The Nonpenetrating Telescopic Sham Needle May Blind Patients with Different Characteristics and Experiences When Treated by Several Therapists

Background. Little is known which factors influence the blinding in acupuncture studies. Aim. To investigate if blinding varied between patients with different characteristics receiving verum or sham acupuncture. Methods. We randomised cancer patients to verum (n = 109) or sham acupuncture (n = 106) with a nonpenetrating telescopic sham needle for nausea. Level of blinding was compared between different sub-groups of patients using Bang's blinding index (BI) ranged −1 to 1 (−1 = all state the opposite treatment, 1 = all identify treatment). Results. Most patients in the verum (74 of 95; 78%, BI 0.72) and the sham (68 of 95; 72%, BI −0.60). acupuncture group believed they had received verum acupuncture. The probability for a patient to believe he/she received verum acupuncture was related to the received needling type (P = .003) and to the patient's belief in received treatment effects (P = .008). Hospital (P = .425), therapist (P = .434), previous acupuncture experience (P = .578), occurrence of nausea (P = .157), gender (P = .760), and age (P = .357) did not affect blinding. Conclusions. Blinding was successfully achieved irrespective of age, gender, acupuncture experience, treatment effect, or in which hospital or by which therapist the patient received treatment. Patients with higher belief in the effect of the treatment were more likely to believe they had received verum acupuncture

The Role of Long-Term Physical Activity in Relation to Cancer-Related Health Outcomes: A 12-Month Follow-up of the Phys-Can RCT

Purpose: While moderate-to-vigorous intensity physical activity (MVPA) is associated with various health improvements shortly after completion of exercise interventions, it remains unclear which health benefits can be expected when MVPA levels are maintained in the long term in cancer survivors. We aimed to assess the associations of (1) MVPA level at 12-month follow-up and (2) long-term MVPA patterns (from immediately post-intervention to 12-month follow-up) with different cancer-related health outcomes. Methods: In the Physical training and Cancer (Phys-Can) RCT, 577 participants diagnosed with breast (78%), prostate (19%), or colorectal (3%) cancer were randomized to 6 months of exercise during curative cancer treatment. Accelerometer-assessed physical activity and outcome data (ie, cancer-related fatigue, health-related quality of life [HRQoL], anxiety and depression, functioning in daily life, cardiorespiratory fitness, sedentary time and sleep) were collected immediately post-intervention and at 12-month follow-up. Based on the sample’s median of MVPA immediately post-intervention (65 minutes/day) and the changes between the 2 measurement points, 4 categories with different long-term MVPA patterns were created: High & Increasing, High & Decreasing, Low & Increasing, and Low & Decreasing. Multiple linear regression analyses were performed for the analyses. Results: A total of 353 participants were included in the analyses. At 12-month follow-up, a higher MVPA level was significantly associated with lower fatigue in 3 domains (general fatigue [β = −.33], physical fatigue [β = −.53] and reduced activity [β = −.37]), higher cardiorespiratory fitness (β = .34) and less sedentary time (β = −.35). For long-term MVPA patterns, compared to the participants in the “Low & Decreasing” category, those in the “High & Increasing” category reported significantly lower fatigue in 3 domains (general fatigue [β = −1.77], physical fatigue [β = −3.36] and reduced activity [β = −1.58]), higher HRQoL (β = 6.84) and had less sedentary time (β = −1.23). Conclusion: Our results suggest that long-term physical activity is essential for improving health outcomes post-intervention in cancer survivors. Cancer survivors, including those who reach recommended MVPA levels, should be encouraged to maintain or increase MVPA post-intervention for additional health benefits.publishedVersio

Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care

Background: It is not known whether or not delivering acupuncture triggers mechanisms cited as placebo and if acupuncture or sham reduces radiotherapy-induced emesis more than standard care. Methodology/Principal Findings: Cancer patients receiving radiotherapy over abdominal/pelvic regions were randomized to verum (penetrating) acupuncture (n = 109; 99 provided data) in the alleged antiemetic acupuncture point PC6 or sham acupuncture (n = 106; 101 provided data) performed with a telescopic non-penetrating needle at a sham point 2-3 times/week during the whole radiotherapy period. The acupuncture cohort was compared to a reference cohort receiving standard care (n = 62; 62 provided data). The occurrence of emesis in each group was compared after a mean dose of 27 Gray. Nausea and vomiting were experienced during the preceding week by 37 and 8% in the verum acupuncture group, 38 and 7% in the sham acupuncture group and 63 and 15% in the standard care group, respectively. The lower occurrence of nausea in the acupuncture cohort (verum and sham) compared to patients receiving standard care (37% versus 63%, relative risk (RR) 0.6, 95 % confidence interval (CI) 0.5-0.8) was also true after adjustment for potential confounding factors for nausea (RR 0.8, CI 0.6 to 0.9). Nausea intensity was lower in the acupuncture cohort (78% no nausea, 13% a little, 8% moderate, 1% much) compared to the standard care cohort (52% no nausea, 32% a little, 15% moderate, 2% much) (p = 0.002). The acupuncture cohort expected antiemetic effects from their treatment (95%). Patients who expected nausea had increased risk for nausea compared to patients who expected low risk for nausea (RR 1.6; Cl 1.2-2.4). Conclusions/Significance: Patients treated with verum or sham acupuncture experienced less nausea and vomiting compared to patients receiving standard care, possibly through a general care effect or due to the high level of patient expectancy.Original Publication:Anna Enblom, Mats Lekander, Mats Hammar, Anna Johnsson, Erik Onelov, Martin Ingvar, Gunnar Steineck and Sussanne Börjeson, Getting the Grip on Nonspecific Treatment Effects: Emesis in Patients Randomized to Acupuncture or Sham Compared to Patients Receiving Standard Care, 2011, PLOS ONE, (6), 3, .http://dx.doi.org/10.1371/journal.pone.0014766Licensee: Public Library of Science (PLoS)http://www.plos.org

Design of a randomized controlled trial of physical training and cancer (Phys-Can) – the impact of exercise intensity on cancer related fatigue, quality of life and disease outcome

Background: Cancer-related fatigue is a common problem in persons with cancer, influencing health-related quality of life and causing a considerable challenge to society. Current evidence supports the beneficial effects of physical exercise in reducing fatigue, but the results across studies are not consistent, especially in terms of exercise intensity. It is also unclear whether use of behaviour change techniques can further increase exercise adherence and maintain physical activity behaviour. This study will investigate whether exercise intensity affects fatigue and health related quality of life in persons undergoing adjuvant cancer treatment. In addition, to examine effects of exercise intensity on mood disturbance, adherence to oncological treatment, adverse effects from treatment, activities of daily living after treatment completion and return to work, and behaviour change techniques effect on exercise adherence. We will also investigate whether exercise intensity influences inflammatory markers and cytokines, and whether gene expressions following training serve as mediators for the effects of exercise on fatigue and health related quality of life. Methods/design: Six hundred newly diagnosed persons with breast, colorectal or prostate cancer undergoing adjuvant therapy will be randomized in a 2 × 2 factorial design to following conditions; A) individually tailored low-to-moderate intensity exercise with or without behaviour change techniques or B) individually tailored high intensity exercise with or without behaviour change techniques. The training consists of both resistance and endurance exercise sessions under the guidance of trained coaches. The primary outcomes, fatigue and health related quality of life, are measured by self-reports. Secondary outcomes include fitness, mood disturbance, adherence to the cancer treatment, adverse effects, return to activities of daily living after completed treatment, return to work as well as inflammatory markers, cytokines and gene expression. Discussion: The study will contribute to our understanding of the value of exercise and exercise intensity in reducing fatigue and improving health related quality of life and, potentially, clinical outcomes. The value of behaviour change techniques in terms of adherence to and maintenance of physical exercise behaviour in persons with cancer will be evaluated

Nausea and emesis in cancer chemotherapy: aspects of occurrence, assessment and treatmeant

Nausea and emesis are two of the most distressing side-effects cancer patients may experience during chemotherapy. The general aim of this thesis was to acquire knowledge to be used for improving the care of cancer patients during chemotherapy, in particular for the prevention and palliation of chemotherapy-induced nausea and emesis. The studies are predominantly related to four topics: aspects of patients' experiences of well-being during chemotherapy, the effects of different antiemetic treatments on acute and delayed nausea and emesis, risk factors for nausea and emesis and methodological issues involved in measuring the intensity of nausea. A total of 226 patients have participated in six studies. Thirty-nine patients were diagnosed with testicular cancer and the other 187 were ovarian cancer patients. All patients received combination chemotherapy based on cisplatin at the Department of Oncology/Radiumhemmet, Karolinska Hospital in Stockholm. Data were mainly collected with questionnaires assessed before, during and after chemotherapy, in up to four chemotherapy cycles. The results illustrate the recognition of nausea and emesis as the most distressing factor during treatment in a group of men diagnosed with testicular cancer. The important progress made in the pharmacological treatment of acute nausea and emesis is reflected in this thesis, as well as the problems remaining with delayed symptoms. The first step towards improved antiemetic treatment was indicated in the pilot study. The results indicated that ondansetron, a new S-HT3 receptor antagonist, was superior as a single drug to a combination of high-dose metoclopramide and dexamethasone in the prevention of acute, but not delayed, nausea and emesis. The administration of a single, high dose of dexamethasone with ondansetron increased the antiemetic efficacy for acute symptoms, as compared to ondansetron only, but not delayed symptoms. A 15-day follow-up investigating prognostic factors for delayed nausea and emesis revealed that delayed symptoms were more common among older patients with a large tumour burden and tended to be persistent. An evaluation of two of the most frequently used scales for measuring intensity of nausea showed good agreement between findings using a visual analogue scale and a verbal category scale. When the focus is on monitoring the individual patient, the visual analogue scale may be a more sensitive instrument. Despite having a lower prevalence and intensity of acute nausea and emesis, patients treated with a combination of ondansetron and dexamethasone did not report better well-being than patients receiving an antiemetic treatment comprising high-dose metoclopramide and dexamethasone combined with non-pharmacological interventions. The duration of acute nausea was an important factor in explaining the variance in well-being during chemotherapy. This highlights the complicated relationship between different antiemetic interventions, improved antiemetic effect and the patients' assessment of general well-being. Well-being may be an outcome variable to consider, as a complement to the traditional measures of frequency, intensity and duration of nausea and emesis

Improvement of communication and interpersonal competence in telenursing - development of a self-assessment tool

Aims and objectivesThe aim of this study was to develop a self-assessment tool aiming to raise telenurses awareness of their communication and interpersonal competence, and highlight areas in need of improvement. BackgroundSeveral studies have revealed the need for development of communication competence in telenursing. Structured analyses of conversations with patients/callers, is one way to increase telenurses awareness of their unique communication and interpersonal competence. DesignInstrument development, Validation assessment using the method Content Validity Index. MethodThe process to determine content validity was done in two stages; the development stage and the assessment stage. The development stage started with a literature search. The assessment stage was separated into two phases, assessment by an expert group and assessment and test by telenurses. The telenurses also participated in consensus discussions. ResultsA telenursing self-assessment tool with 58 items was developed. The items were sorted into five sections according to the nursing process. ConclusionThis study describes the thorough development process of the telenursing self-assessment tool to be used by telenurses in order to become aware of their unique communication and interpersonal competence when analysing their own conversations with patients/callers. As a formative tool it is meant to provide self-direction, feedback and coaching, and create learning opportunities. Relevance to clinical practiceThe self-assessment tool helps the telenurse to follow the nursing process, to be patient-centred, and it is meant to provide self-direction, feedback, and coaching, as well as create learning opportunities. The tool can contribute to the development of communication and interpersonal competence in telephone advice nursing. Further development of the tool may provide an objective scoring instrument for evaluating communication training and education in the field.Funding Agencies|National Medical Advisory Service Ltd (in Swedish Sjukvardsradgivningen SVR AB); County Council of Ostergotland, Sweden</p

The next of kin experiences of symptoms and distress among patients with colorectal cancer : diagnosis and treatment affecting the life situation

Purpose To identify symptoms/distress among patients with colorectal cancer undergoing chemotherapy, from the viewpoint of the next of kin, and to establish whether there are any barriers to reporting these problems. Methods Individual face-to-face interviews with fourteen next of kin were conducted. Qualitative content analysis was used to analyse the transcripts. Results Three areas were identified: symptoms presented, barriers to reporting symptoms/distress, and influences on life for the next of kin. Nine symptoms were raised as most common by the next of kin. Almost all the next of kin denied that they had experienced any barriers to reporting symptoms/distress but some did exist, namely barriers to proper communication and barriers of time. The next of kin made another interpretation of barriers; they did not interpret it as hinder or obstacle. All next of kin talked to a large extent about how the patient's disease and treatment affected them as next of kin. It affected them psychologically, they had to re-valuate their life, and it influenced their social life. Conclusions The symptoms reported during chemotherapy were similar to those found in other studies on patients. Barriers to reporting symptoms were mentioned, but not to a great extent. Although it was not the main purpose of the study, the next of kin raised concerns about the patient's disease and treatment and how it influenced next of kin life

Common Symptoms and Distress Experienced Among Patients with Colorectal Cancer: A Qualitative part of Mixed Method Design

Background : Colorectal cancer is one of the most common types of tumour in the world. Treatment side effects, together with the tumour symptoms, can result in a ‘symptom burden’. To understand the patient’s burden during chemotherapy treatment and plan effective symptom relief there is a need for more knowledge about the experience of symptoms from the patients’ perspective. Objectives : The study was designed to qualitatively identify and describe the most common symptoms among patients treated for colorectal cancer, and discover whether there are barriers to reporting symptoms. Methods : Thirteen Swedish patients diagnosed with colorectal cancer and treated with chemotherapy were interviewed face-to-face. The interviews were audio-taped and transcribed verbatim. The transcripts were analysed by following the principles of qualitative content analysis. Results : Nine symptoms/forms of distress were identified. Those most frequently expressed were fatigue, changed bowel habits, and affected mental well-being, closely followed by nausea, loss of appetite and neurological problems. Of particular note were the affected mental well-being, the magnitude of the neurological problems described, the symptoms related to skin and mucous membrane problems, and the reports of distressing pain. Barriers to symptom control were only expressed by the patients in passing and very vaguely. Conclusion : This study confirms other reports on most common symptoms in colorectal cancer. It also highlights the early onset of symptoms and provides data on less well-studied issues that warrant further study, namely affected mental well-being, the magnitude of the neurological problems and symptoms related to the skin and mucous membranes. Nurses need to be sensitive to the patients’ need presented and not only noting symptoms/distresses they have guidelines for