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OBJECTIVE: The aim of the study is to identify suitable definitions and patient-reported outcome measures (PROMs) to assess each of the six core outcomes previously identified through the COMMA (Core Outcomes in Menopause) global consensus process relating to vasomotor symptoms: frequency, severity, distress/bother/interference, impact on sleep, satisfaction with treatment, and side effects. METHODS: A systematic review was conducted to identify relevant definitions for the outcome of side-effects and PROMs with acceptable measurement properties for the remaining five core outcomes. The consensus process, involving 36 participants from 16 countries, was conducted to review definitions and PROMs and make final recommendations for the measurement of each core outcome. RESULTS: A total of 21,207 publications were screened from which 119 reporting on 40 PROMs were identified. Of these 40 PROMs, 36 either did not adequately map onto the core outcomes or lacked sufficient measurement properties. Therefore, only four PROMs corresponding to two of the six core outcomes were considered for recommendation. We recommend the Hot Flash Related Daily Interference Scale to measure the domain of distress, bother, or interference of vasomotor symptoms and to capture impact on sleep (one item in the Hot Flash Related Daily Interference Scale captures interference with sleep). Six definitions of "side effects" were identified and considered. We recommend that all trials report adverse events, which is a requirement of Good Clinical Practice. CONCLUSIONS: We identified suitable definitions and PROMs for only three of the six core outcomes. No suitable PROMs were found for the remaining three outcomes (frequency and severity of vasomotor symptoms and satisfaction with treatment). Future studies should develop and validate PROMs for these outcomes.
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Sofocos , Menopausia , Medición de Resultados Informados por el Paciente , Humanos , Femenino , Menopausia/fisiología , Consenso , Satisfacción del Paciente , Sistema Vasomotor/fisiopatología , Calidad de VidaRESUMEN
Menopause eventually happens to all people with typically functioning ovaries, and almost one billion women worldwide are postmenopausal. Although the biology of typical menopause is ubiquitous, the experience varies substantially. Factors contributing to the experience include not only individual factors, such as the nature and severity of symptoms, but also psychological, social, and contextual considerations, many of which are modifiable. In this first paper in the Lancet Series on menopause, we argue for a new approach that goes beyond the treatment of specific symptoms, to encompass a broad model to support women transitioning this life stage, using the model of empowerment. WHO defines empowerment as an active process of gaining knowledge, confidence, and self-determination to self-manage health and make informed decisions about care. Rather than focusing on menopause as an endocrine deficiency, we propose an empowerment model that recognises factors modifying the experience, in which the patient is an expert in their own condition and the health-care worker supports the patient to become an equal and active partner in managing their own care.
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Empoderamiento , Menopausia , Humanos , Femenino , Menopausia/psicologíaRESUMEN
The potential risk for mental health conditions over the menopause transition shapes women's expectations and informs putative physiological mechanisms regulating women's mental health. We review evidence from prospective studies reporting on associations between mental health conditions and the menopause transition. Major depressive disorder and the more prevalent subthreshold depressive symptoms are the most common conditions studied. We reviewed 12 prospective studies reporting depressive symptoms, major depressive disorder, or both over the menopause transition and found no compelling evidence for a universal increased risk for either condition. However, specific subgroups of participants, primarily defined by menopause-related risk factors (ie, vasomotor symptoms that are severe or disturb sleep, a long duration of the transition, or reproductive hormone dynamics) and psychosocial risk factors (eg, stressful life events), were vulnerable to depressive symptoms. The increased risk of major depressive disorder over the menopause transition appears predominantly in individuals with previous major depressive disorder. Greater focus on recognising risk factors in primary care is warranted. On the basis of scarce data, we found no compelling evidence that risk of anxiety, bipolar disorder, or psychosis is universally elevated over the menopause transition. Potential misattribution of psychological distress and psychiatric disorders to menopause could harm women by delaying accurate diagnosis and the initiation of effective psychotropic treatments, and by creating negative expectations for people approaching menopause. A paradigm shift is needed. We conclude with recommendations for the detection and treatment of depressive symptoms or major depressive disorder and strategies to promote good mental health over the menopause transition, while responsibly preparing and supporting those at risk.
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Trastorno Depresivo Mayor , Salud Mental , Femenino , Humanos , Trastorno Depresivo Mayor/epidemiología , Estudios Prospectivos , Menopausia/psicología , Salud de la Mujer , Depresión/epidemiología , Depresión/psicologíaRESUMEN
BACKGROUND: Emerging evidence suggests that perceived gender discrimination negatively impacts mental wellbeing in young women. PURPOSE: This study explored whether a similar relationship exists in middle-aged and older women. METHODS: A total of 3081 women (aged ≥52 years) from the English Longitudinal Study of Ageing provided data on perceived gender discrimination in 2010/11. Depressive symptoms, loneliness, quality of life and life satisfaction were assessed in 2010/11 and in 2016/17. RESULTS: Perceived gender discrimination was reported by 282 (9.2%) participants. Cross-sectionally, women who perceived gender discrimination reported more depressive symptoms (ß = 0.34, 95% CI 0.11 to 0.57) and had higher loneliness scores (ß = 0.14, 95% CI 0.08 to 0.20) than women who did not perceive gender discrimination. They also reported significantly lower quality of life (ß = -2.50, 95% CI -3.49 to -1.51) and life satisfaction (ß = -1.07, 95% CI -1.81 to -0.33). Prospectively, perceived gender discrimination was associated with greater loneliness scores (ß = 0.08, 95% CI 0.02 to 0.14), as well as lower ratings of quality of life (ß = -0.98, 95% CI -0.09 to -1.86), and life satisfaction (ß = -1.04, 95% CI -0.34 to -1.74), independent of baseline values. CONCLUSIONS: Middle-aged and older women who perceive gender discrimination report poorer mental wellbeing than those who do not perceive discrimination. Further, this type of discrimination may be predictive of declining mental wellbeing over time. These findings highlight the need for interventions to target gender-based discrimination to improve the wellbeing of women at mid- and older age.
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Calidad de Vida , Sexismo , Persona de Mediana Edad , Humanos , Femenino , Anciano , Estudios Longitudinales , Soledad , EnvejecimientoRESUMEN
OBJECTIVE: This study aimed to advance understanding of vasomotor symptom (VMS) outcomes measurement using pooled data from three Menopause Strategies Finding Lasting Answers to Symptoms and Health (MsFLASH) trials. METHODS: Participants self-reported VMS frequency, severity, and bother using daily diaries; completed standardized measures of VMS interference, insomnia severity, and sleep quality/disturbance; and completed four treatment satisfaction items. Analyses included descriptive statistics, Pearson correlations (baseline pooled sample, posttreatment pooled sample, posttreatment placebo only), t tests, and analysis of variance. RESULTS: Participants were mostly postmenopausal (82.9%) and a mean of 54.5 years old. VMS frequency was fairly correlated with severity, bother, and interference for pooled baseline and placebo posttreatment samples ( r values = 0.21-0.39, P values < 0.001) and moderately correlated with severity, bother, and interference for pooled posttreatment ( r values = 0.40-0.44, P values < 0.001). VMS severity, bother, and interference were moderately correlated ( r values = 0.37-0.48, P values < 0.001), with one exception. VMS severity and bother were strongly correlated ( r values = 0.90-0.92, P values < 0.001). VMS interference was moderately correlated with insomnia ( r values = 0.45-0.54, P values < 0.001) and fairly to moderately correlated with sleep quality/disturbance ( r values = 0.31-0.44, P values < 0.001). Other VMS outcomes were weakly to fairly correlated with insomnia ( r values = 0.07-0.33, P values < 0.001 to < 0.05) and sleep quality/disturbance ( r values = 0.06-0.26, P values < 0.001 to > 0.05). Greater improvement in VMS and sleep over time was associated with higher treatment satisfaction ( P values < 0.001). CONCLUSIONS: This pooled analysis advances understanding of VMS outcomes measurement and has implications for selecting measures and creating future research.
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Sofocos , Trastornos del Inicio y del Mantenimiento del Sueño , Femenino , Humanos , Persona de Mediana Edad , Sofocos/tratamiento farmacológico , Menopausia , Evaluación de Resultado en la Atención de Salud , Sueño , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
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.
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This study explored the use of Twitter to communicate about menopause. Tweets in English posted between January 2014 and December 2022 with the hashtag "menopause" were extracted. Total global tweets and those from the UK, USA, Australia and Canada were examined. Globally, there were 314,974 tweets about menopause over this period, with an annual average of 34,997. There were notable differences between countries, with a large increase in use in the UK in 2018 and 2019, a reducing trend in use in the USA with a smaller increase in 2018 and 2019, and low stable usage in Australia and Canada.
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Medios de Comunicación Sociales , Femenino , Humanos , Comunicación , Australia , Canadá , MenopausiaRESUMEN
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.
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Terapia Cognitivo-Conductual , Neoplasias de la Próstata , Masculino , Humanos , Antagonistas de Andrógenos/efectos adversos , Andrógenos , Calidad de Vida , Neoplasias de la Próstata/tratamiento farmacológico , Sudor , Recurrencia Local de Neoplasia , Sofocos/terapiaRESUMEN
OBJECTIVES: This study describes translation, cross-cultural adaptation, and validation of the Attitude Towards Menopause (ATM) scale in Persian. METHODS: A standard process was followed for translation and cross-cultural adaptation of the ATM scale into Persian. The content validity index and content validity ratio were used to measure content validity. The construct validity was tested using exploratory factor analysis and confirmatory factor analysis. The average variance extracted and construct reliability were used to indicate convergent and discriminant validity, respectively. Internal consistency and test-retest reliability of the Persian ATM scale were assessed using Cronbach α and intraclass correlation coefficient (ICC). RESULTS: A revised version of the ATM scale, including 26 items assigned to seven factors, was obtained in exploratory factor analysis. The factors were interpreted as negative affect, postmenopausal recovery, control of symptoms, sexuality, psychological losses, unpleasant confrontation, and menstrual freedom, explaining 66.18% of the total variance. The factor structure of the scale was confirmed using confirmatory factor analysis (Comparative Fit Index = 0.90, Tucker-Lewis Index = 0.88, Goodness-of-Fit Index = 0.90, Adjusted Goodness-of-Fit Index = 0.86, Root Mean Square Error of Approximation = 0.07, χ2 / df = 4.56). The values of Cronbach α coefficient and ICC indicated an acceptable level of reliability ( α = 0.70, ICC = 0.89). The construct reliability for all factors was more than or equal to 0.7 except for psychological losses, indicating good discriminating validity. The values of average variances extracted for subscales varied from 0.48 to 0.99, representing adequate convergent validity. CONCLUSIONS: The Persian version of the ATM scale is a reliable and valid tool to evaluate the attitudes of Iranian women toward menopause.
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Comparación Transcultural , Menopausia , Humanos , Femenino , Reproducibilidad de los Resultados , Irán , Encuestas y Cuestionarios , Psicometría , ActitudRESUMEN
BACKGROUND: Although the effectiveness of screening tools for detecting depression in pregnancy has been investigated, there is limited evidence on the cost-effectiveness. This is vital in providing full information to decision makers. This study aimed to explore the cost-effectiveness of different screening tools to identify depression in early pregnancy compared to no screening. METHODS: A decision tree was developed to model the identification and treatment pathways of depression from the first antenatal appointment to 3-months postpartum using the Whooley questions, the Edinburgh Postnatal Depression Scale (EPDS) and the Whooley questions followed by the EPDS, compared to no screening. The economic evaluation took an NHS and Personal Social Services perspective. Model parameters were taken from a combination of sources including a cross-sectional survey investigating the diagnostic accuracy of screening tools, and other published literature. Cost-effectiveness was assessed in terms of the incremental cost per quality adjusted life years (QALYs). Cost-effectiveness planes and cost-effectiveness acceptability curves were produced using a net-benefit approach based on Monte Carlo simulations of cost-outcome data. RESULTS: In a 4-way comparison, the Whooley, EPDS and Whooley followed by the EPDS each had a similar probability of being cost-effective at around 30% for willingness to pay values from £20,000-30,000 per QALY compared to around 20% for the no screen option. CONCLUSIONS: All three screening approaches tested had a higher probability of being cost-effective than the no-screen option. In the absence of a clear cost-effectiveness advantage for any one of the three screening options, the choice between the screening approaches could be made on other grounds, such as clinical burden of the screening options. Limitations include data availability and short time horizon, thus further research is needed. CLINICAL TRIALS REGISTRATION: N/A.
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Depresión Posparto , Depresión , Análisis Costo-Beneficio , Estudios Transversales , Árboles de Decisión , Depresión/diagnóstico , Depresión Posparto/diagnóstico , Femenino , Humanos , Embarazo , Años de Vida Ajustados por Calidad de VidaRESUMEN
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.
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Neoplasias de la Mama , Supervivientes de Cáncer , Alfabetización en Salud , Aplicaciones Móviles , Computadoras de Mano , Femenino , HumanosRESUMEN
OBJECTIVE: Genitourinary symptoms, such as vaginal dryness and pain with sex, are commonly experienced by postmenopausal women. Comparing treatments for these genitourinary symptoms are restricted by the use of different outcome measures in clinical trials and the omission of outcomes, which may be relevant to women. The aim of this project was to develop a Core Outcome Set (COS) to be reported in clinical trials of treatments for genitourinary symptoms associated with menopause. METHODS: We performed a systematic review of randomized controlled trials of treatments for genitourinary symptoms associated with menopause and extracted their outcomes. This list was refined and entered into a two-round modified Delphi survey, which was open to clinicians, researchers, and postmenopausal women from November 2019 to March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." The final COS was determined following two international consensus meetings. RESULTS: A total of 26 unique outcomes were included in the Delphi process, which was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to the Delphi scores to categorize outcomes by importance, which informed the e consensus meetings, attended by 43 participants from 21 countries. The final COS includes eight outcomes: (1) pain with sex, (2) vulvovaginal dryness, (3) vulvovaginal discomfort or irritation, (4) discomfort or pain when urinating, (5) change in most bothersome symptom, (6) distress, bother or interference of genitourinary symptoms, (7) satisfaction with treatment, (8) side effects of treatment. CONCLUSION: These eight core outcomes reflect the joint priorities of postmenopausal women, clinicians, and researchers internationally. Standardized collection and reporting of these outcomes in clinical trials will facilitate the comparison of different treatments for genitourinary symptoms, advance clinical practice, and ultimately improve outcomes for symptomatic women.
Video Summary:http://links.lww.com/MENO/A765 .
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Menopausia , Enfermedades Vaginales , Consenso , Femenino , Humanos , Evaluación de Resultado en la Atención de Salud , Encuestas y Cuestionarios , Resultado del Tratamiento , Enfermedades Vaginales/terapiaRESUMEN
OBJECTIVE: Vasomotor symptoms (VMS) (hot flashes and night sweats) affect most women over the menopause transition. Comparing the safety and effectiveness of treatments for vasomotor symptoms is limited by the use of inconsistent outcome measures, and uncertainty as to which outcomes are most important to symptomatic women. To address this, we have developed a Core Outcome Set (COS) for use in clinical trials of treatments for VMS. METHODS: We systematically reviewed the primary outcomes measured in randomized controlled trials of treatments for VMS. These were refined and entered into a two-round modified Delphi survey completed by clinicians, researchers, and postmenopausal women between November 2019 and March 2020. Outcomes were scored on a nine-point scale from "not important" to "critically important." Two international consensus meetings were held to finalize the COS. RESULTS: Based on the systematic review, 13 separate outcomes were included in the Delphi process. This was completed by 227 participants of whom 58% were postmenopausal women, 34% clinicians, and 8% researchers. Predefined thresholds were applied to categorize importance scores obtained during Round 2 of the Delphi survey. These informed discussions at the consensus meetings which were attended by 56 participants from 28 countries. The final COS includes six outcomes: 1) frequency of VMS, 2) severity of VMS, 3) distress, bother or interference caused by VMS, 4) impact on sleep, 5) satisfaction with treatment, and 6) side-effects of treatment. CONCLUSION: Implementation of this COS will: better enable research studies to accurately reflect the joint priorities of postmenopausal women, clinicians and researchers, standardize outcome reporting, and facilitate combining and comparing results from different studies, and ultimately improve outcomes for women with bothersome VMS.
Video Summary:http://links.lww.com/MENO/A763 .
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Sofocos , Menopausia , Consenso , Femenino , Humanos , Evaluación de Resultado en la Atención de Salud , Encuestas y CuestionariosRESUMEN
Most women experience some premenstrual symptoms during their reproductive years. Yet, this is an under-researched health issue, particularly in the context of work. This study aimed to: (i) understand the prevalence and severity of premenstrual symptoms experienced by working females, and their association with key work outcomes; (ii) explore factors that may be influencing these symptoms and their severity; and (iii) examine how organizations might help staff with premenstrual symptoms that may be impacting their working lives. An online, anonymous survey collected quantitative and qualitative data from 125 working women in the UK. Over 90% of the sample reported some premenstrual symptoms; 40% experienced premenstrual symptoms moderately or severely. Higher symptom severity was significantly (p < 0.05) associated with poor presenteeism, intention to reduce working hours, and higher work absence (time off work, being late, leaving early). Moderate/severe symptoms were significantly associated with several individual-related variables: lower perceived general health, higher alcohol consumption, poorer sleep quality, anxiety, depression, hormonal contraception, and using fewer coping approaches towards premenstrual symptoms (avoiding harm, adjusting energy levels); and work-related variables: poorer work-life balance, lower levels of psychological resilience, higher perceived work demands, less control over work. Disclosure of premenstrual symptoms and sickness absence because of premenstrual symptoms was very low, typically because of perceptions of appropriateness as a reason for work absence, gender of line managers (male), and it being a personal or embarrassing topic. Staff with moderate to severe premenstrual symptoms were statistically more likely to disclose reason for absence than those with milder symptoms. Recommendations and suggestions for employers and line managers include the need to train staff to improve knowledge about women's experience of premenstrual symptoms, to be able to communicate effectively with women and to provide tailored support and resources for those who need it. Implications for future research, policy and practice are discussed.
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Síndrome Premenstrual , Lugar de Trabajo , Femenino , Humanos , Masculino , Síndrome Premenstrual/epidemiología , Presentismo , Prevalencia , Encuestas y CuestionariosRESUMEN
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.
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Antineoplásicos Hormonales/uso terapéutico , Neoplasias de la Mama/tratamiento farmacológico , Tamoxifeno/uso terapéutico , Antineoplásicos Hormonales/farmacología , Neoplasias de la Mama/mortalidad , Supervivientes de Cáncer , Femenino , Humanos , Cumplimiento de la Medicación , Automanejo , Tamoxifeno/farmacologíaRESUMEN
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.
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Ansiedad/terapia , Neoplasias de la Mama/complicaciones , Neoplasias de la Mama/terapia , Terapia Cognitivo-Conductual/métodos , Depresión/terapia , Sofocos/terapia , Enfermeras y Enfermeros/psicología , Sudoración , Adulto , Anciano , Ansiedad/etiología , Ansiedad/psicología , Neoplasias de la Mama/psicología , Depresión/etiología , Depresión/psicología , Femenino , Sofocos/etiología , Sofocos/psicología , Humanos , Persona de Mediana Edad , Psicoterapia de Grupo , Calidad de Vida , Sueño , Encuestas y Cuestionarios , Sudor , Resultado del TratamientoRESUMEN
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.