Obstetrics and Gynaecology - Research Publications
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ItemPriorities for alleviating menopausal symptoms after cancer(LIPPINCOTT WILLIAMS & WILKINS, 2023-02)OBJECTIVE: To determine treatment priorities in women cancer patients attending a dedicated Menopausal Symptoms After Cancer service. METHODS: Cancer type and stage were abstracted from medical records. Women ranked up to three symptoms as treatment priorities from the list "hot flushes/night sweats," "mood changes," "vaginal dryness or soreness," "sleep disturbances," "feeling tired or worn out (fatigue)," "sexual problems and/or pain with intercourse," "joint pain," and "something else" with free-text response. For each prioritized symptom, patients completed standardized patient-reported outcome measures to determine symptom severity and impact. RESULTS: Of 189 patients, most had breast cancer (48.7%, n = 92), followed by hematological (25.8%, n = 49), gynecological (18.0%, n = 34), or colorectal (2.6%, n = 5). The highest (first-ranked) treatment priority was vasomotor symptoms (33.9%, n = 64), followed by fatigue (18.0%, n = 34), vaginal dryness/soreness (9.5%, n = 18), and sexual problems/pain with intercourse (9.5%, n = 18). Symptoms most often selected in the top three ("prioritized") were fatigue (57.7%, n = 109), vasomotor symptoms (57.1%, n = 108), and sleep disturbance (49.2%, n = 93). In patients who prioritized vasomotor symptoms, medians on the "problem," "distress," and "interference" dimensions of the Hot Flash Related Daily Interference Scale were, respectively, 6.0 (interquartile range [IQR], 5.0-8.0), 5.5 (IQR, 3.0-8.0), and 5.0 (IQR, 3.-7.0), indicating moderate severity. In patients who prioritized fatigue, the median Fatigue Scale score was 28 (IQR, 19-36), 37% worse than general population. CONCLUSIONS: Vasomotor symptoms, fatigue, sexual problems, and vaginal dryness/soreness were the leading priorities for treatment. Understanding symptom severity and patient priorities will inform better care for this growing population.
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ItemRandomized control trial of a decision aid for women considering elective egg freezing: The Eggsurance study protocol(SAGE PUBLICATIONS LTD, 2022)BACKGROUND: Uptake of elective egg freezing has increased globally. The decision to freeze eggs is complex, and detailed, unbiased information is needed. To address this, we developed an online Decision Aid for women considering elective egg freezing. Decision Aids are the standard of care to support complex health decisions. OBJECTIVES: This study will measure the impact of the Decision Aid on decision-making (e.g. decisional conflict, engagement in decision-making, distress, and decision delay) and decision quality (e.g. knowledge, level of informed choice, and regret). METHODS AND ANALYSIS: A single-blinded two-arm parallel-group randomized controlled trial. Women considering elective egg freezing will be recruited using social media, newsletters, and fertility clinics. Data will be collected at baseline (recruitment), 6-month, and 12-month post-randomization. The primary hypothesis is that the intervention (Decision Aid plus Victorian Assisted Reproductive Technology Authority website) will reduce decisional conflict (measured using the Decisional Conflict Scale) at 12 months more than control (Victorian Assisted Reproductive Technology Authority website only). Secondary outcomes include engagement in decision-making (Perceived Involvement in Care Scale), distress (Depression, Anxiety, and Stress Scale), decision delay, knowledge, informed choice (Multi-dimensional Measure of Informed Choice), and decisional regret (Decisional Regret Scale). ETHICS: The study was approved by the University of Melbourne Human Research Ethics Committee (Ethics ID: 2056457). Informed consent will be obtained from all participants prior to enrolment. DISCUSSION: This is the first international randomized controlled trial that aims to investigate the effect of an elective egg freezing Decision Aid on decision-related outcomes (e.g. decisional conflict, informed choice, and regret). It is anticipated that participants who receive the Decision Aid will have better decision and health outcomes. REGISTRATION DETAILS: ACTRN12620001032943: Comparing different information resources on the process and quality of decision-making in women considering elective egg freezing.
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ItemThe menopause after cancer study (MACS)-A multimodal technology assisted intervention for the management of menopausal symptoms after cancer-Trial protocol of a phase II study(ELSEVIER INC, 2021-12)AIMS: This study will aim to assess if a composite intervention which involves a specific evidence-based intervention for management of insomnia and non-hormonal pharmacotherapy to manage vasomotor symptoms (VMS) of menopause can improve quality of life for patients experiencing troublesome VMS after cancer who are not eligible for standard systemic menopausal hormone therapy (MHT). Participants will be asked to nominate a partner or companion to support them during this process as an additional form of support. BACKGROUND: The menopause transition and its symptoms represent a significant challenge for many patients after cancer treatment, particularly those for whom conventional MHT is contraindicated. These symptoms include hot flushes, night sweats, urogenital symptoms as well as mood and sleep disturbance. These symptoms can exacerbate the consequences of cancer and its treatment. METHODS: We will recruit 205 women who meet inclusion criteria and enrol them on a composite intervention which consists of four parts: (1) use of non-hormonal pharmacotherapy for the management of troublesome vasomotor symptoms of menopause tailored to the timing of predominant symptoms, (2) digital cognitive behavioural therapy for insomnia through the web based Sleepio service, (3) access to information regarding self-management strategies for the common symptoms of menopause and their consequences and (4) identification of a partner or other support person who commits to providing support during the study period. OUTCOMES: The primary outcome will be cancer specific quality of life measured by the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (EORTC QLQ C30). Secondary outcomes will include sleep quality, bother/interference of vasomotor symptoms and communication between couples about their cancer diagnosis and their menopause experience. Sleep will be measured using the Sleep Condition Indicator (SCI) tool, bother/interference of vasomotor symptoms will be measured by the Hot Flush Rating Scale (HFRS) and communication will be measured using the Couples' Illness Communication Scale (CICS). These validated scales will be administered at baseline, four weeks, three months and six months. REGISTRATION: This study is registered on ClinicalTrials.gov with number NCT04766229.
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ItemExploring knowledge, attitudes and experience of genitourinary symptoms in women with early breast cancer on adjuvant endocrine therapy(WILEY, 2018-03)Clinical trials of adjuvant endocrine therapy in women with early breast cancer have consistently reported that genitourinary symptoms are common. However, little is known about women's experiences of genitourinary symptoms, their views about the symptoms and how they impact on their lives. The aim of this study was to explore knowledge, attitudes and experiences of genitourinary symptoms among women receiving adjuvant endocrine therapy for early breast cancer. Thirty-two semi-structured interviews were conducted and subjected to a rigorous qualitative analysis. Genitourinary symptoms were commonly reported to negatively impact on personal, social and physical activities, were often attributed to anxiety and stress and were a source of embarrassment. Women also commented on the limited information available or provided regarding the potential genitourinary adverse effects of adjuvant endocrine therapy. There was a general lack of awareness that their symptoms could be associated with or exacerbated by adjuvant endocrine therapy. Women indicated a preference to receive information and advice about potential management options from either their general practitioner or specialist. These findings underscore the importance of improving communication and increasing awareness among both clinicians and patients about the potential impact of adjuvant endocrine therapy on genitourinary symptoms.
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ItemNo Preview AvailableHow common is add-on use and how do patients decide whether to use them? A national survey of IVF patients(OXFORD UNIV PRESS, 2021-07)STUDY QUESTION: What is the prevalence and pattern of IVF add-on use in Australia? SUMMARY ANSWER: Among women having IVF in the last 3 years, 82% had used one or more IVF add-on, most commonly acupuncture, preimplantation genetic testing for aneuploidy and Chinese herbal medicine. WHAT IS KNOWN ALREADY: IVF add-ons are procedures, techniques or medicines which may be considered nonessential to IVF, but usually used in attempts to improve the probability of conception and live birth. The use of IVF add-ons is believed to be widespread; however, there is little information about the prevalence and patterns of use in different settings. STUDY DESIGN, SIZE, DURATION: An online survey was distributed via social media to women in Australia who had undergone IVF since 2017. Women were excluded if they were gestational surrogates, used a surrogate, or underwent ovarian stimulation for oocyte donation or elective oocyte cryopreservation only. The survey was open from 21 June to 14 July 2020. PARTICIPANTS/MATERIALS, SETTING, METHODS: Survey questions included demographics, IVF and medical history, and use of IVF add-ons including details of the type of add-on, costs and information sources used. Participants were also asked about the relative importance of evidence regarding safety and effectiveness, factors considered in decision-making and decision regret. MAIN RESULTS AND THE ROLE OF CHANCE: A total of 1590 eligible responses were analysed. Overall, 82% of women had used one or more add-ons and these usually incurred an additional cost (72%). Around half (54%) had learned about add-ons from their fertility specialist, and most reported that the decision to use add-ons was equally shared with the specialist. Women placed a high level of importance on scientific evidence for safety and efficacy, and half (49%) assumed that add-ons were known to be safe. Most women experienced some regret at the decision to use IVF add-ons (66%), and this was more severe among women whose IVF was unsuccessful (83%) and who believed that the specialist had a larger contribution to the decision to use add-ons (75%). LIMITATIONS, REASONS FOR CAUTION: This retrospective survey relied on patient recall. Some aspects were particularly prone to bias such as contributions to decision-making. This approach to capturing IVF add-on use may yield different results to data collected directly from IVF clinics or from fertility specialists. WIDER IMPLICATIONS OF THE FINDINGS: There is a very high prevalence of IVF add-on use in Australia which may be generalisable to other settings with similar models of IVF provision. Although women placed high importance on scientific evidence to support add-ons, most add-ons do not have robust evidence of safety and effectiveness. This suggests that IVF patients are not adequately informed about the risks and benefits of IVF add-ons, or are not aware of the paucity of evidence to support their use. STUDY FUNDING/COMPETING INTEREST(S): This research was supported by a McKenzie Postdoctoral Fellowship Grant (University of Melbourne), a Department of Obstetrics and Gynaecology Innovation Grant (University of Melbourne) and an NHMRC Investigator Grant (APP1195189). A.P. declares that he provides fertility services at Melbourne IVF (part of Virtus Health). J.W. reports grants from Wellcome Trust, during the conduct of the study, and that publishing benefits his career. The remaining authors report no conflict of interest. TRIAL REGISTRATION NUMBER: N/A.
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ItemExploring the facilitators and barriers to using an online infertility risk prediction tool (FoRECAsT) for young women with breast cancer: a qualitative study protocol.(BMJ Journals, 2020-02-10)INTRODUCTION: As cancer treatments may impact on fertility, a high priority for young patients with breast cancer is access to evidence-based, personalised information for them and their healthcare providers to guide treatment and fertility-related decisions prior to cancer treatment. Current tools to predict fertility outcomes after breast cancer treatments are imprecise and do not offer individualised prediction. To address the gap, we are developing a novel personalised infertility risk prediction tool (FoRECAsT) for premenopausal patients with breast cancer that considers current reproductive status, planned chemotherapy and adjuvant endocrine therapy to determine likely post-treatment infertility. The aim of this study is to explore the feasibility of implementing this FoRECAsT tool into clinical practice by exploring the barriers and facilitators of its use among patients and healthcare providers. METHODS AND ANALYSIS: A cross-sectional exploratory study is being conducted using semistructured in-depth telephone interviews with 15-20 participants each from the following groups: (1) premenopausal patients with breast cancer younger than 40, diagnosed within last 5 years, (2) breast surgeons, (3) breast medical oncologists, (4) breast care nurses (5) fertility specialists and (6) fertility preservation nurses. Patients with breast cancer are being recruited from the joint Breast Service of three affiliated institutions of Victorian Comprehensive Cancer Centre in Melbourne, Australia-Peter MacCallum Cancer Centre, Royal Melbourne Hospital and Royal Women's Hospital, and clinicians are being recruited from across Australia. Interviews are being audio recorded, transcribed verbatim and imported into qualitative data analysis software to facilitate data management and analyses. ETHICS AND DISSEMINATION: The study protocol has been approved by Melbourne Health Human Research Ethics Committee, Australia (HREC number: 2017.163). Confidentiality and privacy are maintained at every stage of the study. Findings will be disseminated through peer-reviewed scholarly and scientific journals, national and international conference presentations, social media, broadcast media, print media, internet and various community/stakeholder engagement activities.
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ItemAssessing the usefulness and acceptability of a low health literacy online decision aid about reproductive choices for younger women with breast cancer: the aLLIAnCE pilot study protocol.(Springer Science and Business Media LLC, 2017)BACKGROUND: Young women diagnosed with breast cancer may be confronted by many difficult decisions, especially around fertility preservation prior to commencing cancer treatment. The information to be conveyed is complex, and it may be difficult to weigh up the risks and benefits of the different fertility preservation options available. This complexity is compounded by the widespread low levels of literacy and health literacy in Australia, which may result in greater difficulties in understanding available health information and in decision-making. METHODS/DESIGN: A working group of experts have developed a fertility-related online decision aid for a low health literacy population, guided by health literacy principles. The decision aid will be pilot tested with 30 women diagnosed with early breast cancer between 5 years and 6 months previously. To be eligible, at the time of diagnosis, women must be between 18 and 40 years (inclusive), pre-menopausal, have no history of metastatic disease, have not completed their families, be able to give informed consent and have low health literacy. Participants will be asked to reflect back to the time in which they were diagnosed. Participants will complete a questionnaire before and after reviewing the decision aid to determine the feasibility, use and acceptability of the decision aid. The decision aid will be modified accordingly. Participants may also choose to review a previously developed (high literacy) decision aid and provide feedback in comparison to the low health literacy decision aid. DISCUSSION: This project represents the first study to develop an online fertility decision aid developed from low health literacy models in the context of breast cancer. It is anticipated that the low health literacy decision aid will be useful and acceptable to young women with low health literacy who have been diagnosed with breast cancer and that it will be preferred over the high literacy decision aid. TRIAL REGISTRATION: ACTRN12615001364561p.
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ItemNo Preview AvailableA clinical guide to the management of genitourinary symptoms in breast cancer survivors on endocrine therapy(SAGE PUBLICATIONS LTD, 2017-04)There is increasing attention and concern about managing the adverse effects of adjuvant endocrine therapy for women with early breast cancer as the side effects of therapy influence compliance and can impair quality of life (QoL). Most side effects associated with tamoxifen (TAM) and aromatase inhibitors (AIs) are directly related to estrogen deprivation, and the symptoms are similar to those experienced during natural menopause but appear to be more severe than that seen in the general population. Prolonged estrogen deprivation may lead to atrophy of the vulva, vagina, lower urinary tract and supporting pelvic structures, resulting in a range of genitourinary symptoms that can in turn lead to pain, discomfort, impairment of sexual function and negatively impact on multiple domains of QoL. The genitourinary side effects may be prevented, reduced and managed in most cases but this requires early recognition and appropriate treatment. We provide an overview of practical clinical approaches to understanding the pathophysiology and the management of genitourinary symptoms in postmenopausal women receiving adjuvant endocrine therapy for breast cancer.
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ItemNo Preview AvailableIt's Now or Never: Fertility-Related Knowledge, Decision-Making Preferences, and Treatment Intentions in Young Women With Breast Cancer-An Australian Fertility Decision Aid Collaborative Group Study(AMER SOC CLINICAL ONCOLOGY, 2011-05-01)PURPOSE: For many young women with early breast cancer, fertility is a priority. Interventions to retain fertility options generally need to be accessed before chemotherapy, but many women do not receive information regarding these options in a timely fashion. Knowledge about fertility and decisional conflict has not previously been measured in young patients with breast cancer considering future pregnancies. METHODS: One hundred eleven young women with early breast cancer who had not yet completed their families were recruited around the time of diagnosis. Knowledge regarding fertility-related information, decisional conflict, and preferences regarding fertility information and decision making was measured. RESULTS: From a potential fertility-related knowledge score of 10, the mean was 5.2 (standard deviation = 2.3; range, 0 to 10). Decreased knowledge was associated with increased decisional conflict about pursuing fertility preserving interventions (odds ratio [OR] = 0.57; 95% CI, 0.44 to 0.73; P < .001). Thirty-one percent of women reported that they would consider undertaking in vitro fertilization (IVF) as a method to conserve their fertility, whereas 38% were uncertain. Consideration of IVF was not related to whether subjects were in a committed relationship (OR = 1.20; P = .716) or a definite desire for more children (OR = 1.54; P = .513). CONCLUSION: Around diagnosis, many young patients with breast cancer have low levels of knowledge about fertility issues. Further, low knowledge is associated with increased decisional conflict, which is likely to undermine the quality of decision making. These findings suggest that targeted and timely fertility information may reduce decisional conflict and increase informed choice. Neither relationship status nor firm plans regarding future children reliably predict desire to pursue fertility preservation.
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ItemBreast cancer in young women and its impact on reproductive function(OXFORD UNIV PRESS, 2009)BACKGROUND: Breast cancer is the most common cancer in women in developed countries, and 12% of breast cancer occurs in women 20-34 years. Survival from breast cancer has significantly improved, and the potential late effects of treatment and the impact on quality of life have become increasingly important. Young women constitute a minority of breast cancer patients, but commonly have distinct concerns and issues compared with older women, including queries regarding fertility, contraception and pregnancy. Further, they are more likely than older women to have questions regarding potential side effects of therapy and risk of relapse or a new primary. In addition, many will have symptoms associated with treatment and they present a management challenge. Reproductive medicine specialists and gynaecologists commonly see these women either shortly after initial diagnosis or following adjuvant therapy and should be aware of current management of breast cancer, the options for women at increased genetic risk, the prognosis of patients with early stage breast cancer and how adjuvant systemic treatments may impact reproductive function. METHODS: No systematic literature search was done. The review focuses on the current management of breast cancer in young women and the impact of treatment on reproductive function and subsequent management. With reference to key studies and meta-analyses, we highlight controversies and current unanswered questions regarding patient management. RESULTS: Chemotherapy for breast cancer is likely to negatively impact on reproductive function. A number of interventions are available which may increase the likelihood of future successful pregnancy, but the relative safety of these interventions is not well established. For those who do conceive following breast cancer, there is no good evidence that pregnancy is detrimental to survival. We review current treatment; effects on reproductive function; preservation of fertility; contraception; pregnancy; breastfeeding and management of menopausal symptoms following breast cancer. CONCLUSION: This paper provides an update on the management of breast cancer in young women and is targeted at reproductive medicine specialists and gynaecologists.