Prevention and Treatment of Chemotherapy-Induced Peripheral Neuropathy (CIPN) with Non-Pharmacological Interventions: Clinical Recommendations from a Systematic Scoping Review and an Expert Consensus Process.

Background: Most individuals affected by cancer who are treated with certain chemotherapies suffer of CIPN. Therefore, there is a high patient and provider interest in complementary non-pharmacological therapies, but its evidence base has not yet been clearly pointed out in the context of CIPN. Methods: The results of a scoping review overviewing the published clinical evidence on the application of complementary therapies for improving the complex CIPN symptomatology are synthesized with the recommendations of an expert consensus process aiming to draw attention to supportive strategies for CIPN. The scoping review, registered at PROSPERO 2020 (CRD 42020165851), followed the PRISMA-ScR and JBI guidelines. Relevant studies published in Pubmed/MEDLINE, PsycINFO, PEDro, Cochrane CENTRAL, and CINAHL between 2000 and 2021 were included. CASP was used to evaluate the methodologic quality of the studies. Results: Seventy-five studies with mixed study quality met the inclusion criteria. Manipulative therapies (including massage, reflexology, therapeutic touch), rhythmical embrocations, movement and mind-body therapies, acupuncture/acupressure, and TENS/Scrambler therapy were the most frequently analyzed in research and may be effective treatment options for CIPN. The expert panel approved 17 supportive interventions, most of them were phytotherapeutic interventions including external applications and cryotherapy, hydrotherapy, and tactile stimulation. More than two-thirds of the consented interventions were rated with moderate to high perceived clinical effectiveness in therapeutic use. Conclusions: The evidence of both the review and the expert panel supports a variety of complementary procedures regarding the supportive treatment of CIPN; however, the application on patients should be individually weighed in each case. Based on this meta-synthesis, interprofessional healthcare teams may open up a dialogue with patients interested in non-pharmacological treatment options to tailor complementary counselling and treatments to their needs.

Effect of educational interventions on wound healing in patients with venous leg ulceration: A systematic review and meta-analysis.

Educational interventions for patients with venous leg ulceration (VLU) may promote adherence and self-management, however, their effect on wound healing is unclear. A systematic literature search was performed and randomised controlled trials with a focus on educational interventions were included. Wound healing was analysed by assessing wound healing rate, ulcer size, and the PUSH Score. Additional outcomes comprised pain, quality of life, and functional ability. The study protocol for this work is registered at PROSPERO 2020 (ID: CRD42021286152). Nine studies were included in this meta-analysis. The odds ratio for wound healing was 1.91 (95% CI, 0.99-3.67, P = .053) in favour of educational interventions compared to usual care. Ulcer size reduction was higher (MD: -7.22; 95% CI, -11.91 to -2.53, P = .003) in patients following educational interventions. Included studies also showed significant effects on pain, quality of life, and functional analysis, though no quantitative synthesis was feasible. The overall risk of bias showed some concerns. Educational interventions aim to actively involve patients in their treatment, thereby appearing to be able to have a positive impact on wound healing within 12 weeks. Consequently, integrating educational approaches to routine wound care may be a promising strategy to improve treatment of VLU.

Communication with patients with limited prognosis-an integrative mixed-methods evaluation study.

PURPOSE: Oncological societies advocate the continuity of care, specialized communication, and early integration of palliative care. To comply with these recommendations, an interprofessional, longitudinally-structured communication concept, the Milestone Communication Approach (MCA), was previously developed, implemented, and evaluated. Our research question is: what are possible explanations from the patient perspective for prognosis and advance care planning being rarely a topic and for finding no differences between MCA and control groups concerning distress, quality of life, and mood? METHODS: A pragmatic epistemological stance guided the study. A mixed-methods design was chosen including a pragmatic randomized trial (n = 171), qualitative interviews with patients (n = 13) and caregivers (n = 12), and a content analysis (133 milestone conversations, 54 follow-up calls). Data analysis involved the pillar integration process. RESULTS: Two pillar themes emerged: 1 "approaching prognosis and advance care planning"; 2 "living with a life-threatening illness". Information on prognosis seemed to be offered, but patients' reactions were diverse. Some patients have to deal with having advanced lung cancer while nonetheless feeling healthy and seem not to be ready for prognostic information. All patients seemed to struggle to preserve their quality of life and keep distress under control. CONCLUSION: Attending to patients' questions, worries and needs early in a disease trajectory seems key to helping patients adjust to living with lung cancer. If necessary clinicians should name their predicament: having to inform about prognosis versus respecting the patients wish to avoid it. Research should support better understanding of patients not wishing for prognostic information to successfully improve communication strategies. TRIAL REGISTRATION: Registration: German Clinical Trial Register No. DRKS00013649, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013649 ) and No. DRKS00013469, registration date 12/22/2017, ( https://www.drks.de/drks_web/navigate.do?navigationId=trial.HTML&TRIAL_ID=DRKS00013469 ).

Protocol for the process evaluation of a counselling intervention designed to educate cancer patients on complementary and integrative health care and promote interprofessional collaboration in this area (the CCC-Integrativ study).

BACKGROUND: Conducting a process evaluation is essential to understand how health interventions work in different healthcare settings. Particularly in the case of complex interventions, it is important to find out whether the intervention could be carried out as planned and which factors had a beneficial or hindering effect on its implementation. The aim of this study is to present the detailed protocol of the process evaluation embedded in the controlled implementation study CCC-Integrativ aiming to implement an interprofessional counselling program for cancer patients on complementary and integrative health care (CIH). METHODS: This mixed methods study will draw upon the "Consolidated Framework for Implementation Research" (CFIR) combined with the concept of "intervention fidelity" to evaluate the quality of the interprofessional counselling sessions, to explore the perspective of the directly and indirectly involved healthcare staff, as well as to analyze the perceptions and experiences of the patients. The qualitative evaluation phase consists of analyzing audio-recorded counselling sessions, as well as individual and group interviews with the involved persons. The quantitative evaluation phase applies questionnaires which are distributed before (T0), at the beginning (T1), in the middle (T2) and at the end (T3) of the intervention delivery. DISCUSSION: This protocol provides an example of how a process evaluation can be conducted parallel to a main study investigating and implementing a complex intervention. The results of this mixed methods research will make it possible to identify strengths and weaknesses of the team-based intervention, and to target more specifically the key factors and structures required to implement healthcare structures to meet patients' unmet needs in the context of CIH. To our knowledge, this study is the first applying the CFIR framework in the context of interprofessional CIH counselling, and its results are expected to provide comprehensive and multidisciplinary management of cancer patients with complex supportive healthcare needs.

Factors related to implementation of an interprofessional communication concept in thoracic oncology: a mixed-methods study.

BACKGROUND: An innovative patient-centred interprofessional communication concept with advanced lung cancer patients (Heidelberg Milestone Communication Approach, MCA) has been developed and implemented. Role changes and interprofessional communication are challenging in a busy outpatient oncology service. The aim of the study was to present attitudes to interprofessional collaboration of professions in thoracic oncology during the implementation of MCA and to explore factors and experiences healthcare team members associate with its implementation. METHODS: In a longitudinal study, 3 of the 4 subscales of the validated German translation of the University of the West of England Interprofessional Questionnaire (UWE-IP-D) were collected prior to implementation of MCA (t0) with follow-up data collections at 4 months (t1), 10 months (t2) and 17 months (t3). Descriptive analysis included calculating subscale sum scores and categorizing each subscale into positive, neutral and negative attitudes. Interviews and focus groups on implementation and interprofessional collaboration in the context of MCA were conducted with healthcare staff. The topics were analysed deductively, guided by the Professional Interactions factor of the Tailored Implementation for Chronic Diseases (TICD) framework. RESULTS: The survey with 87 staff (44 nurses, 13 physicians, 12 psycho-social staff, 7 therapists, and 11 others) participating at least once found heterogeneous attitudes. 'Communication and Teamwork' and 'Interprofessional Relationships' were characterized by primarily positive attitudes. Neutral attitudes to 'Interprofessional Interaction' were indicated by the majority of respondents. There were no differences between collection times. Fifteen staff members participated in the interviews and focus groups. The main interprofessional interaction factors associated with implementation concerned the knowledge of the MCA and the impact of the intervention on team roles, on information sharing and on transfer processes between wards. Adaptive processes led to a shift in the perception of responsibilities and interprofessional collaboration. CONCLUSIONS: Positive experiences and potential shortfalls in the implementation were observed. Future introductions of interprofessional communication concepts require further activities which should address the attitudes of healthcare professionals towards interprofessional care. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22/12/2017.

[Heidelberg Milestones Communication (HeiMeKOM) - Experiences, Best Practice Examples and Recommendations from the Final Symposium on January 30 and 31 in 2020]. / Heidelberger Meilenstein Kommunikation (HeiMeKOM) ­ Erfahrungen, Best Practice Beispiele und Empfehlungen aus dem Abschluss-Symposium am 30./31. Januar 2020.

The National Cancer Plan emphasises the importance of medical communication and calls for its integration into medical education and training. In this context, the Milestone Communication Approach meets the communicative challenges in dealing with lung cancer patients. Interprofessional tandems, consisting of doctors and nurses, conduct structured conversations at defined moments with patients and their relatives. The concept aims at shared decision making, continuity in the care of lung cancer patients and the early integration of palliative care. During the symposium on the Heidelberg Milestone Communication in January 2020, recommendations on the care situation of lung cancer patients in advanced stages were developed. In addition, the further adaptability of HeiMeKOM to other settings and hospitals and to other diseases was discussed as well as the possibility of implementing such a concept in standard care. This article presents the experiences, best practice examples and recommendations discussed during the symposium in order to enable their extrapolation to other similarly oriented projects. The long-term goal is to transfer the milestone concept to other hospital, primarily certified lung cancer centers, and to ensure permanent funding. For further dissemination of the concept and, above all, to have it established in standard care, health policy awareness and support are required in addition to the integration of the concept in competence catalogues of continuing medical and nursing education.

Effects of an Interprofessional Communication Approach on Support Needs, Quality of Life, and Mood of Patients with Advanced Lung Cancer: A Randomized Trial.

BACKGROUND: To address the support needs of newly diagnosed patients with lung cancer with limited prognosis, the Milestone Communication Approach (MCA) was developed and implemented. The main elements of the MCA are situation-specific conversations along the disease trajectory conducted by an interprofessional tandem of physician and nurse. The aim of the study was to evaluate the effects of MCA on addressing support needs, quality of life, and mood as compared with standard oncological care. PATIENTS AND METHODS: A randomized trial was conducted with baseline assessment and follow-up assessments at 3, 6, and 9 months in outpatients with newly diagnosed lung cancer stage IV at a German thoracic oncology hospital. The primary outcome was the Health System and Information Needs subscale of the Short Form Supportive Care Needs Survey (SCNS-SF34-G) at 3-month follow-up. Secondary outcomes included the other subscales of the SCNS-SF34-G, the Schedule for the Evaluation of Individual Quality of Life, the Functional Assessment of Cancer Therapy lung module, the Patient Health Questionnaire for Depression and Anxiety, and the Distress Thermometer. RESULTS: At baseline, 174 patients were randomized, of whom 102 patients (MCA: n = 52; standard care: n = 50) provided data at 3-month follow-up. Patients of the MCA group reported lower information needs at 3-month follow-up (mean ± SD, 33.4 ± 27.5; standard care, 43.1 ± 29.9; p = .033). No effects were found for secondary outcomes. CONCLUSION: MCA lowered patient-reported information needs but did not have other effects. MCA contributed to tailored communication because an adequate level of information and orientation set the basis for patient-centered care. IMPLICATIONS FOR PRACTICE: By addressing relevant issues at predefined times, the Milestone Communication Approach provides individual patient-centered care facilitating the timely integration of palliative care for patients with a limited prognosis. The needs of patients with lung cancer must be assessed and addressed throughout the disease trajectory. Although specific topics may be relevant for all patients, such as information about the disease and associated health care, situations of individual patients and their families must be considered. Additionally, using the short form of the Supportive Care Needs Survey in clinical practice to identify patients' problems might support individually targeted communication and preference-sensitive care.

The role of personalised professional relations across care sectors in achieving high continuity of care.

BACKGROUND: High continuity of care has a positive impact on health outcomes, but insight into the mechanisms underlying this impact is limited. Information continuity, on which our study focuses, is especially important when relational continuity is not given, which is often the case at hospital admission or hospital discharge. The aim of this study is to provide insight into the information flows between general practices and hospitals in Germany, and to identify factors associated with these flows of information. METHODS: This is a qualitative interview study in a purposeful sample of staff from hospitals and general practices (general practitioners, care assistants in general practice, hospital management, hospital physicians, and nursing staff). Interviews were conducted via telephone or face-to-face using a self-developed semi-structured interview guide. Stepwise systematic content analysis was used to structure collected material into themes and sub-themes that related to the study aim. Data was analysed by two researchers in several cycles, alternating between inductive and deductive approaches. RESULTS: A total of 49 interviews were conducted. Duration of the interviews varies between 21 and 78 min (mean duration 43 min). Across all groups, more than two thirds of participants were female (n = 34, 69%). The analysis highlighted six interdependent main themes regarding factors that affect information flows between hospitals and general practices: organisational, legal, financial, patient factors, individual characteristics, and emotional & social factors. The latter theme emerged as particularly rich and was therefore divided into four subthemes: appreciation and understanding of the respective other, (intrinsic) motivation, socialisation, and relationships. Organised meetings and events were mentioned as strategies to address emotional and social factors. CONCLUSIONS: Digitalisation can facilitate information flows between care providers. However, knowing each other and good personal relations remain important for effective collaboration. Cooperation between all stakeholders is needed to aim to achieve continuity of care. TRIAL REGISTRATION: DRKS00015183 on DRKS/ Universal Trial Number (UTN): U1111-1218-0992. Date of registration 23/08/2018.

Lung cancer patients' comorbidities and attendance of German ambulatory physicians in a 5-year cross-sectional study.

The majority of lung cancer patients are diagnosed with an advanced stage IV, which has short survival time. Many lung cancer patients have comorbidities, which influence treatment and patients' quality of life. The aim of the study is to describe comorbidities in incident lung cancer patients and explore their attendance of ambulatory care physicians in Germany. In the observed period, 13,111 persons were first diagnosed with lung cancer (1-year incidence of 36.4 per 100,000). The mean number of comorbidities over 4 quarters was 30.77 ± 13.18; mean Charlson Comorbidity Index was 6.66 ± 2.24. In Germany, ambulatory care physicians most attended were general practitioners (2.6 quarters with contact within 4 quarters). Lung cancer was diagnosed by a general practitioner in 38% of the 13,111 incident patients. The average number of ambulatory care physician contacts over 4 quarters was 35.82 ± 27.31. High numbers of comorbidities and contacts in ambulatory care are common in patients with lung cancer. Therefore, a cross-sectoral and interdisciplinary approach is required for effective, patient-centred care. This was a 5-year cross-sectoral study, based on the InGef research database, which covers anonymized health insurance data of 7.2 million individuals in Germany. Incident lung cancer patients in a 5-year period (2013-2017) were identified. Descriptive statistics were calculated for sociodemographic characteristics, comorbidities, and attendance of ambulatory care physicians.

Consideration of sense of coherence in a structured communication approach with stage IV lung cancer patients and their informal caregivers: a qualitative interview study.

OBJECTIVE: Salutogenetic aspects are valuable for consideration in patient-centred care of advanced oncological diseases with a limited life expectancy. The Milestone Communication Approach (MCA), involving physician-nurse tandems, addresses specific challenges and needs over the disease trajectory of patients with stage IV lung cancer and their informal caregivers. This study aims to explore patients' and informal caregivers' salutogenetic experiences with the MCA concept. METHODS: This qualitative study used face-to-face semi-structured interviews with patients and informal caregivers. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data were structured using Qualitative Content Analysis. The material was coded deductively into themes related to the components of sense of coherence (Aaron Antonovsky) and emerging sub-themes. All data was managed and organised in MAXQDA. RESULTS: In 25 interviews, sense of coherence was referred to with all three components: "Comprehensibility" was supported by information conveyed suitably for the patients; "meaningfulness" was addressed as accepting the situation; and "manageability" led to advance care planning the patients were comfortable with. Patients and informal caregivers experienced the interprofessional tandem as an added value for patient care. CONCLUSIONS: Participants appreciate the MCA in its support for coping with a life-limiting disease. Considering salutogenetic aspects facilitates prognostic awareness and advance care planning. Nevertheless, individual needs of patients and informal caregivers require an individualised application of the MCA.

What patients with lung cancer with comorbidity tell us about interprofessional collaborative care across healthcare sectors: qualitative interview study.

BACKGROUND: Patients with lung cancer with comorbidity often require treatment and care by different health professionals, in different settings and at different points in time during the course of the disease. In order to organise and coordinate healthcare efficiently, effective information exchange and collaboration between all involved care providers are required. The aim of this study was to assess the views of patients with advanced lung cancer with comorbidity regarding coordination of treatment and care across healthcare sectors. METHODS: This qualitative study, as part of the main study, The Heidelberg Milestones Communication Approach, used face-to-face guide-based semistructured interviews with patients with advanced lung cancer and their informal caregivers to explore cross-sectoral information exchange and collaboration in Germany. All generated data were audio-recorded, pseudonymised and transcribed verbatim. Data analysis was performed using qualitative content analysis to structure data into themes and subthemes. All data were managed and organised in MAXQDA. RESULTS: In 15 interviews, participants reported that cross-sectoral collaboration functioned well, if treatments occurred as planned. However, treatment gaps were experienced, especially regarding medication and regimen. As a result, participants felt insecure and obliged to take responsibility for the coordination of healthcare. Patients reported to be in favour of an active patient role but felt that healthcare coordination should still be a responsibility of a care provider. A more intensive information exchange, potentially by using an electronic platform, was expected to strengthen cross-sectoral collaboration. CONCLUSION: Patients with lung cancer are uncertain about their role in the coordination of treatment and care across healthcare sectors. Healthcare providers should be more aware of care recipients' willingness of taking on a more active role in healthcare coordination. TRIAL REGISTRATION NUMBER: DRKS00013469.

Implementation of the milestones communication approach for patients with limited prognosis: evaluation of intervention fidelity.

BACKGROUND: Despite improvements in diagnostics and therapy, the majority of lung tumours are diagnosed at advanced stage IV with a poor prognosis. Due to the nature of an incurable disease, patients need to engage in shared decision making on advance care planning. To implement this in clinical practice, effective communication between patients, caregivers and healthcare professionals is essential. The Heidelberg Milestones Communication Approach (MCA) is delivered by a specifically trained interprofessional tandem and consists of four milestone conversations (MCs) at pivotal times in the disease trajectory. MC 1 (Diagnosis): i.e. prognosis; MC 2 (Stable disease): i.e. prognostic awareness; MC 3 (Progression): i.e. reassessment; MC 4 (Best supportive care): i.e. end of treatment. In between MCs, follow-up calls are carried out to sustain communication. This study aimed to assess to what extent the MCA was implemented as planned and consolidated in specialized oncology practice. METHODS: A prospective observational process evaluation study was conducted, which focused on the implementation fidelity of the MCA. All MCs during two assessment periods were included. We analysed all written records of the conversations, which are part of the routine documentation during MCs and follow-up calls. Adherence to key aspects of the manual was documented on structured checklists at the beginning of the implementation of the MCA and after 6 months. The analysis was descriptive. Differences between the two assessment periods are analysed with chi-square tests. RESULTS: A total of 133 MCs and 54 follow-up-calls (t1) and of 172 MCs and 92 follow-up calls (t2) were analysed. MC 2 were the most frequently completed conversations (n = 51 and n = 47). Advance care planning was discussed in 26 and 13% of MC 2 in the respective assessment periods; in 31 and 47% of MC 2, prognostic awareness was recorded. The most frequently documented topic in the follow-up calls was the physical condition in patients (82 and 83%). CONCLUSION: The implementation of a trajectory-specific communication concept was largely successful. Additional studies are needed to understand how fidelity could be further improved. TRIAL REGISTRATION: DRKS00013469 / Date of registration: 22.12.2017.

[HeiMeKOM (Heidelberg Milestones Communication): development of an interprofessional intervention for improvement of communication in patients with limited prognosis]. / HeiMeKOM (Heidelberger Meilenstein Kommunikation): Entwicklung einer interprofessionellen Intervention zur Verbesserung der Kommunikation bei Patient*innen mit eingeschränkter Prognose.

BACKGROUND: The care for patients with advanced disease and limited prognosis and their relatives is complex and characterized by insufficient communication and lack of coordination and continuity. AIM: Development of an interprofessional, practice-guided concept of longitudinally structured communication with the goal of fostering communication, improving quality of life and facilitating early integration of palliative care. METHODS: Multi-level process starting from a draft with discussion and approval within the multiprofessional team and correlation with interviews with patients and relatives. Preparation of a comprehensive concept with review of the literature, problem analysis, theoretical foundation, goal setting and intervention components. Discussion of suitability for daily use, adaptation and further development of the concept. RESULTS AND CONCLUSIONS: Concept with the following components: interprofessional communication training, structured conversations at defined moments in a tandem of physician and nurse with patient and relative, follow-up conversations conducted by the nurse, and respective instruments (conversation protocol, question prompt list, memory cards). Only iterative discussion with and the approval of patients, relatives and the multiprofessional team and their approval will put the concept into practice.

The Heidelberg Milestones Communication Approach (MCA) for patients with prognosis <12 months: protocol for a mixed-methods study including a randomized controlled trial.

BACKGROUND: The care needs of patients with a limited prognosis (<12 months median) are complex and dynamic. Patients and caregivers must cope with many challenges, including physical symptoms and disabilities, uncertainty. and compromised self-efficacy. Healthcare is often characterized by disruptions in the transition between healthcare providers. The Milestones Communication Approach (MCA) is a structured, proactive, interprofessional concept that involves physicians and nurses and is aimed at providing coherent care across the disease trajectory. This study aims to evaluate these aspects of MCA: (1) the training of healthcare professionals, (2) implementation context and outcomes, (3) patient outcomes, and (4) effects on interprofessional collaboration. METHODS/DESIGN: A multiphase mixed-methods design will be used for the study. A total of 100 patients and 120 healthcare professionals in a specialized oncology hospital will be involved. The training outcomes will be documented using a questionnaire. Implementation context and outcomes will be explored through semi-structured interviews and written questionnaires with healthcare professionals and with the training participants and through a content analysis of patient files. Patient outcomes will be assessed in a pragmatic non-blinded randomized controlled trial and in qualitative interviews with patients and caregivers. Trial outcomes are supportive care needs (SCNS-SF34-G), quality of life (SeiQol and Fact-L), depression and anxiety symptoms (PHQ-4), and distress (Distress Thermometer). Qualitative semi-structured interviews on patients' views will focus on shared decision-making, communication needs, feeling empathy, and further utilization of healthcare services. Interprofessional collaboration will be explored using the UWE-IP-D before the implementation of MCA (t0) and after 3 (t1), 9 (t2), and 12 (t3) months. DISCUSSION: Using guideline-concordant early palliative care, MCA aims to foster patient-centered communication with shared decision-making and facilitation of advance care planning including end-of-life decisions, thus increasing patient quality of life and decreasing aggressive medical care at the end of life. It is assumed that the communication skills training and interprofessional coaching will improve the communication behavior of healthcare providers and influence team communications and team processes. TRIAL REGISTRATION: German Clinical Trials Register, DRKS00013649 and DRKS00013469. Registered on 22 December 2017.