In the following, we differentiate among complementary and integrative medicine (CIM), integrative nursing (IN), and integrative oncology (IO). CIM broadly refers to approaches that combine conventional medicine with complementary therapies [1,2]. IN denotes a nursing-specific framework emphasizing complementary, nonpharmacological, nurse-delivered interventions embedded within conventional care [3]. IO describes the broader integration of such approaches into oncology practice, encompassing medical, nursing, and psychosocial perspectives [4].

Patients with cancer show a significant demand for CIM, which involves both traditional and complementary approaches [5,6]. The global prevalence of CIM use among patients with cancer ranges widely from 16.5% to 93.4%, with an average prevalence of 41.1% reported for Germany [5]. This trend is further supported by findings from a survey conducted at German university hospitals, in which nearly half of the patients surveyed (48%) reported previous or current use of CIM in relation to their disease [7].

IN refers to a care approach that combines conventional nursing practices with evidence-informed complementary methods, aiming to holistically address the physical, emotional, social, and spiritual needs of patients [8-10]. IN interventions include a range of naturopathic, nonpharmacological nursing interventions, such as compresses, embrocations, and therapeutic baths and washes [10-12]. In an oncology setting, these IN interventions aim to prevent and manage symptoms and side effects associated with conventional treatment [10,13]. In recent years, a growing body of research, including reviews and evidence syntheses, has emerged on IN interventions both in general [14-16] and in relation to specific symptoms such as mucositis [17], pain [18], and chemotherapy-induced peripheral neuropathy [19]. In addition, individual studies have investigated specific symptom burdens, such as fatigue [20,21] or sleep quality [22,23], as well as postoperative support during the hospital stay [24,25]. A mixed methods systematic review taking a broader perspective on external applications suggests potential benefits for managing cancer-related symptoms but also identifies limitations, including low study quality and methodological inconsistencies among the included studies [15]. A similar pattern is reflected in an overview of systematic reviews, which indicates a generally positive influence of CIM on patient-reported outcomes in patients with cancer, for example, acupuncture has been associated with pain relief, while also acknowledging methodological limitations and, in part, inconclusive findings [26].

IN therefore plays a relevant role in the field of CIM in oncology [10,27,28], with IN interventions being implemented as part of IO programs [27,29]. Ben-Arye et al [30] highlighted the positive impact of nurse involvement in guiding patients to self-administer IO treatments. However, in this context, the influence of IN interventions at the patient level (eg, patient-reported outcomes) and the institutional level (eg, structural factors) have been examined only as part of multimodal programs [31-33].

In addition, research projects in Germany have focused on implementing IN interventions in health care, particularly in outpatient settings [34-36] and in pediatric inpatient care [37-40]. Recent studies in these contexts have demonstrated the considerable potential of IN interventions to support patients with cancer in managing cancer-related symptoms [41], improving patient activation [42], and enhancing their quality of life [35]. However, these findings are only partially generalizable to adult inpatient populations. Consequently, research on the feasibility, implementation, and evaluation of IN for patients with cancer in inpatient settings remains limited in Germany. Despite the considerable growth of research on CIM and IO in recent years, the specific role of IN is still underrepresented in the literature. Evidence on the systematic implementation and sustainability of IN interventions in inpatient oncology settings remains scarce.

In this context, the IMPLEMENT-UKU (Implementation of Integrative Nursing at the Ulm University Hospital) project offers an IN consultation service for patients on participating wards. The project provides a supportive, complementary care approach that uses external naturopathic nursing interventions to supplement conventional treatments in a patient-centered manner.

This evaluation study is embedded within the IMPLEMENT-UKU project and will examine the implementation of IN through a comprehensive, accompanying scientific investigation that integrates the perspectives of patients, their relatives, and hospital staff. It aims to address the following research questions: (1) To what extent can IN be implemented as intended on the participating wards, including the delivery of IN (eg, number of IN consultations, IN interventions) and its acceptance and perception among patients, relatives, and health care professionals (eg, evaluation of IN, perceptions of IN interventions)? (2) What are the key contextual factors influencing the implementation of IN, including identification of relevant contextual factors and assessment of the implementation process, such as barriers and facilitators? (3) What are the indicators of potential effects of IN at the patient level, with a focus on patient-reported outcomes (eg, well-being, quality of life, self-efficacy, and symptom burden)?

This study aligns with the research priorities outlined in the “German Research Agenda for Nursing Oncology,” particularly regarding the management of disease-related symptoms and treatment side effects, as well as the promotion of quality of life across different phases of health and disease [43].

The IMPLEMENT-UKU project and its accompanying evaluation study are being carried out as a single-center initiative at the University Hospital Ulm. Within the framework of the project, patients with cancer on participating wards receive IN interventions as supportive care during their hospital stay as part of a consultation service. Figure 1 illustrates a flowchart of the patient care pathway within the project.

Patients will be referred to an initial IN consultation by nursing or medical staff on the participating wards. Referrals will be based on pertinent and acutely distressing symptoms and problems, such as restlessness, pain, or cancer-related side effects, which are relevant to care and indicate the need for supportive interventions. Following referral, patients will receive an initial IN consultation, which may be followed by additional IN visits and interventions throughout their hospital stay. During the initial IN consultation, the integrative nurse will provide information about IN, the overarching IMPLEMENT-UKU project, and the ongoing evaluation study. The first IN intervention will be conducted directly after this consultation. The number of subsequent IN visits and interventions may vary depending on patient needs and the duration of hospitalization.

Depending on each patient’s symptom burden and individual preferences, patient-tailored IN interventions will be offered alongside routine care. To ensure consistent application, these interventions will be guided by a symptom-driven IN intervention catalog (Table 1). The IN catalog was developed through an expert consensus process, drawing on external naturopathic nursing textbooks [11,12,44-47], academic literature [14,15,18,19,48], and recommendations from previous projects and guidelines [36,49-51]. To ensure intervention fidelity, standard operating procedures are available for all IN interventions.

IN interventions are carried out by nurses who are specially trained in IN. These nurses have completed 3 years of vocational nursing education and have extensive professional experience. In addition, they have received training in CIM and hold qualifications in external naturopathic interventions, such as advanced training in compresses and wraps (40 teaching hours), rhythmic embrocation according to Wegman and Hauschka (80 teaching hours), and mindful body care and therapeutic washing (16 teaching hours), provided by the Association for Anthroposophical Nursing in Germany.

Although IN interventions are tailored to individual patient needs, fidelity is ensured through detailed standard operating procedures, structured nursing training, and standardized project-related documentation by nursing staff (substudy 5). This approach enables monitoring of adherence to the intervention catalog and allows systematic examination of variability, including its relationship to patient characteristics and contextual influences.

A mixed methods research design is used, applying a convergent parallel mixed methods design [52,53]. The decision to use a mixed methods approach was made to enable triangulation of quantitative and qualitative data and to integrate diverse perspectives on the implementation of IN, thereby providing a more comprehensive understanding of the phenomenon. In the field of nursing, mixed methods are also essential for addressing implementation research questions, in addition to single-method approaches [54]. In this convergent parallel design, both types of data are collected simultaneously and with equal priority. They are then evaluated independently and subsequently compared, related, and merged after analysis. This process enables the identification of areas where results converge or diverge, which can be then be explored further during the interpretation phase. The protocol follows the principles outlined in the Good Reporting of a Mixed Methods Study guidelines [55].

This study applies the Consolidated Framework for Implementation Research (CFIR) as its theoretical framework [56,57]. CFIR is a comprehensive framework for studying the implementation of complex interventions in health care settings [58]. The updated version of CFIR includes 5 core domains for analyzing the implementation process [57]: innovation, outer setting, inner setting, individuals, and implementation process. These domains are interrelated and collectively influence the success and sustainability of implementation efforts [56]. However, relying solely on CFIR domains may overlook important contextual influences. Maintaining an open and flexible approach during the implementation process is therefore essential to capture additional relevant factors [58].

To address the primary objectives of the study and reflect the multilevel evaluation approach, 5 interrelated substudies will be conducted, incorporating 3 perspectives: those of patients, relatives, and health care professionals. An overview of these substudies is presented in Table 2, with further details provided in the following sections.

The aim is to explore patients’ perceptions and experiences with IN interventions, including short-term changes in vitality, sense of warmth and strength, and feelings of calm. The study also seeks to identify the potential impact of IN during the inpatient stay on patient-reported outcomes, such as well-being and associated symptom burden.

This substudy aims to explore how patients perceive and experience IN interventions, as well as their level of satisfaction with the implementation of IN. The primary focus is an in-depth examination of individual perceptions to gain a more nuanced understanding of how IN interventions are received and experienced from the patient’s perspective.

Relatives are considered key stakeholders in exploring the feasibility and relevance of transferring low-threshold IN interventions into the home care setting after hospital discharge. The aim of this substudy is to examine relatives’ perspectives on the use of, attitudes toward, and interest in CIM, as well as their perceptions of IN for inpatients.

The involvement of health care professionals, including nursing and medical staff on the participating wards, is essential for capturing implementation processes and complementing the perspectives of patients who have received IN interventions. The objective of this substudy is to explore the facilitators and barriers to the implementation of IN from the perspective of health care professionals, as well as their perceptions of its effects and its impact on routine clinical practice.

In addition to primary data sources, routinely collected data from the IMPLEMENT-UKU project will be used to complement the analysis and assess the feasibility and real-world implementation of IN. This substudy focuses on key implementation indicators, including acceptance, study participation rate, intervention fidelity, and the number of IN visits and interventions performed. Furthermore, the analysis will support the identification of required resources and potential cost factors associated with implementation in routine care.

After the separate analysis of each sub-study, the results will be integrated to generate meta-inferences. The ensuing discussion will examine areas of convergence, divergence, complementarity, and the relationships between the quantitative and qualitative findings, as well as different perspectives on the implementation of IN. The interpretation will be grounded in comparisons and correlations [52,64].

Triangulation approaches will be used to compare and integrate data, enabling both cross-validation and enrichment of the findings [65]. Methodological triangulation will enhance the credibility of results by identifying consistencies and discrepancies across different types of data, such as comparing quantitative and qualitative findings on patients’ perspectives regarding the implementation of IN. Data source triangulation will be applied by incorporating insights from patients, relatives, and health care professionals, enabling a more comprehensive understanding of the implementation of IN for inpatients.

Integrative data analysis will use joint displays to present and synthesize findings, enabling further conclusions [66,67]. A joint display is a matrix that visually aligns and compares results from different data types to support systematic integration. In this study, which follows a convergent design, a side-by-side comparison will be used [67]. Joint displays will be thematically structured, such as according to the domains of to CFIR [57]. These displays will support the development of new insights and conclusions that extend beyond the individual substudies, serving as a foundation for interpretation, discussion, and stakeholder dialogue.

During the integration process, discrepancies between qualitative and quantitative findings will be systematically examined. Rather than being regarded as limitations, these divergences will be considered opportunities for deeper interpretation. They will be mapped in joint displays and explored through iterative team discussions to generate plausible explanations, including contextual factors or subgroup effects. This process will be transparently documented to ensure rigor.

The evaluation study was conducted in accordance with the Declaration of Helsinki and received ethical approval from the Ethics Committee of the University of Ulm, Germany (144/23). All participants will receive detailed verbal and written information about the project and study objectives as part of the informed consent process. Informed consent will be obtained before participation, ensuring that participation is entirely voluntary. Participants may withdraw from the study at any time without providing a reason and without facing any consequences.

This study outlines the protocol for mixed methods research aimed at making a theory-based contribution to the implementation of IN for inpatients and examining its potential effects at the patient level. The following anticipated findings are derived from the study’s research questions: IN visits and interventions are expected to be implemented as intended, with a moderate to high number of IN consultation requests and repeated IN visits and interventions per patient during the hospital stay. Acceptance rates among patients and staff are likely to be high, with health care professionals perceiving IN as a meaningful complement to conventional care. Contextual, structural, and organizational factors are anticipated to act as key barriers and facilitators in the implementation process. Initial results are expected to show improvements in well-being, reductions in symptom burden, and increased self-efficacy. IN interventions are anticipated to be perceived as supportive and not associated with additional burden. Patients may also report short-term subjective benefits such as enhanced vitality, a sense of warmth and strength, and feelings of calm following IN interventions.

The findings can subsequently be compared and contextualized with studies that have implemented CIM or IN in other settings, such as pediatric care [37,38,40,41,68-70] and outpatient oncology care [35,42,71,72], as well as with studies and programs offering IO for patients [33,73-75]. Situating the findings within the framework of implementation science is essential for advancing both the conceptual development and practical integration of IN into routine care [76]. This research is expected to make a substantial contribution to the implementation of IN as a service for inpatients. Furthermore, the findings will support the German Research Agenda for Nursing Oncology and help establish a scientific foundation for IN in oncology care [43].

The findings of this study will first be shared with the interdisciplinary IMPLEMENT-UKU Steering Committee. The results are expected to be suitable for publication in peer-reviewed journals and for presentation at national and international conferences. As part of the dissemination strategy, the results of the individual substudies will be published separately, followed by an integrative mixed methods publication synthesizing the overall findings. In addition, the results will be shared with the general public through patient forums, information events, and the project website. The findings will also inform the ongoing development and improvement of the IMPLEMENT-UKU project’s implementation strategy. The findings may contribute to the development of practical guidelines to support the standardization and facilitation of IN implementation in other hospital settings. Moreover, the study outcomes are expected to inform future research strategies in the fields of IN and implementation science.

The monocentric design of this study may limit the generalizability of findings to other settings and reduce external validity, as the results reflect the specific implementation context at Ulm University Hospital. Furthermore, due to the patient-centered and multimodal nature of the IMPLEMENT-UKU project, the delivery of IN interventions is not fully standardized and may vary between patients. To ensure consistency, all IN interventions are guided by a symptom-driven IN catalog, which supports targeted and structured application. In addition, a standard operating procedure is in place, and all applied IN interventions are documented in detail through project-specific documentation, enabling analysis of IN intervention variability and its impact.

As participation in this study is voluntary, there is potential for recruitment bias and corresponding selection bias. Although a convenience sampling approach will be used, several strategies will mitigate these limitations. Recruitment and sampling procedures will be transparently documented, and reflexivity will be maintained throughout the recruitment and data analysis phases. Reasons for exclusion and refusal to participate will be systematically recorded. For the qualitative interviews, efforts will be made to ensure heterogeneity in key participant characteristics.

As the studies rely primarily on self-report measures, risk of response bias, recall bias, and social desirability bias must be considered. In substudy 3, the cross-sectional design and convenience sampling of relatives from a single hospital limit external validity and generalizability. Substudy 1 uses a pre-post design without a control group. While this design enables the observation of intra-individual changes over time, it does not permit causal inference, as observed effects cannot be attributed solely to the intervention, thereby limiting internal validity. Accordingly, only exploratory analyses are planned to generate preliminary insights into potential effects and inform future research directions. Nevertheless, triangulation across multiple data sources within the patient group will enhance the credibility and trustworthiness of the findings, despite the nonprobabilistic sampling.