[Registered nurses' experience of necessary performed and missed nursing care: a qualitative study]. / Erleben von Pflegefachpersonen in Bezug auf durchgeführte und versäumte Pflege.

Registered nurses' experience of necessary performed and missed nursing care: a qualitative study Abstract: Background: Providing high quality care based on their caring attitude is essential for nurses. Missed Care can cause feelings of guilt and dissatisfaction among them. Studies on their experiential transition between fully performed and missed care are lacking. They may contribute to a more comprehensive understanding of influencing factors and the impact on nurses' experience. Aim: The aim was to explore how nurses at a centre hospital in German-speaking Switzerland describe performance of nursing interventions in terms of the different expressions between performed and missed care. Methods: Between September 2020 and March 2021 the first author conducted eleven qualitative guide-based individual interviews with registered nurses which were analysed using Mayring's qualitative content analysis and knowledge maps. Results: The analysis resulted in five main categories: Optimal care, satisfaction in mediocrity, a huge lack, patients' reactions and influencing factors. Nurses described, in addition to personal experience and expertise, different coping strategies to prevent missed care and maintain patients' and their own satisfaction. Conclusions: In addition to interventions that can prevent missed care, nurses' experience of performed care should be explored further. This can deepen the understanding of its relationship with professional caring attitudes as well as with patient-related and professional satisfaction.

[How do nurses describe timeliness in the delivery of nursing interventions? A qualitative study]. / Wie beschreiben Pflegefachpersonen zeitliche Angemessenheit für das Durchführen von Pflegemassnahmen?

How do nurses describe timeliness in the delivery of nursing interventions? A qualitative study Abstract: Background: Timeliness of nursing interventions is fundamental to professional medical care. Although nurses have developed strategies to manage time resources, nursing interventions are often carried out too early or too late. Both can have a negative impact on the quality of care and safety. However, no publications are available describing nurses' views on the appropriateness of time to perform nursing interventions. Aim: The aim was to describe what registered nurses in the hospital understand by the timeliness to deliver care. Methods: For this qualitative study, eight registered nurses were interviewed individually. Data analysis was performed using content analysis according to Mayring. Results: For the participants, timeliness in performing care interventions can be described as relational and dynamically changing over time. For them it is not limited to a defined point in time and they explain it as a time frame. From their point of view, timely action can prevent harm and suffering and ensure patients safety and well-being. Environmental factors, nursing goals and the urgency of actions influence them whether they act in a timely manner. Conclusion: Among the participating nurses, there exists a shared, often implicit, understanding of timeliness. Results of this study may help to understand the implicit understanding and the related processes and contribute to quality assurance in nursing.

Evaluation of distress management in inpatients with cancer by means of the distress thermometer: A mixed methods approach.

OBJECTIVES: To improve psychosocial care for oncology inpatients, we implemented screening for distress by means of distress thermometer (DT) at the Comprehensive Cancer Centre Zurich in 2011. Since then, several screening barriers have been reported regarding the application of the DT. This study aimed to evaluate the distress screening process between 2012 and 2016 to identify barriers preventing sustainability. METHODS: In this sequential explanatory mixed methods study, we synthesized the results of 2 quantitative retrospective descriptive studies and 1 qualitative focus group study. To compare and analyze the data, we used thematic triangulation. RESULTS: Nurses screened 32% (N = 7034) of all newly admitted inpatients with the DT, and 47% of the screenings showed a distress level ≥5. Of these cases, 9.7% were referred to psycho-oncological services and 44.7% to social services. In 15.7% of these cases, nurses generated a psychosocial nursing diagnosis. In focus group interviews, nurses attributed the low screening rate to the following barriers: adaptation to patients' individual needs, patient-related barriers and resistance, timing, communication challenges, established referral practice, and lack of integration in the nursing process. SIGNIFICANCE OF RESULTS: To improve distress screening performance, the screening process should be tailored to patients' needs and to nurses' working conditions (e.g., timing, knowledge, and setting-specific factors). To gain more evidence on distress management as a basis for practical improvements, further evaluations of distress screening are required.

Randomized clinical trial to evaluate a cancer pain self-management intervention for outpatients.

Objective: Unrelieved pain is common in patients with advanced cancer. Although psychoeducational interventions were found to decrease pain, effects were moderate. The purpose of this study was to evaluate the efficacy of a pain self-management intervention compared with usual care and to explore participants' experiences with pain management and study participation. Methods: A multicenter randomized controlled trial design with post-trial interviews was used. Outpatients with cancer pain and their family caregivers were recruited from three Swiss university hospitals. The intervention group (IG) received the six-week intervention consisting of education, skills building, and nurse coaching. The control group (CG) received usual care. Outcome variables were analyzed using multilevel models. Interpretive description guided the qualitative study part. Results: Twenty-one patients with advanced cancer and seven family caregivers completed the study. The group x time effect showed a statistically significant decrease in average pain (P â€‹= â€‹0.04), but no significant group x time effect for worst pain (P â€‹= â€‹0.06). Pain scores, pain-related knowledge, Pain Management Index, self-efficacy, and performance status improved in the IG (P â€‹< â€‹0.05). Almost all of the interviewed participants perceived the pain management diary, tailored intervention sessions, and weekly support as useful. None experienced study participation as burdensome. Conclusions: This study was the first to test the efficacy of a psychoeducational cancer pain self-management intervention in a German-speaking context, with most patients receiving palliative care. Clinicians can recommend the use of pain management diaries. Tailoring interventions to an individual's situation and dynamic pain trajectory may improve patients' pain self-management. Registration number: This study has been registered via ClinicalTrials.gov: NCT02713919.https://clinicaltrials.gov/ct2/show/NCT02713919?term=NCT02713919&draw=2&rank=1.

Exploring learning processes associated with a cancer pain self-management intervention in patients and family caregivers: A mixed methods study.

AIM: Explore learning processes associated with a psychoeducational pain selfmanagement intervention. BACKGROUND: Self-management of cancer pain is challenging for patients and their family caregivers (FCs). While psychoeducational interventions can support them to handle these tasks, it remains unclear how learning processes are hampered or facilitated. METHODS: A convergent parallel mixed methods design with qualitative data collection embedded in a randomized controlled trial (RCT) was used. Outpatients with cancer and FCs were recruited from three Swiss university hospitals. The six-week intervention consisted of education, skills building, and nurse coaching. Quantitative data on pain management knowledge and self-efficacy were analyzed using multilevel models. Patients and FCs were interviewed post-RCT regarding their learning experiences. Qualitative data analysis was guided by interpretive description. Finally, quantitative and qualitative data were integrated using case level comparisons and a meta-matrix. RESULTS: Twenty-one patients and seven FCs completed this study. The group-by-time effect showed increases in knowledge (p = 0.035) and self-efficacy (p = 0.007). Patients' and FCs' learning through experience was supported by an intervention nurse, who was perceived as competent and trustworthy. After the study, most intervention group participants felt more confident to implement pain self-management. Finally, data integration showed that declining health hampered some patients' pain self-management. CONCLUSIONS: Competent and trustworthy nurses can support patients' and FCs' pain self-management by providing individualized interventions. Using a diary, jointly reflecting on the documented experiences, and addressing knowledge deficits and misconceptions through the use of academic detailing can facilitate patients' and FCs' learning of critical skills.

Pflegefachpersonen denken über eine Definition von "durchgeführter und versäumter Pflege" nach.

Nurses reflect upon a definition of "performed and missed nursing care" - A qualitative study Abstract. Background: It is known that necessary nursing interventions are repeatedly omitted respectively only carried out partially or at a time that is not appropriate. In the literature, this is referred to as "missed nursing care". In the German-speaking region, there is no critically reflected definition of what is meant by "performed and missed nursing care", using qualitative methods. Therefore, we developed one in a three-phase study. Aim: The aim of phase 2, which is the focus of this article, was to critically reflect on the literature-based definition developed in phase 1 with nurses working in acute care hospitals in German-speaking Switzerland in order to specify it in phase 3. Methods: We conducted two focus group interviews with a total of 17 participants. We provided the participants with the preliminary definition and asked them for their reflections. We analysed the interviews content-analytically with the knowledge mapping technique as well as according to Mayring. Results: The participating nurses described that the contents of the definition were relevant and comprehensible for them. However, they also noticed differences from their understanding and gave indications for refining the definition, especially in relation to terms that include a time-related aspect. Conclusions: By involving nurses in the development of the definition, there is now a practical description of "performed and missed nursing care" that can be useful for quality assurance and development of care.

Wie erleben und beurteilen Pflegende das Screening von stationären onkologischen Patient_innen mit dem Belastungsthermometer?

How do nurses experience and interpret the screening of hospitalised cancer patients by means of the distress thermometer? - A qualitative study Abstract. Background: People with cancer experience distress and may need professional support. In 2012, the University Hospital Zurich introduced its distress thermometer (DT) screening, whereby all inpatients were to be screened to gauge their support need. However, after five years, the screening rate was 40 % and the referral rate to psycho oncology was 7.9 %, surprisingly low. Aim: The aim of this qualitative study was to describe how nurses experience the screening and how they interpret the screening and referral rate. Methods: The evaluation of three focus group interviews with 14 nurses followed the principles of qualitative content analysis according to Mayring. Results: The analysis revealed four main categories. The first category "Trying to perform useful screening in a complex daily routine" comprises three subcategories: "Using the benefits of screening for comprehensive care", "The best way to recognize the individuality of the counterpart" and "Failing due to structural and personal barriers". Three further main categories addressing nurses' personal attitudes complete the screening experience: "Experiencing fewer difficulties due to competence and experience", "Being careful due to hesitations", and "Reflecting one's responsibility". Conclusions: Nurses want to use the DT. However, they need more practical and scientific support to usefully integrate screening into their everyday life.

Patient-related complexity of nursing care in acute care hospitals - an updated concept.

RATIONAL: The interest in complexity of nursing care has grown in science and practice in recent years because of changed patient profiles and higher average levels of patient acuity in acute care hospitals. AIM: The aim of this study was to redefine the concept of patient-related 'complexity of nursing care' in acute care hospitals. DESIGN: The hybrid model for concept development was chosen. METHODS: In a first theoretical phase, we performed a narrative literature review regarding defining elements of patient-related 'complexity of nursing care' and developed a working definition. In the fieldwork phase, we investigated collective case studies representing 12 nursing care situations. The theoretical phase was updated before all findings were synthesised, and in the final analytical phase, the preliminary working definition was refined. ETHICS: An ethical committee judged the study as unproblematic (waiver no. 82/14 from 5 December 2014). RESULTS: The concept was redefined confirming previous understandings of patient-related 'complexity of nursing care' as a dynamic, relational concept characterised by the instability, variability and uncertainty that exist. The extent of complexity was determined by multifaceted patient problems and resources as well as extensive knowledge, experience, attention and caring skills of registered nurses interacting with each other. LIMITATIONS: The study did not include organisation-related complexity of nursing care. CONCLUSIONS: The redefinition of the concept may support a common understanding of patient-related demands on nursing care among practitioners, managers and politicians which is important regarding patient safety and health nursing staff.

Self-Care Index and Post-Acute Care Discharge Score to Predict Discharge Destination of Adult Medical Inpatients: Protocol for a Multicenter Validation Study.

BACKGROUND: Delays in patient discharge can not only lead to deterioration, especially among geriatric patients, but also incorporate unnecessary resources at the hospital level. Many of these delays and their negative impact may be preventable by early focused screening to identify patients at risk for transfer to a post-acute care facility. Early interprofessional discharge planning is crucial in order to fit the appropriate individual discharge destination. While prediction of discharge to a post-acute care facility using post-acute care discharge score, the self-care index, and a combination of both has been shown in a single-center pilot study, an external validation is still missing. OBJECTIVE: This paper outlines the study protocol and methodology currently being used to replicate the previous pilot findings and determine whether the post-acute care discharge score, the self-care index, or the combination of both can reliably identify patients requiring transfer to post-acute care facilities. METHODS: This study will use prospective data involving all phases of the quasi-experimental study "In-HospiTOOL" conducted at 7 Swiss hospitals in urban and rural areas. During an 18-month period, consecutive adult medical patients admitted to the hospitals through the emergency department will be included. We aim to include 6000 patients based on sample size calculation. These data will enable a prospective external validation of the prediction instruments. RESULTS: We expect to gain more insight into the predictive capability of the above-mentioned prediction instruments. This approach will allow us to get important information about the generalizability of the three different models. The study was approved by the institutional review board on November 21, 2016, and funded in May 2020. Expected results are planned to be published in spring 2021. CONCLUSIONS: This study will provide evidence on prognostic properties, comparative performance, reliability of scoring, and suitability of the instruments for the screening purpose in order to be able to recommend application in clinical practice. INTERNATIONAL REGISTERED REPORT IDENTIFIER (IRRID): DERR1-10.2196/21447.

["One always has to be watchful": Categorisation of patient-related complexity of nursing care in acute care hospitals]. / "Man muss stets aufmerksam sein".

"One always has to be watchful": Categorisation of patient-related complexity of nursing care in acute care hospitals Abstract. Background: The increase of chronic illnesses and multimorbidity as well as more challenging treatment methods have caused higher acuity and complexity of nursing care situations. Aim: The aim of this study was to explore and establish categories which describe different levels of patient-related complexity of nursing care in order to broaden the understanding of demands on nursing care due to patient situations. Methods: Using a collective case study design, we asked registered nurses and clinical nurse specialists to assess the complexity of twelve nursing care situations through a questionnaire before interviewing them about their deliberations on how they rated the situation. In this sub-study, we performed a qualitative secondary analysis of these data and looked for categories of comparable degrees of complexity. Results: We found five categories of complexity, ranging from "slightly complex" to "highly complex". "Slightly complex" situations demanded a nurse's attention on routine interventions, while "highly complex" situations demanded their constant attention on poorly assessable and poorly controllable conditions with uncertain outcomes. Conclusions: The five categories of complexity describe characteristics of the different levels of complexity in nursing care situations. They can support nursing managers with allocating nursing staff to patients according to their needs and provide a framework for discussing complex nursing care situations in basic and continuing education.

Comparison of the Zurich Observation Pain Assessment with the Behavioural Pain Scale and the Critical Care Pain Observation Tool in nonverbal patients in the intensive care unit: A prospective observational study.

OBJECTIVES: To determine the concordance of Zurich Observation Pain Assessment (ZOPA) with the behavioural Pain Scale (BPS) and the Critical Care Pain Observation Tool (CPOT) to detect pain in nonverbal ICU patients. DESIGN: Prospective observational study [BASEC-Nr. PB_2016-02324]. SETTING: A total of 49 ICU patients from cardiovascular, visceral and thoracic surgery and neurology and neurosurgery were recruited. Data from 24 patients were analyzed. MAIN OUTCOME MEASUREMENTS: Three independent observers assessed pain with the BPS, the CPOT or ZOPA prior, during and after a potential painful nursing intervention. Tools were randomized concerning the pain management after each pain assessment. Frequency of nine additional pain indicating items from a previous qualitative, explorative study was calculated. RESULTS: ZOPA was positive in 32 of 33 measuring cycles (97.0%; 95%CI: 84.2-99.9%), followed by the CPOT (28/33 cycles, 84.8%; 95%CI: 68.1-94.9%) and the BPS (23/33 cycles, 67.0%; 95%CI: 51.3-84.4%). In 22/33 cycles all tools were concordant (66.7%; 95%CI: 48.2-82.0%). Analgesics were provided in 29 out of 33 cycles (87.9%; 95%CI: 71.8-96.6%). Additional pain indicating items were inconsistently reported. CONCLUSION: ZOPA is concordant with the BPS and the CPOT to indicate pain but detects pain earlier due to the low threshold value. Inclusion of further items does not improve pain assessment.

Performed and missed nursing care in Swiss acute care hospitals: Conceptual considerations and psychometric evaluation of the German MISSCARE questionnaire.

AIM: To have at hand a reliable and valid questionnaire to assess performed and missed nursing care in a Swiss acute care context. BACKGROUND: Regular monitoring of performed and missed nursing care is crucial for nurse leaders to make evidence-based decisions. As foundation, we developed a conceptual definition. Based on this, we decided to translate and adapt the MISSCARE. METHOD: In this methodological study, our newly developed German MISSCARE and previously used BERNCA-R were tested in a pilot study using a quantitative crossover design in a sample of 1,030 nurses and midwives in three Swiss acute care hospitals. Data were analysed descriptively, then using exploratory factor analysis and Rasch modelling. RESULTS: We obtained preliminary evidence that the German MISSCARE is sufficiently reliable and valid to measure performed and missed nursing care in our context but would benefit from structural adjustments. In contrast, the BERNCA-R proved insufficiently reliable for our purposes and context. CONCLUSION: Our conceptual definition was essential for the development of the German MISSCARE. Our results support the decision to use this questionnaire. IMPLICATION FOR NURSING MANAGEMENT: The adapted German MISSCARE will allow both monitoring of performed and missed nursing care over time and benchmarking of hospitals.

Capturing interprofessional collaboration between physicians and nurses in an acute care setting. A validation study of the revised German version of the Collaborative Practice Scales.

The relevance of interprofessional collaboration (IPC) is widely acknowledged. Given the lack of a fully validated instrument in the German language for measuring the level of IPC, we built upon the current, albeit psychometrically weak, German-language version of the instrument to devise a new version with improved wording and for subsequent psychometric testing. In a tertiary hospital in German-speaking Switzerland, 160 physicians and 374 nurses completed the revised Collaborative Practice Scales in German (CPS-G) and additional scales regarding positive and negative activation at work and regarding job demands and job resources. A confirmatory factor analysis of the CPS-G was performed, and internal consistency estimates were computed. Partial correlations between the CPS-G and the additional scales were examined for criterion validity. The model fit of the CPS-G was good for physicians (χ2/df = 2.38, p < .001; CFI = .923; RMSEA = .051, 90%-CI (0.037-0.065)) and moderate for nurses (χ2/df = 5, p < .001; CFI = .919; RMSEA = .087, 90%-CI (0.072-0.102)) supporting the two-factor structure of the original English version. Reliability was acceptable in all sub-scales for physicians (inclusion, α = 0.79; consensus, α = 0.80) and nurses (assertiveness, α = 0.77; understanding α = 0.82). As expected, the CPS-G physicians' subscales correlated positively with positive activation and job resources and negatively with negative activation and job demands, albeit not always statistically significantly. Similar correlations were found with the CPS-G nurses' subscales other than in one instance. The CPS-G showed good construct and criterion validity and acceptable internal consistency. It consequently represents a valid instrument ready for application to measure the level of interprofessional collaboration between nurses and physicians in acute care settings.

Validation of the instrument "Complexity of Nursing Care"-A mixed-methods study.

Aims: This study aimed to psychometrically test the instrument "Complexity of Nursing Care" and to broaden the understanding of the instrument's psychometrics and applicability. Design: Embedded mixed-methods design. Methods: We performed a cross-sectional study assessing all stationary patients of five Swiss hospitals daily for up to 5 days with the instrument "Complexity of Nursing Care" over a 1-month period in 2015. The scale's psychometrics were analysed using partial least square structural equation modelling. In the qualitative study section, we completed 12 case studies and analysed them case-wise and across cases. Quantitative and qualitative results were synthesized in tables. Results: Structural equation modelling confirmed a reflective-formative second-order model of the instrument with good psychometric properties leading to a formula for the calculation of a complexity score. Qualitative results evolved descriptions of low and high extent of complexity. Narrative considerations of two raters deepened the understanding of the inter-rater reliability.

Wann und wie berücksichtigen Intensivpflegende Schmerz im Behandlungsprozess von Patientinnen und Patienten auf der Intensivstation? - Eine qualitative Studie.

When and how do intensive care nurses consider pain in the treatment process of ICU patients? A qualitative study Abstract. Background: Pain management is important in the therapeutic spectrum of the intensive care unit. However, guideline recommendations are not consistently implemented. Strategies in clinical reasoning and decision-making regarding pain are hardly described. AIM: Guided by the question "When and how do intensive care nurses consider pain in the treatment process of patients with impaired consciousness and cognition?", we wanted to explore their patterns of thought and decision-making in the context of pain management. METHODS: As part of a Mixed Methods research program on pain assessment in nonverbal intensive care patients we performed a secondary analysis of data from the qualitative substudy using qualitative content analysis according to Mayring. RESULTS: Pain plays an important but subordinate role in the treatment process. After vital functions have been initially stabilized, intensive care nurses assess patients' consciousness and cognition in order to receive further information directly from them. Intensive care nurses differentiate between pain, anxiety, stress and discomfort. Their decisions are based on experience and intuition. CONCLUSIONS: Education promotes intensive care nurses' knowledge and awareness in pain management. Observational pain assessment instruments provide valid information. They support an analytical approach and thus the development of competence in clinical reasoning and decision-making.

Introducing a model for emotional distress in respiratory disease: A systematic review and synthesis of symptom management models.

AIM: To undertake a theoretical systematic review to develop a conceptual model of illness-related emotional distress in the context of symptom management in chronic respiratory disease. DESIGN: We performed a systematic search to identify conceptual models. DATA SOURCES: Electronic databases MEDLINE, CINAHL, EMBASE and PsycINFO were searched and papers included from inception of the search term until June 2017. REVIEW METHODS: The review was conducted following Pound and Campbell's and Turner's theory synthesis. Conceptual models were appraised using Kaplan's criteria. Models were excluded if they referred to a specific condition and/or lacked clarity. RESULTS: This synthesis, which includes five models and additional evidence, yielded a new conceptual model describing the processes of regulation and symptom self-management in chronic respiratory disease. Identified sources of illness-related emotional distress are new or increased symptoms, additional treatment, new restrictions in performance of daily life roles and increased unpredictability. People goals and self-efficacy were identified as further drivers of symptom self-management. The regulation process is embedded in contextual factors. CONCLUSION: Theory synthesis provided transparent guidance in developing a model to understand of the factors driving self-management decisions. Therefore, the model has the potential to guide development of interventions that support symptom self-management in chronic respiratory disease. IMPACT: This newly presented conceptual model of illness-related emotional distress provides an understanding of the factors that drive self-management decisions when peoples experience new or increased symptoms. Such understanding is critical for nursing practice to developing appropriate interventions, especially in support of people decision-making.

"Thrust out of normality"-How adults living with cystic fibrosis experience pulmonary exacerbations: A qualitative study.

AIM AND OBJECTIVES: To explore the experience of pulmonary exacerbation from the perspective of adults with cystic fibrosis. BACKGROUND: While management of pulmonary exacerbations is a pillar of cystic fibrosis care, little is known of patients' perspectives. Understanding the patient's experience is essential for developing and evaluating interventions in support of patient self-management. DESIGN: Qualitative study with longitudinal study in a subsample. METHODS: The study took place from 2015-2016 in a university hospital. Eighteen patients with cystic fibrosis were included who were ≥18 years of age and had no solid organ transplant. Patients' experiences were explored through semistructured interviews and analysed using framework analysis. They each participated in one interview, with a subsample (N = 7) being interviewed twice during and once after antibiotic therapy. RESULTS: Patients (11 men and 7 women; median age 29.5 years, range 19-55 years; median FEV1 45%, range FEV1 23%-105%) experienced pulmonary exacerbations as disruptions of their normality, which led to a substantial increase in their emotional distress. Exacerbations represented a period of threat and domination by CF; that is, symptoms and treatment consumed energy, restricted physical activity and daily life roles. "Noting change," "waiting until antibiotics help," "returning to normality" and "establishing a new normality" characterised their descriptions of the pulmonary exacerbation trajectory. Emotional distress was the major driver for patients' self-management, and personal goals and illness beliefs influenced also patients' self-management decisions. CONCLUSION: The experienced degree and source of emotional distress are drivers for self-management decisions in patients with cystic fibrosis who experience a pulmonary exacerbation. RELEVANCE TO CLINICAL PRACTICE: Our data provide new understanding that will be essential to informing clinical practice, future patient-reported outcomes measures and intervention development.

Comparison of a Behavioral Versus an Educational Weight Management Intervention After Renal Transplantation: A Randomized Controlled Trial.

BACKGROUND: In the first year following renal transplantation, preventing weight gain to minimize overweight or obesity is particularly important. The aim of this study is to test the effect of an 8-month behavioral intervention BMI and physical activity. METHODS: This randomized controlled study included 123 adult kidney or kidney-pancreas recipients. Patients were randomized to usual (1 educational session, then weight self-monitoring) and intervention care (usual care plus 7-8 counseling sessions). Alongside weight, body composition, and physical activity, satisfaction and perceptions regarding care were measured at weeks 2-6 (baseline), then at months 8 and 12. RESULTS: Both groups reported comparably high satisfaction. The intervention group (IG) reported more chronic care-related activities. In patients with BMIs ≥ 18.5, mean weight gain (from baseline) was unexpectedly low in both groups: at month 8, +0.04 kg/m2 in IG patients and +0.14 kg/m2 in the control group (P = 0.590), and respectively, +0.03 kg/m2 and +0.19 kg/m2 at month 12 (P = 0.454). Both groups were physically active, walking averages of 10 807 (IG) and 11 093 (control group) steps per day at month 8 (P = 0.823), and respectively 9773 and 11 217 at month 12 (P = 0.195). CONCLUSIONS: The behavioral intervention had high patient acceptance and supported patients in maintaining their weight, but had no superior effect on a single educational session. Further research is needed to assess patient weight gain risk profiles to stratify the intervention.

Testing a pain self-management intervention by exploring reduction of analgesics' side effects in cancer outpatients and the involvement of family caregivers: a study protocol (PEINCA-FAM).

BACKGROUND: Pain is one of cancer patients' most frequent and distressing symptoms; however, analgesics' side effects often increase symptom burden. Further, with the home rapidly becoming the primary cancer care setting, family caregivers (FCs) commonly play central roles in patients' pain self-management, but with little or no preparation. One US-tested intervention, the PRO-SELF© Plus Pain Control Program (PCP), designed to support cancer outpatients and their FCs in pain self-management, is currently being tested in the Swiss multi-centre PEINCA study. The current PEINCA-FAM study is a sub-study of PEINCA. The aims of PEINCA-FAM are: a) to test the efficacy of the adapted German PRO-SELF © Plus PCP to reduce side effects of analgesics; b) to enhance patients'/FCs' knowledge regarding cancer pain; and c) to explore FCs' involvement in patients' pain self-management. METHODS: This mixed methods project combines a multi-centre randomized controlled clinical trial with qualitative data collection techniques and includes 210 patients recruited from three oncology outpatient clinics. FCs involved in patients' pain self-management are also invited to participate. After baseline evaluation, eligible participants are randomized to a 6-week intervention group and a control group. Both groups complete a daily pain and symptom diary. Intervention group patients/FCs receive the weekly psychoeducational PRO-SELF© Plus PCP interventions; control group patients receive usual care. After completing the six-week study procedures, a subsample of 7-10 patients/FCs per group and hospital (N = 42-60) will be interviewed regarding their pain management experiences. Data collection will take place from April 2016 until December 2018. An intent-to-treat analysis and generalized linear mixed models will be applied. Qualitative data will be analysed by using interpretive description. Quantitative and qualitative results will be combined within a mixed method matrix. DISCUSSION: In clinical practice, specially trained oncology nurses in outpatient clinics could apply the intervention to reduce side effects and to enhance patients'/FCs' self-efficacy and pain management knowledge. TRIAL REGISTRATION: The PEINCA study is registered in the Clinical Trials.gov site (code: NCT02713919, 08 March 2016).