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Physical exercise both during and after curative cancer treatment has been shown to reduce side effects. Evidence in the metastatic cancer setting is scarce, and interventions that improve health-related quality of life (HRQOL) are much needed for patients with metastatic breast cancer (MBC). The multinational randomized controlled PREFERABLE-EFFECT trial assessed the effects of exercise on fatigue and HRQOL in patients with MBC. In total, 357 patients with MBC and a life expectancy of ≥6 months but without unstable bone metastases were recruited at eight study centers across five European countries and Australia. Participants were randomly assigned (1:1) to usual care (control group, n = 179) or a 9-month supervised exercise program (exercise group, n = 178). Intervention effects on physical fatigue (European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire (QLQ)-FA12 scale) and HRQOL (EORTC QLQ-C30 summary score) were determined by comparing the change from baseline to 3, 6 (primary timepoint) and 9 months between groups using mixed models for repeated measures, adjusted for baseline values of the outcome, line of treatment (first or second versus third or higher) and study center. Exercise resulted in significant positive effects on both primary outcomes. Physical fatigue was significantly lower (-5.3 (95% confidence interval (CI), -10.0 to -0.6), Bonferroni-Holm-adjusted P = 0.027; Cohen's effect size, 0.22) and HRQOL significantly higher (4.8 (95% CI, 2.2-7.4), Bonferroni-Holm-adjusted P = 0.0003; effect size, 0.33) in the exercise group than in the control group at 6 months. Two serious adverse events occurred (that is, fractures), but both were not related to bone metastases. These results demonstrate that supervised exercise has positive effects on physical fatigue and HRQOL in patients with MBC and should be recommended as part of supportive care.ClinicalTrials.gov Identifier: NCT04120298 .
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The protocol predefined aim of this study is to assess sustained effects of the OptiTrain trial on several health outcomes, 5 years after the baseline assessment. The OptiTrain study was a prospective, randomised controlled trial with 240 patients with breast cancer undergoing adjuvant chemotherapy that compared the effects of 16 weeks of two exercise programs, RT-HIIT and AT-HIIT, with usual care (UC). After a 5-year follow-up, eligible participants were evaluated for the primary outcome of cancer-related fatigue (CRF) and secondary outcomes including quality of life, symptoms, muscle strength, cardiorespiratory fitness, body mass, physical activity, and sedentary behavior. Statistical analysis was conducted using linear mixed models adjusted for baseline values. Tumour profile and menopausal status were additionally adjusted for CRF. Mean differences (MD), 95% confidence intervals (CIs), and standardized effect sizes (ES) were reported. At the 5-year follow-up, there were no statistically significant differences in total CRF between the intervention groups and the UC group. RT-HIIT reported significantly reduced pain sensitivity at the gluteus MD = 79.00 (95% CI 10.17, 147.83, ES = 0.55) compared to UC. Clinically meaningful differences for an increase in cognitive CRF and cardiorespiratory fitness were observed for the AT-HIIT versus UC group, and for lower limb strength for the RT-HIIT versus UC group, albeit without statistical significance. Engaging in targeted exercise during adjuvant chemotherapy for breast cancer provides short-term benefits in reducing fatigue and maintaining physical function. However, our 5-year follow-up indicates that these effects are limited in the long term. This underscores the need to support breast cancer survivors maintain their PA levels throughout their survivorship journey.
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Neoplasias da Mama , Fadiga , Treinamento Intervalado de Alta Intensidade , Qualidade de Vida , Treinamento Resistido , Humanos , Neoplasias da Mama/tratamento farmacológico , Feminino , Pessoa de Meia-Idade , Seguimentos , Treinamento Intervalado de Alta Intensidade/métodos , Aptidão Cardiorrespiratória/fisiologia , Estudos Prospectivos , Força Muscular , Adulto , Quimioterapia Adjuvante , Exercício Físico/fisiologia , IdosoRESUMO
PURPOSE: Live-remote exercise interventions, supervised by exercise professionals in a home-based setting, could potentially enhance exercise accessibility for cancer survivors, yet research on their perspectives is limited. This study explored cancer survivors' experience of exercise within the context of a live-remote exercise intervention, to understand factors influencing exercise engagement. METHODS: Four online focus groups with, in total, 22 breast, prostate, and colorectal cancer survivors were conducted between March and June 2023. These individuals had participated in a 12-week live-remote exercise intervention. The semi-structured discussions were transcribed verbatim and analysed using reflexive thematic analysis with an abductive approach. The Capability, Opportunity, Motivation model of Behaviour (COM-B) served as a supportive framework. RESULTS: Nine themes were identified and mapped onto COM-B domains (capability, opportunity, motivation). Factors influencing cancer survivors' exercise engagement included exercise readiness following cancer treatment, bringing exercise closer, in capable hands, peer support through shared experience, life factors as hurdles or support, exercise as an integral component of cancer treatment, caring for myself and others after me, the positive impact of exercise exceeding expectations, and getting into the habit. CONCLUSIONS: Identifying factors shaping exercise engagement, these findings emphasise live-remote's potential benefit in overcoming barriers and fostering participation. Supervised by professionals, it offered psychosocial and exercise support, facilitating the integration of exercise into daily life. IMPLICATIONS FOR CANCER SURVIVORS: Elucidating key factors for exercise engagement within a live-remote context is essential for developing and implementing live-remote exercise interventions to ensure accessible, integrated exercise for optimal post-treatment well-being for cancer survivors.
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Sobreviventes de Câncer , Terapia por Exercício , Grupos Focais , Motivação , Humanos , Sobreviventes de Câncer/psicologia , Feminino , Masculino , Pessoa de Meia-Idade , Idoso , Terapia por Exercício/métodos , Exercício Físico/psicologia , Exercício Físico/fisiologia , Neoplasias/terapia , Neoplasias/psicologia , Neoplasias da Mama/terapia , Neoplasias da Mama/psicologia , Adulto , Neoplasias Colorretais/terapia , Neoplasias Colorretais/psicologia , Pesquisa Qualitativa , Neoplasias da Próstata/psicologia , Neoplasias da Próstata/terapiaRESUMO
PURPOSE: The aim of this study was to explore patients' experiences of being prepared for allogenic haematopoietic cell transplantation and to explore their perceived self-efficacy and preparedness for self-care after allogenic haematopoietic cell transplantation. METHODS: Nine participants, who recently underwent allo-HCT, were interviewed regarding their views on preparedness, self-efficacy and self-care. The interviews were analysed using inductive qualitative content analysis. RESULTS: An overarching theme, Life is taken apart, then you have to know how to put the pieces together, and four sub-themes: Convert information into something understandable; Taking responsibility, maintaining and preparing for an uncertain time in life; Balancing vigilance with independence; and Reorientating in an altered body places new demands on self-care illustrate the dismantlement of life during treatment and how actions and approaches can build a new life. CONCLUSIONS: Both participants and healthcare professionals prioritised preparing for allo-HCT in the period before admission. However, during admission, preparation decreased and the time was not used for preparatory learning. This meant that participants were well prepared for the acute phase but unprepared for life after completion of treatment. Among the participants, self-efficacy was good. They sought information about taking care of their health before and in the aftermath of allo-HCT. IMPLICATIONS FOR CANCER SURVIVORS: This study provides insight into, and knowledge about, how patients prepare before, during and after treatment. This knowledge should primarily be directed towards healthcare professionals to be used for future patients who may need advice and support, as well as continued preparation for a life after transplantation.
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INTRODUCTION: Quality care in breast cancer is higher if patients are treated in a Breast Center with a dedicated and specialized multidisciplinary team. Quality control is an essential activity to ensure quality care, which has to be based on the monitoring of specific quality indicators. Eusoma has proceeded with the up-dating of the 2017 Quality indicators for non-metastatic breast cancer based on the new diagnostic, locoregional and systemic treatment modalities. METHODS: To proceed with the updating, EUSOMA setup a multidisciplinary working group of BC experts and patients' representatives. It is a comprehensive set of QIs for early breast cancer care, which are classified as mandatory, recommended, or observational. For the first time patient reported outcomes (PROMs) have been included. As used in the 2017 EUSOMA QIs, evidence levels were based on the short version of the US Agency for Healthcare Research and Quality. RESULTS: This is a set of quality indicators representative for the different steps of the patient pathway in non-metastatic setting, which allow Breast Centres to monitor their performance with referring standards, i.e minimum standard and target. CONCLUSIONS: Monitoring these Quality Indicators, within the Eusoma datacentre will allow to have a state of the art picture at European Breast Centres level and the development of challenging research projects.
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Neoplasias da Mama , Indicadores de Qualidade em Assistência à Saúde , Humanos , Feminino , Neoplasias da Mama/diagnóstico por imagem , Neoplasias da Mama/terapia , Qualidade da Assistência à SaúdeRESUMO
BACKGROUND: To successfully implement exercise programs for patients with metastatic breast cancer (MBC), services and patient education should consider patients' knowledge, preferences, values, and goals. Hence, gaining insight into their perspectives on exercise and exercise programming is important. METHOD: In this cross-sectional survey, we recruited patients with MBC from the Netherlands, Germany, Poland, Spain, and Sweden. We collected data on patients' knowledge and skills about exercise and outcome expectations. We identified barriers to and facilitators of participation in exercise programs, and patients' preferences for program content and modes of exercise delivery. RESULTS: A total of 420 patients participated in the survey. Respondents were, on average, 56.5 years old (SD 10.8) and 70% had bone metastases. Sixty-eight percent reported sufficient skills to engage in aerobic exercise, but only 35% did so for resistance exercise. Respondents expected exercise to have multiple physical benefits, but a few patients expected exercise to worsen their pain (5%). Not having access to an exercise program for cancer patients (27%), feeling too tired (23%), and/or weak (23%) were the most often reported barriers. Facilitators for exercising regularly were previous positive physical (72%) and emotional (68%) experiences with exercising, and receiving personalized advice from a physiotherapist or sport/fitness instructor (62%). Patients were most interested in walking and preferred exercising at a public gym, although there were differences by country. Fifty-seven percent did not know whether their insurance company reimburses exercise programs and only 9% would be willing to pay more than 50 per month to participate. CONCLUSION: A large percentage of patients with MBC lack the skills to engage in regular exercise as recommended by exercise guidelines for people with cancer. Patients may benefit from personalized advice and appropriate training facilities to overcome barriers. When implementing exercise interventions, attention should be given to reimbursement and the relatively low willingness-to-pay.
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Neoplasias da Mama , Humanos , Pessoa de Meia-Idade , Feminino , Neoplasias da Mama/terapia , Estudos Transversais , Exercício Físico , Inquéritos e Questionários , Terapia por ExercícioRESUMO
BACKGROUND: Research led by nurses has evolved rapidly over the last 2 decades globally. Assessing the work that has been conducted so far can help the specialty to strategically shape future directions of nurse-led cancer research. OBJECTIVE: The aim of this study was to provide a comprehensive, up-to-date synthesis of all nurse-led cancer research published articles over 20 years. METHODS: A bibliometric analysis was used. Three databases were used to retrieve nurse-led cancer research publications for the period from January 1, 2004, to March 11, 2022. RESULTS: A total of 7043 original articles were retrieved. A significant increase in nurse-led cancer research over the past 2 decades was evident. The United States and United Kingdom were the most productive countries in terms of the number of published articles. Minimal international collaboration was observed among low- or middle-income countries versus high-income countries. Breast cancer, palliative care, and quality of life received the most attention in nurse-led cancer research, followed by education, pain, and communication. Very few publications addressed cancer prevention, breaking bad news, and cancer rehabilitation. CONCLUSION: Areas to consider in the future include more international collaborations on commonly agreed research agendas, capacity building to allow more research beyond the few countries that dominate the publications, and more focus on low- or middle-income countries. IMPLICATIONS FOR PRACTICE: The findings of this study provide direction for future research led by cancer nurses and the areas that warrant further investigation.
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BACKGROUND: Adherence to adjuvant tamoxifen therapy is suboptimal, and acceptance of tamoxifen for primary prevention is poor. Published results indicate effect of low-dose tamoxifen therapy. Using questionnaire data from a randomised controlled trial, we describe side effects of standard and low-dose tamoxifen in healthy women. METHODS: In the KARISMA trial, 1440 healthy women were randomised to 6 months of daily intake of 20, 10, 5, 2.5, 1 mg of tamoxifen or placebo. Participants completed a 48-item, five-graded Likert score symptom questionnaire at baseline and follow-up. Linear regression models were used to identify significant changes in severity levels across doses and by menopausal status. RESULTS: Out of 48 predefined symptoms, five were associated with tamoxifen exposure (hot flashes, night sweats, cold sweats, vaginal discharge and muscle cramps). When comparing these side effects in premenopausal women randomised to low doses (2.5, 5 mg) versus high doses (10, 20 mg), the mean change was 34% lower in the low-dose group. No dose-dependent difference was seen in postmenopausal women. CONCLUSIONS: Symptoms related to tamoxifen therapy are influenced by menopausal status. Low-dose tamoxifen, in contrast to high-dose, was associated with less pronounced side effects, a finding restricted to premenopausal women. Our findings give new insights which may influence future dosing strategies of tamoxifen in both the adjuvant and preventive settings. TRIAL REGISTRATION: ClinicalTrials.gov ID: NCT03346200.
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Neoplasias da Mama , Efeitos Colaterais e Reações Adversas Relacionados a Medicamentos , Feminino , Humanos , Tamoxifeno/uso terapêutico , Fogachos/induzido quimicamente , Fogachos/tratamento farmacológico , Fogachos/prevenção & controle , Pré-Menopausa , Inquéritos e Questionários , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/induzido quimicamente , Antineoplásicos Hormonais/efeitos adversosRESUMO
INTRODUCTION: Around 25% of metastatic breast cancer (mBC) patients develop brain metastases, which vastly affects their overall survival and quality of life. According to the current clinical guidelines, regular magnetic resonance imaging screening is not recommended unless patients have recognized central nervous system-related symptoms. PATIENT PRESENTATION: The patient participated in the EFFECT study, a randomized controlled trial aimed to assess the effects of a 9-month structured, individualized and supervised exercise intervention on quality of life, fatigue and other cancer and treatment-related side effects in patients with mBC. She attended the training sessions regularly and was supervised by the same trainer throughout the exercise program. In month 7 of participation, her exercise trainer detected subtle symptoms (e.g., changes in movement pattern, eye movement or balance), which had not been noticed or reported by the patient herself or her family, and which were unlikely to have been detected by the oncologist or other health care providers at that point since symptoms were exercise related. When suspicion of brain metastases was brought to the attention of the oncologist by the exercise trainer, the response was immediate, and led to early detection and treatment of brain metastases. CONCLUSION AND CLINICAL IMPLICATIONS: The brain metastases of this patient were detected earlier due to the recognition of subtle symptoms detected by her exercise trainer and the trust and rapid action by the clinician. The implementation of physical exercise programs for cancer patients requires well-trained professionals who know how to recognize possible alterations in patients and also, good communication between trainers and the medical team to enable the necessary actions to be taken.
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Neoplasias Encefálicas , Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/terapia , Terapia por Exercício/métodos , Qualidade de Vida , Exercício Físico , Neoplasias Encefálicas/terapiaRESUMO
PURPOSE: Supervised exercise is a potentially promising supportive care intervention for people with metastatic breast cancer (MBC), but research on the patients' perspective is limited. The aim of the current focus group study was to gain an in-depth understanding of MBC patients' perceived barriers, facilitators, and preferences for supervised exercise programs. METHODS: Eleven online focus groups with, in total, 44 MBC patients were conducted in four European countries (Germany, Poland, Spain, Sweden). Main topics of the semi-structured discussions covered attitudes towards participation in supervised exercise programs, perceived facilitators, experienced barriers, and exercise preferences. Interviews were transcribed verbatim, translated into English, and coded based on a preliminary coding framework, supplemented by themes emerging during the sessions. The codes were subsequently examined for interrelations and re-organized into overarching clusters. RESULTS: Participants had positive attitudes towards exercise, but experienced physical limitations and insecurities that inhibited their participation. They expressed a strong desire for exercise tailored to their needs, and supervision by an exercise professional. Participants also highlighted the social nature of group training as an important facilitator. They had no clear preference for exercise type, but rather favored a mixture of different activities. Flexible training modules were considered helpful to increase exercise program adherence. CONCLUSIONS: MBC patients were generally interested in supervised exercise programs. They preferred group exercise that facilitates social interaction, but also expressed a need for individualized exercise programs. This suggests the relevance to develop flexible exercise programs that are adjusted to the individual's needs, abilities, and preferences.
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Neoplasias da Mama , Humanos , Feminino , Neoplasias da Mama/terapia , Exercício Físico , Pesquisa Qualitativa , Terapia por Exercício , Grupos FocaisRESUMO
PURPOSE: Registered nurses have a key role in supporting patients during the trajectory of allogeneic hematopoietic cell transplantation (allo-HCT). However, the circumstances for performing nursing are not previously outlined therefore the purpose of this study was to explore the conditions for nursing care in allo-HCT. METHOD: An explorative design, inspired by Experienced based co-design was used to gather experiences, thoughts and visions of nursing care in allo-HCT by means of workshops. Thematic analysis was applied to analyse the data. RESULT: An overarching theme that was defined from the data was nursing as a balancing act and illustrating conditions for performing nursing in a highly medical-technical environment. The theme included three sub-themes: Fragmented care vs holistic care outlining how the holistic approach to care disappeared when the care became fragmented; Proximity vs distance illuminating the balance between seeing the patient as an independent person despite illness and the need for support; Teamwork vs stand-alone demonstrating the difficulties inherent in adapting to both teamwork and independence in nursing. CONCLUSION: This study shows that the conditions for RNs and nursing care in allo-HCT care is to balance tasks and approach towards the patient and themselves. RNs must weigh and balance what is most important in the moment and where something else often has to be put aside. It is difficult for RNs to find the time to plan each patient's care and to support the patient in the way they see as most optimal to prepare for discharge, self-care and rehabilitation.
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Transplante de Células-Tronco Hematopoéticas , Enfermeiras e Enfermeiros , Cuidados de Enfermagem , Humanos , AutocuidadoRESUMO
BACKGROUND: Regular exercise has been shown to have beneficial health effects in cancer survivors, including improving quality of life and other important health outcomes. However, providing people with cancer with easily accessible, high-quality exercise support and programs is a challenge. Therefore, there is a need to develop easily accessible exercise programs that draw upon the current evidence. Supervised, distance-based exercise programs have the benefit of reaching out to many people whilst providing the support of an exercise professional. The aim of the EX-MED Cancer Sweden trial is to examine the effectiveness of a supervised, distance-based exercise program, in people previously treated for breast, prostate, or colorectal cancer, on health-related quality of life (HRQoL), as well as other physiological and patient-reported health outcomes. METHODS: The EX-MED Cancer Sweden trial is a prospective randomised controlled trial including 200 people that have completed curative treatment for breast, prostate, or colorectal cancer. Participants are randomly allocated to an exercise group or a routine care control group. The exercise group will participate in a supervised, distanced-based exercise program delivered by a personal trainer who has undertaken specialised exercise oncology education modules. The intervention consists of a combination of resistance and aerobic exercises with participants completing two 60-min sessions per week for 12 weeks. The primary outcome is HRQoL (EORTC QLQ-C30) assessed at baseline, 3- (end of intervention and primary endpoint) and 6-months post-baseline. Secondary outcomes are physiological (cardiorespiratory fitness, muscle strength, physical function, body composition) and patient-reported outcomes (cancer-related symptoms, fatigue, self-reported physical activity), and self-efficacy of exercise. Furthermore, the trial will explore and describe the experiences of participation in the exercise intervention. DISCUSSION: The EX-MED Cancer Sweden trial will provide evidence regarding the effectiveness of a supervised, distance-based exercise program for survivors of breast, prostate, and colorectal cancer. If successful, it will contribute to the implementation of flexible and effective exercise programs as part of the standard of care for people following cancer treatment, which is likely to contribute to a reduction in the burden of cancer on the individual, health care system and society. TRIAL REGISTRATION: www. CLINICALTRIALS: gov NCT05064670. Registered on October 1, 2021.
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Neoplasias Colorretais , Próstata , Masculino , Humanos , Qualidade de Vida , Estudos Prospectivos , Suécia , Exercício Físico , Terapia por Exercício/efeitos adversos , Terapia por Exercício/métodos , Neoplasias Colorretais/terapia , Ensaios Clínicos Controlados Aleatórios como AssuntoRESUMO
AIM: This qualitative study aimed to explore the experience of being family caregivers of patients treated for oesophageal cancer 2 years after treatment. To better understand the family caregiver's situation, a conceptual model was used in the analysis. The results of the study can guide future interventions to support family caregivers of patients treated for oesophageal cancer. DESIGN: A qualitative descriptive study using semi-structured telephone interviews. An abductive approach was used in the analysis to reach deeper knowledge about the family caregivers' experiences and to better understand deeper patterns. METHODS: A qualitative study was conducted and included 13 family caregivers of patients surgically treated for oesophageal cancer in Sweden in 2018 who participated in a population-based nationwide cohort study. Individual telephone interviews were held in 2020, 2 years after the patients' surgery. The analysis of the interviews started with an inductive approach using thematic analysis. Thereafter, a deductive approach was used to interpret the findings in relation to the conceptual model, The Cancer Family Caregiving Experience. RESULTS: The most essential/evident stress factors for the family caregivers were distress regarding the patients' nutrition, fear of tumour recurrence and worry about the future. In addition, a transition was experienced, going from a family member to a caregiver, and the many psychosocial aspects of this transition were highlighted during the disease trajectory. CONCLUSION: Despite, the long-term survival of the patient, family caregivers were still struggling with psychosocial consequences because of the patient's cancer diagnosis and treatment. Furthermore, there is a need to improve supportive interventions for family caregivers during the whole disease trajectory. IMPACT: The current study includes comprehensive information about the family caregivers' experiences when caring for a patient treated for oesophageal cancer. Family caregivers struggle with the psychosocial consequences of the patient's cancer and worry about tumour recurrence even 2 years after surgery. These findings can be useful in the development of supportive interventions, which may facilitate life for family caregivers. PATIENT OR PUBLIC CONTRIBUTION: The study was discussed and planned together with our research partnership group including patients and family caregivers. In addition, the manuscript was reviewed by some of the members to cross-check the results and discussed them to avoid misinterpretation.
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Cuidadores , Neoplasias Esofágicas , Humanos , Cuidadores/psicologia , Estudos de Coortes , Recidiva Local de Neoplasia , Família/psicologia , Neoplasias Esofágicas/cirurgia , Pesquisa QualitativaRESUMO
BACKGROUND: Patients are affected by various symptoms after allogeneic hematopoietic stem cell transplantation (allo-HSCT) that can affect recovery. Research has mainly focused on symptom occurrence; thus, little is known about patients' overall symptom burden. OBJECTIVE: The aim of this study was to examine patient-reported symptom burden in the first year after allo-HSCT and whether a high symptom burden 4 months after allo-HSCT predicts recovery, that is, general health and sick leave, 1 year after transplantation. METHODS: Allo-HSCT patients aged 18 to 65 years were included (n = 189). Questionnaire data were collected on admission to the allo-HSCT unit, as well as 4 and 7 months and 1 year after allo-HSCT. Logistic regression evaluated relationships between demographic characteristics, chronic graft-versus-host disease, physical activity, and a high symptom burden. RESULTS: Tiredness, susceptibility to infection, disinterest in sex, and physical weakness remained the most frequent symptoms, while distressing symptoms varied during the first year after allo-HSCT.Poor general health 1 year after allo-HSCT was associated with older age, low physical activity, and a high symptom burden 4 months after allo-HSCT. Full-time sick leave 1 year after allo-HSCT was associated with chronic graft-versus-host disease, low physical activity, and a high symptom burden 4 months after transplantation. CONCLUSIONS: Experiencing a high symptom burden 4 months after allo-HSCT can affect recovery 1 year after transplantation. Furthermore, low physical activity 4 months after allo-HSCT can predict both general health and sick leave 1 year after transplantation. IMPLICATIONS FOR PRACTICE: Repeated symptom assessment, including experienced distress, is central for reducing overall symptom burden and supporting recovery after allo-HSCT.
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Doença Enxerto-Hospedeiro , Transplante de Células-Tronco Hematopoéticas , Humanos , Doença Enxerto-Hospedeiro/etiologia , Estudos Retrospectivos , Transplante de Células-Tronco Hematopoéticas/efeitos adversos , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: In early breast cancer, neoadjuvant chemotherapy (NACT) is increasingly used. The proof of efficacy is pathologically complete response (pCR), i.e. the absence of invasive tumour in breast and lymph nodes at surgery. Today, pCR is a common endpoint in pharmaceutical trials since it is significantly associated with survival especially in triple-negative and HER2-positive subtypes. Apart from the mitigation of treatment-related toxicity and symptoms, physical exercise mediates anti-tumoral systemic effects associated with tumour regression in preclinical and clinical models. The aim of Neo-ACT is to test the hypothesis that physical exercise can improve pCR rates in breast cancer patients receiving NACT. METHOD: The Neo-ACT trial is a prospective clinical trial, randomising T1-3N0-2 breast cancer patients planned for NACT to either a home-based physical exercise intervention supported by a mobile application or routine care. The primary endpoint is pCR; secondary endpoints are patient-reported quality of life, toxicity-related outcomes, and oncological outcomes such as Residual Cancer Burden, objective radiological tumour response, as well as overall, breast cancer-specific and disease-free survival at 2, 5 and 10 years. The intervention consists of a combination of high-intensity interval and resistance training of progressing intensity, and includes at least 150 min of moderate to vigorous physical activity per week, inclusive of two weekly 60-min exercise sessions. In order to show an improvement in pCR of 10%, a total of 712 participants need to be included in the analysis. The Neo-ACT has been registered at clinicaltrials.gov on January 11, 2022 (NCT05184582). EXPECTED RESULTS: If Neo-ACT can prove the oncological efficacy of physical exercise, implementation of training programmes into NACT schedules will be pursued. The use of a digitally led exercise intervention aims to test the potential of such a strategy for use in rural areas and areas of limited resources.
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Neoplasias da Mama , Terapia Neoadjuvante , Protocolos de Quimioterapia Combinada Antineoplásica/efeitos adversos , Neoplasias da Mama/tratamento farmacológico , Neoplasias da Mama/patologia , Quimioterapia Adjuvante , Exercício Físico , Feminino , Humanos , Preparações Farmacêuticas , Estudos Prospectivos , Qualidade de VidaRESUMO
Enhanced screening and efficient cancer treatments have led to a growing number of cancer survivors. In Sweden over 500 000 individuals have or have had cancer [1]. Cancer survivors can experience a wide range of disease and treatment related symptoms, that profoundly affect their health related quality of life. For example, women treated for breast cancer have on average 25 percent lower physical fitness compared to women without a cancer diagnosis. Recent evidence suggests that exercise has a positive effect on physical fitness, muscle strength, cancer related fatigue and quality of life among cancer survivors. An effective exercise prescription for health related outcomes in adult cancer survivors includes aerobic training at a moderate intensity for a total of 150 minutes per week. Adding resistance training two times per week has additional effects on muscle strength and physical functioning. Supervised exercise programs seem to be more effective than unsupervised or home based programs.
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Neoplasias da Mama , Sobreviventes de Câncer , Adulto , Neoplasias da Mama/terapia , Exercício Físico/fisiologia , Feminino , Humanos , Força Muscular , Qualidade de VidaRESUMO
BACKGROUND: Many patients with metastatic breast cancer experience cancer- and treatment-related side effects that impair activities of daily living and negatively affect the quality of life. There is a need for interventions that improve quality of life by alleviating fatigue and other side effects during palliative cancer treatment. Beneficial effects of exercise have been observed in the curative setting, but, to date, comparable evidence in patients with metastatic breast cancer is lacking. The aim of this study is to assess the effects of a structured and individualized 9-month exercise intervention in patients with metastatic breast cancer on quality of life, fatigue, and other cancer- and treatment-related side effects. METHODS: The EFFECT study is a multinational, randomized controlled trial including 350 patients with metastatic breast cancer. Participants are randomly allocated (1:1) to an exercise or control group. The exercise group participates in a 9-month multimodal exercise program, starting with a 6-month period where participants exercise twice a week under the supervision of an exercise professional. After completing this 6-month period, one supervised session is replaced by one unsupervised session for 3 months. In addition, participants are instructed to be physically active for ≥30 min/day on all remaining days of the week, while being supported by an activity tracker and exercise app. Participants allocated to the control group receive standard medical care, general written physical activity advice, and an activity tracker, but no structured exercise program. The primary outcomes are quality of life (EORTC QLQ-C30, summary score) and fatigue (EORTC QLQ-FA12), assessed at baseline, 3, 6 (primary endpoint), and 9 months post-baseline. Secondary outcomes include physical fitness, physical performance, physical activity, anxiety, depression, pain, sleep problems, anthropometric data, body composition, and blood markers. Exploratory outcomes include quality of working life, muscle thickness, urinary incontinence, disease progression, and survival. Additionally, the cost-effectiveness of the exercise program is assessed. Adherence and safety are monitored throughout the intervention period. DISCUSSION: This large randomized controlled trial will provide evidence regarding the (cost-) effectiveness of exercise during treatment of metastatic breast cancer. If proven (cost-)effective, exercise should be offered to patients with metastatic breast cancer as part of standard care. TRIAL REGISTRATION: ClinicalTrials.gov NCT04120298 . Registered on October 9, 2019.
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Neoplasias da Mama , Qualidade de Vida , Atividades Cotidianas , Neoplasias da Mama/terapia , Exercício Físico , Terapia por Exercício/efeitos adversos , Fadiga/etiologia , Fadiga/terapia , Feminino , HumanosRESUMO
Mammographic density change has proven to be a reliable proxy for tamoxifen therapy response. The primary aim of this study was to identify time to tamoxifen-induced mammographic density change. We also analyzed side effects and adherence to therapy. In all, 42 women were randomized to 10 or 20 mg of daily oral tamoxifen. Mammograms were taken at baseline, 3, 6, and 9 months. Mammographic density change was measured using the automated STRATUS tool. Adverse events were monitored through a web-based questionnaire based on the FACT-ES tool. Nine out of the 42 (21%) participants discontinued therapy due to adverse events leaving 33 women in the study. A significant decrease in density was seen after 3 months of therapy. Dose did not seem to affect density change, side effects or adherence. Given the size of the study, additional studies are needed to confirm our data.
Assuntos
Neoplasias da Mama , Tamoxifeno , Mama , Densidade da Mama , Neoplasias da Mama/tratamento farmacológico , Feminino , Humanos , Mamografia , Tamoxifeno/efeitos adversosRESUMO
BACKGROUND: Screening for colorectal cancer is done with lower gastrointestinal endoscopy or stool-based tests. There is little evidence from randomised trials to show primary colonoscopy reduces mortality in colorectal cancer. We aimed to investigate the effect of screening with once-only colonoscopy or two rounds of faecal immunochemical test screening on colorectal cancer mortality and incidence. METHODS: We did a randomised controlled trial in Sweden (SCREESCO). Residents in 18 of 21 regions who were age 60 years in the year of randomisation were identified from a population register maintained by the Swedish Tax Agency. A statistician with no further involvement in the trial used a randomised block method to assign individuals to once-only colonoscopy, two rounds of faecal immunochemical testing (OC-Sensor; 2 years apart), or a control group (no intervention; standard diagnostic pathways), in a ratio of 1:6 for colonoscopy versus control and 1:2 for faecal immunochemical testing versus control. Masking was not possible due to the nature of the trial. The primary endpoints of the trial are colorectal cancer mortality and colorectal cancer incidence. Here, we report preliminary participation rates, baseline findings, and adverse events from March, 2014, to December, 2020, in the two intervention groups after completion of recruitment and screening, up to the completion of the second faecal immunochemical testing round. Analyses were done in the intention-to-screen population, defined as all individuals who were randomly assigned to the respective study group. This study is registered with ClinicalTrials.gov, NCT02078804. FINDINGS: Between March 1, 2014, and Dec 31, 2020, 278 280 people were included in the study; 31 140 were assigned to the colonoscopy group, 60 300 to the faecal immunochemical test group, and 186 840 to the control group. 10 679 (35·1%) of 30 400 people who received an invitation for colonoscopy participated. 33 383 (55·5%) of 60 137 people who received a postal faecal immunochemical test participated. In the intention-to-screen analysis, colorectal cancer was detected in 49 (0·16%) of 31 140 people in the colonoscopy group versus 121 (0·20%) of 60 300 in the faecal immunochemical test group (relative risk [RR] 0·78, 95% CI 0·56-1·09). Advanced adenomas were detected in 637 (2·05%) people in the colonoscopy group and 968 (1·61%) in the faecal immunochemical test group (RR 1·27, 95% CI 1·15-1·41). Colonoscopy detected more right-sided advanced adenomas than faecal immunochemical testing. There were two perforations and 15 major bleeds in 16 555 colonoscopies. No intervention-related deaths occurred. INTERPRETATION: The diagnostic yield and the low number of adverse events indicate that the design from this trial, both for once-only colonoscopy and faecal immunochemical test screening, could be transferred to a population-based screening service if a benefit in disease-specific mortality is subsequently shown. FUNDING: Swedish regions, County Council, Regional Cancer Center Mellansverige, Swedish Cancer Society, Aleris Research and Development Fund, Eiken Chemical.