Establishing the sensitivity and specificity of the gynaecological cancer distress screen.

OBJECTIVE: Nuanced distress screening tools can help cancer care services manage specific cancer groups' concerns more efficiently. This study examines the sensitivity and specificity of a tool specifically for women with gynaecological cancers (called the Gynaecological Cancer Distress Screen or DT-Gyn). METHODS: This paper presents cross-sectional data from individuals recently treated for gynaecological cancer recruited through Australian cancer care services, partner organisations, and support/advocacy services. Receiver operating characteristics analyses were used to evaluate the diagnostic accuracy of the DT-Gyn against criterion measures for anxiety (GAD-7), depression (patient health questionnaire), and distress (IES-R and K10). RESULTS: Overall, 373 individuals aged 19-91 provided complete data for the study. Using the recognised distress thermometer (DT) cut-off of 4, 47% of participants were classified as distressed, while a cut-off of 5 suggested that 40% had clinically relevant distress. The DT-Gyn showed good discriminant ability across all measures (IES-R: area under the curve (AUC) = 0.86, 95% CI = 0.82-0.90; GAD-7: AUC = 0.89, 95% CI = 0.85-0.93; K10: AUC = 0.88, 95% CI = 0.85-0.92; PHQ-9: AUC = 0.85, 95% CI = 0.81-0.89) and the Youden Index suggested an optimum DT cut-point of 5. CONCLUSIONS: This study established the psychometric properties of the DT-Gyn, a tool designed to identify and manage the common sources of distress in women with gynaecological cancers. We suggest a DT cut point ≥5 is optimal in detecting 'clinically relevant' distress, anxiety, and depression in this population.

Feasibility and acceptability of a culturally-adapted Women's Wellness After Cancer Programme for Chinese women treated for gynaecological cancer: A pilot randomised controlled trial.

Objective: To assess the feasibility and acceptability of a culturally-adapted Women's Wellness After Cancer Programme (WWACPHK) for improving health-related quality of life, anxiety and depressive symptoms and enhancing self-efficacy in engaging in healthy lifestyles among Chinese women treated for gynaecological cancer. Methods: This pilot randomised controlled trial was conducted from May to December 2018. Twenty-six women aged 18 or above who had completed treatment for gynaecological cancer were recruited from a gynaecology outpatient clinic of a public hospital in Hong Kong. They were randomised into intervention (n = 15) or control (n = 11) groups. All data collectors were blinded to the group allocation. Intervention participants were given access to the WWACPHK website and an online discussion forum facilitated by a trained research nurse for 12 weeks, while control participants received standard care. Trial feasibility was assessed by recruitment, consent, and retention rates and website use. Acceptability was explored through semi-structured interviews. Additionally, we trialed the data collection procedure and collected preliminary data on health-related quality of life, anxiety and depressive symptoms, dietary and exercise self-efficacy. Results: Of the 26 participants (Median age = 53.5 years) randomised, three participants dropped out of the study. Recruitment, consent and retention of participants and website use were satisfactory. No posting was made on the discussion forum. The intervention participants (n = 13) exhibited significantly greater improvement than the controls (n = 10) in perceived self-efficacy in adhering to an exercise routine at post-intervention (Cohen's d effect size(d) = 1.06, 95% confidence interval (CI): 0.18, 1.92) and 12-weeks after completion (d = 1.24, 95% CI: 0.32, 2.13). All participants were satisfied with the intervention. Conclusions: The WWACPHK is feasible and acceptable to Chinese women treated for gynaecological cancer and may improve their exercise self-efficacy. A larger-scale study is required to confirm its effects. Trial registrationhttps://www.isrctn.com identifier: ISRCTN12149499.

Cultural Adaptation of the Younger Women's Wellness After Cancer Program for Younger Chinese Women With Breast Cancer: A Pilot Randomized Controlled Trial.

BACKGROUND: The incidence of breast cancer in younger women, that is, aged 50 years or younger, in Hong Kong is increasing. The Internet-based Younger Women's Wellness After Cancer Program (YWWACP) is a whole-lifestyle intervention that can help young women to manage their health and risks of chronic diseases. OBJECTIVES: The study aimed to test the acceptability and feasibility of the culturally adapted YWWACP in Hong Kong (YWWACPHK) and to evaluate its preliminary effects in improving health-related quality of life, distress, sexual function, menopausal symptoms, dietary intake, physical activity, and sleep among younger Chinese women with breast cancer. INTERVENTION/METHODS: Women aged 18 to 50 years with breast cancer were recruited from an oncology outpatient department. The participants in the intervention group received the 12-week YWWACPHK, whereas the control group received standard care. RESULTS: Sixty women consented to participate. At 12 weeks after intervention completion, the intervention group showed a significant increase in the pain subscale scores of sexual function and more improvement in the level of physical activity than the control group, with Hedge g effect sizes 0.66 and 0.65, respectively. Nineteen intervention group participants reported that they were satisfied with the program and suggestions for improvement were provided. CONCLUSION: The implementation of YWWACPHK is feasible. The preliminary findings suggest that YWWACPHK could increase the level of physical activity among the participants. IMPLICATIONS FOR PRACTICE: Nurses could utilize YWWACPHK to support younger Chinese patients with breast cancer to maintain a healthy lifestyle, subject to wider confirmation of these results through a larger study.

Prevalence and predictors of sleep problems in women following a cancer diagnosis: results from the women's wellness after cancer program.

PURPOSE: Using a discrete dataset from the Women's Wellness after Cancer Program (WWACP), we examine the prevalence and predictors of self-reported sleep problems in women previously treated for cancer. METHODS: Participants were 351 women (Mage = 53.2, SD = 8.8) from the WWACP who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Sleep problems were measured using the Pittsburgh Sleep Quality Index (PSQI). Baseline data (i.e. prior to intervention randomisation) were analysed. RESULTS: Most women (59%) reported clinically significant sleep disturbance (PSQI > 5), 40% reported insufficient sleep duration (< 7 h), 38% self-reported poor sleep quality and 28% reported poor habitual sleep efficiency (sleep efficiency < 75%). Fewer psychological and vasomotor climacteric symptoms, age < 45 years and having a partner were associated with reduced odds (AOR < 1) of sleep problems. Higher levels of pain-related disability, and an intermediate compared to 'high' level of education, were associated with increased odds (AOR > 1) of sleep problems. CONCLUSIONS: These findings confirm previous studies that have found a high prevalence of sleep problems in women previously treated for cancer. A range of sociodemographic, climacteric and pain-related factors were associated with sleep problems in this study. IMPLICATIONS FOR CANCER SURVIVORS: Targeted interventions to improve sleep quality after cancer treatment should be explored in this population. Predictors identified in this study could inform intervention targeting and development.

Sleep and health-related quality of life in women following a cancer diagnosis: results from the Women's Wellness after Cancer Program in Australia.

PURPOSE: Sleep disturbance after cancer treatment could compromise recovery. This paper examined the associations between post-treatment sleep problems and health-related quality of life (HRQoL), and the effectiveness of an e-enabled lifestyle intervention on sleep outcomes. METHODS: The Women's Wellness after Cancer Program (WWACP) was examined in a single blinded, multi-centre randomised controlled trial. Data were collected from 351 women (Mage = 53.2, SD = 8.8; intervention n = 175, control group n = 176) who had completed surgery, chemotherapy and/or radiotherapy for breast, gynaecological or blood cancers within the previous 24 months. Participants completed the Pittsburgh Sleep Quality Index (PSQI) at baseline (prior to intervention randomisation), and at 12 and 24 weeks later. Sociodemographic information, menopausal symptoms (Greene Climacteric Scale) and HRQoL (36-Item Short Form Health Survey; SF-36) were also collected. Linear panel regression was used to examine the association between sleep variables and SF36 Physical Component Summary (PCS) and Mental Component Summary (MCS) scores. A difference-in-difference regression model approach was used to examine the intervention effect on the sleep outcomes. RESULTS: After adjustment for potential confounders, the sleep variables (except sleep duration) significantly predicted physical, but not mental, HRQoL. There was no statistically significant effect of the intervention on sleep outcomes at 12 or 24 weeks. CONCLUSION: Women who have completed treatment for cancer experience sleep problems that are associated with decreased physical HRQoL. Improving sleep through targeted interventions should improve their physical HRQoL. Improved targeting of the sleep components of the WWACP should be explored.

Improving health-related quality of life in women with breast, blood, and gynaecological Cancer with an eHealth-enabled 12-week lifestyle intervention: the women's wellness after Cancer program randomised controlled trial.

BACKGROUND: The residual effects of cancer and its treatment can profoundly affect women's quality of life. This paper presents results from a multisite randomized controlled trial that evaluated the clinical benefits of an e-health enabled health promotion intervention (the Women's Wellness after Cancer Program or WWACP) on the health-related quality of life of women recovering from cancer treatment. METHODS: Overall, 351 women previously treated for breast, blood or gynaecological cancers were randomly allocated to the intervention (WWACP) or usual care arms. The WWACP comprised a structured 12-week program that included online coaching and an interactive iBook that targeted physical activity, healthy diet, stress and menopause management, sexual wellbeing, smoking cessation, alcohol intake and sleep hygiene. Data were collected via a self-completed electronic survey at baseline (t0), 12 weeks (post-intervention, t1) and 24 weeks (to assess sustained behaviour change, t2). The primary outcome, health-related quality of life (HRQoL), was measured using the Short Form Health Survey (SF-36). RESULTS: Following the 12-week lifestyle program, intervention group participants reported statistically significant improvements in general health, bodily pain, vitality, and global physical and mental health scores. Improvements were also noted in the control group across several HRQoL domains, though the magnitude of change was less. CONCLUSIONS: The WWACP was associated with improved HRQoL in women previously treated for blood, breast, and gynaecological cancers. Given how the synergy of different lifestyle factors influence health behaviour, interventions accounting for the reciprocity of multiple health behaviours like the WWACP, have real potential for immediate and sustainable change. TRIAL REGISTRATION: The protocol for this randomised controlled trial was submitted to the Australian and New Zealand Clinical Trials Registry on 15/07/2014 and approved on 28/07/2014 ( ACTRN12614000800628 ).

Determining the psychometric properties of the Greene Climacteric Scale (GCS) in women previously treated for breast cancer: A pooled analysis of data from the Women's Wellness after Cancer Programs.

OBJECTIVES: This paper examines the utility of a common climacteric symptoms scale, the Greene Climacteric Scale (GCS), in two groups of women with a history of breast cancer, those who were at menopause before commencing breast cancer treatment, and those who were not. STUDY DESIGN: This pooled analysis of 297 women previously diagnosed with breast cancer, aged 28-74 years, was undertaken on baseline data from two structured lifestyle interventions: the Women's Wellness After Cancer Program (WWACP) and the Younger Women's Wellness After Cancer Program (YWWACP). Data were split into two data subsets (women who were post-menopausal on commencement of breast cancer treatment and those who were either pre- or peri­menopausal). Multitrait/multi-item analysis was conducted to test scaling assumptions for each group separately. RESULTS: GCS domain scores were positively skewed, with significant floor effects for vasomotor symptoms and ceiling effects for sexual dysfunction. Multitrait analysis showed acceptable convergent validity (77% of items correlated ≥ 0.40 with their hypothesized domains) but weak discriminant validity for anxiety, depression, and somatic symptoms in both groups. The exploratory factor analysis in women who were menopausal at the commencement of breast cancer treatment and those who were not revealed distinct factor structures that accounted for 60.2% and 62.7% of the total variance, respectively. CONCLUSIONS: The original GCS factor structure was not replicated in this sample. Among women previously treated for breast cancer, the presence of multiple concurrent and severe menopausal symptoms with possible treatment-related causes underpins the need for a breast cancer-specific measure to enhance their identification and management. TRIAL IDS, AUSTRALIAN AND NEW ZEALAND CLINICAL TRIALS REGISTRY: WWACP, ACTRN12614000800628; YWWACP, ACTRN12614001087640.

A nurse-led sexual rehabilitation programme for rebuilding sexuality and intimacy after treatment for gynaecological cancer: Study protocol for a randomized controlled trial.

AIM: To implement a nurse-led sexual rehabilitation programme for gynaecological cancer (GC) survivors and to evaluate its effects on their sexual functioning, sexual distress and marital satisfaction. DESIGN: An assessor-blinded, randomized controlled trial. METHODS: The development of the nurse-led sexual rehabilitation intervention was guided by the concept of sexual health, as stated in the Neotheoretical Framework of Sexuality; the explicit permission giving, limited information, specific suggestions and intensive therapy model; and evidence-based nursing interventions for sexuality. Four intervention sessions will be delivered along the treatment trajectory. Women newly diagnosed (within 3 months) with GC will be recruited from the gynaecological units of three hospitals in Hong Kong. The participants (N = 172) will be randomly assigned to the intervention group to receive the nurse-led sexual rehabilitation programme, or to an attention control group to receive attention on four occasions during the same period when the intervention group receives the intervention. Sexual functioning, sexual distress and marital quality will be measured at baseline, 1 month after the completion of cancer treatment, after completion of the sexual rehabilitation programme and 12 months after cancer treatment. Semi-structured interviews will be conducted with the participants in the intervention group to explore their experiences with and feelings towards the programme. The study was funded in March 2019 and ethics approval was obtained in January 2019. DISCUSSION: Positive outcomes of the nurse-led sexual rehabilitation programme will contribute to scientific and practical knowledge about nursing interventions to help GC survivors and their partners to resume a satisfying intimate relationship and adapt to changes in sexuality after treatment. IMPACT: This study will contribute to the evidence for and advance research on the effectiveness of nurse-led sexuality rehabilitation interventions to support women and their partners to rebuild sexuality and intimacy after treatment for GC.

A psychometric evaluation of the Female Sexual Function Index in women treated for breast cancer.

BACKGROUND: We aimed to determine the psychometric properties and factor structure of the 19-item Female Sexual Function Index (FSFI) in 132 sexually active women previously treated for breast cancer. METHODS: Confirmatory factor analysis explored three models: (a) second-order six-factor, (b) six-factor, and (c) five-factor models combining the desire and arousal subscales. RESULTS: Results revealed excellent reliability for the total score (Cronbach's α = 0.94), and domain scores (all Cronbach's αs > 0.90), and good convergent and discriminant validity. The six-factor model provided the best fit of the models assessed, but a marginal overall fit (Tucker-Lewis index = 0.91, comparative fit index = 0.93, root mean square error of approximation = 0.09). Exploratory factor analyses (EFA) supported a four-factor structure, revealing an arousal/orgasm factor alongside the original pain, lubrication, and satisfaction domains. CONCLUSION: The arousal/orgasm factor suggests a "sexual response" construct, potentially arising from an underlying latent factor involving physical and mental stimulation in conceptualizations of arousal and orgasm in women treated for breast cancer. Finally, the EFA failed to capture an underlying desire factor, potentially due to measurement error associated with the small number of items (two) in this domain. Despite evidence that the FSFI has sound psychometric properties, our results suggest that the current conceptualizations of the FSFI might not accurately represent sexual functioning in women previously treated for breast cancer. Further research is required to elucidate the factors that influence desire, arousal, and orgasm in sexually active women in this population, and the reasons underlying sexual inactivity. Practical and theoretical implications for FSFI use in this population are discussed.

Screening for distress in women with gynaecological cancer: Adaptation of the distress thermometer for gynaecological oncology patients.

OBJECTIVE: Generic distress screening tools may not recognise the unique concerns reported in some cancer populations. The face and content validity of a screening tool derived from the National Cancer Comprehensive Network distress thermometer and problem list and adapted specifically for women with gynaecological cancer is presented. METHODS: Building on existing work, panels of clinicians and researchers, and focus groups with women treated for gynaecological cancer, developed a nuanced distress screening tool. RESULTS: The clinical reference group used an iterative process to reduce 54 items to 22 across four domains (practical/family/psychological/physical). These items were included in the draft tool, which was reviewed by two focus groups of long-term cancer survivors. Participants unanimously thought the tool was necessary though several changes were recommended. The final draft tool contained a global distress score and 25 items across the four domains. CONCLUSIONS: This measure provides a structured screening tool tailored to the concerns of women with gynaecological cancer, enhancing communication between clinicians and their patients about potentially identified and unrecognised sources of distress. Future research will focus on establishing sensitivity and specificity of this tool and further assessing its utility in clinical settings for all gynaecological cancers (including rare cancers like vulvar cancer).

Women's Wellness with Type 2 Diabetes Program (WWDP): Qualitative findings from the UK and Australian feasibility study.

AIMS: To undertake a qualitative study of a multimodal behavioural intervention and research protocol developed to improve wellness in women with type 2 diabetes mellitus (T2DM), the Women's Wellness with Type 2 Diabetes program (WWDP). METHODS: Semi-structured interviews were conducted with 15 participants who completed the WWDP. The interviews were transcribed verbatim and analysed thematically in an iterative process. RESULTS: Themes developing from interviews were broadly grouped into three domains, 1) Hope for a better everyday life; 2) Reflection of the program and its contents; and 3) Impacts on health and wellbeing. Participants viewed the WWDP as a necessary and valuable approach that was crucial in helping them adopt strategies to improve their wellbeing and prevent complications associated with T2DM. Some participants expressed ambivalence towards their adherence to the program due to day-to-day life commitments. The most appreciated feature of the program were the individualised approach adopted by the consultation nurse via skype, convenient appointments, the provision of credible and factual information and the accessible website. CONCLUSIONS: This study critically evaluated perceptions of participants towards the WWDP and provided important recommendations for improving the delivery and sustainability of the program in future. Participants perceived the program as an effective means of supporting their T2DM self-management and improving wellbeing.

International feasibility study for the Women's Wellness with Type 2 Diabetes Programme (WWDP): An eHealth enabled 12-week intervention programme for midlife women with type 2 diabetes.

AIMS: The current study aimed to examine feasibility of participant recruitment and retention rates for the Women's Wellness with Type 2 Diabetes program (WWDP), and to assess initial efficacy of the program in improving wellbeing outcomes. METHODS: 70 midlife women with type 2 diabetes mellitus (T2DM) participated in a 12-week wellness-focused intervention, the WWDP. The WWDP involved a structured book (with participatory activities), an interactive website and nurse consultations. This study had an Australian and a UK arm. Analyses were conducted using chi-square, McNemar, paired t-test, and Wilcoxon signed-ranks tests. RESULTS: The attrition rate for the sample was 22.2%. Overall, significant improvement was observed in diabetes distress (DD), diabetes self-efficacy, weight, BMI, menopausal symptoms and sleep symptoms from baseline to program completion at 12 weeks. Australian participants were also more likely to meet fruit recommendation guidelines and had significant waist- and hip-circumference reductions. CONCLUSIONS: Good retention rates and initial efficacy findings indicated feasibility of the WWDP as a promising 12-week health and wellness program for women with T2DM. They also suggest incorporating a focus on self-efficacy and gendered information may be important in improving wellness and health outcomes related to distress and menopause.

Physical activity and menopausal symptoms in women who have received menopause-inducing cancer treatments: results from the Women's Wellness After Cancer Program.

OBJECTIVE: This randomized controlled trial tested a digitally-delivered whole-of-lifestyle program for women previously treated for cancer. We investigated (1) associations between self-reported physical activity (PA) and menopausal symptoms and (2) if the intervention was associated with beneficial changes in PA and menopausal symptoms. METHODS: Women were randomized to intervention (n = 142) or control (n = 138). The intervention targeted lifestyle behavior including PA. Self-reported PA (International Physical Activity Questionnaire - Short Form) and menopausal symptom (Green Climacteric Scale, GCS) data were collected at baseline, with measures repeated at 12 weeks (end of intervention) and 24 weeks (to assess sustainability). Generalized estimating equation models explored associations between PA and GCS scores. Mixed-effects generalized equation models analyzed changes within and between groups in PA and GCS scores. RESULTS: Total GCS scores were 1.83 (95% CI: 0.11-3.55) and 2.72 (95% CI: 1.12-4.33) points lower in women with medium and high levels of PA, respectively, than in women with low levels of PA. Total average GCS scores were 1.02 (0.21-2.26) and 1.61 (0.34-2.87) points lower in those undertaking moderate or vigorous intensity PA, respectively. Time spent walking, and performing moderate and vigorous PA were not different between intervention and control. The average GCS decrease of 0.66 points (95% CI: 0.03-1.29; p time = 0.03) over 24 weeks was not different between groups. CONCLUSION: This exploratory study established a stepwise association between moderate and vigorous PA and a lower total menopausal symptom score. The intervention did not appear to increase self-reported PA in women treated for early stage breast, reproductive, and blood cancers.

The Association Between Web-Based or Face-to-Face Lifestyle Interventions on the Perceived Benefits and Barriers to Exercise in Midlife Women: Three-Arm Equivalency Study.

BACKGROUND: Noncommunicable diseases pose a significant threat to women's health globally, with most diseases being attributed to modifiable risk factors such as physical inactivity. Women perceive a range of benefits and barriers to exercise; however, there is little evidence about the effect of different lifestyle intervention delivery modes on perceptions of exercise. OBJECTIVE: This study aimed to compare the effect of a multiple health behavior change (MHBC) intervention called the Women's Wellness Program. This intervention was delivered in 3 different modes on perceived exercise benefits, perceived exercise barriers, and actual physical activity and exercise in midlife women. METHODS: Women aged 45 to 65 years were recruited via the study website. They were assigned in blocks to 3 different treatment groups (A: Web-based independent; B: face-to-face with nurse consultations; and C: Web-based with virtual nurse consultations). All participants received the 12-week intervention that utilizes principles from social-cognitive theory to provide a structured guide to promote healthy lifestyle behaviors with an emphasis on regular exercise and healthy eating. Data were collected using a self-report Web-based questionnaire at baseline (T1) and postintervention (T2) including perceived exercise benefits and barriers and exercise and physical activity. A data analysis examined both within- and between-group changes over time. RESULTS: Participants in this study (N=225) had a mean age of 50.9 years (SD 5.9) and most were married or living with a partner (83.3%, 185/225). Attrition was 30.2% with 157 participants completing the final questionnaire. Women in all intervention groups reported a significant increase in positive perceptions of exercise (P<.05); a significant increase in exercise and overall physical activity (P<.01) with moderate-to-large effect sizes noted for overall physical activity (d=0.5 to d=0.87). Participants receiving support from registered nurses in the face-to-face and Web-based groups had a greater magnitude of change in benefit perceptions and physical activity than those in the Web-based independent group. There was no significant change in exercise barrier perceptions within or between groups over time. CONCLUSIONS: The results of this study suggest that the (MHBC) intervention is effective in increasing exercise benefit perceptions, overall physical activity, and exercise in midlife women. Although Web-based programs are cost-effective and flexible and can be delivered remotely, providing a range of options including face-to-face group delivery and personalized electronic health coaching from registered nurses has the potential to enhance participant engagement and motivation.

Life stress and symptoms of anxiety and depression in women after cancer: The mediating effect of stress appraisal and coping.

OBJECTIVE: This paper examines the direct and intermediary relationships between life stress, stress appraisal, and resilience, and increased anxiety and depressive symptoms in Australian women after cancer treatment. METHODS: Data examined from 278 women aged 18 years and older previously treated for breast, gynaecological, or blood cancer, participating in the Australian Women's Wellness after Cancer Program. Serial mediation models interrogated the effect of stressful life events (List of Threatening Experiences-Modified) mediated by appraisal and coping (Perceived Stress Scale and Connor-Davidson Resilience Scale), on symptoms of anxiety and depression (Zung Self-rating Anxiety Scale and Center for Epidemiologic Studies Depression Scale). RESULTS: Over one-quarter (30.2%) of participants reported 1 or more stressful life events, other than their cancer, in the previous 6 months. Results indicate that perceived stress fully mediated the relationships between life stress, anxiety (indirect effect = 0.09, Bias-corrected bootstrap 95% CI 0.02-0.18, Percent mediation = 0.51), and depressive symptoms (indirect effect = 0.11, Bias-corrected bootstrap 95% CI 0.02-0.23, Percent mediation = 0.71) and accounted for more than half of the relationship between predictor and outcome. CONCLUSIONS: Findings indicate that stress appraisal mediated the relationship between past life stressors and anxiety and depressive symptoms. This analysis also highlights the need to consider wellness within a broader care context to identify potentially vulnerable patients to possibly avert future health concerns.

Exposure to stress across the life course and its association with anxiety and depressive symptoms: Results from the Australian Women's Wellness After Cancer Program (WWACP).

OBJECTIVES: Earlier life stressors can increase the risk of persistent anxiety and depressive symptoms in women after cancer, though our understanding of the underlying mechanisms is limited. In this study, we tested alternative life course models to determine which best described associations between exposure to stressors in childhood, adolescence, and adulthood, and self-reported health in women previously treated for breast, gynaecological, and blood cancer. STUDY DESIGN: Data were drawn from 351 Australian women within 2 years of completing active cancer treatment who were participating in the Women's Wellness After Cancer Program (WWACP) randomised controlled trial. A model-building framework compared "accumulative risk" and "sensitive period" stress exposure hypotheses with the saturated model to determine best fit. MAIN OUTCOME MEASURES: Symptoms of anxiety and depression were measured using the Center for Epidemiologic Studies Depression Scale (CES-D) and the Zung Self-rating Anxiety Scale (SAS). RESULTS: Participants with the greatest number of stressful life events (SLEs) reported higher anxiety scores and more depressive symptoms. Alternative life course models for psychological distress (measured through the CES-D and SAS) and stress were compared with the saturated model (i.e., the accumulative risk). The more restrictive "sensitive period" models were the best fit for depressive symptoms though none was significantly better than another. In contrast, an "early sensitive" model provided the best fit for anxiety data. CONCLUSIONS: Anxiety scores were higher in women with early life stressors. This study highlights the need for whole-of-life supportive care approaches for women previously treated for cancer, which should include targeted strategies for effective management of stress, anxiety and depression.

Menopausal symptom clusters and their correlates in women with and without a history of breast cancer: a pooled data analysis from the Women's Wellness Research Program.

OBJECTIVES: This analysis examined climacteric symptoms clusters in women with and without breast cancer, and explored how sociodemographic, health, and modifiable lifestyle factors predicted symptom clusters. METHODS: This pooled analysis of four Women's Wellness Research Program (WWRP) studies comprised individual-level data from 969 Australian women aged 40 to 63 years, 293 of whom had been previously treated for breast cancer and 678 without a breast cancer history. Climacteric symptoms, menopausal status, sociodemographic characteristics, and health and lifestyle factors were assessed. Principal component analysis was used to determine symptom clusters for each group separately before linear regression with backwards selection was used to identify the significant correlates of the identified clusters. RESULTS: Women with a history of breast cancer reported more sleep disturbance (P < 0.01), difficulty concentrating (P < 0.01), muscular/joint pain (P < 0.01), crying (P < 0.01) and irritability (P < 0.01), and vasomotor symptoms (P < 0.01) than women from the noncancer group. Principal component analysis with quartimax rotation revealed two distinct solutions explaining 60.9% and 57.6% of the variance in the groups, respectively. For both groups, symptom clusters were increased among those with unhealthy lifestyle behaviors (and chemotherapy among the after cancer group, P < 0.05 for all), though to a lesser extent in the breast cancer group. CONCLUSIONS: In this study, women after treatment for breast cancer reported a broad range of bothersome climacteric symptoms. Similar symptom clusters were also noted for women with and without a history of breast cancer, though correlates differed across groups, and might reflect different underlying etiologies.

The Women's wellness after cancer program: a multisite, single-blinded, randomised controlled trial protocol.

BACKGROUND: Despite advances in cancer diagnosis and treatment have significantly improved survival rates, patients post-treatment-related health needs are often not adequately addressed by current health services. The aim of the Women's Wellness after Cancer Program (WWACP), which is a digitised multimodal lifestyle intervention, is to enhance health-related quality of life in women previously treated for blood, breast and gynaecological cancers. METHODS: A single-blinded, multi-centre randomized controlled trial recruited a total of 351 women within 24 months of completion of chemotherapy (primary or adjuvant) and/or radiotherapy. Women were randomly assigned to either usual care or intervention using computer-generated permuted-block randomisation. The intervention comprises an evidence-based interactive iBook and journal, web interface, and virtual health consultations by an experienced cancer nurse trained in the delivery of the WWACP. The 12 week intervention focuses on evidence-based health education and health promotion after a cancer diagnosis. Components are drawn from the American Cancer Research Institute and the World Cancer Research Fund Guidelines (2010), incorporating promotion of physical activity, good diet, smoking cessation, reduction of alcohol intake, plus strategies for sleep and stress management. The program is based on Bandura's social cognitive theoretical framework. The primary outcome is health-related quality of life, as measured by the Functional Assessment of Cancer Therapy-General (FACT-G). Secondary outcomes are menopausal symptoms as assessed by Greene Climacteric Scale; physical activity elicited with the Physical Activity Questionnaire Short Form (IPAQ-SF); sleep measured by the Pittsburgh Sleep Quality Index; habitual dietary intake monitored with the Food Frequency Questionnaire (FFQ); alcohol intake and tobacco use measured by the Australian Health Survey and anthropometric measures including height, weight and waist-to-hip ratio. All participants were assessed with these measures at baseline (at the start of the intervention), 12 weeks (at completion of the intervention), and 24 weeks (to determine the level of sustained behaviour change). Further, a simultaneous cost-effectiveness evaluation will consider if the WWACP provides value for money and will be reported separately. DISCUSSION: Women treated for blood, breast and gynaecological cancers demonstrate increasingly good survival rates. However, they experience residual health problems that are potentially modifiable through behavioural lifestyle interventions such as the WWACP. TRIAL REGISTRATION: The protocol for this study was registered with the Australian and New Zealand Clinical Trials Registry, Trial ID: ACTRN12614000800628 , July 28, 2014.