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      Anxiety and depression among women with newly diagnosed vulvar cancer – A nationwide longitudinal study

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          Abstract

          Introduction

          Our objective was to investigate the trajectories of anxiety, depression, emotional and social functioning in women with newly diagnosed vulvar cancer from the time of diagnosis to 12 months after treatment. A further aim was to identify risk factors for high levels of anxiety.

          Material and methods

          PROVE (PROspective Vulvar Cancer Evaluation) is a nationwide longitudinal cohort study investigating quality of life in women with newly diagnosed vulvar cancer by the following validated patient‐reported outcome measures at diagnosis, and 3 and 12 months after treatment: The Hospital Anxiety and Depression Scale, the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire C30, and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Vulvar module VU34. Mean scores, changes over time and associations were analyzed by generalized estimated equations and log‐linear regression models, adjusted for possible confounders.

          Results

          Between 2019 and 2021, 105 (69%) women completed the questionnaires at all three time points. At diagnosis, 42% of the women reported elevated anxiety levels, decreasing significantly to 30% during the first 12 months. Insomnia, persisting vulvar symptoms and high information needs were significantly associated with a high level of anxiety (relative risk [RR] 2.1, 95% CI 1.2–3.7 for insomnia; RR 2.8, 95% CI 1.7–4.6 for vulvar symptoms, RR 2.7, 95% CI 1.5–4.9 for information needs). We found a trend towards a higher level of anxiety in younger women (<65 years: RR 1.5, 95% CI 1.0–2.5). Participants reported a low and stable prevalence of depression (14%) and high social functioning throughout the study period.

          Conclusions

          Women with newly diagnosed vulvar cancer report a high level of anxiety at diagnosis. Despite a significant improvement, anxiety remains widely prevalent during the first year of follow‐up. Targeting insomnia, vulvar symptoms and unmet needs may decrease anxiety during surveillance.

          Abstract

          In this Swedish nationwide study, women reported a high level of anxiety and poor emotional functioning, particularly at diagnosis. Insomnia, persisting vulvar symptoms and high information needs were associated with elevated anxiety levels and could serve to identify women at risk and as intervention tools to decrease anxiety.

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          Most cited references40

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          The hospital anxiety and depression scale.

          A self-assessment scale has been developed and found to be a reliable instrument for detecting states of depression and anxiety in the setting of an hospital medical outpatient clinic. The anxiety and depressive subscales are also valid measures of severity of the emotional disorder. It is suggested that the introduction of the scales into general hospital practice would facilitate the large task of detection and management of emotional disorder in patients under investigation and treatment in medical and surgical departments.
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            The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Statement: guidelines for reporting observational studies.

            Much biomedical research is observational. The reporting of such research is often inadequate, which hampers the assessment of its strengths and weaknesses and of a study's generalisability. The Strengthening the Reporting of Observational Studies in Epidemiology (STROBE) Initiative developed recommendations on what should be included in an accurate and complete report of an observational study. We defined the scope of the recommendations to cover three main study designs: cohort, case-control, and cross-sectional studies. We convened a 2-day workshop in September 2004, with methodologists, researchers, and journal editors to draft a checklist of items. This list was subsequently revised during several meetings of the coordinating group and in e-mail discussions with the larger group of STROBE contributors, taking into account empirical evidence and methodological considerations. The workshop and the subsequent iterative process of consultation and revision resulted in a checklist of 22 items (the STROBE Statement) that relate to the title, abstract, introduction, methods, results, and discussion sections of articles. 18 items are common to all three study designs and four are specific for cohort, case-control, or cross-sectional studies. A detailed Explanation and Elaboration document is published separately and is freely available on the Web sites of PLoS Medicine, Annals of Internal Medicine, and Epidemiology. We hope that the STROBE Statement will contribute to improving the quality of reporting of observational studies.
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              The European Organization for Research and Treatment of Cancer QLQ-C30: a quality-of-life instrument for use in international clinical trials in oncology.

              In 1986, the European Organization for Research and Treatment of Cancer (EORTC) initiated a research program to develop an integrated, modular approach for evaluating the quality of life of patients participating in international clinical trials. We report here the results of an international field study of the practicality, reliability, and validity of the EORTC QLQ-C30, the current core questionnaire. The QLQ-C30 incorporates nine multi-item scales: five functional scales (physical, role, cognitive, emotional, and social); three symptom scales (fatigue, pain, and nausea and vomiting); and a global health and quality-of-life scale. Several single-item symptom measures are also included. The questionnaire was administered before treatment and once during treatment to 305 patients with nonresectable lung cancer from centers in 13 countries. Clinical variables assessed included disease stage, weight loss, performance status, and treatment toxicity. The average time required to complete the questionnaire was approximately 11 minutes, and most patients required no assistance. The data supported the hypothesized scale structure of the questionnaire with the exception of role functioning (work and household activities), which was also the only multi-item scale that failed to meet the minimal standards for reliability (Cronbach's alpha coefficient > or = .70) either before or during treatment. Validity was shown by three findings. First, while all interscale correlations were statistically significant, the correlation was moderate, indicating that the scales were assessing distinct components of the quality-of-life construct. Second, most of the functional and symptom measures discriminated clearly between patients differing in clinical status as defined by the Eastern Cooperative Oncology Group performance status scale, weight loss, and treatment toxicity. Third, there were statistically significant changes, in the expected direction, in physical and role functioning, global quality of life, fatigue, and nausea and vomiting, for patients whose performance status had improved or worsened during treatment. The reliability and validity of the questionnaire were highly consistent across the three language-cultural groups studied: patients from English-speaking countries, Northern Europe, and Southern Europe. These results support the EORTC QLQ-C30 as a reliable and valid measure of the quality of life of cancer patients in multicultural clinical research settings. Work is ongoing to examine the performance of the questionnaire among more heterogenous patient samples and in phase II and phase III clinical trials.
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                Author and article information

                Contributors
                diana.zach@regionstockholm.se
                Journal
                Acta Obstet Gynecol Scand
                Acta Obstet Gynecol Scand
                10.1111/(ISSN)1600-0412
                AOGS
                Acta Obstetricia et Gynecologica Scandinavica
                John Wiley and Sons Inc. (Hoboken )
                0001-6349
                1600-0412
                27 October 2023
                February 2024
                : 103
                : 2 ( doiID: 10.1111/aogs.v103.2 )
                : 396-406
                Affiliations
                [ 1 ] Department of Gynecological Cancer, Karolinska University Hospital, Department of Women's and Children's Health Karolinska Institutet Stockholm Sweden
                [ 2 ] Department of Gynecology and Obstetrics Aarhus University Hospital Aarhus Denmark
                [ 3 ] Department of Clinical Medicine Aarhus University Aarhus Denmark
                [ 4 ] Department of Obstetrics and Gynecology, Skåne University Hospital, Department of Clinical Sciences Lund University Lund Sweden
                [ 5 ] Department of Obstetrics and Gynecology, Sahlgrenska University Hospital, Gothenburg, Sahlgrenska Academy Gothenburg University Gothenburg Sweden
                [ 6 ] Department of Obstetrics and Gynecology and Department of Biomedical and Clinical Sciences Linköping University Linköping Sweden
                [ 7 ] Department of Oncology and Department of Biomedical and Clinical Sciences Linköping University Linköping Sweden
                Author notes
                [*] [* ] Correspondence

                Diana Zach, Department of Gynecological Cancer, Karolinska University Hospital, Department for Women's and Children's Health, Karolinska Institutet, 171 76 Stockholm, Sweden.

                Email: diana.zach@ 123456regionstockholm.se

                Author information
                https://orcid.org/0000-0002-2871-5951
                https://orcid.org/0000-0001-5702-4116
                https://orcid.org/0000-0002-1068-9732
                Article
                AOGS14710 AOGS-23-0665.R2
                10.1111/aogs.14710
                10823412
                37891709
                45aa4130-7a66-41f2-8884-516dfdc69334
                © 2023 The Authors. Acta Obstetricia et Gynecologica Scandinavica published by John Wiley & Sons Ltd on behalf of Nordic Federation of Societies of Obstetrics and Gynecology (NFOG).

                This is an open access article under the terms of the http://creativecommons.org/licenses/by-nc/4.0/ License, which permits use, distribution and reproduction in any medium, provided the original work is properly cited and is not used for commercial purposes.

                History
                : 08 October 2023
                : 14 August 2023
                : 13 October 2023
                Page count
                Figures: 3, Tables: 4, Pages: 11, Words: 6389
                Funding
                Funded by: Radiumhemmets Forskningsfonder , doi 10.13039/501100007232;
                Award ID: 009618
                Funded by: Stockholm läns landsting , doi 10.13039/501100011727;
                Award ID: ALF 2018‐2023
                Funded by: Svenska Sällskapet för Gynekologisk Cancer
                Award ID: Stipendium 2018
                Categories
                Original Research Article
                Oncology
                Custom metadata
                2.0
                February 2024
                Converter:WILEY_ML3GV2_TO_JATSPMC version:6.3.6 mode:remove_FC converted:29.01.2024

                Obstetrics & Gynecology
                anxiety,clinical oncology,patient‐reported outcomes,quality of life,vulvar cancer

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