The motivation of breast cancer patients to participate in a national randomized control trial.

PURPOSE: Clinical trials are essential for development of better cancer care. Therefore, patient willingness to participate in these trials is important. The aim of this study was to assess motivation and thoughts of breast cancer patients concerning participation in a clinical trial. METHODS: Twenty-one patients participated in two semi-structed interviews about participating in a clinical trial testing the efficacy of cryotherapy for the prevention of chemotherapy-induced peripheral neuropathy in breast cancer patients treated with paclitaxel. The interviews took place before and after the intervention and were coded and categorized following the steps in Braun & Clarke's thematic analysis to identify motivational factors and experiential themes. RESULTS: Four overarching themes were identified: (1) reasons to participate in the trial, (2) personal resources, (3) safety, and (4) experience of the randomization. The most frequent reason for participating in the trial was to support research and help others, but many also participated hoping to receive the intervention treatment. The study showed that a surplus of personal resources played an important role when the patients decided to participate in the trial. Differences were found between patients belonging to the intervention and the control group in relation to these themes. Finally, both groups experienced the extra examinations received during the trial as an additional source of safety. CONCLUSION: This qualitative study found different factors influencing the experience of participating in a clinical trial, e.g., intervention-status, personal resources, and safety. This knowledge can be valuable when planning future clinical trials involving breast cancer patients.

Web-based cognitive training for breast cancer survivors with cognitive complaints-a randomized controlled trial.

BACKGROUND: Cognitive complaints are common amongst breast cancer survivors, and no standard treatment exists. The present study evaluates whether web-based cognitive training can alleviate subjectively reported and objectively assessed cognitive complaints in a sample of breast cancer survivors. The primary and secondary outcomes were an objective measure of working memory and a measure of perceived cognitive functioning. Additional outcomes were neuropsychological tests of memory, executive function, working memory and questionnaire-based assessment of anxiety, depression and somatization. METHODS: A total of 157 female breast cancer survivors were recruited from an existing cohort and through announcements in open access cancer-related Internet fora and randomly allocated to either web-based cognitive training (eCogT) with telephone support (n = 94) or a waitlist control (WLC) condition (n = 63). eCogT encompassed 30 training sessions over 6 weeks. Neuropsychological assessments were undertaken over the telephone, and questionnaire data was collected online. Data was collected at baseline, post-intervention and at 5-month follow-up. RESULTS: Mixed linear models revealed no statistically significant change in primary or secondary outcome at follow-up in either group. Statistically significant improvements (p 0.040-0.043) were found in the eCogT group for verbal learning and on a working memory test. CONCLUSIONS: Web-based cognitive training did not result in improvements of the primary or secondary outcome. Improved performance was observed on verbal learning and working memory. These effects were observed at 5-month follow-up, indicating long-term effects of training. The intervention may be applied in a clinical setting at low cost and without risk of adverse effects.© 2016 The Authors Psycho-Oncology Published by John Wiley & Sons Ltd.

Long-term subjective cognitive functioning following adjuvant systemic treatment: 7-9 years follow-up of a nationwide cohort of women treated for primary breast cancer.

BACKGROUND: There is growing concern among breast cancer (BC) patients and survivors about cognitive impairment following systemic treatments. The aim of the present study was to investigate the long-term effects of standard systemic adjuvant therapies on subjective cognitive impairment (SCI) in a large nationwide cohort of BC survivors 7-9 years after primary surgery. METHODS: Participants were recruited from the nationwide Psychosocial Factors and Breast Cancer inception cohort of Danish women treated for primary BC. SCI was assessed with the Cognitive Failures Questionnaire and women allocated to systemic treatment according to nationwide standard protocols were compared with women who had not received any systemic treatments. RESULTS: A total of 1889 recurrence-free survivors were eligible for analysis. No difference in SCI was found between survivors across standardized systemic treatment protocols when analyses were stratified by menopausal status and adjusted for possible sociodemographic and treatment-related confounders. The frequency of significant SCI in a subgroup of survivors in the age range 65-74 years was ∼7%. CONCLUSIONS: No differences in long-term SCI at 7-9 years post surgery were found between women who had received systemic therapies and those who had not. Furthermore, the observed proportion of survivors with significant SCI was comparable to normative data. These results are important to communicate to patients, survivors, and clinicians alike, especially in the light of increasing concern about cognitive impairment following systemic therapies.

Stressful life events are associated with a poor in-vitro fertilization (IVF) outcome: a prospective study.

BACKGROUND: There is preliminary evidence to suggest an impact of stress on chances of achieving a pregnancy with in-vitro fertilization (IVF). The majority of the available research has focused on stress related to infertility and going through IVF-treatment, and it is still unclear whether non-fertility-related, naturally occurring stressors may influence IVF pregnancy chances. Our aim was to explore the association between IVF-outcome and negative, i.e. stressful, life-events during the previous 12 months. METHODS: Prior to IVF, 809 women (mean age: 31.2 years) completed the List of Recent Events (LRE) and questionnaires measuring perceived stress and depressive symptoms. RESULTS: Women who became pregnant reported fewer non-fertility-related negative life-events prior to IVF (Mean: 2.5; SD: 2.5) than women who did not obtain a pregnancy (Mean: 3.0; SD: 3.0) (t(465.28) = 2.390, P = 0.017). Logistic regression analyses revealed that the number of negative life-events remained a significant predictor of pregnancy (OR: 0.889; P = 0.02), when controlling for age, total number of life-events, perceived stress within the previous month, depressive symptoms, and relevant medical factors related to the patient or treatment procedure, including duration of infertility, number of oocytes retrieved and infertility etiology. Mediation analyses indicated that the association between negative life events and IVF pregnancy was partly mediated by the number of oocytes harvested during oocyte retrieval. CONCLUSION: A large number of life-events perceived as having a negative impact on quality of life may indicate chronic stress, and the results of our study indicate that stress may reduce the chances of a successful outcome following IVF, possibly through psychobiological mechanisms affecting medical end-points such as oocyte retrieval outcome.

Chemotherapy-induced nausea, vomiting, and fatigue--the role of individual differences related to sensory perception and autonomic reactivity.

BACKGROUND: In spite of antiemetics, postchemotherapy side effects continue to be common and may affect compliance to cancer treatment. Among the known factors associated with increased symptom severity are: younger age, treatment toxicity, expected severity, and distress, but little is still known about the role of other factors. The aim of our study was to investigate the role of individual differences related to sensory perception for posttreatment side effects. METHODS: Hundred and twenty-five women receiving adjuvant chemotherapy for breast cancer completed measures of absorption, autonomic perception, somatosensory amplification, trait anxiety, and expected severity at baseline. Pretreatment distress and posttreatment nausea, vomiting, and fatigue were assessed at the 1st, 4th, 6th and last cycles of chemotherapy. RESULTS: While univariate analyses showed several factors to be associated with side effects, only absorption and pretreatment distress remained independent predictors of nausea and fatigue when controlling for the remaining factors. Posttreatment vomiting was only predicted by expected severity of vomiting. CONCLUSION: Chemotherapy-induced side effects are related to increased autonomic nervous system activity, and absorption has been associated with increased autonomic nervous system reactivity to stress. The results suggest that individuals with high absorption may be at greater risk for developing side effects. Improved precision in identifying patients at risk of experiencing more severe side effects after cancer treatment will increase the ability to target treatments aimed at reducing these side effects.

Anticipatory nausea: the role of individual differences related to sensory perception and autonomic reactivity.

BACKGROUND: Anticipatory nausea (AN) during chemotherapy has been difficult to control with conventional antiemetics. AN can lead cancer patients to delay or discontinue chemotherapy, possibly compromising the treatment. PURPOSE: The aim is to investigate the possible influence on the development of AN of individual differences in absorption, somato-sensory amplification, and autonomic perception-measures theorized to be related to sensory perception and autonomic reactivity. METHODS: Prior to treatment, 125 women (M age = 48.5 years) undergoing adjuvant chemotherapy for breast cancer rated their expected severity of side effects and completed the Tellegen Absorption Scale, the Somato-Sensory Amplification Scale, and the Autonomic Perception Questionnaire. AN, as well as anticipatory vomiting (AV), distress, and worry/anxiety, were measured prior to the fourth, sixth, and last cycle of chemotherapy. Posttreatment nausea (PN), vomiting, and fatigue were measured after the first, fourth, sixth, and last cycle. RESULTS: 34% of the women reported AN before 1 or more cycles. When controlling for treatment characteristics and other known predictors, AN was significantly associated with high absorption in addition to severity of PN, pretreatment worry/anxiety, and not receiving radiotherapy between chemotherapy sessions. AV was not associated with any of the variables investigated. Our data suggest that the association is strongest in the early phases of treatment. CONCLUSIONS: Our results partly confirm the results of a previous study showing absorption and autonomic perception as predictors of anticipatory side effects in cancer patients receiving chemotherapy. Individuals high in absorption may be more autonomically reactive to aversive stimuli and, subsequently, more conditionable. Additional radiotherapy could be a competing stimulus, reducing the conditioning of chemotherapy-related nausea. Further studies investigating possible psycho-physiological mechanisms in the development of AN are needed.

Cognitive processes involved in the evaluation of life satisfaction: implications for well-being.

Extensive research has been conducted on the level and the predictors of well-being in old age, but less is known about the cognitive processes used by the aging individual to evaluate life satisfaction. To investigate the relationship between well-being in the present and in previous decades in life and explore the cognitive processes involved in these evaluations, 203 old participants aged 70-85 years were interviewed and their level of present life satisfaction and depressive symptoms was measured. One year later, depressive symptoms were recorded for a follow-up sample of 65 participants. The results showed that evaluating old age as the best part of life was related to increased well-being. Evaluations of positive periods in life were based on general positive qualities, whereas specific negative events were given as reasons for nominations of negative periods in life. Deviations from this general pattern were related to lower levels of well-being. Use of comparison strategies to evaluate present life satisfaction was frequently reported, and the use of temporal comparisons was predictive of changes in depression over a one-year period. The present study indicates that the cognitive processes used in the evaluation of life satisfaction are related to present and future well-being.

Empirical weighting of the Standardized Mini Mental State Examination items among nursing home residents.

Missing items in the Mini Mental State examination are dealt with in different ways. The main aims of this study were to calculate a weighted item score for organic disorder on the basis of the item score of the Standardized Mini Mental State Examination (SMMSE) test regardless of the completeness of the test and to compare the criterion validity of the weighted scores with the ordinal scores for the SMMSE test. With a participation of 91%, the study included 100 nursing residents. All residents were tested with the SMMSE test and concurrently diagnosed in accordance with the ICD-10 by a consultant psychiatrist. The two assessments were mutually blinded. Multiple conditional forward logistic regression was used to select the items that most strongly predicted organic disorder as assessed by the psychiatrist. The weighted score had significantly better validity parameters, performed better on a receiver operating curve (ROC), and was better at dichotomizing the population into organic disorder than the commonly used ordinal score. We propose that missing items in the SMMSE should be scored as missing and included in empirical weighting on SMMSE items, which will then be substantially more valid than the SMMSE score itself.

Concurrent validity of the GMS-AGECAT (A3) package in a Danish nursing home population.

AIM: To validate the Danish version of the GMS-AGECAT (A3), the Standardized Mini Mental State Examination (SMMSE) and the Geriatric Depression Scale-15 (GDS-15) by comparing them to clinical ICD-10 criteria in a Danish nursing home population. METHODS: With a participation of 91%, the study included 100 residents. All residents were interviewed with the GMS-AGECAT (A3), SMMSE and GDS-15 by an MD and then blindly diagnosed by a consultant geriatric psychiatrist. All residents approached for an interview were included, also those who were not able to communicate (the non-accessibles). RESULTS: The prevalence of clinical psychiatric ICD-10 main diagnoses was 56%. The non-accessibles had significantly higher psychiatric morbidity and lower ADL scores (modified Barthel ADL index) compared to those who were able to communicate. With the non-accessibles (N = 100) included, the optimal screening and diagnostic cutpoint for the GMS-AGECAT organic diagnoses was 2/3, with 96% sensitivity, 73% specificity, 77% predictive value of a positive test and 95% predictive value of a negative test. The SMMSE and GDS-15 had better screening properties compared to the GMS-AGECAT but only 60% of the residents were able to complete the SMMSE and 78% were able to complete the GDS-15. CONCLUSION: The Danish version of the GMS-AGECAT has relevant diagnostic and screening properties for organic disorders in Danish nursing home populations.