Implementing a nurse-delivered cognitive behavioural therapy intervention to reduce the impact of hot flushes/night sweats in women with breast cancer: a qualitative process evaluation of the MENOS4 trial.

BACKGROUND: Hot flushes and night sweats are life-altering symptoms experienced by many women after breast cancer treatment. A randomised controlled trial (RCT) was conducted to explore the effectiveness of breast care nurse (BCN)-led group cognitive behavioural therapy (CBT). This paper reported findings from a qualitative process evaluation to optimise the CBT intervention and explore the determinants of implementation into routine practice. METHODS: Qualitative process evaluation occurred in parallel with the RCT to explore patient and healthcare staff experiences and perspectives using semi-structured interviews pre-and post-intervention. Normalisation Process Theory (NPT) informed data collection, analysis, and reporting of findings. The analysis involved inductive thematic analysis, NPT coding manual and subsequent mapping onto NPT constructs. RESULTS: BCNs (n = 10), managers (n = 2), surgeons (n = 3) and trial participants (n = 8) across six recruiting sites took part. All stakeholders believed group CBT met a need for non-medical hot flushes/night sweats treatment, however, had little exposure or understanding of CBT before MENOS4. BCNs believed the work fitted with their identity and felt confident in delivering the sessions. Despite little understanding, patients enrolled onto group CBT because the BCNs were trusted to have the knowledge and understanding to support their needs and despite initial scepticism, reported great benefit from group-based participation. Both managers and surgeons were keen for BCNs to take responsibility for all aspects of CBT delivery, but there were some tensions with existing clinical commitments and organisational priorities. CONCLUSIONS: Both healthcare staff and patient participants believe BCN-led group CBT is a beneficial service but barriers to long-term implementation into routine care suggest there needs to be multi-level organisational support. TRIAL REGISTRATION: NCT02623374 - Last updated 07/12/2015 on ClinicalTrials.gov PRS.

A multicentre randomised controlled trial of a guided self-help cognitive behavioural therapy to MANage the impact of hot flushes and night sweats in patients with prostate CANcer undergoing androgen deprivation therapy (MANCAN2).

BACKGROUND: Androgen deprivation therapy (ADT) is prescribed to almost half of all men diagnosed with prostate cancer. Although ADT is effective treatment, with virtually all men with advanced disease showing initial clinical response, it is associated with troublesome side effects including hot flushes and night sweats (HFNS). HFNS can be both frequent and severe and can have a significant impact on quality of life (QoL). They can occasionally be so debilitating that patients stop ADT altogether, despite the increased risk of disease relapse or death. Previous research has found that guided self-help cognitive behavioural therapy (CBT) can be effective in reducing HFNS due to ADT when delivered by a clinical psychologist. MANCAN2 aims test whether we can train the existing NHS Prostate Cancer Nurse Specialist (CNS) team to deliver guided self-help CBT and whether it is effective in reducing the impact of HFNS in men undergoing ADT. METHODS: MANCAN2 is a phase III multicentre randomised controlled trial and process evaluation. Between 144 and 196 men with prostate cancer who are currently receiving ADT and are experiencing problematic HFNS will be individually randomised in a 1:1 ratio in groups of 6-8 participants to either treatment as usual (TAU) or participation in the guided self-help CBT intervention plus TAU. A process evaluation using the normalisation process theory (NPT) framework will be conducted, to understand the CNS team's experiences of delivering the intervention and to establish the key influencers to its implementation as a routine practice service. Fidelity of implementation of the intervention will be conducted by expert assessment. The cost-effectiveness of the intervention and participant adherence to the trial intervention will also be assessed. DISCUSSION: MANCAN2 will advance the program of work already conducted in development of management strategies for HFNS. This research will determine whether the severity of ADT-induced HFNS in men with prostate cancer can be reduced by a guided self-help CBT intervention, delivered by the existing NHS prostate cancer CNS team, within a multicentre study. The emphasis on this existing team, if successful, should facilitate translation through to implementation in routine practice. TRIAL REGISTRATION: ISRCTN reference 58720120 . Registered 13 December 2022.

Disparities in access to mobile devices and e-health literacy among breast cancer survivors.

BACKGROUND: The number of e-health interventions developed for breast cancer survivors continues to increase. However, issues with engagement and retention are common. This study aimed to explore e-health literacy rates and access to smartphones and tablets in a large sample of breast cancer survivors. METHODS: In study 1, women were recruited from outpatient breast clinics across England and Wales. Eligible women were asked to complete a questionnaire pack to assess their access to devices and their e-health literacy. Multiple regression analyses were run to assess the relationship between technology access and e-health literacy with sociodemographic variables such as age, social deprivation, and education. Study 2 presents a smaller sample recruited through social media who answered a questionnaire relating to use of mobile devices and e-health, and apps. RESULTS: Two thousand nine women participated in the study. Seventy-one percent had access to a smartphone, 54% had access to a tablet, and 20% did not have access to either device. Multiple logistic regressions showed that women who were younger, had higher levels of education, and who were from less deprived areas were more likely to have access to either device. Poorer e-health literacy was associated with being older, having less education, and not having access to a mobile device. CONCLUSIONS: Whilst the results show relatively widespread access to mobile devices, there is evidence of a digital divide across some groups. Online interventions should be developed with consideration of individuals who are less e-health-literate and less technologically adept in order to increase the likelihood of engagement.

Development of a self-management intervention to improve tamoxifen adherence in breast cancer survivors using an Intervention Mapping framework.

OBJECTIVE: Up to 50% of women prescribed tamoxifen do not take it as prescribed for the full duration, which increases risk of recurrence and mortality. The current paper describes the development of a self-management intervention aiming to improve adherence in breast cancer survivors taking tamoxifen. METHODS: The intervention was developed following an Intervention Mapping approach. The content of the intervention was determined by theories of health behaviour and empirical evidence. Development was an iterative process involving input from expert researchers, clinicians and patient representatives. RESULTS: The intervention was designed to improve both intentional and unintentional non-adherence. Key features included modifying unhelpful illness and treatment beliefs, improving confidence for coping with side effects and developing strategies for remembering to take tamoxifen. CONCLUSION: Intervention Mapping proved a useful tool for developing an intervention which is grounded in theory and empirical evidence. The intervention has the potential to improve adherence in breast cancer survivors but needs to be trialled before the effectiveness of the intervention can be determined.

Effectiveness of nurse-led group CBT for hot flushes and night sweats in women with breast cancer: Results of the MENOS4 randomised controlled trial.

OBJECTIVE: Troublesome hot flushes and night sweats (HFNS) are experienced by many women after treatment for breast cancer, impacting significantly on sleep and quality of life. Cognitive behavioural therapy (CBT) is known to be effective for the alleviation of HFNS. However, it is not known if it can effectively be delivered by specialist nurses. We investigated whether group CBT, delivered by breast care nurses (BCNs), can reduce the impact of HFNS. METHODS: We recruited women with primary breast cancer following primary treatment with seven or more HFNS/week (including 4/10 or above on the HFNS problem rating scale), from six UK hospitals to an open, randomised, phase 3 effectiveness trial. Participants were randomised to Group CBT or usual care (UC). The primary endpoint was HFNS problem rating at 26 weeks after randomisation. Secondary outcomes included sleep, depression, anxiety and quality of life. RESULTS: Between 2017 and 2018, 130 participants were recruited (CBT:63, control:67). We found a 46% (6.9-3.7) reduction in the mean HFNS problem rating score from randomisation to 26 weeks in the CBT arm and a 15% (6.5-5.5) reduction in the UC arm (adjusted mean difference -1.96, CI -3.68 to -0.23, P = .039). Secondary outcomes, including frequency of HFNS, sleep, anxiety and depression all improved significantly. CONCLUSION: Our results suggest that specialist nurses can be trained to deliver CBT effectively to alleviate troublesome menopausal hot flushes in women following breast cancer in the NHS setting.

Moderators of the effect of psychosocial interventions on fatigue in women with breast cancer and men with prostate cancer: Individual patient data meta-analyses.

OBJECTIVE: Psychosocial interventions can reduce cancer-related fatigue effectively. However, it is still unclear if intervention effects differ across subgroups of patients. These meta-analyses aimed at evaluating moderator effects of (a) sociodemographic characteristics, (b) clinical characteristics, (c) baseline levels of fatigue and other symptoms, and (d) intervention-related characteristics on the effect of psychosocial interventions on cancer-related fatigue in patients with non-metastatic breast and prostate cancer. METHODS: Data were retrieved from the Predicting OptimaL cAncer RehabIlitation and Supportive care (POLARIS) consortium. Potential moderators were studied with meta-analyses of pooled individual patient data from 14 randomized controlled trials through linear mixed-effects models with interaction tests. The analyses were conducted separately in patients with breast (n = 1091) and prostate cancer (n = 1008). RESULTS: Statistically significant, small overall effects of psychosocial interventions on fatigue were found (breast cancer: ß = -0.19 [95% confidence interval (95%CI) = -0.30; -0.08]; prostate cancer: ß = -0.11 [95%CI = -0.21; -0.00]). In both patient groups, intervention effects did not differ significantly by sociodemographic or clinical characteristics, nor by baseline levels of fatigue or pain. For intervention-related moderators (only tested among women with breast cancer), statistically significant larger effects were found for cognitive behavioral therapy as intervention strategy (ß = -0.27 [95%CI = -0.40; -0.15]), fatigue-specific interventions (ß = -0.48 [95%CI = -0.79; -0.18]), and interventions that only targeted patients with clinically relevant fatigue (ß = -0.85 [95%CI = -1.40; -0.30]). CONCLUSIONS: Our findings did not provide evidence that any selected demographic or clinical characteristic, or baseline levels of fatigue or pain, moderated effects of psychosocial interventions on fatigue. A specific focus on decreasing fatigue seems beneficial for patients with breast cancer with clinically relevant fatigue.

Internet-based cognitive behavioral therapy aimed at alleviating treatment-induced menopausal symptoms in breast cancer survivors: Moderators and mediators of treatment effects.

OBJECTIVES: Results from our recently conducted randomized controlled trial (RCT) indicated that Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, is effective in reducing the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms in breast cancer survivors with treatment-induced menopausal symptoms. STUDY DESIGN: We used data of 235 women and compared the iCBT groups combined (n = 156) with the control group (n = 79). Bootstrapped multiple regression analyses with interaction terms (group x potential moderator) or indirect effects (mediation pathway) were conducted. MAIN OUTCOME MEASURES: Reductions in perceived impact of HF/NS and overall levels of menopausal symptoms. RESULTS: Women with lower levels of education benefited most from the iCBT. Age, time since diagnosis, current endocrine treatment, oophorectomy, frequency of HF/NS, and psychological distress did not moderate the treatment effects. Factors that mediated treatment effects were the development of healthier beliefs about experiencing hot flushes in a social context, about the impact of night sweats on sleep and daily functioning, and about the ability to control and cope with hot flushes. The acquisition of behavioral coping strategies and decreased psychological distress did not mediate treatment effects. CONCLUSION: The results suggest that women with lower levels of education may benefit most from the current iCBT program, with or without therapist support. The development of healthier HF/NS beliefs contribute significantly to the observed positive effect of iCBT on the burden of menopausal symptoms. CLINICAL TRIAL INFORMATION: NCT02672189.

Cost-utility, cost-effectiveness, and budget impact of Internet-based cognitive behavioral therapy for breast cancer survivors with treatment-induced menopausal symptoms.

PURPOSE: Internet-based cognitive behavioral therapy (iCBT), with and without therapist support, is effective in reducing treatment-induced menopausal symptoms and perceived impact of hot flushes and night sweats (HF/NS) in breast cancer survivors. The aim of the current study was to evaluate the cost-utility, cost-effectiveness, and budget impact of both iCBT formats compared to a waiting list control group from the Dutch healthcare perspective. METHODS: A Markov model was constructed with a 5-year time horizon. Costs and health outcomes were measured alongside a randomized controlled clinical trial and included quality-adjusted life years (QALYs), overall levels of menopausal symptoms, and perceived impact of HF/NS. Uncertainty was examined using probabilistic and deterministic sensitivity analyses, together with a scenario analysis incorporating a different perspective. RESULTS: iCBT was slightly more expensive than the waiting list control, but also more effective, resulting in incremental cost-utility ratios of €23,331/QALY and €11,277/QALY for the guided and self-managed formats, respectively. A significant reduction in overall levels of menopausal symptoms or perceived impact of HF/NS resulted in incremental costs between €1460 and €1525 for the guided and €500-€753 for the self-managed format. The estimated annual budget impact for the Netherlands was €192,990 for the guided and €74,592 for the self-managed format. CONCLUSION: Based on the current trial data, the results indicate that both guided and self-managed iCBT are cost-effective with a willingness-to-pay threshold of well below €30,000/QALY. Additionally, self-managed iCBT is the most cost-effective strategy and has a lower impact on healthcare budgets.

Nonadherence to tamoxifen in breast cancer survivors: A 12 month longitudinal analysis.

OBJECTIVE: Previous research has shown that up to 50% of breast cancer survivors prescribed tamoxifen do not take it as recommended, which is associated with increased risk of recurrence and mortality. Little research has attempted to identify modifiable psychosocial factors associated with tamoxifen nonadherence. This study aimed to examine how tamoxifen adherence rates change over a year and to identify modifiable predictors of nonadherence. METHOD: Three hundred and forty-five breast cancer survivors who were in their first year of tamoxifen prescription were sent questionnaires at 4 points over a 12-month period. Questionnaires assessed demographic and clinical factors, side effects, beliefs about the illness and medication, social support, distress and tamoxifen adherence. Adherence was assessed using the Medication Adherence Rating Scale. Latent Growth Modeling was used to identify predictors of tamoxifen nonadherence. RESULTS: Reported rates of nonadherence increased over time (37-48%). Several demographic, clinical, and psychosocial variables were associated with nonadherence. Women who were nonadherent were more likely to be from a minority ethnic group, to have more negative medication beliefs and to have lower confidence in their ability to take tamoxifen. CONCLUSIONS: These demographic and clinical variables can be used to identify women at higher risk of nonadherence. The modifiable psychosocial variables can be used as the basis for psychological interventions to improve adherence in this population. Interventions should focus on both intentional and unintentional nonadherence. (PsycINFO Database Record (c) 2019 APA, all rights reserved).

Efficacy of Internet-Based Cognitive Behavioral Therapy for Treatment-Induced Menopausal Symptoms in Breast Cancer Survivors: Results of a Randomized Controlled Trial.

PURPOSE: We evaluated the effect of Internet-based cognitive behavioral therapy (iCBT), with or without therapist support, on the perceived impact of hot flushes and night sweats (HF/NS) and overall levels of menopausal symptoms (primary outcomes), sleep quality, HF/NS frequency, sexual functioning, psychological distress, and health-related quality of life in breast cancer survivors with treatment-induced menopausal symptoms. PATIENTS AND METHODS: We randomly assigned 254 breast cancer survivors to a therapist-guided or a self-managed iCBT group or to a waiting list control group. The 6-week iCBT program included psycho-education, behavior monitoring, and cognitive restructuring. Questionnaires were administered at baseline and at 10 weeks and 24 weeks postrandomization. We used mixed-effects models to compare the intervention groups with the control group over time. Significance was set at P < .01. An effect size (ES) of .20 was considered small, .50 moderate and clinically significant, and .80 large. RESULTS: Compared with the control group, the guided and self-managed iCBT groups reported a significant decrease in the perceived impact of HF/NS (ES, .63 and .56, respectively; both P < .001) and improvement in sleep quality (ES, .57 and .41; both P < .001). The guided group also reported significant improvement in overall levels of menopausal symptoms (ES, .33; P = .003), and NS frequency (ES, .64; P < .001). At longer-term follow-up (24 weeks), the effects remained significant, with a smaller ES for the guided group on perceived impact of HF/NS and sleep quality and for the self-managed group on overall levels of menopausal symptoms. Additional longer-term effects for both intervention groups were found for hot flush frequency. CONCLUSION: iCBT, with or without therapist support, has clinically significant, salutary effects on the perceived impact and frequency of HF/NS, overall levels of menopausal symptoms, and sleep quality.

Neurokinin 3 receptor antagonism rapidly improves vasomotor symptoms with sustained duration of action.

OBJECTIVE: Seventy percent of postmenopausal women experience vasomotor symptoms, which can be highly disruptive and persist for years. Hormone therapy and other treatments have variable efficacy and/or side effects. Neurokinin B signaling increases in response to estrogen deficiency and has been implicated in hot flash (HF) etiology. We recently reported that a neurokinin 3 receptor (NK3R) antagonist reduces HF in postmenopausal women after 4 weeks of treatment. In this article we report novel data from that study, which shows the detailed time course of this effect. METHODS: Randomized, double-blind, placebo-controlled, single-center, crossover trial of an oral NK3R antagonist (MLE4901) for vasomotor symptoms in women aged 40 to 62 years, experiencing ≥7 HF/24 hours some of which were reported as bothersome or severe (Clinicaltrials.gov NCT02668185). Thirty-seven women were randomized and included in an intention-to-treat analysis. To ascertain the therapeutic profile of MLE4901, a post hoc time course analysis was completed. RESULTS: By day 3 of treatment with MLE4901, HF frequency reduced by 72% (95% CI, -81.3 to -63.3%) compared with baseline (51 percentage point reduction compared with placebo, P < 0.0001); this effect size persisted throughout the 4-week dosing period. HF severity reduced by 38% compared with baseline by day 3 (95% CI, -46.1 to -29.1%) (P < 0.0001 compared with placebo), bother by 39% (95% CI, -47.5 to -30.1%) (P < 0.0001 compared with placebo), and interference by 61% (95% CI, -79.1 to -43.0%) (P = 0.0006 compared with placebo); all continued to improve throughout the 4-week dosing period (to -44%, -50%, and -70%, respectively by day 28, all P < 0.0001 compared with placebo). CONCLUSIONS: NK3R antagonism rapidly relieves vasomotor symptoms without the need for estrogen exposure.

More than just side-effects: The role of clinical and psychosocial factors in non-adherence to tamoxifen.

OBJECTIVES: Tamoxifen non-adherence is apparent in up to half of breast cancer survivors and is associated with increased risk of recurrence and reduced quality of life. However, factors contributing to non-adherence in this population are currently poorly understood. This study explored the relationship between key components of the Common Sense Model of Illness Representations (CSM)/the Theory of Planned Behaviour (TPB) and intentional and unintentional non-adherence in a large sample of women prescribed tamoxifen following primary breast cancer. DESIGN: Cross-sectional questionnaire study (n = 777). METHODS: Women were eligible if they were over 18, had been diagnosed with primary breast cancer, and had been prescribed tamoxifen. Participants were recruited in clinic or online and completed questionnaires assessing illness perceptions, treatment beliefs, adherence, quality of life, social support, distress, and the key TPB components. Logistic regressions were conducted to test elements from each model and to identify correlates of intentional and unintentional non-adherence. RESULTS: Patients were classified as non-adherent based on Medication Adherence Rating Scale scores; 44% of the population were non-adherent; 41% reported unintentional non-adherence, and 9% reported intentional non-adherence. Study variables accounted for more variance in intentional (Nagelkerke R2  = 46%) than unintentional non-adherence (Nagelkerke R2  = 17%). Intentional non-adherence was best explained by a combination of TPB and CSM variables, but these variables did not contribute significantly to unintentional non-adherence. CONCLUSIONS: The TPB and the CSM provide a useful framework for understanding intentional tamoxifen non-adherence. Elements from both models should be considered when designing interventions to increase adherence rates. Statement of contribution What is already known about this subject? Non-adherence to tamoxifen is common and is associated with poor clinical outcomes. Few modifiable predictors of tamoxifen non-adherence have been identified. What does this study add? Unintentional non-adherence is reported much more frequently than intentional non-adherence. Elements from the CSM and TPB provide a useful framework for understanding non-adherence to tamoxifen. Unique correlates were found for intentional and unintentional non-adherence.

Management of hot flushes in UK breast cancer patients: clinician and patient perspectives.

INTRODUCTION: Menopausal problems are among the most prevalent and distressing problems following breast cancer treatment, with 70% women experiencing hot flushes and night sweats (HFNS). A working party was set up to support the development of new research into the management of these problems. METHODS: We conducted surveys to explore the need as perceived by women with breast cancer and establish current UK management practices. A patient survey was conducted through a charity, Breast Cancer Care, and a health professional survey via the UK Breast Intergroup. The HFNS Problem Rating Scale was used, as well as specific questions addressing the aims of the study. RESULTS: Six hundred and sixty-five patients responded and 185 health professionals. Twenty-eight percent women had considered stopping adjuvant endocrine treatment because of HFNS, yet 34% had never been asked about HFNS by any health professional. The most commonly offered interventions were SSRIs, such as venlafaxine, yet only 25% patients had been offered these drugs. Cognitive behavioural therapy was rarely suggested (2%) despite good evidence. DISCUSSION: This study shows a lack of coherence in the management of HFNS in breast cancer survivors, which may lead to reduced adherence to adjuvant therapy. There is an urgent need to develop guidelines to support management of HFNS after breast cancer.

Understanding tamoxifen adherence in women with breast cancer: A qualitative study.

OBJECTIVE: Non-adherence to tamoxifen is common in breast cancer survivors and is associated with poor clinical outcomes. This study aimed to understand womens' experiences of taking tamoxifen and to identify factors which may be associated with non-adherence. DESIGN: A qualitative study using semi-structured interviews. METHODS: Thirty-two breast cancer survivors who had been prescribed tamoxifen took part in interviews conducted face to face or over the telephone. They were transcribed verbatim and analysed using inductive thematic analysis with elements of grounded theory. RESULTS: A key theme identified in the data was weighing up costs and benefits of treatment, which resulted in women falling into three groups; tamoxifen is keeping me alive, tamoxifen is not worth the reduced risk of recurrence, or conflicting beliefs about the harms and benefits of treatment. Additional themes were living with risk of recurrence and information & support. CONCLUSIONS: Women who believed that the necessity of tamoxifen outweighed its costs were more likely to be adherent, whereas women who thought that the benefits did not outweigh the side effects were more likely to have discontinued. A third more ambivalent group believed strongly in the importance of treatment, but were struggling with side effects and were often non-adherent. Patients sometimes felt unsupported and discussed a need for more comprehensive information. To increase adherence, future research needs to explore ways to increase beliefs around tamoxifen necessity and how to help women cope with side effects. Statement of contribution What is already known on this subject? Non-adherence to tamoxifen is associated with increased risk of recurrence and mortality. Up to 50% of patients are non-adherent to tamoxifen by the fifth year of treatment Few consistent predictors of tamoxifen non-adherence have been identified. What does this study add? Many women report not knowing how to manage their side effects. Non-adherence is related to how women weigh up their side effects against their medication beliefs. Interventions aiming to increase necessity beliefs and improve symptom management may be effective.

Barriers and facilitators of adjuvant hormone therapy adherence and persistence in women with breast cancer: a systematic review.

PURPOSE: Nonadherence to hormone therapy in breast cancer survivors is common and associated with increased risk of mortality. Consistent predictors of nonadherence and nonpersistence are yet to be identified, and little research has examined psychosocial factors that may be amenable to change through intervention. This review aimed to identify predictors of nonadherence and nonpersistence to hormone therapy in breast cancer survivors in order to inform development of an intervention to increase adherence rates. METHODS: Studies published up to April 2016 were identified through MEDLINE, Embase, Web of Science, PsycINFO, CINAHL and gray literature. Studies published in English measuring associations between adherence or persistence and any predictor variables were included. Eligible studies were assessed for methodological quality, data were extracted and a narrative synthesis was conducted. RESULTS: Sixty-one eligible articles were identified. Most studies focused on clinical and demographic factors with inconsistent results. Some evidence suggested that receiving specialist care and social support were related to increased persistence, younger age and increased number of hospitalizations were associated with nonadherence, and good patient-physician relationship and self-efficacy for taking medication were associated with better adherence. A small amount of evidence suggested that medication beliefs were associated with adherence, but more high-quality research is needed to confirm this. CONCLUSION: Some psychosocial variables were associated with better adherence and persistence, but the results are currently tentative. Future high-quality research should be carried out to identify psychosocial determinants of nonadherence or nonpersistence that are modifiable through intervention.

An Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors: results of a pilot study.

OBJECTIVE: Previous studies demonstrated that a cognitive behavioral therapy (CBT) program delivered in group sessions is effective in alleviating treatment-induced menopausal symptoms in women with breast cancer, but also that in-person CBT is inconvenient for some women and can result in low levels of program compliance. A promising, alternative approach is to use the Internet to make this form of CBT more accessible and feasible for patients. The objective of this study was to evaluate the feasibility and to generate preliminary data on the efficacy of a guided, Internet-based CBT program. METHODS: Twenty-one participants with treatment-induced menopausal symptoms started the guided Internet-based CBT program. Self-report questionnaires were completed at baseline and at 10 weeks (posttreatment). Counselors' evaluations were obtained via interviews. Primary outcomes were program usage, compliance rates, and participant and counselor satisfaction. Secondary outcomes were overall levels of endocrine symptoms and hot flush/night sweats problem rating. RESULTS: Ninety percent of participants completed the program as planned. Satisfaction rates were high among participants and counselors. Small revisions to the program were advised. There was a significant decrease over time in overall levels of endocrine symptoms and hot flush/night sweats problem rating. CONCLUSIONS: These findings suggest that an Internet-based CBT program for women with treatment-induced menopausal symptoms is feasible and promising in terms of efficacy. The efficacy of the CBT program is currently being investigated in a larger randomized controlled trial.

Measuring illness representations in breast cancer survivors (BCS) prescribed tamoxifen: Modification and validation of the Revised Illness Perceptions Questionnaire (IPQ-BCS).

OBJECTIVE: The Revised Illness Perceptions Questionnaire (IPQ-R), widely used to assess illness perceptions, may fail to measure unique characteristics of different illnesses. This study modified and validated the IPQ-R for breast cancer survivors to provide detailed understanding of the specific illness perceptions held by these patients. DESIGN: Initial modifications were made following qualitative interviews and were revised in a think-aloud study. The modified scale was tested in 753 breast cancer survivors prescribed tamoxifen. Modifications included adding a tamoxifen consequences scale and adapting the timeline scales to measure beliefs around risk of recurrence and cure. A confirmatory factor analysis was conducted on the modified questionnaire and an exploratory factor analysis on the causal beliefs scale. Test-retest reliability, internal consistency and construct validity were also examined. RESULTS: The proposed eight-factor structure showed acceptable model fit, with high loadings and good reliability for all subscales. Correlations between subscales were consistent with theory and previous research. CONCLUSIONS: The IPQ-BCS is valid and reliable, and provides unique understanding of specific perceptions held by this population, including beliefs surrounding risk of recurrence and consequences of ongoing hormonal treatment. Identifying these perceptions will aid development of interventions targeting depression, fear of recurrence and medication non-adherence.

Factor Structure of the Gotland Scale of Male Depression in Two Samples of Men With Prostate Cancer: Implications for Treating Male Depression.

Up to a quarter of all prostate cancer (PCa) patients suffer from clinically significant depression but treatments are inconsistent and short-lived in their efficacy. One possible reason could be that "male depression" is not adequately diagnosed by the criteria for major depressive disorder (MDD) used in many clinical settings. In response to this limitation, the Gotland Scale of Male Depression (GSMD) was developed to identify the extra symptoms of MDD in men. Although the factor structure of the GSMD has been reported in non-PCa samples, it has not been determined for this group of men. Two samples of PCa patients were recruited, 191 from Australia and 138 from the United Kingdom and all patients received the GSMD individually, plus a background questionnaire. Two-factor solutions were identified for each of the two samples. The Australian sample was characterized by changes in emotional and somatic function, followed by depressed mood. The U.K. sample exhibited the same two-factor solution but in reverse order of weighting. Targeted treatments for depression in PCa patients may benefit from identification of the loadings that individual patients have on these two GSMD factors so that specific clinical profiles and treatment needs may be based on this information about their depression.

Factors related to the experience of menopausal symptoms in women prescribed tamoxifen.

INTRODUCTION: Menopausal symptoms are frequent and severe in breast cancer survivors taking tamoxifen; however, treatment options are limited for these patients as hormonal replacement therapy is contraindicated. This study aimed to explore the experience and attribution of menopausal symptoms and identify factors related to the experience of menopausal symptoms in women taking tamoxifen. METHODS: Women who had been prescribed tamoxifen for a diagnosis of primary breast cancer were recruited from oncology clinics across England and from online advertisements. Seven hundred and forty women completed questionnaires assessing illness perceptions, social support, mood and symptom duration/severity. RESULTS: Eighty-four percent of women had experienced hot flushes and 80% experienced night sweats; of these, 60% experienced severe symptoms. Symptoms persisted throughout 5 years of treatment and were mainly attributed to tamoxifen. Logistic regressions showed that depressive symptoms, previous chemotherapy and being employed were associated with increased odds of hot flush or night sweat prevalence. Symptom severity was associated with depression, being employed and attributing symptoms to tamoxifen. DISCUSSION: These findings have clinical implications in terms of targeting women who are more at risk and offering non-hormonal treatment options, such as cognitive behavioural therapy, to help women to develop self-management strategies for coping with menopausal symptoms.

Design of a randomized controlled trial of Internet-based cognitive behavioral therapy for treatment-induced menopausal symptoms in breast cancer survivors.

BACKGROUND: Menopausal symptoms are common and may be particularly severe in younger women who undergo treatment-induced menopause. Medications to reduce menopausal symptoms are either contra-indicated or have bothersome side effects. Previous studies have demonstrated that face-to-face cognitive behavioral therapy (CBT) is effective in alleviating menopausal symptoms in women with breast cancer. However, compliance with face-to-face CBT programs can be problematic. A promising approach is to use the Internet to make this form of CBT more accessible and feasible for patients. This study is evaluating the efficacy and cost-effectiveness of an Internet-based CBT program, with or without therapist guidance, in alleviating or reducing the severity of menopausal symptoms. METHODS/DESIGN: In a multicenter, randomized controlled trial we are evaluating the efficacy of two Internet-based CBT programs in alleviating or reducing the impact of menopausal symptoms, and particularly hot flushes and night sweats, in breast cancer survivors who have experienced a treatment-induced menopause. Secondary outcomes include sexual functioning, sleep quality, hot flush frequency, psychological distress, health-related quality of life and cost-effectiveness. We will recruit 248 women who will be randomized to either a therapist guided or a self-management version of the 6-week Internet-based CBT program, or to a usual care, waiting list control group. Self-administered questionnaires are completed at baseline (T0), and at 10 weeks (T1) and 24 weeks (T2) post-randomization. DISCUSSION: Internet-based CBT is a potentially useful treatment for reducing menopausal symptoms in breast cancer survivors. This study will provide evidence on the efficacy and cost-effectiveness of such an Internet-based CBT program, with or without therapist support. If demonstrated to be efficacious and cost-effective, the availability of such structured supportive intervention programs will be a welcome addition to standard medical treatment offered to cancer patients with treatment-induced menopause. TRIAL REGISTRATION: The study is retrospectively registered at ClinicalTrials.gov on January 26th 2016 ( NCT02672189 ).