF, and another third used the Female Sexual Function Inventory. There were few commonalities among studies, though nearly all demonstrated worse SF after cancer treatment or compared to healthy controls. QOL measures are better suited to screening while dedicated SF questionnaires provide data for more in depth assessment. This systematic review will assist oncology clinicians and researchers in their selection of measures of SF and encourage integration of this quality of life domain in patient care.

Improving patients' understanding of terms and phrases commonly used in self-reported measures of sexual function.

INTRODUCTION: There is a significant gap in research regarding the readability and comprehension of existing sexual function measures. Patient-reported outcome measures may use terms not well understood by respondents with low literacy. AIM: This study aims to test comprehension of words and phrases typically used in sexual function measures to improve validity for all individuals, including those with low literacy. METHODS: We recruited 20 men and 28 women for cognitive interviews on version 2.0 of the Patient-Reported Outcome Measurement Information System(®) (PROMIS(®) ) Sexual Function and Satisfaction measures. We assessed participants' reading level using the word reading subtest of the Wide Range Achievement Test. Sixteen participants were classified as having low literacy. MAIN OUTCOME MEASURES: In the first round of cognitive interviews, each survey item was reviewed by five or more people, at least two of whom had lower than a ninth-grade reading level (low literacy). Patient feedback was incorporated into a revised version of the items. In the second round of interviews, an additional three or more people (at least one with low literacy) reviewed each revised item. RESULTS: Participants with low literacy had difficulty comprehending terms such as aroused, orgasm, erection, ejaculation, incontinence, and vaginal penetration. Women across a range of literacy levels had difficulty with clinical terms like labia and clitoris. We modified unclear terms to include parenthetical descriptors or slang equivalents, which generally improved comprehension. CONCLUSIONS: Common words and phrases used across measures of self-reported sexual function are not universally understood. Researchers should appreciate these misunderstandings as a potential source of error in studies using self-reported measures of sexual function. This study also provides evidence for the importance of including individuals with low literacy in cognitive pretesting during the measure development.