International development of a patient-centered core outcome set for assessing health-related quality of life in metastatic breast cancer patients.

PURPOSE: For patients living with metastatic breast cancer (MBC), achieving best possible health-related quality of life, along with maximizing survival, is vital. Yet, we have no systemic way to determine if we achieve these goals. A Core Outcome Set (COS) that allows standardized measurement of outcomes important to patients, but also promotes discussing these outcomes during clinical encounters, is long overdue. METHODS: An international expert group (EG) of patient advocates, researchers, medical specialists, nurse specialists, and pharmaceutical industry representatives (n = 17) reviewed a list of relevant outcomes retrieved from the literature. A broader group (n = 141: patients/patient advocates (n = 45), health care professionals/researchers (n = 64), pharmaceutical industry representatives (n = 28), and health authority representatives (n = 4)) participated in a modified Delphi procedure, scoring the relevance of outcomes in two survey rounds. The EG finalized the COS in a consensus meeting. RESULTS: The final MBC COS includes 101 variables about: (1) health-related quality of life (HRQoL, n = 26) and adverse events (n = 24); (2) baseline patient characteristics (n = 9); and (3) clinical variables (n = 42). Many outcome that cover aspects of HRQoL relevant to MBC patients are included, e.g. daily functioning (including ability to work), psychosocial/emotional functioning, sexual functioning, and relationship with the medical team. CONCLUSION: The COS developed in this study contains important administrative data, clinical records, and clinician-reported measures that captures the impact of cancer. The COS is important for standardization of clinical research and implementation in daily practice and has received accreditation by the International Consortium for Health Outcomes Measurement (ICHOM).

CYP2D6 genotype predicts tamoxifen discontinuation and drug response: a secondary analysis of the KARISMA trial.

BACKGROUND: Guidelines regarding whether tamoxifen should be prescribed based on women's cytochrome P450 2D6 (CYP2D6) genotypes are conflicting and have caused confusion. This study aims to investigate if CYP2D6 metabolizer status is associated with tamoxifen-related endocrine symptoms, tamoxifen discontinuation, and mammographic density change. PATIENTS AND METHODS: We used data from 1440 healthy women who participated the KARISMA dose determination trial. Endocrine symptoms were measured using a modified Functional Assessment of Cancer Therapy - Endocrine Symptoms (FACT-ES) questionnaire. Change in mammographic density was measured and used as a proxy for tamoxifen response. Participants were genotyped and categorized as poor, intermediate, normal, or ultrarapid CYP2D6 metabolizers. RESULTS: The median endoxifen level per mg oral tamoxifen among poor, intermediate, normal and ultrarapid CYP2D6 metabolizers were 0.18 ng/ml, 0.38 ng/ml, 0.56 ng/ml and 0.67 ng/ml, respectively. Ultrarapid CYP2D6 metabolizers were more likely than other groups to report a clinically relevant change in cold sweats, hot flash, mood swings, being irritable, as well as the overall modified FACT-ES score, after taking tamoxifen. The 6-month tamoxifen discontinuation rates among poor, intermediate, normal, and ultrarapid CYP2D6 metabolizers were 25.7%, 23.6%, 28.6%, and 44.4%, respectively. Among those who continued and finished the 6-month tamoxifen intervention, the mean change in dense area among poor, intermediate, normal, and ultrarapid CYP2D6 metabolizers were -0.8 cm2, -4.5 cm2, -4.1 cm2, and -8.0 cm2 respectively. CONCLUSIONS: Poor CYP2D6 metabolizers are likely to experience an impaired response to tamoxifen, measured through mammographic density reduction. In contrast, ultrarapid CYP2D6 metabolizers are at risk for exaggerated response with pronounced adverse effects that may lead to treatment discontinuation.

ESO-ESMO 4th International Consensus Guidelines for Breast Cancer in Young Women (BCY4).

The 4th International Consensus Conference for Breast Cancer in Young Women (BCY4) took place in October 2018, in Lugano, Switzerland, organized by the European School of Oncology (ESO) and the European Society of Medical Oncology (ESMO). Consensus recommendations for the management of breast cancer in young women were updated from BCY3 with incorporation of new evidence to inform the guidelines. Areas of research priorities were also identified. This article summarizes the ESO-ESMO international consensus recommendations, which are also endorsed by the European Society of Breast Specialists (EUSOMA).

Optitrain: a randomised controlled exercise trial for women with breast cancer undergoing chemotherapy.

BACKGROUND: Women with breast cancer undergoing chemotherapy suffer from a range of detrimental disease and treatment related side-effects. Exercise has shown to be able to counter some of these side-effects and improve physical function as well as quality of life. The primary aim of the study is to investigate and compare the effects of two different exercise regimens on the primary outcome cancer-related fatigue and the secondary outcomes muscle strength, function and structure, cardiovascular fitness, systemic inflammation, skeletal muscle gene activity, health related quality of life, pain, disease and treatment-related symptoms in women with breast cancer receiving chemotherapy. The second aim is to examine if any effects are sustained 1, 2, and 5 years following the completion of the intervention and to monitor return to work, recurrence and survival. The third aim of the study is to examine the effect of attendance and adherence rates on the effects of the exercise programme. METHODS: This study is a randomised controlled trial including 240 women with breast cancer receiving chemotherapy in Stockholm, Sweden. The participants are randomly allocated to either: group 1: Aerobic training, group 2: Combined resistance and aerobic training, or group 3: usual care (control group). During the 5-year follow-up period, participants in the exercise groups will receive a physical activity prescription. Measurements for endpoints will take place at baseline, after 16 weeks (end of intervention) as well as after 1, 2 and 5 years. DISCUSSION: This randomised controlled trial will generate substantial information regarding the effects of different types of exercise on the health of patients with breast cancer undergoing chemotherapy. We expect that dissemination of the knowledge gained from this study will contribute to developing effective long term strategies to improve the physical and psychosocial health of breast cancer survivors. TRIAL REGISTRATION: OptiTrain - Optimal Training Women with Breast Cancer (OptiTrain), NCT02522260 ; Registration: June 9, 2015, Last updated version Feb 29, 2016. Retrospectively registered.

Patient-reported stressful events and coping strategies in post-menopausal women with breast cancer.

The objective of this paper was to explore what stressful events post-menopausal women with primary or recurrent breast cancer experience, how bothersome these events were and which coping strategies these women used. Data were collected from 131 patients diagnosed with primary or recurrent breast cancer. The Daily Coping Assessment was used. Thematic analysis was applied to form themes of stressful events. Six types of stressful events were extracted. The most frequently experienced events for women with primary cancer and those with recurrent cancer were 'distressing bodily symptoms'. The most bothersome event among primary cancer was 'everyday concerns' and in the recurrent group, 'distressing psychological reactions'. The most commonly used strategies were 'acceptance', 'distraction' and 'relaxation'. This study shows that women in different parts of the cancer trajectory differ in what they perceive to be stressful events when reporting them in their own words in a diary. The differences have an impact on the subsequent coping strategies they used.

The management of breakthrough cancer pain--educational needs a European nursing survey.

Poorly managed cancer pain is well known to profoundly impact the patient's daily life and interfere with quality of life. Nurses who cared for patients with cancer from 12 European countries participated in a survey of breakthrough cancer pain practice. The purpose was to investigate how nurses assess breakthrough cancer pain, use of standardised tools, confidence in supporting patients and awareness of medications. Responses from 1241 participants showed country variations. The majority of the sample was female, Germany had the highest proportion of male nurses (21.0%), followed by Greece (15.8%). A significantly larger proportion of nurses with longer experience and more education (78.8%) used a comprehensive definition of breakthrough cancer pain. Significant variations in training were found; 71% of Finnish nurses had received training compared with 6% of Greek nurses. Training and using a standardised assessment tool was associated with a significant increase in the nurses' perceived ability to distinguish between breakthrough and background pain. Nurses in countries with the highest proportion of training were most confident in supporting patients. In conclusion, there still exists problems with effective management of patients' breakthrough cancer pain, continuing inability to define the difference between background and breakthrough cancer pain leads to poor treatment.

Evidence-based practice among Swedish medical social workers.

We have explored Swedish medical social workers' attitudes, beliefs, knowledge, and behavior concerning evidence-based practice (EBP) and investigated the properties of a questionnaire to measure EBP. One hundred seventy-four Swedish medical social workers within university hospital care and primary care participated in a cross-sectional survey. Our results showed positive attitudes toward EBP and the use of evidence to support clinical decision making. EBP was seen as necessary and something that needed to be implemented more often. The main barriers to implementing EBP were lack of time (78%), the perception that EBP does not take into account the limitations of the clinical practice setting (78%), and lack of knowledge about relevant research (46%).

The requirements of a specialist Breast Centre.

INTRODUCTION: In recognition of the advances and evidence based changes in clinical practice that have occurred in recent years and taking into account the knowledge and experience accumulated through the voluntary breast unit certification programme, Eusoma has produced this up-dated and revised guidelines on the requirements of a Specialist Breast Centre (BC). METHODS: The content of these guidelines is based on evidence from the recent relevant peer reviewed literature and the consensus of a multidisciplinary team of European experts. The guidelines define the requirements for each breast service and for the specialists who work in specialist Breast Centres. RESULTS: The guidelines identify the minimum requirements needed to set up a BC, these being an integrated Breast Centre, dealing with a sufficient number of cases to allow effective working and continuing expertise, dedicated specialists working with a multidisciplinary approach, providing all services throughout the patients pathway and data collection and audit. It is essential that the BC also guarantees the continuity of care for patients with advanced (metastatic) disease offering treatments according to multidisciplinary competencies and a high quality palliative care service. The BC must ensure that comprehensive support and expertise may be needed, not only through the core BC team, but also ensure that all other medical and paramedical expertise that may be necessary depending on the individual case are freely available, referring the patient to the specific care provider depending on the problem. CONCLUSIONS: Applying minimum requirements and quality indicators is essential to improve organisation, performance and outcome in breast care. Efficacy and compliance have to be constantly monitored to evaluate the quality of patient care and to allow appropriate corrective actions leading to improvements in patient care.

Breast surgeons performing immediate breast reconstruction with implants - assessment of resource-use and patient-reported outcome measures.

Oncoplastic surgery, including immediate breast reconstruction (IBR), is expanding as a result of public demand. IBR in women with breast carcinoma is resource intense and the reconstruction is often completed concurrently with adjuvant oncological treatment. A series of 223 patients with implant-based IBRs, performed by breast surgeons 2005-2008, were analysed for use of resources and outcome. Low overall major complication rates (19,7%) were identified, even though 41% of the patients had received post-mastectomy radiation. A total of 1.1 reoperations per patient were required. Patient-reported outcomes using the EQ-5D and a disease-specific questionnaire at a median of four years follow-up were analysed. Patients' general health-state was high (0.83), whereas negative impact on intimate situations and the sensibility of the breast was reported. Our audit concludes that trained breast surgeon specialists perform implant-based IBRs with a satisfactory outcome when evaluated by subjective and objective analyses.

Caritas, spirituality and religiosity in nurses' coping.

The purpose of this qualitative study was to investigate registered nurses' coping processes when working with terminally ill and dying cancer patients, with special focus on religious aspects of coping resources. What religious components can be identified as coping resources in oncology nurses' orienting system and what function has religiosity in the nurse's work? The theoretical reference is care philosophy and the psychology of religion and coping. The material consists of interviews with 15 Swedish registered oncology nurses. The results highlight different dynamic aspects of the nurses' life orientation such as caritas, religiosity, spirituality and atheism and demonstrate that religiosity can have a protective function that facilitates coping, as the nurse has something to turn to. Religious coping dominated by basic trust where prayer is used as a coping strategy may support the nurse.

Importance of dietary advice, nutritional supplements and compliance for maintaining body weight and body fat after hip fracture.

OBJECTIVE: Poor nutritional status amongst elderly individuals with hip fractures is well documented. Studies have suggested that 30-50 % of patients admitted to orthopaedic departments suffer from protein-energy malnutrition (PEM). DESIGN: An 6 month intervention study. SETTING: The study was conducted in Sweden between February 2005 and October 2006. PARTICIPANTS: Elderly patients with hip fractures (n=32). METHODS: Evaluation of compliance with individual nutritional support and whether body weight and body fat (BF) could be maintained after six months. Evaluation of possible effects of nutritional supplements and dietary advice after hip fracture on BMI, BF, and Mini Nutritional Assessment (MNA). RESULTS: Overall compliance with supplement intake was 73%. After six months, BMI was unchanged. Women's BF had decreased (P < 0.01), although the mean calorie intake with nutritional support was 34 calories per kg body weight/day. Three groups could be identified: one group with increased body weight and BF, one with loss of body weight and BF, and one with increased body weight together with increased TBW and loss of BF. PARTICIPANTS who consumed 0-1 supplements daily lost more weight than those who consumed 2 supplements daily. There was a positive difference (p= < 0.001) for women between MNA values at baseline and after six months. CONCLUSION: In the present study compliance was satisfactory at the group level, and the energy and protein intake increased significantly. BMI was unchanged during the 6 months period. However, the women lost BF during the study period of with some had increasing total body water (TBW). MNA values for women changed in a positive direction.

Fatigue dimensions in patients with advanced cancer in relation to time of survival and quality of life.

To understand the relation between fatigue and patients emotional situation at the end of life, this cross-sectional study aimed to explore the association between multidimensional aspects of fatigue, emotional functioning and quality of life (QoL) in patients with advanced cancer at the end of life. Patients with advanced cancer answered fatigue related measurements (Borg Category Ratio-10 scale, Multidimensional Fatigue Inventory-20, Swedish Occupational Fatigue Inventory and the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire Core-30), when admitted for specialised palliative care. A total of 228 patients with a median length of survival of 63 days were included. In relation to time of survival, fatigue increased closer to death, in both global and multidimensional aspects, as well as the patient's experience of being sleepy. Marital status was found to affect the experience of fatigue in both global and multidimensional ratings of fatigue. The association between the experience of fatigue and feelings of being tense, worried, irritable or depressed and rated QoL decreased and was not evident closer to death. Fatigue in all dimensions increased, as patients got closer to death. The association between fatigue and both QoL and negative emotions faded away during the last days and weeks of life.

European Oncology Nursing Society extravasation guidelines.

An infrequent, but potential complication of chemotherapy is vesicant chemotherapy extravasation. Vesicants have the potential to cause blistering and ulceration when they extravasate from the vein or are inadvertently administered into the tissue. In 2007, the European Oncology Nursing Society published guidelines for extravasation prevention, detection, and management. Recommended management includes topical heating for plant alkaloid extravasations and topical cooling for anthracycline and other antitumor antibiotic vesicants. For treatment of antracycline extravasations topical dimethylsulfoxide (DMSO), sodium thiosulfate, and hyaluronidase have been described in the literature but due to lack of evidence to support their use as vesicant extravasation antidotes, it is recommended that these agents are studied further. Furthermore, Savene (dexrazoxane) is the only registered drug for the treatment of antracycline extravasation. Nurses need to be aware of current evidence-based guidelines for detecting and managing vesicant extravasations and need to be prepared to administer evidence-based treatment.

Health-related quality of life in significant others of patients dying from lung cancer.

This study compares health-related quality of life (HRQOL) in significant others of patients dying from lung cancer, with a general population sample. Further, it explores the course of HRQOL from diagnosis (T1), at a time point close to the patient's death (T2), and six months after the patient's death (T3). The group comparisons at T1 showed that the significant others scored significantly lower on the scales in the mental domain compared with a general population sample. These results were the same at T3, when the significant others also scored lower on most of the scales in the physical and social domains. In the longitudinal analyses, there were significant changes in four scales, and three patterns of change were identified: a decrease-increase pattern for 'self-rated health' and 'positive affect'; a constant decrease pattern for 'family functioning'; and a decrease-stable pattern for 'satisfaction with family functioning'. Thus, living with inoperable lung cancer in the family and then facing the death of a family member affects most of the HRQOL dimensions.

Coping processes in a multidisciplinary healthcare team--a comparison of nurses in cancer care and hospital chaplains.

The purpose of this paper is to compare the coping processes of hospital chaplains and nurses in cancer care and to discuss the findings in relation to work and stress in a multidisciplinary team. The results of the research question--'what coping processes are used when confronting existential issues?'--reveal that, as members of the multidisciplinary healthcare team, both professions need space in work for significance; the nurse needs to be able to help the patient 'do good' and the hospital chaplain needs to be available to meet the patient. Boundary demarcation was found to be the most common coping strategy.

Effectively nursing patients receiving aromatase inhibitor therapy.

Inhibiting estrogen production is a common means of preventing breast cancer recurrence. The aromatase inhibitors (AIs) are becoming the preferred treatment over tamoxifen as adjuvant therapy for postmenopausal women with hormone-sensitive early breast cancer. Like all adjuvant therapies, AIs have adverse events (AEs) associated with their use, many of which resemble symptoms common to menopause. Because of the greater efficacy of AIs in preventing breast cancer recurrence over tamoxifen, these AEs may be considered tolerable by many patients and often can be effectively managed and/or prevented. Educating patients about anticipated AEs may help them understand, accept, and cope with these AEs. This article reviews the AEs associated with different adjuvant AI treatments and highlights some strategies to manage them effectively. It also highlights the importance of patient education regarding AI therapy and involvement in treatment decisions, which may lead to better long-term adherence and ultimately to better outcomes.

Can individualised nutritional support improve healing in therapy-resistant leg ulcers?

OBJECTIVE: This study investigated whether an individually designed programme of nutritional support can improve healing in otherwise therapy-resistant venous leg ulcers. METHOD: Six primary health-care patients, aged between 79 and 93 years, with venous ulcers that had been open for one year or more (range: 1.5-8 years) were recruited into the study. The patients were asked to follow an individualised diet plan which included the use of liquid dietary supplements. Ulcer area, anthropometric and biochemical variables, and energy and nutrient intake were assessed before intervention and then regularly for nine months. RESULTS: At nine months ulcer healing had occurred in two patients, of whom one had had ulcers on both legs. In a third patient the ulceration on one leg had healed and that on the other leg had almost healed. In a fourth patient, the ulcer area reduced by approximately 90%. CONCLUSION: The use of nutritional support might have assisted the wound healing in these patients. Although the relationship between nutritional supplementation and wound healing is not well defined, an appropriate nutritional plan is recommended if undernourishment is suspected and leg ulcers are not healing.

Coping with radiation therapy: strategies used by women with breast cancer.

The purpose of this qualitative study was to describe coping strategies used by women with breast cancer during and after radiation therapy. Content analysis was used to structure the statements provided by the patients in the Wheel Questionnaire. The patients used several problem- and emotion-focused strategies to cope with the treatment, and the strategies changed over time. Family and friends had a positive impact on the coping process for the three points of measurement: before treatment started, on completion of treatment, and 3 months after treatment. Contact with colleagues at work also provided the women with a sense of normalcy. The women used a broad spectrum of own activities to aid recovery, instead of leaving their treatment solely to medicine. The women also found that a hopeful and optimistic attitude was a helpful strategy for coping with the treatment.

Coping with radiation therapy: effects of a nursing intervention on coping ability for women with breast cancer.

A randomized study was carried out to investigate whether a nursing intervention, using Orem's self-care theory as a framework, would affect the coping ability of women with breast cancer during and following radiation therapy. The intervention consisted of promoting of behaviours to support the patient to restore, maintain or increase their abilities to interact with the situation and adapt to the demands of radiation treatment. The control and experimental groups both consisted of 67 patients. The Wheel Questionnaire was used to evaluate the effect of the intervention. Our results showed that the intervention provided patients older than 59 years the ability to cope with the treatment (df = 2, F = 3.463, P = > 0.05). The present study supports the idea that individual interventions aimed at improving well-being helps patients. It also highlights the fact that individual approaches to improving well-being are needed. Such interventions should be directed to patients at risk for poor adjustment, such as those older than 50 years of age.

Perceived symptoms and quality of life in women with breast cancer receiving radiation therapy.

The purpose of this study was to describe symptoms, side-effects and quality of life (QoL) of women with breast cancer during and following treatment with radiation therapy. The sample consisted of 134 women with breast cancer. Symptoms were measured using a modified version of the Oncology Treatment Toxicity Tool (OTTAT) and QoL was measured using the Cancer Rehabilitation Evaluation System-short form (CARES-sf). The results showed an increase in experienced symptoms and their severity as the treatment progressed. QoL was perceived as poorest at baseline before treatment had started. During the treatment, QoL scores leveled out and an improvement could be seen after completion of treatment. The study findings provide directions and suggestions for assessment and management of perceived symptoms for women receiving radiation therapy for breast cancer from the second week and up to 2 weeks after completion of therapy is the critical time-period for targeting interventions for experienced symptoms and side-effects from radiation therapy.