Psychometric validation of the European Organisation for Research and Treatment of Cancer-Quality of Life Questionnaire Sexual Health (EORTC QLQ-SH22).

BACKGROUND: The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group developed a questionnaire to assess sexual health in patients with cancer and cancer survivors. This study evaluates the psychometric properties of the questionnaire. METHODS: The 22-item EORTC sexual health questionnaire (EORTC QLQ-SH22) was administered with the EORTC QLQ-C30 to 444 patients with cancer. The hypothesised scale structure, reliability and validity were evaluated through standardised psychometric procedures. RESULTS: The cross-cultural field study showed that the majority of patients (94.7%) were able to complete the QLQ-SH22 in less than 20 min; 89% of the study participants did not need any help to fill in the questionnaire. Multi-item multi-trait scaling analysis confirmed the hypothesised scale structure with two multi-item scales (sexual satisfaction, sexual pain) and 11 single items (including five conditional items and four gender-specific items). The internal consistency yielded acceptable Cronbach's alpha coefficients (.90 for the sexual satisfaction scale, .80 for the sexual pain scale). The test-retest correlations (Pearson's r) ranged from .70 to .93 except for the scale communication with professionals (.67) and male body image (.69). The QLQ-SH22 discriminates well between subgroups of patients differing in terms of their performance and treatment status. CONCLUSION: The study supports the reliability, the content and construct validity of the QLQ-SH22. The newly developed questionnaire is clinically applicable to assess sexual health of patients with cancer at different treatment stages and during survivorship for clinical trials and for clinical practice.

Phase 1-3 of the cross-cultural development of an EORTC questionnaire for the assessment of sexual health in cancer patients: the EORTC SHQ-22.

To develop and pretest an European Organization for the Research and Treatment of Cancer Sexual Health Questionnaire (EORTC SHQ-22) for the assessment of physical, psychological, and social aspects of sexual health (SH) in male and female cancer patients and survivors. Questionnaire construction started with creating a list of relevant SH issues based on a comprehensive literature review. Issues were subsequently evaluated for relevance and prioritization by 78 healthcare professionals (HCP) and 107 patients from 12 countries during in-depth interviews (phase 1). Extracted issues were operationalized into items (phase 2). Phase 3 focused on pretesting the preliminary questionnaire in a cross-cultural patient sample (n = 171) using debriefing interviews. Psychometric properties were preliminary determined using a principal component analysis and Cronbach's alpha. We derived 53 relevant SH issues from the literature. Based on HCP and patient interviews, 22 of these 53 issues were selected and operationalized into items. Testing the preliminary 22-item short questionnaire resulted in a change of wording in five items and two communication-related items; no items were removed. Preliminary psychometric analysis revealed a two-factor solution and 11 single items; both scales showed good reliability indicated by a Cronbach's alpha of 0.87 (sexual satisfaction) and 0.82 (sexual pain). Cross-cultural pretesting of the preliminary EORTC SH questionnaire has indicated excellent applicability, patient acceptance, and comprehensiveness as well as good psychometric properties. The final development phase, that is psychometric validation (phase four) including large-scale, cross-cultural field testing of the EORTC SHQ-22, has commenced.

Assessing Patient-reported Quality of Life Outcomes in Vulva Cancer Patients: A Systematic Literature Review.

OBJECTIVES: Vulva cancer (VC) treatment carries a high risk of severe late effects that may have a negative impact on quality of life (QoL). Patient-reported outcome measures (PROMs) are increasingly used when evaluating disease- and treatment-specific effects. However, the adequacy of measures used to assess sequelae and QoL in VC remains unclear. The aims of the present study were to evaluate disease- and treatment-related effects as measured by PROMs in VC patients and to identify available VC-specific PROMs. METHODS/MATERIALS: A systematic literature search from 1990 to 2016 was performed. The inclusion criterion was report of disease- and treatment-related effects in VC patients using PROMs in the assessment. Methodological and reporting quality was in accordance with the Preferred Reporting Items for Systematic Reviews and Meta-Analyses statement. This systematic review was performed as part of phase 1 of the development of a European Organisation for Research and Treatment of Cancer QoL questionnaire for VC patients. RESULTS: The search revealed 2299 relevant hits, with 11 articles extracted including a total of 535 women with VC; no randomized controlled trials were identified. The selected studies exhibited great heterogeneity in terms of PROMs use. Twenty-one different instruments assessed QoL. Most of the questionnaires were generic. Different issues (sexuality, lymphedema, body image, urinary and bowel function, vulva-specific symptoms) were reported as potentially important, but the results were not systematically collected. Only one VC-specific questionnaire was identified but did not allow for assessment and reporting on a scale level. CONCLUSIONS: Vulva cancer treatment is associated with considerable morbidity deteriorating QoL. To date, there is no validated PROM available that provides adequate coverage of VC-related issues. The study confirms the need for a VC-specific QoL instrument with sensitive scales that allows for broad cross-cultural application for use in clinical trials.

La comunicación entre el paciente oncológico y los profesionales. El cuestionario de comunicación de la EORTC / The communication between cancer patients and professionals. The EORTC communication questionnaire

Este trabajo pretende introducir el área de la comunicación entre el paciente oncológico y los profesionales, y destacar el impacto que tiene en el paciente. Además, se presenta el cuestionario de comunicación de la EORTC. La comunicación entre el paciente y los profesionales es uno de los elementos claves del soporte que se ofrece a dichos pacientes. En dicha comunicación participan un rango importante de profesionales. Hay una necesidad de realizar más investigación sobre la comunicación. Se presentan dos modelos principales de atención al paciente: el Paternalista y el de Atención Centrada en el Paciente con cáncer. Este último lleva asociada la Comunicación Centrada en el Paciente - CCP. Se revisa la relación entre comunicación y otros PRO: Calidad de Vida, información, y Satisfacción con los Cuidados. Existen diferencias culturales en comunicación que pueden estar relacionadas con el modelo de atención al paciente. El Grupo de Calidad de Vida de la Organización Europea para la Investigación y Tratamiento del Cáncer-EORTC está desarrollando una escala de comunicación entre el paciente oncológico y los profesionales. La mayoría del contenido de dicho cuestionario se centra en las conductas de los profesionales. Los aspectos culturales tienen un papel fundamental en el desarrollo del instrumento. El cuestionario se basa en el modelo de Comunicación Centrada en el Paciente - CCP. Se presenta el cuestionario EORTC QLQ-COMU26, que consta de seis escalas y cuatro ítems individuales. Se describen las tres primeras fases que se han dado en su creación. En la actualidad su funcionamiento psicométrico se está valorando en un estudio internacional (AU)

The aims of the present work are to introduce to the field of communication between the cancer patient and the professionals, to remark the positive influence communication may have on the patient, and to present the EORTC communication questionnaire. Communication between patient and professional is a key element in the support that is offered to cancer patients. It is important to consider different professionals communicate with cancer patients. There is a need of research in communication between patients and professionals. Two main models of patient care are presented: Paternalistic and Patient-Centered Cancer Care. Patient-Centered Care includes Patient- Centered Communication - PCC. The relation between communication and other PROs - Quality of Life, Information and Satisfaction with Care - is presented. There are cross-cultural differences in communication that could be related to the model of patient care. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group is developing a questionnaire to assess communication between cancer patient and the professionals. This Communication questionnaire mainly assesses professionals’ behaviors. Cultural aspects have a key role in the development of the EORTC questionnaire. This instrument is based on the Patient- Centered Communication - PCC model. The EORTC QLQ-COMU26 is presented. It includes six scales and four individual items. The three phases of the questionnaire development process are described. At the present moment the EORTC QLQ-COMU26 is being field-tested in a larger international study (phase IV), to ensure it is an appropriate and psychometrically valid instrument (AU)

EORTC QLQ-COMU26: a questionnaire for the assessment of communication between patients and professionals. Phase III of the module development in ten countries.

PURPOSE: Communication between patients and professionals is one major aspect of the support offered to cancer patients. The European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Group (QLG) has developed a cancer-specific instrument for the measurement of different issues related to the communication between cancer patients and their health care professionals. METHODS: Questionnaire development followed the EORTC QLG Module Development Guidelines. A provisional questionnaire was pre-tested (phase III) in a multicenter study within ten countries from five cultural areas (Northern and South Europe, UK, Poland and Taiwan). Patients from seven subgroups (before, during and after treatment, for localized and advanced disease each, plus palliative patients) were recruited. Structured interviews were conducted. Qualitative and quantitative analyses have been performed. RESULTS: One hundred forty patients were interviewed. Nine items were deleted and one shortened. Patients' comments had a key role in item selection. No item was deleted due to just quantitative criteria. Consistency was observed in patients' answers across cultural areas. The revised version of the module EORTC QLQ-COMU26 has 26 items, organized in 6 scales and 4 individual items. CONCLUSIONS: The EORTC COMU26 questionnaire can be used in daily clinical practice and research, in various patient groups from different cultures. The next step will be an international field test with a large heterogeneous group of cancer patients.

Prospective Fathers: Psychosocial Adaptation and Involvement in the Last Trimester of Pregnancy.

BACKGROUND: Paternal involvement in pregnancy has been recognized to have an impact on new-born's outcomes and only recently got under the spot light of mental health perspective. The aim of this study was to test differences in paternal involvement in pregnancy, perceived stress and relationship quality regarding complications in pregnancy and pregnancy duration (gestational weeks) in the last trimester of pregnancy. The role of personality traits (neuroticism and extroversion), relationship quality satisfaction and perceived stress in prospective father's perception of pregnancy involvement were examined. SUBJECTS AND METHOD: One-hundred forty-three primiparus couples in the last trimester of their pregnancy participated in the study. Prospective fathers completed a booklet with questionnaires including The Quality of Marriage Index, The Perceived Stress Scale, Eysenck Personality Questionnaire and Partner's Involvement in Pregnancy Scale. Prospective mothers completed only Eysenck Personality Questionnaire and questions on pregnancy complications and demographics. RESULTS: The prospective fathers showed high involvement in their partner's pregnancies, elevated levels of perceived stress and high relationship quality. There were found no differences in the above named variables regarding complications in pregnancy and pregnancy duration. Higher involvement of prospective fathers was related with older age, lower male neuroticism and higher female extroversion, better relationship quality and lower perceived stress. CONCLUSION: The findings demonstrate that prospective father's involvement in pregnancy is supported with psychological factors, namely personality traits, quality of relationship and perceived stress. These results should lead to target interventions that can modify and improve fathers' involvement perspective and promoting a couples mental health during pregnancy: thus clinically important for promotion of healthy prenatal behaviour and decrease in mothers' emotional distress.

Information disclosure to cancer patients: EORTC QLQ-INFO25 questionnaire.

Information is one of the main interventions given to cancer patients. Important research into information disclosure has been conducted and major advances have been made. We present the main theoretical models used to understand the information field and describe the current situation regarding the principal factors related to information: patients' needs, coping strategies, illness representations, cross-cultural differences, the role of the family, and strategies to enhance information giving, such as professional training and patient-targeted interventions. We highlight the need to assess patients' characteristics and desires through questionnaires and interviews and present the European Organisation for Research and Treatment of Cancer Quality of Life Group information questionnaire (EORTC QLQ-INFO 25). This instrument evaluates the level of information patients have received in different areas of their disease, treatment and care, and evaluates qualitative aspects. Finally, we describe the key areas of the information field and discuss how these areas could change in the future.

Psychometric validation of the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24).

AIM: A validation study was conducted to evaluate the psychometric properties of the European Organisation for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire-Endometrial Cancer Module (EORTC QLQ-EN24). This module was designed to assess disease and treatment specific aspects of the quality of life (QoL) of patients with endometrial cancer. METHODS: Two hundred and sixty-eight women with endometrial cancer were recruited in different phases of treatment: after pelvic surgery (Group 1); during adjuvant chemotherapy and/or radiotherapy (Group 2); after completion of treatment (Group 3). Patients completed the EORTC QLQ-C30, the endometrial cancer module and a short debriefing questionnaire. RESULTS: Multi-trait scaling analyses confirmed the hypothesised scale structure of the QLQ-EN24. Internal consistency reliability was good with Cronbach's alpha coefficients ranging from 0.74 to 0.86 (lymphoedema 0.80, urological symptoms 0.75, gastrointestinal symptoms 0.74, body image problems 0.86 and sexual/vaginal problems 0.86). Convergent and discriminant validity did not show any scaling errors for the subscales. The QLQ-EN24 module discriminated well between clinically different groups of patients. All items exhibited a high completion rate with less than 2% missing values except for the sexuality items (19%). CONCLUSION: The validation study supports the reliability, the convergent and divergent validity of the EORTC QLQ-EN24. This newly developed QLQ-EN24 module is a useful instrument for the assessment of the QoL in patients treated for endometrial cancer in clinical trials.

Sexual health difficulties in a population-based sample of Croatian women aged 18-35 and the effects of the dual (career and motherhood) role.

INTRODUCTION: The prevalence of sexual health difficulties among women in Croatia is presently unknown. Although women under 40 years of age may be exposed to the most intense demands of the dual role (career and motherhood), they are often assumed to be at lower risk for sexual difficulties. AIM: To assess the prevalence of sexual difficulties in a population-based study of women aged 18-35 and to explore the possible impact of the dual role on female sexual health. METHODS: The study was carried out in April 2010 on a multistage probability sample of 1,000 women aged 18-35 years. The response rate was 37.3% (1,680 women refused to participate). Multivariate logistic regression was used to analyze the correlates of sexual difficulties, including the dual role. MAIN OUTCOME MEASURES: The prevalence of the four most common female sexual health difficulties (lack of desire, lubrication difficulties, inability to reach orgasm, and pain during intercourse) were measured using the one-item indicators from the Global Study of Sexual Attitudes and Behaviors. RESULTS: Among coitally experienced women (N = 870), 27.6% reported having a lack of desire, 23.6% pain during sexual intercourse, 23.1% inability to reach orgasm, and 18.5% difficulties with genital lubrication. All four difficulties were negatively associated with sexual satisfaction, but only the lack of sexual interest and inability to reach orgasm seemed to substantially decrease sexual well-being. In multivariate analyses, age, education, being in a steady relationship or married, and partner communication about sexuality were significant correlates of reported sexual difficulties. The dual role was not a significant predictor of sexual health difficulties. CONCLUSIONS: A substantial proportion of participants reported one or more sexual health difficulties that lasted for at least 2 months. Women in the dual role were not at an increased risk of experiencing difficulties in sexual functioning.

Stress and anxiety in relation to amniocentesis: do women who perceive their partners to be more involved in pregnancy feel less stressed and anxious?

AIM: To assess whether imminent amniocentesis is associated with the perception of increased stress and state anxiety in women and their partners and whether greater partner's involvement during pregnancy alleviates women's stress and anxiety. METHODS: Two hundred twenty women awaiting amniocentesis and 90 male partners participated in the study. The State-Trait Anxiety Inventory, Perceived Stress Scale, and Partner's Involvement in Pregnancy Scale were administered. Statistical analysis was performed using t test, one way ANOVA, and Pearson correlation test. RESULTS: Imminent amniocentesis caused increased stress (17.6 +/- 6.8; t = 7.32, P < 0.001) and anxiety (42.0 +/- 11.9; t = 8.51, P < 0.001) in pregnant women, but not their partners (stress: 14.3 +/- 6.1; t = 0.17, P = 0.862; anxiety: 36.4 +/- 10.40; t = 0.66, P = 0.510). Stress was even more pronounced in women who experienced another stressor, like unplanned pregnancy, prenatal-related nausea and vomiting, or chromosomal aberration in a previous pregnancy. Significant negative correlation was found for women's stress and their perception of their partner's involvement during pregnancy (r = -0.23; P = 0.001); the same was not found for women's anxiety. CONCLUSION: Greater partner's involvement during pregnancy could diminish women's stress, but elevated state anxiety just before amniocentesis could not be alleviated in the same way. Thus, health care professionals must pay greater attention to the psychological status of women undergoing amniocentesis to help them better cope with the situation.