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Contains fulltext : 125819.pdf (Publisher’s version ) (Closed access) Abstract Objective: To determine the reasons for women's anxiety and psychological stress before and during colposcopy, in order to define strategies to decrease their stress. Methods: Qualitative study with 15 women participating in four focus groups between April 2011 and April 2012. All participants were diagnosed with a cervical cytological abnormality and attended a gynecologist's clinic to undergo colposcopy. The focus group interview was audio-taped and transcribed verbatim. The data were analyzed using qualitative content analysis to identify themes. Results: Psychological stress before colposcopy was seen as being caused by unsatisfactory explanation of abnormal cervical smears and the colposcopy procedure itself. Additionally, a fear of cancer, pain and discomfort, embarrassment, waiting time in the hospital, and a longer interval between referral and the actual colposcopy appointment increased psychological stress and anxiety. Women indicated that more detailed and practical information about the cervical smear result and the colposcopy procedure may reduce stress and anxiety. Conclusion: In order to minimize the adverse psychological consequences of an abnormal cervical smear and colposcopy, timely, practical and detailed information needs to be provided to the women, and waiting and access times need to be as short as possible. These measures may reduce the psychological stress and anxiety, however some stress and anxiety will always remain, and may even be desirable in order to ensure proper follow-up of abnormal cervical smears.

Objective: To synthesize patients' views on the impact of stroke on their roles and self. Data Sources: PubMed, CINAHL, Embase, PsycINFO, and Cochrane searched from inception to September 2010, using a combination of relevant Medical Subject Headings and free-text terms. This search was supplemented by reference tracking. Study Selection: Qualitative studies reporting the views of people poststroke. The search yielded 494 records. Opinion articles, quantitative studies, or those reporting somatic functioning were excluded. Thirty-three studies were included. Data Extraction: Data extraction involved identifying all text presented as "results" or "findings" in the included studies, and importing this into software for the analysis of qualitative data. Data Synthesis: The abstracted text was coded and then subject to a thematic analysis and synthesis, which was discussed and agreed by the research team. Three overarching themes were identified: (1) managing discontinuity is a struggle; (2) regaining roles: to continue or adapt? and (3) context influences management of roles and self. Regaining valued roles and self was an ongoing struggle, and discontinuity and uncertainty were central to the adjustment process after stroke. Conclusions: The thematic synthesis provides new insights into the poststroke experience. Regaining or developing a new self and roles was problematic. Interventions targeted at self-management should be focused on the recognition of this problem and included in rehabilitation, to facilitate adjustment and continuity as far as possible in life poststroke. (C) 2013 by the American Congress of Rehabilitation Medicine

Item does not contain fulltext DNA-testing for BRCA1/2 or Lynch syndrome is possible from the age of 18 years, although surveillance usually starts at 25. Some patients regret their decision of testing before age 25. This retrospective study evaluates whether the testing age should be above 25 years to prevent adverse effects such as regret or decisional conflict, by determining the percentage and characteristics of patients reporting these problems. 111 of 219 patients (51 %) tested for BRCA1/2 mutations or Lynch syndrome between 18 and 25 years from July 1996 to February 2011, returned self-report surveys. Primary measures were regret, decisional conflict and family influence. Secondary measures included quality of life (QoL), coping style, impact of genetic testing, and risk perception. Median age was 27 [21-40] years, with 86 % female. 73 % was tested for BRCA1/2, 27 % for Lynch syndrome. Only 3 % reported regret, however 39 % had moderate (32 %) to severe (7 %) decisional conflict. Regression analysis revealed that decisional conflict was associated with more monitoring/neutral coping style (p < 0.03) or paternal/no family mutation (p < 0.02); there were no differences in QoL, impact or risk perception. 42 % were mutation carriers, showing equal decisional conflict to non-carriers. 68 % would recommend testing

Context. There is a lack of longitudinal studies investigating fatigue from before cancer treatment to long after successful cancer treatment.Objectives. This prospective follow-up study aimed to determine the prevalence and predictors of persistent fatigue in cancer survivors in the first year after completion of cancer treatment.Methods. Sixty patients with various malignancies were assessed before (T1), shortly after curative cancer treatment (T2), and one year after T2 (T3). Fatigue was assessed monthly between T2 and T3. Fatigue severity was measured using the subscale of the Checklist Individual Strength. Questionnaires were used to measure impaired sleep and rest, physical activity, social support, fatigue catastrophizing, and somatic-related attributions regarding fatigue. Linear regression analyses were performed to identify predictors of persistent fatigue.Results. In total, 22% of survivors had severe persistent fatigue over the last six months in the first year after cancer treatment. Fatigue at T1, T2, and negative interactions predicted the severity of persistent fatigue. Analyses without fatigue showed that more negative interactions, impaired sleep and rest, fatigue catastrophizing, and lower self-reported physical activity at T2 were associated with the severity of persistent fatigue.Conclusion. Twenty-two percent of the survivors had severe persistent fatigue in the year after cancer treatment. Fatigue and cognitive behavioral factors predicted persistent fatigue in the year after cancer treatment. Diagnosis or cancer treatment did not predict persistent fatigue. The implication is that cognitive behavioral therapy for postcancer fatigue, aimed at the fatigue-perpetuating factors, could be offered from two months after successful cancer treatment. J Pain Symptom Manage 2013;45:213-222. (C) 2013 U.S. Cancer Pain Relief Committee. Published by Elsevier Inc. All rights reserved.

Item does not contain fulltext CONTEXT: Cancer patients are at increased risk for distress. The Distress Thermometer (DT) and problem list (PL) are short-tools validated and recommended for distress screening in cancer patients. OBJECTIVE: To investigate the level of distress and problems experienced by survivors of differentiated non-medullary thyroid carcinoma (DTC), using the DT and PL and whether this correlates with clinical and demographical variables. PARTICIPANTS, DESIGN AND SETTING: All 205 DTC patients, under follow-up at the outpatient clinic of our university hospital, were asked to fill in the DT and PL, hospital anxiety and depression scale (HADS), illness cognition questionnaire (ICQ) and an ad hoc questionnaire. Receiver Operator Characteristic analysis (ROC) was used to establish the optimal DT cut-off score according to HADS. Correlations of questionnaires scores with data on diagnosis, treatment and follow-up collected from medical records were analyzed. RESULTS: Of the 159 respondents, 145 agreed to participate [118 in remission, median follow-up 7.2 years (range 3 months-41 years)]. Of these, 34.3% rated their distress score >/=5, indicating clinically relevant distress according to ROC analysis. Patients reported physical (86%) over emotional problems (76%) as sources of distress. DT scores correlated with HADS scores and ICQ subscales. No significant correlations were found between DT scores and clinical or demographical characteristics except for employment status. CONCLUSION: Prevalence of distress is high among patients with DTC even after long-term remission and cannot be predicted by clinical and demographical characteristics. DT and PL are useful screening instruments for distress in DTC patients and could easily be incorporated into daily practice.

Contains fulltext : 109223.pdf (Publisher’s version ) (Open Access) According to the Dutch Guideline on Hereditary Colorectal Cancer published in 2008, patients with recently diagnosed colorectal cancer (CRC) should undergo microsatellite instability (MSI) testing by a pathologist immediately after tumour resection if they are younger than 50 years, or if a second CRC has been diagnosed before the age of 70 years, owing to the high risk of Lynch syndrome (MIPA). The aim of the present MIPAPS study was to investigate general distress and cancer-specific distress following MSI testing. From March 2007 to September 2009, 400 patients who had been tested for MSI after newly diagnosed CRC were recruited from 30 Dutch hospitals. Levels of general distress (SCL-90) and cancer-specific distress (IES) were assessed immediately after MSI result disclosure (T1) and 6 months later (T2). Response rates were 23/77 (30%) in the MSI-positive patients and 58/323 (18%) in the MSI-negative patients. Levels of general distress and cancer-specific distress were moderate. In the MSI-positive group, 27% of the patients had high general distress at T1 versus 18% at T2 (p = 0.5), whereas in the MSI-negative group, these percentage were 14 and 18% (p = 0.6), respectively. At T1 and T2, cancer-specific distress rates in the MSI-positive group and MSI-negative group were 39 versus 27% (p = 0.3) and 38 versus 36% (p = 1.0), respectively. High levels of general distress were correlated with female gender, low social support and high perceived cancer risk. Moderate levels of distress were observed after MSI testing, similar to those found in other patients diagnosed with CRC. Immediately after result disclosure, high cancer-specific distress was observed in 40% of the MSI-positive patients. 01 juni 2012

ObjectiveThe determinants that cause impaired quality of life (QOL) in patients in long-term remission of Cushing's syndrome (CS) are unknown. The aim of this study was to get more insight into the patient and disease characteristics related to impaired QOL in these patients.DesignCross-sectional study.MethodsThe QOL of 123 patients in remission of CS (age 52.2±12.0 years, 106 women, duration of remission 13.3±10.4 years, 80% pituitary CS), assessed with seven validated questionnaires, was compared with the QOL of an age- and sex-matched control group (n=105). To investigate the influence of the aetiology of CS on QOL, patients in remission of pituitary and adrenal CS were compared. Furthermore, the influence of hormonal deficiencies, treatment strategy, duration of remission, gender and age on QOL was investigated.ResultsQOL in the total patient group and each patient subgroup was significantly worse on practically all dimensions of questionnaires compared with the control group (PConclusionsQOL remains impaired in patients in long-term remission of CS regardless of aetiology, presence of hormonal deficiencies and treatment strategies. More research is needed to establish the causes.

Item does not contain fulltext BACKGROUND: : Attitudes toward guilt and forgiveness may be important factors determining distress in cancer patients. Direct comparative studies in patients with different life expectancies exploring attitudes toward guilt and forgiveness are lacking. Also, sociodemographic and religious characteristics determining the attitudes toward guilt and forgiveness are unknown. OBJECTIVE: : The objective of this study was to compare attitudes toward guilt and forgiveness in cancer patients without evidence of disease and advanced cancer patients. METHODS: : A descriptive research design was used. Ninety-seven patients without evidence of disease and 55 advanced cancer patients filled out the Dutch Guilt Measurement Instrument and the Forgiveness of Others Scale. RESULTS: : Both groups had an attitude of nonreligious guilt and forgiveness, but not of religious guilt. No significant differences in attitudes toward guilt and forgiveness were observed between the 2 groups. In contrast to sociodemographic characteristics, religious characteristics were relevant predictors for guilt and forgiveness. Significant differences in relations between images of God and attitudes toward guilt were observed between the 2 patient groups. CONCLUSIONS: : An attitude of nonreligious guilt and forgiveness was found in cancer patients, irrespective of the stage of disease. Religious characteristics were significantly associated with attitudes of guilt and forgiveness. This correlation differed in the early and the advanced setting of disease. IMPLICATIONS FOR PRACTICE: : The observed relations between religious characteristics and attitudes of guilt and forgiveness suggest that a careful examination of the role of religious beliefs and values is relevant in the clinical care of patients with cancer, both in the setting of early and advanced disease.

Item does not contain fulltext OBJECTIVE: A randomised controlled trial (RCT) demonstrated that cognitive behaviour therapy (CBT) for fatigue during curative cancer treatment was effective shortly after cancer treatment. This study aimed to identify which patient characteristics predict fatigue improvement after CBT. In addition, the long-term effectiveness was investigated. METHODS: Patients with various malignancies participated in the RCT (n = 210). Participants were assessed before cancer treatment (T1), postintervention (T2), which was at least 2 months after cancer treatment, and after 1-year follow-up (T3). Monthly fatigue assessments were completed between T2 and T3. A regression analysis with interactions was performed to determine if domains of quality of life (EORTC-QLQ-C30) functioning (Health Survey Short Form-36) or psychological distress (Symptom Checklist-90) moderated the effect of CBT on fatigue. Analyses of covariance were used to study the long-term effectiveness of CBT. RESULTS: Fatigue at T2 was predicted by a significant interaction between self-reported cognitive functioning and CBT. No interactions were found between other domains of quality of life, functioning, psychological distress and CBT. At T3, no significant difference on fatigue was found between CBT and usual care. Exploratory analyses showed that the difference nearly reached significance until 7 months postintervention. CONCLUSIONS: Patients who experienced more concentration and memory problems at T1 benefited more from CBT for fatigue and are indicators. After a year of follow-up, the effect of CBT for fatigue was no longer observed, and the effect on fatigue seemed to be diminished 7 months postintervention. The implication is that CBT for fatigue should be offered to patients with cancer with the highest chance to benefit. Copyright (c) 2011 John Wiley & Sons, Ltd.

Contains fulltext : 97762.pdf (Publisher’s version ) (Closed access) BACKGROUND: Coping strategies may be important factors influencing quality of life (QOL), depression, and hopelessness. However, most studies on this issue were performed in patients still undergoing anticancer treatment. Unknown is which coping strategies are of importance for palliative-cancer patients who no longer receive treatment. OBJECTIVE: The objectives of this study were to assess coping strategies in curatively treated and palliative-cancer patients no longer receiving anticancer treatment and to examine the relation of these coping strategies with QOL, depression, and hopelessness. METHODS: A descriptive research design was used. Ninety-two curative and 59 palliative patients filled out the COPE-Easy abbreviated version, the European Organisation for Research-and-Treatment of Cancer QOL-Questionnaire version 2.0, Beck Depression Inventory for Primary Care, and Beck Hopelessness Scale. RESULTS: In both curative and palliative patients, active coping strategies and acceptance were beneficial in terms of QOL, depression, and hopelessness, unlike avoidant coping strategies and venting of emotions. Palliative patients scored higher on the coping strategy, seeking moral support. For the outcome variable, emotional functioning, significant interactions were observed between the variable, curative/palliative care setting, and the coping strategy, seeking moral support. For the outcome variable, role functioning, significant interactions were observed between the variable, curative/palliative care setting, and the coping strategy, waiting. CONCLUSIONS: Coping strategies were significantly correlated to QOL, depression, and hopelessness. However, this correlation differed in the curative and palliative, end-of-life care setting. IMPLICATIONS FOR PRACTICE: The observed relations between coping strategies, QOL, depression, and hopelessness give room to cognitive-behavioral nursing interventions. Specific attention is needed for differences in coping strategies between curative and palliative patients.

Contains fulltext : 95824.pdf (Publisher’s version ) (Closed access) OBJECTIVE: Cognitive behavior therapy (CBT) leads to a significant reduction in fatigue severity and impairment in patients with chronic fatigue syndrome (CFS). The purpose of the present study was to determine whether the effect of CBT for CFS on fatigue and impairment is mediated by a decrease in avoidance behavior and focusing on fatigue. METHODS: For this purpose, we reanalyzed a randomized controlled trial which was previously conducted to test the efficacy of CBT for CFS. Two hundred nineteen patients completed assessment prior and subsequent to treatment or a control group period. RESULTS: Mediation analysis revealed that a decrease in focusing on fatigue mediated the effect of CBT for CFS on fatigue and impairment. Avoidance of activity and avoidance of aversive stimuli were not significantly changed by treatment and were therefore excluded from mediation analysis. CONCLUSION: A decrease in the focus on fatigue seems to contribute to the treatment effect of CBT for CFS.

Contains fulltext : 98458.pdf (Publisher’s version ) (Closed access) OBJECTIVE: We investigated whether providing targeted information on an individual level by mail and by phone reduces anxiety in women referred to the colposcopy clinic. DESIGN: Randomised controlled trial. POPULATION: Women referred to the colposcopy clinic. METHODS: Between December 2007 and April 2010, 169 patients with abnormal smear results were randomised into two study arms. Group A received individually targeted information about the diagnosis and procedure by mail and phone. Group B received the standard folder about colposcopies alone. Patients were requested to fill out a questionnaire prior to their first colposcopy appointment. MAIN OUTCOME MEASURES: The questionnaire included the hospital anxiety and depression scale (HADS), and the Spielberger state-trait anxiety inventory (STAI), as well as a short self-administered questionnaire. RESULTS: Twenty women were excluded from further analyses after randomisation, leaving 149 women for evaluation. The median STAI state anxiety score was high (50.0), but there was no significant difference in median STAI state anxiety and HADS anxiety scores between both groups. However, knowledge about human papillomavirus and the colposcopy procedure did significantly increase in group A (P = 0.004). CONCLUSIONS: Anxiety levels before primary colposcopy are surprisingly high, and are not reduced following individually targeted information given before colposcopy.

Background: Patients with mild cognitive impairment (MCI) have to deal with an uncertain prognosis and also face a multitude of memory-related problems and psychosocial consequences. A newly developed group programme proved to be feasible, however, it needed confirmation by a controlled study. Aim: This controlled study evaluates this group therapy for MCI patients aimed to help them accept and manage the memory problems and the psychosocial consequences. The programme combines elements from psychoeducation, cognitive rehabilitation and cognitive-behavioural therapy. Patients and Methods: Ninety-three MCI patients received treatment, with 30 patients being first assigned to a waiting list, thus serving as their own control group. Pre- and post-treatment acceptance and helplessness were assessed using subscales of the Illness Cognition Questionnaire, while distress and general well-being were gauged with the Geriatric Depression Scale and subscales of the RAND-36. Results: Linear mixed model analyses showed that, relative to the controls, acceptance had increased more in the intervention group compared to the waiting-list period (p = 0.034). Distress and general well-being showed no changes. Treatment responders demonstrating a clinically significant effect on acceptance and two of three secondary outcome measures had higher baseline levels of helplessness and fewer self-reported memory complaints in daily life than patients who did not improve. Conclusion: The intervention helped the patients deal better with their uncertain future in that they were overall better able to accept their condition, with especially the female patients showing a decrease in helplessness cognitions, although the effects were relatively small.

Item does not contain fulltext Depressive disorder is assumed to be highly prevalent in advanced cancer patients, but the diagnosis of depressive disorder in patients with advanced cancer is difficult. The more robust the assessment instrument to diagnose depressive disorder is, the lower the reported prevalence of depressive disorder in advanced cancer patients. This study confirms a low prevalence of depressive disorder (3%) in 64 advanced cancer outpatients using a robust structured clinical assessment (SCAN 2.1). Furthermore, in this article we discuss possible implications of using predefined psychiatric labeling in the assessment of mood symptoms in advanced cancer patients. 01 februari 2012

Item does not contain fulltext BACKGROUND: Depression is assumed to be common in chronically ill patients during their last phase of life and is associated with poorer outcomes. The prevalence of depression is widely varying in previous studies due to the use of different terminology, classification, and assessment methods. AIM: To explore the reported incidence of depressive disorder, as registered in the last phase of life of patients who died from cardiovascular disease, cancer or COPD, in a sample of primary care patients. DESIGN AND SETTING: A historic cohort study, using a 20-year period registration database of medical records in four Dutch general practices (a dynamic population based on the Continuous Morbidity Registration database). METHOD: Medical history of the sample cohort was analysed for the diagnosis of a new episode of depressive disorder and descriptive statistics were used. RESULTS: In total 982 patients were included, and 19 patients (1.9%) were diagnosed with a new depressive disorder in the last year of their life. The lifetime prevalence of depressive disorder in this sample was 8.2%. CONCLUSION: The incidence of depressive disorder in the last phase of life is remarkably low in this study. These data were derived from actual patient care in general practice. Psychiatric diagnoses were made by GPs in the context of both patient needs and delivered care. A broader concept of depression in general practice is recommended to improve the diagnosis and treatment of mood disorders in patients in the last phase of life.

Item does not contain fulltext New models of cancer care and survivorship ask for empowered patients. But how do we measure that patients can derive strength from themselves (intrapersonal) and their perceived social support (interpersonal)? The 40-item Cancer Empowerment Questionnaire (CEQ) measures psychological empowerment as an individual outcome measure. The CEQ was validated in 140 nonmetastatic female breast cancer survivors (mean 5.5 years postsurgery). Principal component analysis elicited four factors representing intrapersonal (personal strength) and interpersonal (social support, community, health care) aspects of empowerment. The CEQ provides a reliable (Cronbach's alpha = 0.73-0.94) and valid first attempt to operationalize psychological empowerment in cancer care.

Contains fulltext : 128513.pdf (Publisher’s version ) (Closed access) BACKGROUND: Results of existing studies are inconclusive concerning the relationship between chemotherapy and subjective cognitive functioning (SCF). The aim of this study was to evaluate SCF of breast cancer (BC) patients and to find predictors of impaired SCF. Both satisfaction and frequency of complaints about SCF were measured. METHODS: BC patients who were about to receive chemotherapy (N = 74) and patients with a benign breast disease (BBD) (N = 63) participated. Before chemotherapy started (Time 1) and 3 months after ending chemotherapy (and at comparable moments for the BBD group) (Time 2), women completed validated questionnaires concerning the frequency of complaints and satisfaction with SCF, fatigue, perceived stress, anxiety, and depressive symptoms. RESULTS: No differences were found between the BBD and BC patients concerning the frequency of complaints about SCF across time. Satisfaction with SCF decreased across time in BC patients but remained stable across time in BBD patients (p < 0.001; p = 0.003 after controlling for state anxiety and perceived stress). Correlation coefficients between the satisfaction and the frequency of complaints about SCF ranged between -0.26 and -0.49. Depressive symptoms and satisfaction with SCF (Time 1) predicted the frequency of complaints about SCF (Time 2). Diagnosis, frequency of complaints about SCF, and state anxiety (Time 1) predicted satisfaction with SCF (Time 2). CONCLUSIONS: BC patients do not differ in the frequency of complaints about SCF compared with BBD patients, but their satisfaction with SCF decreased after treatment. Psychological factors predicted the frequency of complaints about SCF. Psychological factors and diagnosis predicted satisfaction with SCF.

Item does not contain fulltext BACKGROUND: To improve psychosocial care, the National Comprehensive Cancer Network recommends the use of the Distress Thermometer (DT) to detect distress among cancer patients. OBJECTIVES: The objectives of this study were to describe the prevalence of distress in breast cancer survivors (BCSs) and to investigate demographic, treatment, and psychosocial variables associated with distress and problems most often reported on the problem list. Moreover, we assessed how many BCSs requested referral to a professional for additional support. METHODS: In a cross-sectional study, 258 BCSs identified at an outpatient clinic of a university hospital were asked to complete the following questionnaires: DT, Quality of Life Questionnaire, Hospital Anxiety and Depression Scale, and Illness Cognition Questionnaire. RESULTS: Of the 258 identified BCSs, 129 (50 %) completed all questionnaires. After a mean follow-up period of 5.6 (SD, 10) years, 47 (36 %) of these 129 BCSs experienced distress as assessed by the DT. BCSs experienced significantly more distress in the first 2 years than in the period between 2 and 5 years after surgery. Also, more distress was experienced in BCSs treated with surgery, radiotherapy, and chemotherapy compared to those treated with surgery only. Problems most frequently encountered were fatigue (57 %), decrease in muscle strength (47 %), and lack of physical fitness (42 %). Thirty one (69 %) of the distressed BCSs requested or considered referral to a professional. Regression analysis showed that reduced quality of life, reduced cognitive function, and fatigue were predictors of distress. CONCLUSION: The current study found that more than one third of all BCSs experienced distress. Screening remains an important part of BCSs' care. The professional should be aware of the potential problems and distress patients may experience.

Item does not contain fulltext This controlled study examines the efficacy of a comprehensive group program aimed at care partners of patients with mild cognitive impairment (MCI), which comprises elements of psychoeducation, cognitive rehabilitation, and cognitive behavioral therapy. Pre- and posttreatment quantitative and qualitative data were collected in the significant others of 84 patients with MCI, 27 of whom had first been assigned to a waiting list, thus serving as their own control group. Also, the significant others rated their sense of competence, well-being, distress, acceptance, helplessness, and awareness. Quantitative data analysis did not reveal statistically significant differences between the control and the intervention condition, but qualitative results suggest that at program completion the significant others reported gains in knowledge, insight, acceptance, and coping skills. In the present sample of significant others, the group intervention was not proven effective. Suggestions for program adjustments and alternative outcome measures are discussed. 11 p.

Contains fulltext : 118735.pdf (Publisher’s version ) (Closed access) The present study examines the long-term effects of a 10-session cognitive behavioural group therapy for patients with mild cognitive impairment (MCI) and their significant others 6 to 8 months after completion of the intervention. Forty-seven MCI patients and 47 significant others participated in the follow-up assessment. Results of the RAND-36, Illness Cognition Questionnaire, IQCODE, GDS-15 and Sense of Competence Questionnaire at follow-up were compared with the post-intervention assessment. Our findings showed that the increased level of acceptance in the MCI patients was maintained at follow-up, with an increased insight into their cognitive decline compared with post-intervention assessment (p < 0.001). In both the patients and the significant others, helplessness and wellbeing were worse at follow up (p < 0.05), but sense of competence increased in the significant others (p

Contains fulltext : 106932.pdf (Publisher’s version ) (Open Access) Radboud Universiteit Nijmegen, 26 maart 2013 Promotores : Prins, J.B., Groot, R. de Co-promotores : Verhaak, C.M., Merkus, P.J.F.M.

Item does not contain fulltext OBJECTIVE: The Pictorial Representation of Self and Illness Measure (PRISM) measures in a simple, graphic way the burden of suffering due to illness. The question addressed in this study is whether the PRISM is a valid instrument to measure suffering in cancer survivors experiencing severe fatigue. METHOD: Quantitative and qualitative data of a previous randomized controlled trial demonstrating the efficacy of cognitive behavior therapy (CBT) especially designed for postcancer fatigue was used to assess convergent validity and sensitivity to change in a sample of 83 cancer survivors. MEASURES: The PRISM, yielding self-illness separation (SIS-fatigue = suffering due to fatigue; SIS-cancer = suffering due to cancer), fatigue severity (Checklist Individual Strength; CIS-fatigue), functional impairment, psychological well-being, quality of life, and coping with the experience of cancer (Impact of Event Scale; IES). RESULTS: Moderate significant correlations were found with the PRISM and the above-mentioned measures. On the basis of SIS scores, the sample was divided into two separate groups: cancer survivors who suffered more because of fatigue and cancer survivors who suffered more because they had cancer in the past. The two groups had different scores on CIS-fatigue and IES, in line with that aspect that caused them the most suffering. The qualitative data confirmed this finding. Participants in the CBT condition demonstrated a significant difference between SIS-fatigue at baseline versus 6 months later compared with those in the waiting list condition. No change of SIS-cancer was found. CONCLUSION: The PRISM seems to be a valuable tool in fatigue research and clinical practice.

Item does not contain fulltext BACKGROUND: Patients in a palliative care trajectory frequently suffer from depression. To distinguish depression from normal sadness, the use of screening instruments could facilitate the diagnostic process. However, in palliative care, screening instruments may not discern physical symptom burden from psychological distress, due to the high number of physical symptoms in palliative patients. OBJECTIVES: The aim of this study was to explore physical symptom burden and psychological distress in patients with advanced cancer in relation to scores on screening instruments for depression. METHODS: Patients with advanced cancer were asked to fill out the Beck Depression Inventory (BDI-II), Beck Depression Inventory Primary Care (BDI-PC), Hospital Anxiety and Depression Scale (HADS), and Memorial Symptom Assessment Scale Short Form (MSAS-SF). The relationship between scores on screening tools for depression and different physical symptom clusters was explored. RESULTS: In the sample of 65 patients, screening instruments for depression correlated highly with different somatic symptom clusters. The BDI-II cognitive subscale was the only scale that was not significantly correlated with any of the somatic symptom clusters. CONCLUSION: Screening tools for the detection of depression in patients with advanced cancer may not provide an accurate evaluation of depression. These tools seem to measure physical symptom burden as well, especially when patients suffer from symptoms of the clusters fatigue/anorexia/cachexia, neuropsychology, debility, or pain. In this study, the BDI-II cognitive subscale seems to differentiate best from somatic symptom burden.

PURPOSE: The aim of this study was to compare conventional medical follow-up with follow-up containing additional nursing consultations regarding the psychosocial adjustment and health-related quality of life (HRQOL) of head and neck cancer patients. METHODS: Using a quasi-experimental design, patients were enrolled consecutively into two groups. Experimental care covered six 30-min bimonthly nursing follow-up consultations during the first year posttreatment. Data were collected at posttreatment months 1 (baseline), 6, and 12 for both groups. RESULTS: The intervention group was significantly worse at baseline, based on two of the seven adjustment scales and on the majority of HRQOL scales. However, their outcome at 6 and 12 months was consistent with that of the group which received conventional follow-up. Thus, the intervention group had a larger improvement in scores, and this was significant for one of the seven adjustment scales and 19 of the 33 HRQOL scales at 6 and 12 months, respectively. Most of the differences in HRQOL scales were clinically relevant at 6 months. CONCLUSION: These results suggest that nurse-led consultations for patients with head and neck cancer have a positive effect, primarily with respect to HRQOL. Nurse-led follow-up leads to a similar psychosocial adjustment as conventional follow-up, even among patients who showed worse performance at the start of follow-up. Thus, nurse-led follow-up may be a cost-effective way to improve follow-up care for this patient group. ispartof: Supportive Care in Cancer vol:21 issue:2 pages:537-547 ispartof: location:Germany status: published

Contains fulltext : 116440.pdf (Publisher’s version ) (Open Access) BACKGROUND: Violence in families affects children. Exposure to violence is seen as child abuse. Figures show that about one third of children exposed to violence become victim or perpetrator in their adult life: known as intergenerational transmission. Violence also affects sexual and reproductive health. To prevent problems in adult life, children need help and support. However, while trying to protect their parents, children often do not seek help, or perceive the threshold as too high. Since almost all children of the current generation have access to the internet, an online intervention will make help better available for this target group. In 2011, an internet-based self-support method for children, adolescents and young adults exposed to family violence was developed in the Netherlands: "Feel the ViBe". The intervention was developed in close collaboration with the target group. This article describes the protocol of the RCT to study the effectiveness of this intervention. METHODS/DESIGN: This study is a randomized controlled trial using the method of minimization to randomize the participants in two parallel groups with a 1:1 allocation ratio, being an intervention group, having access to "Feel the ViBe" and usual care (UC), and a control group, having access to minimally enhanced usual care (mEUC) followed by access to the intervention after twelve weeks. Outcomes are measured with questionnaires on PTSD symptoms, mental health and sexual and reproductive health. Routine Outcome Measurement (ROM) will be used to measure a direct effect of participating in the intervention. Data from a web evaluation questionnaire (WEQ), user statistics and qualitative analysis of online data will be used to support the findings. To compare results Cohen's d effect sizes will be used. DISCUSSION: A RCT and process evaluation will test effectiveness and provide information of how the effects can be explained, how the intervention meets the expectation of participants and which possible barriers and facilitators for implementation exist. A qualitative analysis of the data will add information to interpret the quantitative data. This makes "Feel the ViBe" unique in its field. TRIAL REGISTRATION: The Netherlands National Trial Register (NTR), trial ID NTR3692. 11 p.

Contains fulltext : 108150.pdf (Publisher’s version ) (Open Access) PURPOSE Depression is highly prevalent in palliative care patients. In clinical practice, there is concern about both insufficient and excessive diagnosis and treatment of depression. In the Netherlands, family physicians have a central role in delivering palliative care. We explored variation in family physicians' opinions regarding the recognition, diagnosis, and management of depression in palliative care patients. METHODS We conducted a focus group study in a sample of family physicians with varied practice locations and varying expertise in palliative care. Transcripts were analyzed independently by 2 researchers using constant comparative analysis in ATLAS.ti. RESULTS In 4 focus group discussions with 22 family physicians, the physicians described the diagnostic and therapeutic process for depression in palliative care patients as a continuous and overlapping process. Differentiating between normal and abnormal sadness was viewed as challenging. The physicians did not strictly apply criteria of depressive disorder but rather relied on their clinical judgment and strongly considered patients' context and background factors. They indicated that managing depression in palliative care patients is mainly supportive and nonspecific. Antidepressant drugs were seldom prescribed. The physicians described difficulties in diagnosing and treating depression in palliative care, and gave suggestions to improve management of depression in palliative care patients in primary care. CONCLUSIONS Family physicians perceive the diagnosis and management of depression in palliative care patients as challenging. They rely on open communication and a long-standing physician-patient relationship in which the patient's context is of great importance. This approach fits with the patient-centered care that is promoted in primary care. 01 juli 2012

Contains fulltext : 109284.pdf (Publisher’s version ) (Open Access) ABSTRACT: BACKGROUND: After completion of curative breast cancer treatment, patients go through a transition from patient to survivor. During this re-entry phase, patients are faced with a broad range of re-entry topics, concerning physical and emotional recovery, returning to work and fear of recurrence. Standard and easy-accessible care to facilitate this transition is lacking. In order to facilitate adjustment for all breast cancer patients after primary treatment, the BREATH intervention is aimed at 1) decreasing psychological distress, and 2) increasing empowerment, defined as patients' intra- and interpersonal strengths. METHODS/DESIGN: The non-guided Internet-based self-management intervention is based on cognitive behavioural therapy techniques and covers four phases of recovery after breast cancer (Looking back; Emotional processing; Strengthening; Looking ahead). Each phase of the fully automated intervention has a fixed structure that targets consecutively psychoeducation, problems in everyday life, social environment, and empowerment. Working ingredients include Information (25 scripts), Assignment (48 tasks), Assessment (10 tests) and Video (39 clips extracted from recorded interviews). A non-blinded, multicentre randomised controlled, parallel-group, superiority trial will be conducted to evaluate the effectiveness of the BREATH intervention. In six hospitals in the Netherlands, a consecutive sample of 170 will be recruited of women who completed primary curative treatment for breast cancer within 4 months. Participants will be randomly allocated to receive either usual care or usual care plus access to the online BREATH intervention (1:1). Changes in self-report questionnaires from baseline to 4 (post-intervention), 6 and 10 months will be measured. DISCUSSION: The BREATH intervention provides a psychological self-management approach to the disease management of breast cancer survivors. Innovative is the use of patients' own strengths as an explicit intervention target, which is hypothesized to serve as a buffer to prevent psychological distress in long-term survivorship. In case of proven (cost) effectiveness, the BREATH intervention can serve as a low-cost and easy-accessible intervention to facilitate emotional, physical and social recovery of all breast cancer survivors. TRIAL REGISTRATION: This study is registered at the Netherlands Trial Register (NTR2935).

Contains fulltext : 107811.pdf (Publisher’s version ) (Open Access) PURPOSE: Persistent fatigue is a long-term adverse effect experienced in about a quarter of patients cured of cancer. It was shown that cognitive behavior therapy (CBT) especially designed for postcancer fatigue is highly effective in reducing severe fatigue. However, it is unclear by what mechanism the fatigue reduction is reached. In many fatigue reduction programs, an increase in physical activity is assumed to reduce fatigue. The purpose of the present study is to determine whether the effect of CBT on fatigue is mediated by an increase in physical activity. METHODS: Data of a previous randomized controlled trial on the efficacy of CBT for postcancer fatigue were reanalyzed (CBT, n = 41; waiting list condition, n = 42). Actigraphy was used to assess the level of objective physical activity. Cancer survivors were assessed prior as well as after the CBT and waiting list period. The mediation hypothesis was tested according to guidelines of Baron and Kenny. A non-parametric bootstrap approach was used to test statistical significance of the mediation effect. RESULTS: Although CBT effectively reduced postcancer fatigue, no change in level of objective physical activity was found. The mean mediation effect was 1.4% of the total treatment effect. This effect was not significant. CONCLUSION: The effect of CBT for postcancer fatigue is not mediated by a persistent increase in objective physical activity. 01 juli 2012

Background Current practice for patients with breast cancer referred for genetic counseling, includes face-to-face consultations with a genetic counselor prior to and following DNA-testing. This is based on guidelines regarding Huntington’s disease in anticipation of high psychosocial impact of DNA-testing for mutations in BRCA1/2 genes. The initial consultation covers generic information regarding hereditary breast cancer and the (im)possibilities of DNA-testing, prior to such testing. Patients with breast cancer may see this information as irrelevant or unnecessary because individual genetic advice depends on DNA-test results. Also, verbal information is not always remembered well by patients. A different format for this information prior to DNA-testing is possible: replacing initial face-to-face genetic counseling (DNA-intake procedure) by telephone, written and digital information sent to patients’ homes (DNA-direct procedure). Methods/design In this intervention study, 150 patients with breast cancer referred to the department of Clinical Genetics of the Radboud University Nijmegen Medical Centre are given the choice between two procedures, DNA-direct (intervention group) or DNA-intake (usual care, control group). During a triage telephone call, patients are excluded if they have problems with Dutch text, family communication, or of psychological or psychiatric nature. Primary outcome measures are satisfaction and psychological distress. Secondary outcome measures are determinants for the participant’s choice of procedure, waiting and processing times, and family characteristics. Data are collected by self-report questionnaires at baseline and following completion of genetic counseling. A minority of participants will receive an invitation for a 30 min semi-structured telephone interview, e.g. confirmed carriers of a BRCA1/2 mutation, and those who report problems with the procedure. Discussion This study compares current practice of an intake consultation (DNA-intake) to a home informational package of telephone, written and digital information (DNA-direct) prior to DNA-testing in patients with breast cancer. The aim is to determine whether DNA-direct is an acceptable procedure for BRCA1/2 testing, in order to provide customized care to patients with breast cancer, cutting down on the period of uncertainty during this diagnostic process. Trial registration The study is registered at the Dutch Trial Registry http://www.trialregister.nl (NTR3018).

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Contains fulltext : 110156.pdf (Publisher’s version ) (Closed access) OBJECTIVE: To validate the Dutch translation of the Fear of Progression Questionnaire-Short Form (FoP-Q-SF) for patients with systemic sclerosis (SSc). Although concerns about the future are often expressed by patients with SSc, there is no valid quantitative measure available to assess the extent to which patients with SSc are troubled by those concerns. METHODS: Measurement properties of the FoP-Q-SF were assessed using a cross-sectional design that included 215 patients with SSc. Patients completed the FoP-Q-SF as well as questionnaires on physical and psychological functioning. Psychometric properties of the FoP-Q-SF were assessed using the Consensus-Based Standards for the Selection of Health Status Measurement Instruments checklist. RESULTS: The mean +/- SD FoP-Q-SF score in patients with SSc was 30.05 +/- 8.97. There were no indications of floor or ceiling effects. Confirmatory factor analysis supported the single-factor structure of the questionnaire (chi(2) [52] = 96.84, P < 0.001, root mean square error of approximation = 0.064, chi-square/df ratio = 1.86). Cronbach's alpha was 0.86 for the questionnaire. Most of our a priori hypotheses (11 of 12) were confirmed, supporting the construct validity of the questionnaire. CONCLUSION: A valid measure is now available to assess fear of disease progression in patients with SSc, which is significant since fear of progression is one of the most important stressors in this patient population. 5 p.

Item does not contain fulltext PURPOSE: Perceiving favourable changes from one's illness may go hand in hand with experiencing harmful psychosocial effects. Each of these constructs should be considered when examining children's levels of psychological adjustment following stressful life events. A paediatric instrument that accounts for both positive and negative impact of stressful events has not been investigated in The Netherlands before. The aim of the study was to investigate psychometric properties of the Dutch version of the Benefit and Burden Scale for Children (BBSC), a 20-item questionnaire that intends to measure potential benefit and burden of illness in children. METHODS: Dutch paediatric survivors of childhood cancer aged 8-18 (N = 77) completed the BBSC and other psychological questionnaires: Pediatric Quality of Life Inventory (health-related quality of life), State-Trait Anxiety Inventory for Children (anxiety), Children's Revised Impact of Event Scale (posttraumatic stress) and Strengths and Difficulties Questionnaire (behavioural functioning). Reliability and validity were evaluated. RESULTS: Internal consistency (Cronbach's alpha, benefit 0.84, burden 0.72), test-retest reliability (benefit r = 0.74, burden r = 0.78) and homogeneity (mean inter-item correlation, benefit r = 0.34, burden r = 0.22) were satisfactory. Burden was associated with HRQoL (-), anxiety (+), posttraumatic stress symptoms (+) and behavioural problems. Benefit did not correlate with the psychological outcomes. CONCLUSIONS: The Dutch version of the BBSC shows promising psychometric properties. Perceived benefit and disease-related burden are distinct constructs; both should be considered when examining children's psychological adjustment to potentially traumatic experiences. The BBSC may be useful as monitoring and screening instrument.

Contains fulltext : 96823.pdf (Publisher’s version ) (Closed access) BACKGROUND: Cancer patients are presented with advice and instructions during treatment and at discharge. Most recommendations aim at relief of physical problems, psychosocial well-being, and patients' health care behaviors. Patients often struggle to incorporate advice into daily life, and this influences symptom relief, quality of life, and even longevity. OBJECTIVE: The aim of this study was to gain insight into the content and form of discharge advice to cancer patients and to determine the factors that hinder or promote the actual adoption of advice by patients. METHODS: Using a descriptive, exploratory research design, data were collected using structured interviews in a convenience sample of 21 head and neck cancer patients who had completed treatment with curative intent 2 to 6 months earlier. Descriptive statistics and a thematic content analysis procedure were used to analyze the data. RESULTS: Findings showed that advice or instructions received by individual patients had a range from 1 to 13, and that 17 out of 21 patients received 4 advices or more. Relevant influencing factors included patient characteristics (cognition, emotion, behavior, and social aspects) and characteristics of health professionals (content and efficacy of advice, professional attitude, behavior, and communication). CONCLUSIONS: Cancer patients try but often struggle to fit the multitude and complexity of advice from health professionals into everyday life. IMPLICATIONS FOR PRACTICE: There seems to be an excellent opportunity for health professionals to support cancer patients by further tailoring of follow-up care. Knowledge and insight into the challenges patients face posttreatment will benefit both professionals and patients.

Contains fulltext : 96192.pdf (Publisher’s version ) (Closed access) CONTEXT: It is unknown whether cancer patients with different life expectancies have different attitudes and emotions toward death and an afterlife. Also, it is unclear whether these attitudes and emotions toward death and afterlife influence patients' distress. OBJECTIVES: To assess the relationship of attitudes and emotions towards death and an afterlife with quality of life, depression and hopelessness in cancer patients without evidence of disease and advanced cancer patients facing death. METHODS: Ninety-one cancer patients without evidence of disease and 57 advanced cancer patients completed the Dutch Attitudes Toward Death and Afterlife Scale. Emotions toward death were measured using the Self-Confrontation Method. Quality of life was measured with the Satisfaction with Life Scale and the European Organization for Research and Treatment of Cancer (EORTC) Quality-of-Life Questionnaire. Depression and hopelessness were measured with the Beck Depression Inventory for Primary Care and the Beck Hopelessness Scale. RESULTS: Average scores on attitudes and emotions toward death and an afterlife were not significantly different between the two groups. However, in the no evidence of disease group, a negative association between negative emotions and social functioning was observed, which was not present in the advanced cancer group. In the advanced cancer group, associations were observed that were not present in the no evidence of disease group: positive associations between an explicitly religious attitude and global health status and between reincarnation belief and role and cognitive functioning, and a negative association between other-directed emotions and social functioning. CONCLUSION: Patients without evidence of disease and advanced cancer patients do not differ in attitudes or emotions toward death, but the relationship between these attitudes and emotions and aspects of quality of life varies. When there is no evidence of disease, negative emotions play the most important role, whereas in the advanced cancer situation, attitudes toward death and an afterlife, which may provide meaning and value, become more prominent.

Contains fulltext : 128581.pdf (Publisher’s version ) (Open Access) BACKGROUND: Generic fully automated Web-based self-management interventions are upcoming, for example, for the growing number of breast cancer survivors. It is hypothesized that the use of these interventions is more individualized and that users apply a large amount of self-tailoring. However, technical usage evaluations of these types of interventions are scarce and practical guidelines are lacking. OBJECTIVE: To gain insight into meaningful usage parameters to evaluate the use of generic fully automated Web-based interventions by assessing how breast cancer survivors use a generic self-management website. Final aim is to propose practical recommendations for researchers and information and communication technology (ICT) professionals who aim to design and evaluate the use of similar Web-based interventions. METHODS: The BREAst cancer ehealTH (BREATH) intervention is a generic unguided fully automated website with stepwise weekly access and a fixed 4-month structure containing 104 intervention ingredients (ie, texts, tasks, tests, videos). By monitoring https-server requests, technical usage statistics were recorded for the intervention group of the randomized controlled trial. Observed usage was analyzed by measures of frequency, duration, and activity. Intervention adherence was defined as continuous usage, or the proportion of participants who started using the intervention and continued to log in during all four phases. By comparing observed to minimal intended usage (frequency and activity), different user groups were defined. RESULTS: Usage statistics for 4 months were collected from 70 breast cancer survivors (mean age 50.9 years). Frequency of logins/person ranged from 0 to 45, total duration/person from 0 to 2324 minutes (38.7 hours), and activity from opening none to all intervention ingredients. 31 participants continued logging in to all four phases resulting in an intervention adherence rate of 44.3% (95% CI 33.2-55.9). Nine nonusers (13%), 30 low users (43%), and 31 high users (44%) were defined. Low and high users differed significantly on frequency (P

Item does not contain fulltext PURPOSE: Depression is highly prevalent in advanced cancer patients, but the diagnosis of depressive disorder in patients with advanced cancer is difficult. Screening instruments could facilitate diagnosing depressive disorder in patients with advanced cancer. The aim of this study was to determine the validity of the Beck Depression Inventory (BDI-II) and a single screening question as screening tools for depressive disorder in advanced cancer patients. METHODS: Patients with advanced metastatic disease, visiting the outpatient palliative care department, were asked to fill out a self-questionnaire containing the Beck Depression Inventory (BDI-II) and a single screening question "Are you feeling depressed?" The mood section of the PRIME-MD was used as a gold standard. RESULTS: Sixty-one patients with advanced metastatic disease were eligible to be included in the study. Complete data were obtained from 46 patients. The area under the curve of the receiver operating characteristics analysis of the BDI-II was 0.82. The optimal cut-off point of the BDI-II was 16 with a sensitivity of 90% and a specificity of 69%. The single screening question showed a sensitivity of 50% and a specificity of 94%. CONCLUSIONS: The BDI-II seems an adequate screening tool for a depressive disorder in advanced cancer patients. The sensitivity of a single screening question is poor. 01 februari 2012

Contains fulltext : 97351.pdf (Publisher’s version ) (Closed access) Current diagnostic practices have shortened the interval between colorectal cancer (CRC) diagnosis and genetic analysis for Lynch syndrome by MSI-testing. We studied the relation of time between MSI-testing since CRC diagnosis (MSI-CRC interval) and psychological distress. We performed a cross-sectional study in 89 patients who had previously been treated for CRC. Data were collected during MSI-testing after genetic counseling. Psychological distress was measured with the IES, the SCL-90 and the POMS; social issues with the ISS, ISB and the ODHCF. The median time of MSI-CRC interval was 24 months (range 0-332), with 23% of the patients diagnosed less than 12 months and 42% more than 36 months prior to MSI-testing. In 34% of the patients cancer specific distress was high (IES scores >26). Mean psychopathology (SCL-90) scores were low, mean mood states (POMS) scores were moderate. Interval MSI-CRC was not related to psychological distress. High cancer specific distress was reported by 24% of patients diagnosed with CRC less than 12 months ago versus 39 and 35% by those diagnosed between 12 and 36 months and more than 36 months ago respectively. Distress was positively related to female gender (P = 0.04), religiousness (P = 0.01), low social support (P = 0.02) and difficulties with family communication (P < 0.001). Shortened time interval between CRC diagnosis and MSI-testing is not associated with higher psychological distress. Females, religious persons, those having low social support and those reporting difficulties communicating hereditary colorectal cancer with relatives are at higher risk for psychological distress.

Background According to the Word Health Organization, patients who can benefit from palliative care should be identified earlier to enable proactive palliative care. Up to now, this is not common practice and has hardly been addressed in scientific literature. Still, palliative care is limited to the terminal phase and restricted to patients with cancer. Therefore, we trained general practitioners (GPs) in identifying palliative patients in an earlier phase of their disease trajectory and in delivering structured proactive palliative care. The aim of our study is to determine if this training, in combination with consulting an expert in palliative care regarding each palliative patient's tailored care plan, can improve different aspects of the quality of the remaining life of patients with severe chronic diseases such as chronic obstructive pulmonary disease, congestive heart failure and cancer. Methods/Design A two-armed randomized controlled trial was performed. As outcome variables we studied: place of death, number of hospital admissions and number of GP out of hours contacts. Discussion We expect that this study will increase the number of identified palliative care patients and improve different aspects of quality of palliative care. This is of importance to improve palliative care for patients with COPD, CHF and cancer and their informal caregivers, and to empower the GP. The study protocol is described and possible strengths and weaknesses and possible consequences have been outlined. Trial Registration The Netherlands National Trial Register: NTR2815

Background BRCA mutation carriers have a 40-80% life-time risk of developing breast cancer. They may opt for yearly breast cancer surveillance or for prophylactic mastectomy. Both options show increased survival rates. It is a complex choice to be made between these two options. As a result most women experience high levels of distress and high needs for information. To fulfill the needs for psychosocial support and information we have introduced group medical consultations (GMCs). A GMC provides individual medical visits conducted within a group. This 90 minute group-visit with 8-12 patients gives patients the opportunity to spend more time with their clinician and a behavioral health professional and learn from other patients experiencing similar topics. However, it should be noted that group sessions may increase fear in some patients or influence their decision making. Methods/design In this randomized controlled trial, 160 BRCA mutation carriers diagnosed maximally 2 years ago are recruited from the Radboud University Nijmegen Medical Centre. Participants are randomized in a 1:1 ratio to either the GMC intervention group (onetime participation in a GMC instead of a standard individual visit) or to a usual care control group. Primary outcome measures are empowerment and psychological distress (SCL 90). Secondary outcome measures are fear of cancer, information needs before the consultation and the received information, self-examination of the breasts, patient satisfaction, quality of life and cost-effectiveness. Data are collected via self-reported questionnaires 1 week before the visit, and at 1 week and at 3 months follow-up. A pilot study was conducted to test all procedures and questionnaires. Discussion The possibility for interaction with other BRCA mutation carriers within a medical visit is unique. This study will assess the effectiveness of GMCs for BRCA mutation carriers to improve empowerment and decrease distress compared to individual visits. If GMCs prove to be effective and efficient, implementation of GMCs in regular care for BRCA mutation carriers will be recommended. Trial registration The study is registered at ClinicalTrials.gov (NCT01329068)

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