Pam Fradkin

Use of a cancer registry is preferable to a direct-to-community approach for recruitment to a cohort study of wellbeing in women newly diagnosed with invasive breast cancer

BackgroundBreast cancer (BC) mortality is declining such that the number of survivors of BC in the community is increasing. BC survivors report a range of sequelae from their cancer and its management beyond the period of their immediate treatment. Previous studies to document these have generally been small, clinic-based or commenced years after diagnosis. We have recruited a large cohort of women newly diagnosed with invasive BC from the community who will be followed for five years in order to systematically document the physical, psychological and socio-economic consequences of BC and its treatment. The aim of this manuscript is to describe the issues encountered in the recruitment of this community-based study population.MethodsWomen residing in the southern Australian state of Victoria newly diagnosed with invasive BC were recruited to this cohort study using two approaches: directly from the community using an advertising campaign and contemporaneously using an invitation to participate from the Victorian Cancer Registry (VCR).ResultsOver the two and half year recruitment period, 2135 women were recruited and agreed to receive the enrollment questionnaire (EQ). Of these, 1684 women were eligible and completed an EQ, with the majority of participants having been recruited through the VCR (n = 1321). Only 16% of women contacted by the VCR actively refused participation following a letter of invitation and phone follow-up. The age distribution and tumour characteristics of participants are consistent with state-wide data and their residential postcodes include 400 of a possible 699. Recruitment through a direct community awareness program aimed at women with newly diagnosed invasive BC was difficult, labour-intensive and expensive. Barriers to the recruitment process were identified.ConclusionMost of the women in this study were recruited through a state-based cancer registry. Limitations to recruitment occurred because we required questionnaires to be completed within 12 months of diagnosis in a setting where there is several months delay in notification of new cases to the Registry. Characteristics of the cohort suggest that it is generally representative of women in the state of Victoria newly diagnosed with BC.

A pragmatic approach to the classification of menopausal status for community-based research.

Objective: The aim of this article was to describe a pragmatic approach to the menopausal status classification of clinical research study participants that allows for women who have gynecological circumstances that mask their natural menstrual pattern. Design: We demonstrate the application of an algorithm for the Health and Wellbeing After Breast Cancer study based on self-reported menstrual cycle pattern, gynecological history, presence or absence of vasomotor symptoms, and systemic hormone use to classify women with newly diagnosed breast cancer as premenopausal, perimenopausal, or postmenopausal for research purposes. Results: Within 12 months of their breast cancer diagnosis, 1,684 participants, mean ± SD age 57.4 ± 11.9 years, completed a comprehensive womens health questionnaire. Menopausal status in 71.8% of the women was classified by reported bilateral oophorectomy, age, greater than 12 months of amenorrhea, or regular menstrual cycles and absence of symptoms. Status in the remainder was classified by progression through the decision tree. Conclusions: The Health and Wellbeing After Breast Cancer study menopausal classification algorithm is a useful tool for research involving female participants that allows for the classification of women who have had a hysterectomy and/or use systemic hormonal contraception or hormone therapy.

Menopausal symptoms in breast cancer survivors nearly 6 years after diagnosis.

ObjectiveWe investigated the prevalence and severity of menopausal symptoms, nearly 6 years from diagnosis, in women who had not experienced recurrent breast cancer or a new primary breast cancer (active disease) and were no longer taking oral adjuvant endocrine therapy (OAET). MethodsA total of 1,683 women recruited within 12 months of diagnosis with invasive breast cancer completed an enrollment questionnaire and five annual follow-up questionnaires. Only women who had never reported active disease and were not taking OAET at their fifth follow-up were included in the analysis. Women previously recruited to a study of sex steroid levels provided community control data. Menopausal symptoms were assessed with the Menopause-Specific Quality of Life Questionnaire (MenQOL). ResultsEight hundred forty-three women without active disease and not taking OAET completed the fifth follow-up questionnaire, on average, 5.8 years after diagnosis. Most had stage I (59.5%) and hormone receptor–positive disease (77.9%) at diagnosis and were postmenopausal (92.8%). Those aged 50 to 59 years were more likely to report any symptoms (P = 0.01) and more severe symptoms (P < 0.001) than older and younger women. There was no independent impact of chemotherapy on MenQOL vasomotor and sexual domain scores. Women with breast cancer had significantly higher vasomotor domain (P ⩽ 0.002) and sexual domain (P ⩽ 0.004) scores than community controls. ConclusionsVasomotor and sexual symptoms are highly prevalent in breast cancer survivors and are not simply a function of OAET or chemotherapy. Given the adverse impact of these symptoms, effective interventions are needed to alleviate them in women who have completed their breast cancer treatment.

Breast cancer survivors' beliefs about the causes of breast cancer.

Objective: To explore the beliefs held by breast cancer (BC) survivors about the factors that contribute to the development of their BC.

Understanding discontinuation of oral adjuvant endocrine therapy by women with hormone receptor-positive invasive breast cancer nearly 4 years from diagnosis.

ObjectiveThe aim of this study was to investigate the extent of discontinuation of oral adjuvant endocrine therapy (OAET) in women nearly 4 years from the diagnosis of their first episode of invasive breast cancer and the reasons for such discontinuation. MethodsWe used a large, prospective cohort study of women who had been diagnosed with their first episode of invasive breast cancer between 2004 and 2006, recruited through a state-based cancer registry. All participants completed an enrollment questionnaire (EQ) within 12 months of diagnosis and annual follow-up questionnaires (FQs) thereafter. The data in this report were obtained from the EQ and the first three FQs. ResultsA total of 1,370 women with hormone receptor–positive disease completed the EQ. At the completion of the third FQ nearly 4 years from diagnosis, 1,193 women remained in the study. Use of OAET peaked by 2 years postdiagnosis. At nearly 4 years from diagnosis, 18% of the 1,193 women remaining in the study were not taking OAET. Of these women, just more than half had ceased therapy mainly owing to a range of adverse effects, predominantly estrogen deficiency symptoms, but the remainder (8% of women remaining in the study) had never used OAET. ConclusionsOur study confirms that early discontinuation of OAET due to estrogen deficiency symptoms remains an important issue despite calls for strategies to address this problem. The number of women potentially suitable for OAET but not receiving it was almost as great as the number of those who have discontinued therapy.

Prevalence of menopausal symptoms in Asian midlife women: a systematic review

Abstract Objective To systematically review published articles for the prevalence of menopausal symptoms in Asian women. Methods A comprehensive and systematic literature search was performed using MEDLINE, EMBASE, PsycINFO, CINAHL, SCOPUS and Google scholar in June 2013 to retrieve all English-language studies that included information on the prevalence of menopausal symptoms in women living in Asian countries. Risk of bias of included studies was assessed using a risk-of-bias tool explicitly designed for the systematic review of prevalence studies. Results Twenty-three independent studies met our inclusion criteria. Physical symptoms were the most prevalent symptoms compared to psychological, vasomotor and sexual symptoms. There was a wide variation in the prevalence of all symptoms across the menopausal stages due to the differences in modes of recruitment, study design, sampling procedures, the time frame over which symptoms were assessed and use of different diagnostic or screening tools. A high level of bias was observed for both external and internal validity for most studies. Conclusion Although there is a wide variation in the reported prevalence of menopausal symptoms, physical symptoms predominate, followed by psychological symptoms, vasomotor symptoms and sexual symptoms. Further studies of representative samples are necessary to understand whether the variations in prevalence reporting are a function of methodological issues or due to ethnic, cultural or other socioeconomic differences.

Breast reconstruction following mastectomy for invasive breast cancer is strongly influenced by demographic factors in women in Victoria, Australia.

This study explored factors associated with the likelihood of reconstruction after unilateral mastectomy and the wellbeing of women after reconstruction. Data were from a questionnaire completed on average 1.8 years after diagnosis by 1429 women in the BUPA Health and Wellbeing After Breast Cancer Study. Logistic regression was used to model factors associated with reconstruction. The Psychological General Wellbeing Questionnaire was used to assess wellbeing. A total of 25.4% of 366 women who had a unilateral mastectomy had undergone a reconstruction nearly two years after diagnosis. Being younger (p<0.001), educated beyond school (p<0.04), living in the metropolitan area (p<0.001), having private health insurance (p=0.003), not having dependent children (p=0.004) and not having radiotherapy (p<0.001) explained just over 40% of the variation in reconstruction status. There was a modest difference between women who did and did not have a reconstruction in terms of wellbeing. Demographic factors strongly influence the likelihood of reconstruction after mastectomy.

Use of complementary and alternative therapy by women in the first 2 years after diagnosis and treatment of invasive breast cancer.

Objective: Our aim was to document patterns of consultation with alternative practitioners, use of complementary and alternative medicine (CAM) commonly used to alleviate menopausal symptoms, and lifestyle changes made by women in the first 2 years after their diagnosis with invasive breast cancer. Methods: A total of 1,588 women in the MBF Foundation Health and Wellbeing After Breast Cancer Study completed both the enrollment questionnaire and the first follow-up questionnaire (FQ1), on average, 41 and 92 weeks after diagnosis, respectively. The Menopause Quality of Life Questionnaire and the Psychological General Wellbeing Index were included in the FQ1. Logistic regression analysis was used to examine characteristics associated with consulting a CAM practitioner or using CAMs. Results: At the time of completion of the FQ1, 16.4% of women had consulted a CAM practitioner and 10.6% reported using at least one CAM commonly used to alleviate menopausal symptoms. Women who consulted a CAM practitioner and women who were using at least one CAM at the time of completion of the FQ1 were, on average, younger and more educated and had a higher Menopause Quality of Life Questionnaire score than did women who did not. Of the women, 33.6% reported having made a dietary change, and the most common lifestyle change was an increase in physical activity, which was reported by 29.0% of women. Conclusions The frequency of use of CAMs in common usage for menopausal symptoms by women with breast cancer was lower than anticipated, increased with time from diagnosis, and is associated with more severe menopausal symptoms.

Lack of knowledge of hormone receptor status and use of endocrine therapy in invasive breast cancer.

OBJECTIVE The aim of this study was to investigate the level of understanding in women with newly diagnosed invasive breast cancer of the key clinical features of their disease that are important determinants in treatment decision making. METHODS The 1684 women aged between 26 and 88 years at diagnosis enrolled in a 5-year cohort study were asked by questionnaire about their estrogen receptor (ER) and progesterone receptor (PR) status and about their past or current treatment with adjuvant endocrine therapy. Information was linked with their ER and PR status determined from the histopathology report. Logistic regression analysis was used to explore the relationship between age and education status and the likelihood of being able to correctly report hormone receptor status, as well as the relationship between the likelihood of receiving adjuvant endocrine therapy and knowledge of hormone receptor status in women who were ER or PR positive. RESULTS Not being able to correctly report hormone receptor status was associated with being older and having a lower level of education. Of women who were ER positive or PR positive or both and were at least 40 weeks from diagnosis, having received some form of endocrine therapy was significantly associated with self-identification as being ER or PR positive (OR=1.82, 95% CI 1.24-2.68, p=0.002), even when age was taken into account. CONCLUSIONS That self-knowledge of hormone receptor status was independently associated with likelihood of receiving endocrine therapy suggests that the methods of helping women understand the nature of their breast cancer are worthy of review.

Vasomotor symptoms and urogenital atrophy in older women: a systematic review

Abstract Objective Our aim was to systematically review published articles for the prevalence of persistent estrogen depletion symptoms among women aged 65+ years. Methods A systematic literature search of English-language publications was performed using MEDLINE, EMBASE, CINAHL, and PsycINFO. Twenty-three studies that included information on the prevalence of vasomotor and/or urogenital atrophy symptoms among older women (65 + years) met our inclusion criteria. Risk of bias of the included studies was assessed using a risk-of-bias tool explicitly designed for the systematic review of prevalence studies. Results The available data suggest that vasomotor symptoms are experienced by a considerable proportion of older women, that symptoms of urogenital atrophy including urinary incontinence are widespread, and that women remain sexually active well into later life. A high degree of variability was observed for the prevalence of estrogen deficiency symptoms for women age 65+ years. Discrepancies in modes of recruitment, sampling procedures, time frames over which symptoms were assessed and use of different and non-validated assessment tools contributed to the inconsistencies across the published studies. Conclusion Larger and appropriately sampled studies, employing validated questionnaires, are still needed to establish the prevalence of persistent estrogen depletion symptoms in women aged 65+ years.