[Attitude and beliefs of healthcare workers toward influenza vaccination in Internal Medicine: A cross-sectional survey]. / Attitude et croyances du personnel soignant en Médecine Interne vis-à-vis de la vaccination antigrippale saisonnière : étude transversale descriptive.

INTRODUCTION: The rate of vaccination in HCWs in France remains low. We aimed to analyze the attitude and beliefs of HCWs toward influenza vaccination in Internal Medicine wards. METHODS: We conducted a cross-sectional survey of HCWs in the departments of Internal Medicine of two tertiary hospitals in France. An anonymous questionnaire designed for this study was used to collect demographic, health beliefs and attitudes, and medical knowledge related to the influenza and influenza vaccine. The survey started shortly prior the 2019 influenza season. RESULTS: The surveys were completed by 158 (29[18-62] years-old ; 75.9% female ; 69.6% non-medical workers) of 187 (84.5%) HCWs. Overall, influenza vaccination coverage rate was 50.6% (n=80/158). Higher vaccination coverage was found in physician and in HCWs who had a better knowledge about the virus transmission. The reason to fulfill vaccination recommendations was to protect the patients, their relatives and themselves for more than 80% of HCWs compliant to vaccination recommendation. More than a third of HCWs (n=59/158; 37.3%) refused to be vaccinated or hesitated. Among them, 12 (12/59, 20.3%) believed that influenza vaccine could cause flu. The main reasons for reluctant HCWs to eventually accept to be vaccinated were a mandatory vaccination program and the demonstration of a better vaccine efficacy to prevent the disease. CONCLUSION: Influenza vaccination coverage among HCWs in Internal Medicine remains low. Education campaigns targeting in priority nurses and nurse assistants is mandatory to improve the compliance of HCWs to vaccination recommendation.

Quality of life and patient satisfaction after implant-based breast reconstruction with or without acellular dermal matrix: randomized clinical trial.

BACKGROUND: Acellular dermal matrix (ADM) in implant-based breast reconstructions (IBBRs) aims to improve cosmetic outcomes. Six-month data are presented from a randomized trial evaluating whether IBBR with ADM provides higher health-related quality of life (HRQoL) and patient-reported cosmetic outcomes compared with conventional IBBR without ADM. METHODS: In this multicentre open-label RCT, women with breast cancer planned for mastectomy with immediate IBBR in four centres in Sweden and one in the UK were allocated randomly (1 : 1) to IBBR with or without ADM. HRQoL, a secondary endpoint, was measured as patient-reported outcome measures (PROMs) using three validated instruments (EORTC-QLQC30, QLQ-BR23, QLQ-BRR26) at baseline and 6 months. RESULTS: Between 24 April 2014 and 10 May 2017, 135 women were enrolled, of whom 64 with and 65 without ADM were included in the final analysis. At 6 months after surgery, patient-reported HRQoL, measured with generic QLQ-C30 or breast cancer-specific QLQ-BR23, was similar between the groups. For patient-reported cosmetic outcomes, two subscale items, cosmetic outcome (8·66, 95 per cent c.i. 0·46 to 16·86; P = 0·041) and problems finding a well-fitting bra (-13·21, -25·54 to -0·89; P = 0·038), yielded higher scores in favour of ADM, corresponding to a small to moderate clinical difference. None of the other 27 domains measured showed any significant differences between the groups. CONCLUSION: IBBR with ADM was not superior in terms of higher levels of HRQoL compared with IBBR without ADM. Although two subscale items of patient-reported cosmetic outcomes favoured ADM, the majority of cosmetic items showed no significant difference between treatments at 6 months. Registration number: NCT02061527 ( www.clinicaltrials.gov).

ANTECEDENTES: Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant'based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health'related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM. MÉTODOS: Se ha propuesto la utilización de mallas dérmicas acelulares (acellular dermal matrix, ADM) en las reconstrucciones mamarias con prótesis (implant'based breast reconstructions, IBBR) como forma de mejorar los resultados estéticos. Se presentan los resultados a 6 meses de un ensayo aleatorizado, que evaluó si la IBBR con ADM proporcionaba mejor calidad de vida relacionada con la salud (health'related quality of life, HRQOL) y mejores resultados estéticos percibidos por la paciente en comparación con la IBBR convencional sin ADM. RESULTADOS: Entre el 24 de abril de 2014 y el 10 de mayo de 2017, se consideraron 135 mujeres, de las que se incluyeron en el análisis final 64 con ADM y 65 sin ADM. A los 6 meses de la intervención, la HRQOL medida con los cuestionarios QLQ-C30 (genérico) y QLQ-BR23 (específico para el cáncer de mama) fue similar en los dos grupos. Con respecto a los resultados estéticos percibidos por la paciente, se obtuvieron mejores puntuaciones a favor de la ADM en dos sub-escalas: "resultado estético" (8,66, i.c. del 95%, 0,46-16,86, P = 0,041) y "problemas para encontrar un sujetador que se ajuste bien" −13,21 (i.c. del 95% −25, 54 a −0,89, P = 0,038), lo que representa una diferencia clínica pequeña-moderada. No hubo diferencias significativas entre los dos grupos en ninguno de los otros 27 dominios medidos. CONCLUSIÓN: No se pudo demostrar la superioridad de la IBBR con ADM mediante variables relacionadas con la calidad de vida. Aunque se obtuvieron mejores puntuaciones con la ADM en dos sub-escalas de los PROMs, no hubo diferencias entre ambos tratamientos en la mayoría de las variables estéticas a los 6 meses.

Effects and moderators of coping skills training on symptoms of depression and anxiety in patients with cancer: Aggregate data and individual patient data meta-analyses.

PURPOSE: This study evaluated the effects of coping skills training (CST) on symptoms of depression and anxiety in cancer patients, and investigated moderators of the effects. METHODS: Overall effects and intervention-related moderators were studied in meta-analyses of pooled aggregate data from 38 randomized controlled trials (RCTs). Patient-related moderators were examined using linear mixed-effect models with interaction tests on pooled individual patient data (n = 1953) from 15 of the RCTs. RESULTS: CST had a statistically significant but small effect on depression (g = -0.31,95% confidence interval (CI) = -0.40;-0.22) and anxiety (g = -0.32,95%CI = -0.41;-0.24) symptoms. Effects on depression symptoms were significantly larger for interventions delivered face-to-face (p = .003), led by a psychologist (p = .02) and targeted to patients with psychological distress (p = .002). Significantly larger reductions in anxiety symptoms were found in younger patients (pinteraction < 0.025), with the largest reductions in patients <50 years (ß = -0.31,95%CI = -0.44;-0.18) and no significant effects in patients ≥70 years. Effects of CST on depression (ß = -0.16,95%CI = -0.25;-0.07) and anxiety (ß = -0.24,95%CI = -0.33;-0.14) symptoms were significant in patients who received chemotherapy but not in patients who did not (pinteraction < 0.05). CONCLUSIONS: CST significantly reduced symptoms of depression and anxiety in cancer patients, and particularly when delivered face-to-face, provided by a psychologist, targeted to patients with psychological distress, and given to patients who were younger and received chemotherapy.

Effects and moderators of psychosocial interventions on quality of life, and emotional and social function in patients with cancer: An individual patient data meta-analysis of 22 RCTs.

OBJECTIVE: This individual patient data (IPD) meta-analysis aimed to evaluate the effects of psychosocial interventions (PSI) on quality of life (QoL), emotional function (EF), and social function (SF) in patients with cancer, and to study moderator effects of demographic, clinical, personal, and intervention-related characteristics. METHODS: Relevant studies were identified via literature searches in 4 databases. We pooled IPD from 22 (n = 4217) of 61 eligible randomized controlled trials. Linear mixed-effect model analyses were used to study intervention effects on the post-intervention values of QoL, EF, and SF (z-scores), adjusting for baseline values, age, and cancer type. We studied moderator effects by testing interactions with the intervention for demographic, clinical, personal, and intervention-related characteristics, and conducted subsequent stratified analyses for significant moderator variables. RESULTS: PSI significantly improved QoL (ß = 0.14,95%CI = 0.06;0.21), EF (ß = 0.13,95%CI = 0.05;0.20), and SF (ß = 0.10,95%CI = 0.03;0.18). Significant differences in effects of different types of PSI were found, with largest effects of psychotherapy. The effects of coping skills training were moderated by age, treatment type, and targeted interventions. Effects of psychotherapy on EF may be moderated by cancer type, but these analyses were based on 2 randomized controlled trials with small sample sizes of some cancer types. CONCLUSIONS: PSI significantly improved QoL, EF, and SF, with small overall effects. However, the effects differed by several demographic, clinical, personal, and intervention-related characteristics. Our study highlights the beneficial effects of coping skills training in patients treated with chemotherapy, the importance of targeted interventions, and the need of developing interventions tailored to the specific needs of elderly patients.

Prostate cancer screening in men aged 50 to 69 years (STHLM3): A prospective population-based diagnostic study. Grönberg H, Adolfsson J, Aly M, Nordström T, Wiklund P, Brandberg Y, Thompson J, Wiklund F, Lindberg J, Clements M, Egevad L, Eklund M.Lancet Oncol. 2015 Dec;16(16):1667-76. [Epub 2015 Nov 10]. doi: 10.1016/S1470-2045(15)00361-7.

BACKGROUND: The prostate-specific antigen (PSA) test is used to screen for prostate cancer but has a high false-positive rate that translates into unnecessary prostate biopsies and overdiagnosis of low-risk prostate cancers. We aimed to develop and validate a model to identify high-risk prostate cancer (with a Gleason score of at least 7) with better test characteristics than that provided by PSA screening alone. METHODS: The Stockholm 3 (STHLM3) study is a prospective, population-based, paired, screen-positive, diagnostic study of men without prostate cancer aged 50 to 69 years randomly invited by date of birth from the Swedish Population Register kept by the Swedish Tax Agency. Men with prostate cancer at enrolment were excluded from the study. The predefined STHLM3 model (a combination of plasma protein biomarkers [PSA, free PSA, intact PSA, hK2, MSMB, MIC1], genetic polymorphisms [232 SNPs], and clinical variables [age, family, history, previous prostate biopsy, prostate exam]), and PSA concentration were both tested in all participants enrolled. The primary aim was to increase the specificity compared with PSA without decreasing the sensitivity to diagnose high-risk prostate cancer. The primary outcomes were number of detected high-risk cancers (sensitivity) and the number of performed prostate biopsies (specificity). The STHLM3 training cohort was used to train the STHLM3 model, which was prospectively tested in the STHLM3 validation cohort. Logistic regression was used to test for associations between biomarkers and clinical variables and prostate cancer with a Gleason score of at least 7. This study is registered with ISCRTN.com, number ISRCTN84445406. FINDINGS: The STHLM3 model performed significantly better than PSA alone for detection of cancers with a Gleason score of at least 7 (P<0.0001), the area under the curve was 0·56 (95% CI: 0·55-0·60) with PSA alone and 0·74 (95% CI: 0·72-0·75) with the STHLM3 model. All variables used in the STHLM3 model were significantly associated with prostate cancers with a Gleason score of at least 7 (P<0·05) in a multiple logistic regression model. At the same level of sensitivity as the PSA test using a cutoff of≥3ng/ml to diagnose high-risk prostate cancer, use of the STHLM3 model could reduce the number of biopsies by 32% (95% CI: 24-39) and could avoid 44% (35-54) of benign biopsies. INTERPRETATION: The STHLM3 model could reduce unnecessary biopsies without compromising the ability to diagnose prostate cancer with a Gleason score of at least 7, and could be a step towards personalised risk-based prostate cancer diagnostic programmes. FUNDING: Stockholm County Council (Stockholms Läns Landsting).

Self-perceived, but not objective lymphoedema is associated with decreased long-term health-related quality of life after breast cancer surgery.

BACKGROUND: The primary aim was to compare long-term health-related quality of life (HRQoL) in patients undergoing sentinel lymph node biopsy (SLNB) alone versus axillary lymph node dissection (ALND), with or without axillary metastases. Secondary aims were to a) investigate agreement between objectively measured and self-reported lymphoedema and b) compare, with respect to HRQoL, women with objective arm lymphoedema without subjective ratings and those with no objective but subjective ratings of arm lymphoedema. METHODS: The three study groups were defined by axillary surgery: 1) SLNB alone (N = 140), 2) ALND in patients without axillary metastases (N = 125) and 3) ALND in patients with axillary metastases (N = 155). Preoperatively, one and three years postoperatively arm volume was measured and questionnaires regarding self-perceived symptoms of arm lymphoedema and HRQoL were completed (The Swedish Short Form-36 Health Survey, SF-36). RESULTS: Out of the original 516 who had axillary surgery, 420 (81%) completed the study. There were no statistically significant differences in HRQoL between the three study groups. No statistically significant agreement was found between self-perceived and objectively measured arm lymphoedema. Women without self-perceived arm lymphoedema, regardless of objective arm lymphoedema or not, scored higher on all eight SF-36 domains than those who reported self-perceived arm lymphoedema. CONCLUSION: Women reporting self-perceived arm lymphoedema, regardless of objective lymphoedema or not, have a decreased long-term health-related quality of life. This indicates that more attention should be given to the subjective reports of symptom in order to better help these women.

Phase III development of the European Organization for Research and Treatment of Cancer Quality of Life Questionnaire module for women undergoing breast reconstruction.

BACKGROUND: Comprehensive outcome assessments after breast reconstruction (BRR) require surgery-specific patient-reported outcome measures. The aims of this study were to assess the relevance, acceptability and redundancy of questions/items (phase III pretesting) of a new BRR questionnaire evaluating patients' health-related quality of life before and after BRR. Phase III occurred in collaboration with the European Organization for Research and Treatment of Cancer (EORTC) following earlier development phases that identified 31 items. METHODS: The EORTC BRR subgroup applied decision-making rules to each question according to eight EORTC criteria. A total of 197 patients (from the UK, Austria, Belgium, Italy and Sweden) were recruited. Forty-seven patients completed pre- and post-BRR questionnaires prospectively, and 150 reported post-BRR questionnaires only retrospectively. Qualitative debriefing interviews were undertaken in 189 patients. Preliminary psychometric analyses were performed. RESULTS: Thirty-one items fulfilled 'relevance', with none producing 'difficulties'. Ten items were not a priority for 10 per cent of respondents. Of these, two questions concerning muscle twitching in the affected breast and problem with donor-site swelling were deleted. Three redundant items were deleted: weakness in arm, which correlated significantly to the Quality of Life Questionnaire (QLQ) BR23 breast questionnaire, and shape and colour of the affected nipple. Descriptive statistics reduced the module to 26 items conceptualized into three provisional scales (disease treatment/surgery-related symptoms, sexuality and cosmetic outcome) within the newly completed questionnaire, EORTC QLQ-BRR26. CONCLUSION: The QLQ-BRR26 is available for psychometric validation in a large-field international sample. The intended use for QLQ-BRR26 is alongside EORTC QLQ-C30 and QLQ-BR23, in women treated by mastectomy for breast cancer and undergoing all types of BRR.

The early development phases of a European Organisation for Research and Treatment of Cancer (EORTC) module to assess patient reported outcomes (PROs) in women undergoing breast reconstruction.

INTRODUCTION: A comprehensive evaluation of breast reconstruction (BRR) surgery includes measurement of patient reported outcomes (PROs). There is, however, a lack of validated BRR-specific PRO measures (PROMs) that adequately assess relevant issues. This study is developing a European Organisation for Research and Treatment of Cancer (EORTC) questionnaire/module specific for PROs in BRR to supplement the cancer-core and breast cancer EORTC questionnaires, respectively: the QLQ-C30 and QLQ-BR23. METHODS: Phases I and II of questionnaire development followed EORTC guidelines including a systematic literature review to identify all potential 'issues' (concepts relevant to PROs) and semi-structured interviews with 89 patients and 9 European multi-disciplinary health care professionals (HCPs) (Sweden, Italy and the United Kingdom [UK]). Interviewers asked participants the 'relevance' of outcomes identified in the literature and captured additional 'issues' of importance. RESULTS: The literature search and interviews of patients and HCPs yielded 69 issues relating to BRR operationalised into 31 provisional items (single questions) for the module, which was conceptualised to contain five scales: treatment/surgery related symptoms (affecting the shoulder, arm and reconstructed breast), body image, sexuality, cosmetic outcomes (pertaining to three areas: breast, donor site and nipple) and overall satisfaction. DISCUSSION: The provisional development of the EORTC BRR module has 31 items addressing issues of importance to patients as well as HCPs. Further international testing is underway as a UK National Cancer Research Network trial to ensure that this PROM will be psychometrically and clinically robust and applicable for use in clinical trials, cohort studies, national audit and clinical practice.

Translation and validation of the Polish version of the EORTC QLQ-OPT30 module for the assessment of health-related quality of life in patients with uveal melanoma.

The purpose of this study was to translate into Polish and validate the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life Questionnaire Ophthalmic Module (QLQ-OPT30). The QLQ-OPT30 was translated and pilot-tested according to EORTC guidelines. Patients were qualified based on the histological or ophthalmoscopic and ultrasonographic diagnosis of uveal melanoma. Each patient filled out the Polish version of the EORTC Quality of Life Questionnaire (EORTC QLQ-C30), the QLQ-OPT30 module and a personal questionnaire. Patients were divided into three groups according to treatment type, melanoma localisation and possible negative outcomes of the disease or treatment. Reliability and validity test were performed and patients' comments were analysed. Our study included 94 patients--50 women (53.2%) and 44 men (46.8%) in the mean age of 58.4 (±13) years. Treatment type and melanoma location did not influence the health-related quality of life. The QLQ-OPT30, apart from two scales, showed positive internal consistency (Cronbach's alpha coefficients range: 0.70-0.88). We found the Polish version of the EORTC QLQ-OPT30 module a useful tool for measuring health-related quality of life in uveal melanoma patients. Although its discriminative validity is somewhat limited it still can be recommended for clinical use in the Polish population.

Individually tailored treatment with epirubicin and paclitaxel with or without capecitabine as first-line chemotherapy in metastatic breast cancer: a randomized multicenter trial.

Anthracyclines and taxanes are active cytotoxic drugs in the treatment of early metastatic breast cancer. It is yet unclear whether addition of capecitabine to the combination of these drugs improves the treatment outcome. Patients with advanced breast cancer were randomized to first-line chemotherapy with a combination of epirubicin (Farmorubicin(®)) and paclitaxel (Taxol(®)) alone (ET) or in combination with capecitabine (Xeloda(®), TEX). Starting doses for ET were epirubicin 75 mg/m(2) plus paclitaxel 175 mg/m(2), and for TEX epirubicin 75 mg/m(2), paclitaxel 155 mg/m(2), and capecitabine 825 mg/m(2) BID for 14 days. Subsequently, doses were tailored related to side effects. Primary endpoint was progression-free survival (PFS); secondary endpoints were overall survival (OS), time to treatment failure (TTF), objective response (OR), safety and quality of life (QoL). 287 patients were randomized, 143 to ET and 144 to TEX. Median PFS was 10.8 months for patients treated with ET, and 12.4 months for those treated with TEX (HR 0.84, 95% CI 0.65-1.07, P = 0.16); median OS was 26.0 months for women in the ET versus 29.7 months in the TEX arm (HR 0.84, 95% CI 0.63-1.11, P = 0.22). OR was achieved in 44.8% (ET) and 54.2% (TEX), respectively (χ(2) 3.66, P = 0.16). TTF was significantly longer for patients treated with TEX, 6.0 months, versus 5.2 months following ET (HR 0.73, 95% CI 0.58-0.93, P = 0.009). Severe hematological side effects related to epirubicin and paclitaxel were evenly distributed between the treatment arms, mucositis, diarrhea, and Hand-Foot syndrome were significantly more frequent in the TEX arm. Toxicity-adjusted treatment with ET and TEX showed similar efficacy in terms of PFS, OS, and OR. In this trial with limited power, the addition of capecitabine to epirubicin and paclitaxel as first-line treatment did not translate into clinically relevant improvement of the outcome.

Less correspondence between expectations before and cosmetic results after risk-reducing mastectomy in women who are mutation carriers: a prospective study.

PURPOSE: The primary aim was to describe satisfaction with the cosmetic results six months and one year after risk-reducing mastectomy (RRM) with immediate breast reconstruction. Another aim was to ascertain associations between ratings on "correspondence between the overall results and expectations before RRM" and age, mutation carrier status, salpingo-oophorectomy (SOE) before RRM, body image, and with sexual pleasure and discomfort. METHODS: 91/100 women who underwent RRM between 1997 and 2005 were included. Assessments were made six and twelve months after RRM with questionnaires regarding satisfaction with the cosmetic results, sexuality (SAQ), and body image (BIS). RESULTS: At both assessment points, >70% of the women considered the overall results of RRM to correspond to their expectations. Over 80% were satisfied with the size of their breasts, but 49% indicated at the one-year assessment that at least one breast was too hard and 73% indicated that they had no or only minor sensitivity in the breasts. In the univariate analyses, associations between "correspondence between the overall results and expectations before RRM" and mutation carrier status (p = 0.039) and SOE (p = 0.025) were found, but only mutation carrier status remained in the multivariate analysis (0.037). CONCLUSION: The majority of the women reported that the results of RRM corresponded to their expectations, with lower levels of correspondence in mutation carriers than in non-carriers. Overall satisfaction with the cosmetic result was high, but a majority of the women were unsatisfied with the softness of the reconstructed breasts. These results can be useful when informing patients about RRM.

Health-related quality of life in patients with high-risk melanoma randomised in the Nordic phase 3 trial with adjuvant intermediate-dose interferon alfa-2b.

PURPOSE: To compare health-related quality of life (HRQoL) and side-effects in patients with high-risk melanoma participating in a randomised phase III trial of adjuvant interferon alfa-2b (IFN). PATIENTS AND METHODS: A total of 855 patients with histologically verified resected cutaneous melanoma in AJCC stage IIb (T4 N0 M0) or stage III (Tx N1-3 M0) were randomised to: Arm A: observation only (n = 284); Arm B: 1-year treatment: induction: IFN alfa-2b, 10 MU (flat dose), SC, 5 days/week, 4 weeks, maintenance: IFN alfa-2b, 10 MU (flat dose), SC, 3 days/week for 12 months (n = 285); or Arm C: 2 years of same treatment as Arm B. HRQoL was assessed using The European Organisation for Research and Treatment of Cancer Core Questionnaire (EORTC QLQ-C30) before randomisation and at 8 pre-defined time-points during 2 years. IFN-related side-effects were assessed by a study-specific questionnaire. RESULTS: > 80% of eligible patients returned questionnaires at the different assessment points. Statistically significant interactions between randomisation arm and time after randomisation were found for almost all EORTC QLQ-30 variables. While patients in Arm A improved or remained at baseline levels; patients in Arms B and C reported decreased functioning and quality of life, and an increase in side-effects during their treatment. Patients in Arm B improved after the 12th month assessment, when IFN treatment was scheduled to end, to the 16th month assessment (p < 0.001). The same pattern of improvement was found for 5 of 7 interferon-related side-effects. CONCLUSION: A significant negative impact on HRQoL of IFN treatment was demonstrated, however the impact were reversible when treatment was stopped.

Health-related quality of life during hormone therapy after breast cancer: a randomized trial.

AIM: To study the effects of menopausal hormone therapy (HT) on health-related quality of life in women after breast cancer. PATIENTS AND METHODS: In the Stockholm trial, breast cancer survivors were randomized to HT (estradiol and progestogen) or to a control group (no treatment). A subgroup of 75 women was studied (38 with HT, 37 controls). Fifty patients were on concomitant tamoxifen. Patients completed three questionnaires (EORTC QLQ C-30, EORTC QLQ-BR 23 and the Hospital Anxiety and Depression Scale (HADS)) during 1 year of treatment. RESULTS: A significant group-by-time interaction was found for improvement of insomnia in the HT group (p < 0.001). Within the HT group, but not in the control group, there was significant improvement for HADS anxiety, HADS depression, emotional, cognitive, and social functions and global quality of life. When HT was added to tamoxifen, the increase in global quality of life was significant (p < 0.01). CONCLUSION: The effects of HT on quality of life in breast cancer survivors have not previously been reported. The present data suggest that this controversial treatment may improve quality of life after breast cancer.

High satisfaction rate ten years after bilateral prophylactic mastectomy - a longitudinal study.

Women from families with an increased risk for breast/ovarian cancer have undergone bilateral prophylactic mastectomy (BPM) since the early 1990s at the Karolinska University Hospital in Sweden. Perceptions of BPM as reported by the first women who underwent the procedure have previously been evaluated on a short-term basis (1-3 years). The present study aims to evaluate the long-term (10 years) physical and psychological consequences of BPM in the same cohort of women. Some of the very first women to undergo BPM participated in the present interview study (n= 13). The semi-structured interviews focused on the women's long-term experiences related to BPM and immediate breast reconstruction. Overall, the women were satisfied with their decision to undergo BPM and perceived a negligible remaining risk of getting breast cancer. For most women, the operation had not resulted in changes in family life or lifestyle (n= 8), although some described that the relationship with their spouse was affected (8/13), either in a negative (n= 5) or positive (n= 3) way. The cosmetic results were mainly positive (n= 10). Recurrent counselling and support during the whole process of decision, treatment and follow up is recommended.

Ductal carcinoma in situ of the breast. Long-term follow-up of health-related quality of life, emotional reactions and body image.

AIMS: To investigate and compare long-term health-related quality of life (HRQoL), body image, and emotional reactions in women with ductal carcinoma in situ of the breast (DCIS) treated with different surgical methods. PATIENTS AND METHODS: A total of 162 women were included in the study (47 had mastectomy and immediate breast reconstruction (IBR), 51 sector resection alone and 64 sector resection and postoperative radiotherapy). All women included in the study were asked to complete three questionnaires 4-15 years after surgery: the SF-36 for HRQoL, the Hospital Anxiety and Depression (HAD) scale, and the Body Image Scale (BIS). The response rate was 81%. RESULTS: Women in all three study groups had, overall, a very satisfactory HRQoL in the long term, similar to women in the general population. Women who underwent mastectomy and IBR scored significantly higher on physical functioning and bodily pain than the other two study groups as well as their age-adjusted norm groups. The addition of radiotherapy to breast-conserving therapy did not seem to have any negative impact on long-term HRQoL. Our results show significant differences between the three study groups for six of ten BIS items, with a greater proportion of women in the mastectomy and IBR group reporting problems. CONCLUSIONS: Women treated for DCIS have a very satisfactory long-term HRQoL. However, body image appeared to be negatively affected in mastectomy and IBR patients. Our results indicate that these women need more preoperative information about what changes in body image to expect after surgery.

Health-related quality of life and distress in cancer patients: results from a large randomised study.

To compare the effectiveness of individual support, group rehabilitation and a combination of the two in improving health-related quality of life (HRQOL) and psychological well-being in cancer patients during 24 months after diagnosis, as compared with standard care (SC). Furthermore, to compare the study sample and a random sample of the Swedish population with regard to HRQOL. A total of 481 consecutive patients, newly diagnosed with cancer, were randomly assigned to one of the four alternatives. Data on HRQOL and psychological well-being were collected at baseline and after 3, 6, 12 and 24 months. The interventions did not improve HRQOL or psychological well-being, as compared with SC. At 3 months, the study sample reported an HRQOL comparable with the normal population. Many cancer patients are able to manage their cancer-related concerns with the support available from SC. However, it is reasonable to assume that the findings suffer from a lack of data from especially vulnerable patients and a possible Hawthorne effect. It cannot be concluded that cancer patients have no need for additional psychosocial interventions. Future projects should include screening and target interventions for those at risk for significant and prolonged psychological distress.

Anemia and quality of life including anemia-related symptoms in patients with solid tumors in clinical practice.

The aim of this study was to explore in a clinical setting the association between hemoglobin (Hb) level and quality of life (QoL) including anemia-related symptoms in patients with cancer disease. The study was performed in the outpatient units at the Oncology Clinic, Karolinska University Hospital, during spring 2004. One hundred-sixty patients responded to the questionnaires and Hb levels were available in 133 of their medical files. Anemia was not a common problem as only 12 out of 133 patients had an Hb level below 110 g/L. The Hb level was not related to general QoL but to FACT-An Trial Outcome Index (rs = 0.186, p = 0.036), measuring anemia-related symptoms as well as functional and physical well-being. However, two patients with Hb < 110 g/L had minor anemia-related symptoms (FACT AnS > or = 40), while 22 patients with Hb > or = 110 g/L had more pronounced symptoms (FACT AnS < 40). There was no difference in anemia-related symptoms between patients with and without ongoing cancer treatment, but patients with ongoing cancer treatment had decreased physical (p = 0.025) and functional (p = 0.011) well-being as compared to those without ongoing treatment. Patients with lung cancer on cancer treatment had lower FACT-An Trial Outcome Index than patients with breast cancer on treatment (mean values 71.8 and 99.1 for patients with lung and breast cancer, respectively, p = 0.009), and also a tendency to lower Hb levels (mean values 119 and 127 for patients with lung and breast cancer, respectively, p = 0.052). Physical and functional aspects might be more important to consider than increasing the Hb level to reduce the fatigue.

Individuals with an increased risk of colorectal cancer: perceived benefits and psychological aspects of surveillance by means of regular colonoscopies.

PURPOSE: To evaluate the psychological consequences of genetic counseling followed by a surveillance program using colonoscopy among individuals with increased risk of colorectal cancer. PATIENTS AND METHODS: Two hundred sixty-five individuals, participating in a surveillance program with colonoscopy, were mailed a survey questionnaire that assessed their experience of the surveillance program and their perception of the risk of colorectal cancer. The Hospital Anxiety and Depression scale and the Swedish Short Form-36 Health Survey was also included. RESULTS: Two hundred forty individuals completed the questionnaire and were divided into the following risk groups: risk group 1, an individual with a mutation in hMLH1 or hMSH2 and a lifetime colorectal cancer risk of 80% (n = 28); risk group 2, a lifetime colorectal cancer risk of 40% (n = 129); and risk group 3, a lifetime colorectal cancer risk of 20% (n = 83). Among all individuals, the mean for perceived benefit was 8.0, and the perception of discomfort was 3.3 on the visual analog scale (1-10). In risk group 1, 61% underestimated personal risks as being 40% or less. Approximately 50% of the subjects in risk groups 2 and 3 either under- or overestimated their lifetime risk. According to the Swedish Short Form-36 Health Survey and the Hospital Anxiety and Depression scale, the study sample resembled the reference population. CONCLUSION: A majority of the study sample understood why they were under surveillance, and regular colonoscopies were well-tolerated. The wide range of risk perception as well as low-risk perception in mutation positive subjects is acceptable, as long as these individuals adhere to surveillance programs and do not demonstrate increased levels of anxiety or depression.

The EORTC ophthalmic oncology quality of life questionnaire module (EORTC QLQ-OPT30). Development and pre-testing (Phase I-III).

AIMS: The research objective was to develop a questionnaire module to be used, in addition to the European Organisation into Research and Treatment of Cancer (EORTC) QLQ-C30, for measurement of quality of life (QL) among patients with uveal melanoma treated with methods such as transpupillary thermotherapy, plaque radiotherapy, proton beam radiotherapy, local resection, and enucleation. The present paper describes the development through Phases I-III. METHODS: Relevant QL issues were generated from literature search and from interviews with ophthalmologists, nurses, and patients with uveal melanoma representing three major treatment options: enucleation, plaque brachytherapy, and proton beam therapy. RESULTS: The provisional module was pretested in 61 patients from Finland, Sweden, and UK. The EORTC QLQ-OPT30 module consists of 26 items for all patients, and four additional items for patients receiving treatments other than enucleation. It measures ocular irritation, vision impairment, headache, worry about recurrent disease, problems with driving, problems with appearance functional problems due to vision impairment, and problems reading. CONCLUSIONS: Several treatment modalities are available for uveal melanoma. There is limited knowledge of the impact of these treatments on QL in the long and short term. We hope that the OPT30 module together with the EORTC QLQ-C30 core questionnaire can be a useful tool in research.

Preoperative psychological reactions and quality of life among women with an increased risk of breast cancer who are considering a prophylactic mastectomy.

A consecutive sample of 56 women with a familial risk for breast cancer who were considering a prophylactic mastectomy (PM) completed questionnaires preoperatively concerning risk perception, expectations with regard to surgery, anxiety and depressive symptoms (the Hospital Anxiety and Depression Scale (HAD) scale) and quality of life (The Swedish SF-36 Health Survey). 16 had had a previous breast cancer (Group BC) and 40 had not (Group R). They were compared with normative data from an age-matched random sample of the Swedish population and with a reference sample of women with breast cancer. Most women estimated their breast cancer risk accurately. No statistically significant differences were found between Group BC and the normative sample on the HAD scale and SF-36, but Group R reported better physical functioning, emotional role functioning and mental health than the reference sample with breast cancer. Group BC scored closer to them than to the normative sample. Levels of emotional problems and quality of life were comparable to normative values among women considering PM. All women in the present study had previous genetic counselling and our results suggest that their interest in PM was not due to an overestimation of their personal risk.