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  • 1
    Online Resource
    Online Resource
    (186) VAGINAL CHANGES, SEXUAL FUNCTIONING AND DISTRESS OF WOMEN WITH LOCALLY ADVANCED CERVICAL CANCER TREATED IN THE EMBRACE VAGINAL MORBIDITY SUBSTUDY
    Oxford University Press (OUP) ; 2023
    In:  The Journal of Sexual Medicine Vol. 20, No. Supplement_4 ( 2023-07-06)
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    In: The Journal of Sexual Medicine, Oxford University Press (OUP), Vol. 20, No. Supplement_4 ( 2023-07-06)
    Abstract: The EMBRACE-vaginal morbidity substudy prospectively evaluated physician-assessed vaginal changes and patient-reported-outcomes (PRO) on vaginal and sexual functioning problems, and sexual distress in the first 2-years after radio(chemo)therapy with image-guided adaptive brachytherapy for locally advanced cervical cancer. Methods Eligible patients had FIGO 2009 stage IB1-IIIB cervical cancer with no or only limited ( & lt;5mm) vaginal involvement. Comprehensive assessment of vaginal changes was done before treatment, at 4-6 weeks and 3, 6, 12 and 24 months thereafter and graded using CTCAE. PRO were assessed at the same timepoints using validated Quality of Life and sexual questionnaires. Statistical methods included Generalized Linear Mixed Model analysis and Spearman’s rho correlation coefficients. Results 113 eligible patients were included. Over time, mostly mild (grade 1) vaginal changes were reported in 10.8-36.8% of the participants. At 24 months, 46.7% reported not being sexually active, mostly because of losing interest in sex or lacking a partner. Among the 41-53 sexually active women, 43.2-51.3% reported vaginal functioning problems starting at 4-6 weeks and more severe sexual problems and distress were reported by 5-15% of them. Physician-assessed vaginal changes and PRO sexual satisfaction differed significantly (p≤.05) between baseline and first follow-up, without further changes over time. No or only small associations between vaginal changes and vaginal functioning problems and sexual distress were found. Conclusions Relatively mild vaginal changes were reported after image-guided radio(chemo)therapy and brachytherapy according to EMBRACE-protocol. Although vaginal and sexual functioning problems and sexual distress were frequently reported, the rate of more substantial problems and distress was relatively low. These results are favorable compared to previous data, potentially due to the combination of tumors with limited vaginal involvement, EMBRACE-specific treatment optimization and rehabilitation recommendations. The lack of association between vaginal changes, vaginal functioning problems and sexual distress shows that sexual functioning is more complex than vaginal morbidity alone. Conflicts of Interest The authors declare that they have no competing interests. The EMBRACE vaginal morbidity substudy was supported by Elekta AB and Varian Medical system through unrestricted research grants and study sponsoring through the Medical University of Vienna.
    Type of Medium: Online Resource
    ISSN: 1743-6095 , 1743-6109
    URL: Article
    DOI: 10.1093/jsxmed/qdad062.045
    Language: English
    Publisher: Oxford University Press (OUP)
    Publication Date: 2023
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  • 2
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    Online Resource
    A sexual rehabilitation intervention for women with gynaecological cancer receiving radiotherapy (SPARC study): design of a multicentre randomized controlled trial
    Springer Science and Business Media LLC ; 2021
    In:  BMC Cancer Vol. 21, No. 1 ( 2021-12-04)
    Details
    In: BMC Cancer, Springer Science and Business Media LLC, Vol. 21, No. 1 ( 2021-12-04)
    Abstract: Sexual problems are frequently reported after treatment with radiotherapy (RT) for gynaecological cancer (GC), in particular after combined external beam radiotherapy and brachytherapy (EBRT+BT). Studies demonstrate that psychosexual support should include cognitive behavioural interventions and involvement of the patient’s partner, if available. Therefore, we developed a nurse-led sexual rehabilitation intervention, including these key components. The intervention was previously pilot-tested and results demonstrated that this intervention improves women’s sexual functioning and increases dilator compliance. The objective of the current study is to investigate the (cost-)effectiveness of the intervention compared to optimal care as usual (CAU). We expect that women who receive the intervention will report a statistically significant greater improvement in sexual functioning and – for women who receive EBRT+BT – higher compliance with dilator use, from baseline to 12 months post-RT than women who receive optimal care as usual (CAU). Methods/design The intervention is evaluated in the SPARC (Sexual rehabilitation Programme After Radiotherapy for gynaecological Cancer) study, a multicentre, randomized controlled trial (RCT). The primary endpoint is sexual functioning. Secondary outcomes include body image, fear of sexual activity, sexual-, treatment-related- and psychological distress, health-related quality of life and relationship satisfaction. A cost-effectiveness analysis (CEA) will be conducted in which the costs of the intervention will be related to shifts in other health care costs and the impact on patient outcome. The study sample will consist of 220 women with GC treated with RT in specialized GC treatment centres (N = 10). Participants are randomized to either the intervention- or CAU control group (1:1), and within each centre stratified by type of radiotherapy (EBRT+BT vs. EBRT only) and having a partner (yes/no). All women complete questionnaires at baseline (T1) and at 1, 3, 6, and 12 months post-RT (T2, T3, T4 and T5, respectively). Discussion There is a need to improve sexual functioning after RT for GC. This RCT will provide evidence about the (cost-)effectiveness of a nurse-led sexual rehabilitation intervention. If proven effective, the intervention will be a much needed addition to care offered to GC survivors and will result in improved quality of life. Trial registration ClinicalTrials.gov, NCT03611517 . Registered 2 August 2018.
    Type of Medium: Online Resource
    ISSN: 1471-2407
    URL: Article
    DOI: 10.1186/s12885-021-08991-2
    Language: English
    Publisher: Springer Science and Business Media LLC
    Publication Date: 2021
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